Disease & Vaccine Information

Pertussis (Whooping Cough) Overview



Pertussis

Pertussis: The Disease

Pertussis, commonly referred to as whooping cough, is a highly contagious respiratory disease caused by the Bordetella (B.) pertussis bacterium. B. pertussis bacteria attach themselves to the mucus membranes of the respiratory tract and cause inflammation in the body.  The major symptom of B. pertussis whooping cough disease is uncontrollable coughing. 

Symptoms of B. pertussis at its onset are similar to the common cold, or an allergy attack with stuffy or runny nose, dry cough, loss of appetite, fatigue and, sometimes, a low fever. After one to two weeks, the disease usually progresses to bursts of spasmodic coughing (paroxysms) with large amounts of mucous, gagging and vomiting with or without a whoop that becomes worse at night.  During the day, the child or adult may look and feel fine with the exception of frequent coughing spasms. A final recovery stage with only occasional coughing fits may last for weeks or even months.   Learn more about Pertussis

Pertussis Vaccine

In the U.S. today, pertussis vaccine is administered only in a combination shot (DTaP, Tdap) that contains vaccines for diphtheria (D), tetanus (T), and pertussis (whooping cough) (P). The CDC’s Advisory Committee on Immunization Practices (ACIP) currently recommends administration of a pertussis containing vaccine (DTaP) at two, four, and six months old; between 15 and 18 months old; and between four and six years old. Another booster dose is recommended at 12-13 years of age (Tdap).  While the ACIP also recommends that pregnant women receive a dose of Tdap vaccine during each pregnancy, between 27 and 36 weeks gestation, regardless of a previous history of Tdap vaccine,  this recommendation contradicts the information provided by the vaccine manufacturers. The product insert of both Boostrix and Adacel, the two available Tdap vaccines in the U.S., state that the safety and effectiveness of vaccination has “not been established in pregnant women”.  

The whole cell pertussis vaccine was created in 1912 and licensed in 1914. In the 1940’s, the pertussis vaccine was combined with diphtheria and tetanus to become the DPT vaccine and licensed for routine use.  This vaccine was replaced with a purified, less reactive acellular DTaP vaccine in 1996.  (DPT was available in some doctor’s offices in the U.S. until about 1999). DPT is still given to infants and children in many developing countries because it costs only pennies to manufacture a dose.    Learn more about Pertussis vaccine

Pertussis Quick Facts

Pertussis

  • Pertussis, commonly referred to as whooping cough, is a respiratory disease caused by the Bordetella (B.) pertussis bacterium. B. pertussis bacteria attach themselves to the mucus membranes of the respiratory tract and cause inflammation in the body.  Only a lab test will positively confirm the exact organism causing the whooping cough symptoms. 
  • Pertussis whooping cough is highly contagious. Whooping cough disease circulates all year long, however, in North America, more cases are diagnosed in the summer and fall. 
  • In 1922, there were 107,473 pertussis cases reported in the U.S. with 5,099 deaths.  In the United States, deaths from pertussis infections dropped by more than 75% between 1922 and 1948, the year beforethe DPT vaccine was licensed. Mortality associated with pertussis declined dramatically in the 1940’s as living conditions improved.  

Pertussis Vaccine

  • There are currently 9 different pertussis vaccines licensed in United States.  DTaP/Tdap vaccines packaged in single dose vials contain reduced bioactive pertussis toxin, less endotoxin than the DTP vaccine, and may contain trace amounts of mercury, along with an aluminum adjuvant. Depending upon the vaccine manufacturer, vaccines containing pertussis may contain varying amounts of inactivated pertussis toxin, filamentous hemagglutinin (FDA), pertactin, fimbriae, formaldehyde, polysorbate 80 (Tween 80), gluteraldehyde, 2-phenoxoyethanol, aluminum and thimerosal (mercury). 
  • IMPORTANT: Parents should monitor their children carefully day and night for at least 72 hours after vaccination.  Pertussis vaccine has been documented to cause high fever; severe local reactions at the site of the injection; high pitched screaming and uncontrollable crying; collapse/shock (hypotonic/hyporesponsive episode); lethargy (excessive sleepiness); convulsions with or without fever; and brain inflammation (encephalopathy). 
  • As of November 1, 2022, there had been 5,987 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following pertussis-containing vaccination, including 864 deaths and 5,123 serious injuries.
Continue reading quick facts

Learn More About Pertussis (Whooping Cough) and Pertussis Vaccine

NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents below, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

What is Pertussis (Whooping Cough)?

Pertussis, commonly referred to as whooping cough, is a highly contagious respiratory disease caused by the Bordetella (B.) pertussis bacterium. B. pertussis bacteria attach themselves to the mucus membranes of the respiratory tract and cause inflammation in the body.  The major symptom of B. pertussis whooping cough disease is uncontrollable coughing. 

In advanced stages, thick mucous develops in the lungs and clogs air passages, triggering violent episodes of coughing, choking and vomiting up of mucus followed by a high-pitched intake of breath that sounds like "whoop." With whooping cough disease, it is possible to have such violent coughing spells, especially at night, that large amounts of mucous are vomited up through the mouth and nose and interfere with breathing. 

The B. pertussis bacteria release several toxins, including pertussis toxin (PT) and endotoxin. In severe cases of whooping cough disease, complications include high fever, brain inflammation, convulsions, pneumonia, pneumothorax, hernias, subdural hematomas and death. 

Symptoms of B. pertussis at its onset are similar to the common cold, or an allergy attack with stuffy or runny nose, dry cough, loss of appetite, fatigue and, sometimes, a low fever. After one to two weeks, the disease usually progresses to bursts of spasmodic coughing (paroxysms) with large amounts of mucous, gagging and vomiting with or without a whoop that becomes worse at night.  During the day, the child or adult may look and feel fine with the exception of frequent coughing spasms. A final recovery stage with only occasional coughing fits may last for weeks or even months.  Click here to hear what whooping cough can sound like.

Sometimes infants or older children and adults don’t cough with a whoop. Small babies and very young children, who are gasping for air, may have a red face, bulging eyes, blue lips and may stop breathing for a few seconds or longer because the thick mucus clogs their small airways.  Sometimes babies must have the mucous suctioned from their throats so they can breathe. 

Adults and adolescents with whooping cough may have milder symptoms, such as a persistent, mucous-producing cough that goes on for 4-8 weeks. Often older children and adults do not make the whooping cough when they cough. 

Symptoms of pertussis are sometimes milder in those who have had one or more doses of pertussis containing vaccines (DPT, DTaP, Tdap)  and doctors or nurses may not suspect B. pertussis whooping cough in vaccinated children, adolescents and adults, who present with a bad cough.  Many cases of pertussis go undetected because they are mistakenly diagnosed by medical personnel as an allergy attack, bronchitis, influenza or other upper respiratory infection.

The only sure way to find out if you or your child have B. pertussis or Bordetella parapertussis (or another respiratory disease caused by other viruses or bacteria), is to have a lab test that will positively confirm the exact organism causing the whooping cough symptoms.  Bordetella parapertussis, another pertussis disease, can look identical to B, pertussis whooping cough, however symptoms are generally milder.  B. parapertussis is increasing in the U.S. and other countries, which have had high pertussis vaccination rates for few decades. There are estimates that perhaps 30 percent or more of whooping cough disease in highly vaccinated populations is caused by B. parapertussis organisms.  It is possible to have both B. pertussis and B. parapertussis infections at the same time. Parapertussis is often milder than B. pertussis but can also involve serious complications, which lead to pneumonia and death.   Pertussis vaccines widely used around the world do not protect against B. parapertussis. There is no vaccine for B. parapertussis. 

It is important to be equally concerned and knowledgeable about the risks of pertussis disease as we are about the risks of pertussis vaccine. Both B. pertussis whooping cough and the pertussis vaccine carry risks. Pertussis disease has the potential to cause seizures, brain damage, and even death, just as the vaccine can.  Most of America’s medical community believes that the risk of serious injury or death from pertussis is greater than the risk of injury or death, which can be caused by pertussis vaccine. However, recognition of and concern about the risks of pertussis disease does not diminish our need and responsibility to acknowledge the need to minimize pertussis vaccine risks.

The challenge today is for parents, physicians, scientists, manufacturers and health officials to recognize the risks of both the disease and the vaccine and work to protect the health and well being of every child.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Is Pertussis Contagious?

pertussis

Pertussis whooping cough is highly contagious. Whooping cough disease is transmitted from person to person through coughing, sneezing and by coming into direct contact with nasal secretions and mucus from the respiratory tract of a person who is actively contagious.  Whooping cough disease circulates in all months but, in North America, more cases are diagnosed in the summer and fall. 

The incubation period for B. pertussis after contact with an infected person and before symptoms begin is between 4 and 21 days, but typically in the range of 7 to 10 days. People are most contagious in the early stages when symptoms may be mild and include only a stuffy or runny nose and nagging, dry cough. They can remain contagious for several weeks after the spasmodic coughing fits, with or without whooping, begins.  Antibiotics are usually prescribed to help prevent transmission to others and lower the risk of complications, such as pneumonia. 

Children and adults, who have gotten one or more doses of pertussis-containing vaccines (DPT, DtaP, Tdap), as well as those who have never been vaccinated at all, can experience a mild or serious case of B. pertussis whooping cough. However, according to the CDC, those who have already had B. pertussis whooping cough once or have had one or more pertussis vaccinations often have a milder case, even though they can still transmit the disease to others.  

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Resources

1 CDC Pertussis Causes and Transmission. Aug. 7, 2017

2 Ibid

3 CDC. Pertussis– Clinical Features  Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

4 CDC. Pertussis - Medical Management Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book). 13th ed. 2015.

5 Ibid

 

What is the History of Pertussis in America and Other Countries?

disease history

What Is the Incidence of Pertussis in the US?

In 1922, there were 107,473 pertussis cases reported in the U.S. with 5,099 deaths.  In the United States, deaths from pertussis infections dropped by more than 75% between 1922 and 1948, the year before the DPT vaccine was licensed. In 1948, the mortality rate was less than 1 pertussis death per 100,000 persons and would never be higher than that again.   Mortality associated with pertussis declined dramatically in the 1940’s as living conditions improved, including sanitation and hygiene and access to health care.  During the past quarter century, reports of whooping cough cases have increased among babies less than six months old and among teenagers and adults but mortality has remained low.  In 2013, there were about 29,000 reported pertussis cases and 13 pertussis-related deaths in America, with nine of those deaths in infants under age one.  

According to the CDC, in 2017, out of a U.S. population of 326 million people, there were 15,808 reported cases of pertussis including 13 deaths, with 4 deaths occurring in infants under age one year.  Out of 3,663 cases occurring in children from six months of age through six years of age, 44 percent of cases occurred in children who had completed the primary DTaP series. 

However, many cases of whooping cough are never diagnosed or reported. Every three to five years, there are reported increases in whooping cough disease in the U.S. and other countries, no matter how high the vaccination rate. 

What Is the Incidence of Pertussis in Other Countries?

In underdeveloped countries with poor sanitation, nutrition and limited access to health care, whooping cough disease still causes significant complications and death, especially in infants and small children.  The World Health Organization estimates that globally 85 percent of children have gotten three pertussis shots. However each year, approximately 160,000 children under age five die from pertussis complications such as pneumonia, with over 60 percent of these children live in Africa.   Mortality rates from infectious diseases are always higher where people live in poverty, with crowding and poor sanitation, industrial pollution, substandard nutrition, and lack of access to health care facilities.  In 2015, the World Health Organization reported 142,512 cases of pertussis globally. 

In the U.S., Canada, Australia, Europe and other developed countries, whooping cough disease is much more manageable due to:

  • raised standards of living and availability of antibiotics to control secondary infections like pneumonia;
  • the use of suction to clear mucous from the throats and airways of babies and resuscitate those, who choke on mucus and stop breathing;
  • rehydration techniques to control the loss of body fluids from high fever, vomiting, or diarrhea.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

Resources

1 CDC Achievements in Public Health, 1900-1999 Impact of Vaccines Universally Recommended for Children -- United States, 1990-1998. MMWR. Apr. 02, 1999 48(12);243-248

2 National Center for Health Statistics. U.S. Vital Statistics Mortality Data 1940-1949. Table 2 – Death Rates for Selected Causes, Whooping Cough (All Races, Both Sexes) 1948 . Pg. 38.

3 Grove RD, Hetzel AM. Vital Statistics Rates in the United States 1940-1960. General Mortality (1921-1929), Section C, Table 65: Whooping Cough . Pg. 577. U.S. Public Health Service National Center for Health Statistics 1968.

4 Chow MYK, Khandaker G, McIntyre P. Global Childhood Deaths From Pertussis: A Historical Review. Clin Infect Dis. 2016 Dec 1; 63(Suppl 4): S134–S141.

5 Brooks DA, Clover R. Pertussis Infection in the United States: Role for Vaccination of Adolescents and Adults. J Am Board Fam Med November-December 2006 vol. 19 no. 6

6 CDC. 2013 Final Pertussis Surveillance Report. Aug. 15, 2014.

7 CDC 2017 Provisional Pertussis Surveillance Report. Jan 5, 2018 66(52)

8 CDC 2017 Provisional Pertussis Surveillance Report. Jan 5, 2018 66(52)

9 CDC Pertussis Frequently Asked Questions Aug 7, 2017

10 WHO Pertussis June 21, 2011

11 World Health Organization/UNICEF. A record 123 million children were immunized globally in 2017 but millions of children are still not reached by potential life saving vaccines. 2017.

12 Yeung KHT, Ducios P et al. An update of the global burden of pertussis in children younger than 5 years: a modeling study. Lancet Infect Dis 2017; 9: 974-980.

13 Korte R, Rehle T, Merkle A. Strategies to maintain health in the Third World. Trop Med Parasitol 1991; 42(4): 428-432.

14 CDC Pertussis in Other Countries. Aug. 7, 2017

 

Can Pertussis Cause Injury and/or Death?

disease injury death

Yes, according to the CDC, during 2017, out of the 15,808 reported cases of pertussis there were 13 deaths, with 4 deaths occurring in children less than one year of age.    

However, there is a gap in medical knowledge in terms of predicting who will have a mild case of B. pertussis whooping cough and who will have a serious or even fatal case of this disease.

Pertussis can be quite serious, especially for young infants, whose tiny air passages can become clogged with thick mucous. Babies and very young children are at highest risk for apnea, pneumonia, seizures, encephalopathy, and death.  The most serious complication of both whooping cough disease (and pertussis vaccine) is brain inflammation leading to varying degrees of permanent brain dysfunction. 

Pertussis toxin (PT) is one of the most lethal toxins in nature. The toxin induces lymphocytosis, leukocytosis, stimulates insulin secretion and sensitizes histamine, which is involved in the immune system’s inflammatory response. 

Pertussis toxin is thought to be the main component of B pertussis bacteria responsible for stimulating the production of protective antibodies during natural whooping cough infection and after pertussis vaccination.

Pertussis toxin is also thought to be the main toxin responsible for causing brain inflammation during B. pertussis whooping cough or after injection of pertussis-containing vaccines. (B. parapertussis bacteria do not secrete pertussis toxin and that is one reason why parapertussis is usually associated with milder symptoms). Because pertussis toxin can cross the blood brain barrier when conditions are right, brain inflammation (encephalitis) with convulsions that causes permanent brain damage has always been the most dreaded complication of both whooping cough and pertussis vaccination. 

Another toxin produced by B. pertussis bacteria during natural infection is endotoxin, which is also present in pertussis vaccines in varying amounts.   When the immune system detects the presence of endotoxins, it produces a defensive inflammatory immune response, including the release of large amounts of histamine that can lead to high fever, swelling, diarrhea, collapse, shock and death. 

The fatality rate for B. pertussis whooping cough disease is highest in infants under six months of age.  Older children and adults can suffer rib fractures from violent coughing fits.  Permanent health problems resulting from whooping cough disease (and the pertussis vaccine can include continuing seizure disorders,  mental retardation, learning disabilities, ADD/ADHD and other chronic illness. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Who is at Highest Risk for Getting Pertussis?

Young infants with developing immune systems, as well as older children, adolescents, and adults may be at risk for developing pertussis.  Studies have indicated that infants do not appear to receive substantial benefits from maternal antibodies, which may put them at a higher risk of developing pertussis.  For many individuals, the pertussis vaccine (DPT, DTaP, TDaP) does not give long lasting protection against the disease and some individuals will never develop temporary immunity despite receiving all recommended boosters.    ,   Over time, the temporary immunity individuals may acquire through vaccination wanes, which often results in outbreaks of B pertussis in fully vaccinated children, teenagers and adults. ,  ,  ,  

Other populations who may be at risk for developing pertussis include healthcare personnel or persons with weakened immune systems. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Who is at Highest Risk for Suffering Complications from Pertussis?

Young infants are at highest risk for developing complications from pertussis. Complications of pertussis in infants include apnea, pneumonia, convulsions, encephalopathy (brain inflammation), and death. The CDC estimates that half of all babies under the age of one who develop pertussis will require hospitalization. Older children, teens, and adults may also be at risk for suffering complications from pertussis. Complications in older children and adults may include rib fractures from severe coughing, loss of bladder control, weight loss, abdominal hernias, otitis media, and fainting.   Pregnant women and persons with diabetes may also be at higher risk of developing pertussis complications. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Can Pertussis be Prevented and are There Treatment Options?

How Do You Treat Pertussis Whooping Cough?

There are no prescription drugs that cure pertussis, but many doctors routinely prescribe antibiotics to try to reduce a person’s ability to transmit the disease to others. Antibiotics are also given to help prevent secondary infections such as bronchitis, pneumonia, and otitis media (inner ear infection). In the past, these complications caused many of the deaths following whooping cough.

In past decades, the antibiotic of choice to treat B. pertussis whooping cough has been erythromycin, but newer antibiotics, such as clarithromycin and azithromycin, are often used today. An additional treatment option may also include the use of Trimethoprim-sulfamethoxasole (Bactrim). However, antibiotics do not eliminate the symptoms of B. pertussis whooping cough, such as the severity or length of paroxysmal coughing. 

Holistic health care approaches to help manage the symptoms of whooping cough disease include chiropractic, homeopathy, naturopathy, acupuncture, diet and vitamin therapy, including supplemental vitamin D and C.  

It is very important to keep those sick with whooping cough properly hydrated with plenty of fluids, as fever, vomiting up of mucous and, sometimes, diarrhea that occurs during a pertussis infection can cause severe dehydration. If untreated, severe dehydration can lead to shock/collapse, unconsciousness and even death. 

Once You Have Had Pertussis Can You Get It Again?

Some people gain immunity after experiencing B. pertussis whooping cough disease. However, it is possible to have more than one bout with whooping cough in life, although subsequent cases are generally milder or may even be experienced without many symptoms.  After recovering from a pertussis infection, natural immunity is thought to last between seven and 20 years 

All vaccines only give temporary protection/immunity from disease, which is why booster doses are often recommended. For many individuals, the pertussis vaccine (DPT, DTaP, TDaP) does not give long lasting protection against the disease and some individuals will never develop temporary immunity despite receiving all recommended boosters. ,  ,   Over time, the temporary immunity individuals may acquire through vaccination wanes, which often results in outbreaks of B pertussis in fully vaccinated children, teenagers and adults. ,  ,  ,   Further, it is possible for fully vaccinated individuals to be asymptomatic (infected, but having no symptoms) and spread B pertussis to others. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

What is Pertussis Vaccine?

pertussis

What Is the Pertussis (DPT, DTaP, Tdap) Vaccine?

In the U.S. today, pertussis vaccine is administered only in a combination shot (DTaP, Tdap) that contains vaccines for diphtheria (D), tetanus (T), and pertussis (whooping cough) (P). The CDC’s Advisory Committee on Immunization Practices (ACIP) currently recommends administration of a pertussis containing vaccine (DTaP) at two, four, and six months old; between 15 and 18 months old; and between four and six years old. Another booster dose is recommended at 12-13 years of age (Tdap).  While the ACIP also recommends that pregnant women receive a dose of Tdap vaccine during each pregnancy, between 27 and 36 weeks gestation, regardless of a previous history of Tdap vaccine,  this recommendation contradicts the information provided by the vaccine manufacturers. The product insert of both Boostrix and Adacel, the two available Tdap vaccines in the U.S., state that the safety and effectiveness of vaccination has “not been established in pregnant women”.  

There are various combination shots that bundle diphtheria, tetanus and pertussis vaccines with vaccines for polio, haemophilus influenza B (HIB, and hepatitis B (see below for descriptions).

The whole cell pertussis vaccine was created in 1912 and licensed in 1914. In the 1940’s, the pertussis vaccine was combined with diphtheria and tetanus to become the DPT vaccine and licensed for routine use.  This vaccine was replaced with a purified, less reactive acellular DTaP vaccine in 1996.  (DPT was available in some doctor’s offices in the U.S. until about 1999). DPT is still given to infants and children in many developing countries because it costs only pennies to manufacture a dose. 

Pertussis Vaccine Ingredients

The whole cell pertussis vaccine (DPT)is not currently used in the U.S., but remains in use in many developing countries. The whole DPT vaccine contains whole B. pertussis bacteria that is heated and washed with formaldehyde,  and contains neurotoxic aluminum  and mercury  along with shock-inducing endotoxin,   and brain damaging bioactive pertussis toxin.   

The purified DTaP/Tdap vaccines are packaged in single dose vials and have been given to American babies since the late 1990’s. These vaccines contain reduced bioactive pertussis toxin, less endotoxin, and either no or reduced (trace amounts) of mercury, along with an aluminum adjuvant. 

Depending upon the vaccine manufacturer, shots containing pertussis vaccine may contain varying amounts of inactivated pertussis toxin, filamentous hemagglutinin (FDA), pertactin, fimbriae, formaldehyde, polysorbate 80 (Tween 80), gluteraldehyde, 2-phenoxoyethanol, aluminum and thimerosal (mercury). 

Other ingredients are included in larger combination shots that bundle pertussis, tetanus and diphtheria vaccines with polio, hepatitis B and/or HIB vaccines. See each manufacturer product insert for a list of vaccine ingredients. 

Read the Product Information Insert

NVIC strongly recommends reading the vaccine manufacturer product information insert before you or your child receives any vaccine, including a shot containing pertussis vaccine. Product inserts are published by drug companies making vaccines and list important information about vaccine ingredients, reported health problems (adverse events) associated with the vaccine, and directions for who should and should not get the vaccine.

Links to pertussis-containing product inserts are available below or you can ask your doctor to give you a copy of the vaccine product insert to read before you or your child is vaccinated. It is best to ask your doctor for a copy of the product inserts for the vaccines you or your child is scheduled to receive well in advance of the vaccination appointment.

Pertussis Vaccines Licensed for Use in the U.S.

The U.S. Food and Drug Administration and U.S. Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) have approved nine different combination shots that include acellular pertussis vaccine. There are different rules for use of these vaccines by different aged groups.

Following is a list of currently available vaccine combination shots that contain pertussis vaccine with links to the manufacturer product inserts (click on the name of the product):

  • Infanrix, a 3 in 1 combination shot containing diphtheria, tetanus toxoids, and acellular pertussis vaccine for children under 7 years of age. It is manufactured by GlaxoSmithKline.
  • Daptacel, a 3 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis vaccine for children under 7 years of age. It is manufactured by Sanofi Pasteur Ltd.
  • Pediarix, a 5 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, hepatitis B recombinant and inactivated poliovirus vaccines for children under 7 years of age. It is manufactured by GlaxoSmithKline.
  • Kinrix, a 4 in 1 combination vaccine containing diphtheria and tetanus toxoids, acellular pertussis and inactivated poliovirus vaccines for children 4 to 6 years old. It is manufactured by GlaxoSmithKline.
  • Quadracel, a 4 in 1 combination vaccine containing diphtheria and tetanus toxoid, acellular pertussis and inactivated poliovirus vaccine for children 4 to 6 years old. It is manufactured by Sanofi Pasteur
  • Pentacel, a 5 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus and Haemophilus b conjugate (tetanus toxoid conjugate) vaccines for children under four years old. It is manufactured by Sanofi Pasteur Ltd.
  • VAXELIS, a 6 in 1 combination shot containing diphtheria and tetanus toxoids and acellular pertussis, Inactivated Poliovirus, Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine for children 6 weeks through 4 years of age. It is manufactured by MCM Vaccine Company.
  • Adacel, a 3 in 1 combination booster shot containing tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine for those 11 years or older. It is manufactured by Sanofi Pasteur Ltd.
  • Boostrix, a 3 in 1 combination booster shot containing tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine for those 10 years or older. It is manufactured by GlaxoSmithKline.

Combination Vaccines

There are some doctors who limit the numbers of vaccines given simultaneously on the same day and will work as partners with parents to choose certain vaccine products and develop individualized schedules for vaccination. If you want your child to receive pertussis vaccine but would prefer a 3 in 1 combination shot (diphtheria, tetanus, pertussis) rather than a 4 in 1 or 5 in 1 combination shot, talk with your doctor.

If your doctor or the nurse administering vaccines refuses to have a discussion with you about vaccine products or schedules, you may want to consider consulting one or more other trusted health care professionals before making a vaccine decision.

Not all pertussis-containing vaccines have been studied in clinical trials to prove the safety and effectiveness of giving the shot simultaneously with other licensed vaccines. Check the product inserts for more information about administering vaccines at the same time with other vaccines.

About INFANRIX Vaccine in Brief

  • Ages: Infanrix is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccines) given to children under age 7 (see GlaxoSmithKline product insert for recommended schedule and other indications).
  • Estimated Efficacy: The mechanism of protection from B. pertussis disease is not well understood. A serologic correlate of protection for pertussis has not been established. In clinical trials the efficacy of the acellular pertussis vaccine component was 86 to 89 percent.
  • Use With Other Vaccines: In clinical trials, Infanrix was given with HIB, pneumococcal, hepatitis B, inactivated polio or MMR vaccines. There is no information in the product insert about the safety or effectiveness of giving Infanrix simultaneously with inactivated or live influenza, rotavirus, varicella or hepatitis A vaccines.
  • Commonly Reported Adverse Events: Pain, redness, and swelling at the site of the injection; drowsiness; irritability/fussiness; loss of appetite.
  • Other Serious Reported Adverse Events: Hypotonic-hyporesponsive (collapse) episode; persistent cry for 3 or more hours; high fever, and convulsions (seizures). After licensure (post-marketing), reported adverse events included bronchitis, cellulitis, respiratory tract infection, lymphadenopathy, thrombocytopenia, anaphylactic reaction, encephalopathy, headache, hypotonia, ear pain, apnea, cough, angiodema, pruritus, rash, fatigue and Sudden Infant Death Syndrome (SIDS).
  • Contraindications (Some reasons Infanrix may not be given to a child – See GlaxoSmithKline product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination
    • Serious allergic reaction to a pervious pertussis vaccination
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause
    • Children with a progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. “Decisions about when to administer Infanrix to infants born prematurely should be based on the individual infant’s medical status and the potential risks and benefits of the vaccine.”

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Infanrix. It is also not known whether Infanrix can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Infanrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About DAPTACEL Vaccine in Brief

  • Ages: Daptacel is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccines) given to children under age 7 (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Estimated Efficacy: The mechanism of protection from B. pertussis disease is not well understood. A serologic correlate of protection for pertussis has not been established. In clinical trials the efficacy of the acellular pertussis vaccine component was 78 to 85 percent.
  • Use With Other Vaccines: In clinical trials, Daptacel was given with HIB, inactivated polio (IPV), hepatitis B, pneumococcal, and MMR or varicella vaccines. There is no information in the product insert about the safety or effectiveness of giving Daptacel simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines. Daptacel has been noted to reduce meningococcal antibody responses to Menactra when administered one month after Menactra. In cases where Daptacel and Menactra are to be administered, the vaccines were recommended to be given at the same time or else one month apart, with Menactra administered first.
  • Commonly Reported Adverse Events: injection site soreness, tenderness, redness, and increase in arm circumference; fussiness/irritability; inconsolable crying; decreased activity/lethargy.
  • Other Serious Reported Adverse Events: Convulsions (seizures), including infantile spasms; bronchiolitis; pneumonia; meningitis; sepsis; irritability; unresponsiveness. After licensure (post-marketing), reported adverse events have also included cyanosis, nausea, diarrhea, cellulitis, and allergic reaction.
  • Contraindications (Some reasons Daptacel may not be given to a child – See Sanofi Pasteur product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination
    • Serious allergic reaction to a pervious pertussis vaccination
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Daptacel. It is not known whether Daptacel can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Daptacel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Pediarix Vaccine in Brief

  • Ages: Pediarix is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and recombinant hepatitis B vaccines) given to children under age 7 (see GlaxoSmithKline product insert for recommended schedule and other indications).
  • Estimated Efficacy: The mechanism of protection from B. pertussis disease is not well understood. A serologic correlate of protection for pertussis has not been established. The efficacy of the acellular pertussis vaccine component of Pediarix is estimated to be 71 to 89 percent.
  • Use with Other Vaccines: In clinical trials, Pediarix was given with HIB conjugate vaccine (no longer licensed in the U.S.) or pneumococcal vaccines. There is no information in the product insert about the safety or effectiveness of giving Pediarix simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines.
  • Commonly Reported Adverse Events: Local injection site reactions (pain, redness, or swelling); fussiness, high fever (Pediarix is associated with higher rates of fever relative to separately administered vaccines. The prevalence of fever was highest on the day of vaccination and the day following vaccination.)
  • Other Serious Reported Adverse Events: High fever that requires medical attention (In a safety study that evaluated medically attended fever after Pediarix or separately administered vaccines when co-administered with 7-valent pneumococcal and Hib conjugate vaccines, infants who received Pediarix had a higher rate of medical encounters for fever within the first 4 days following the first vaccination); febrile and afebrile convulsions (seizures); gastroenteritis, bronchiolitis; asthma, diabetes mellitus, and chronic neutropenia; anaphylactic reactions (hives, swelling, difficulty breathing, hypotension or shock), demyelinating diseases.
  • Contraindications (Some reasons why Pediarix may not be given to a child – See GlaxoSmithKline product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination
    • Serious allergic reaction to a pervious pertussis vaccination
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)
    • Sensitivity to any component of Pediarix, including yeast or neomycin and polymixin B (antibiotics).
    • Apnea following intramuscular vaccination has been observed in some infants born prematurely. “Decisions about when to administer an intramuscular vaccine, including Pediarix, to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination.”
    • Children with a bleeding disorder (thrombocytopenia)

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Pediarix. It is not known whether Pediarix can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Pediarix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Kinrix Vaccine in Brief

  • Ages: Kinrix is a 4 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio vaccines) given to children 4 to 6 years old (see GlaxoSmithKline product insert for recommended schedule and other indications).
  • Estimated Efficacy: The mechanism of protection from B. pertussis disease is not well understood. A serologic correlate of protection for pertussis has not been established. The efficacy of the acellular pertussis vaccine component of Kinrix is estimated to be equal to that of Infanrix (86 to 89 percent).
  • Use with Other Vaccines: In clinical trials, Kinrix was administered simultaneously with the second dose of MMR or MMR and Varicella vaccine. There is no information in the product insert about the safety or effectiveness of giving Kinrix simultaneously with inactivated or live influenza, hepatitis B, or hepatitis A vaccines.
  • Commonly Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; drowsiness; fever; loss of appetite.
  • Other Serious Reported Adverse Events: Gastroenteritis, dehydration, and cellulitis. After licensure (post-marketing) reported adverse event reports have also included apnea, collapse or shock-like state (hypotonic-hyporesponsive episode), convulsions (with or without fever), injection site vesicles; pruritus (intense itching); allergic reactions, including anaphylaxis; urticaria; angioedema; lympadenopathy, and thrombocytopenia.
  • Contraindications (Some reasons why Kinrix should not be given to a child – See GlaxoSmithKline product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination
    • Serious allergic reaction to a pervious pertussis vaccination
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause.
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)
    • Severe allergic reaction to any component of Kinrix, including neomycin and polymixin B (antibiotics).

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Kinrix. It is not known whether Kinrix can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Kinrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Quadracel Vaccine in Brief

  • Ages: Quadracel is a 4 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio vaccines) given to children 4 to 6 years old (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Estimated Efficacy: The mechanism of protection from B. pertussis disease is not well understood. A serologic correlate of protection for pertussis has not been established. The efficacy of the acellular pertussis vaccine component of Quadracel is estimated to be equal to that of DAPTACEL.
  • Use with Other Vaccines: In clinical trials, Quadracel was administered simultaneously with the MMR and varicella. There is no information in the product insert about the safety or effectiveness of giving Quadracel simultaneously with inactivated or live influenza, hepatitis B, or hepatitis A vaccines.
  • Commonly Reported Adverse Events: Injection site pain, including redness, swelling and increase in arm circumference; malaise; muscle pain; headache.
  • Other Serious Reported Adverse Events: After licensure (post-marketing) reported adverse event reports have also included cyanosis; convulsions (with or without fever); injection site abscess; injection site cellulitis; pallor; screaming; allergic reactions, including anaphylaxis; urticarial, and dyspnea
  • Contraindications and precautions (Some reasons why Quadracel should not be given to a child – See Sanofi Pasteur product insert for complete list):
    • Serious allergic reaction following administration of a pertussis, tetanus, diphtheria, or polio containing vaccine or any ingredient of Quadracel vaccine
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause.
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)
    • Seizures within 3 days of a previous pertussis vaccination
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause
    • If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receiving a tetanus containing vaccine, assessment of the possible risks and potential benefits of receiving Quadracel should be carefully considered. 

NVIC NOTE: Some doctors only vaccinate children who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Quadracel. It is not known whether Quadracel can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Quadracel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Pentacel Vaccine in Brief

  • Ages: Pentacel is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and haemophilus influenza b conjugate vaccines) for children under age 5 (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Estimated Efficacy: The mechanism of protection from B. pertussis disease is not well understood. A serologic correlate of protection for pertussis has not been established. The efficacy of the acellular pertussis vaccine component of Pentacel is estimated to be the same as for Daptacel (78-85 percent) except evidence in pre-licensure clinical trials raises questions about whether Pentacel has a lower long-term efficacy compared to Daptacel. (While Pentacel and Daptacel (vaccines contain the same pertussis antigens, manufactured by the same process, Pentacel vaccine contains twice the amount of detoxified pertussis toxin (PT) and four times the amount of filamentous hemagglutinin (FHA) as Daptacel vaccine.)
  • Use with Other Vaccines: In clinical trials, Pentacel was given with hepatitis B, pneumococcal, MMR or varicella vaccines. There is no information in the product insert about the safety or effectiveness of giving Pentacel simultaneously with inactivated or live influenza, rotavirus, or hepatitis A vaccines
  • Commonly Reported Adverse Events: Systemic reactions that occurred in clinical trials in more than 50 percent of participants following any dose included fussiness/irritability and inconsolable crying; fever; injection site reactions, including tenderness, abscess and increase in arm circumference. Cases of encephalopathy and death occurred in clinical trials but were not causally attributed to Pentacel vaccine by investigators.
  • Other Serious Reported Adverse Events: After licensure (post marketing), there have been reports of febrile and afebrile convulsions (seizures); bronchiolitis, gastroenteritis, dehydration, pneumonia, lethargy/somnolence; hypotonic/hyporesponsive episode (collapse); apnea, cyanosis, asthma,
  • Contraindications (Some reasons why Pentacel may not be given to a child – See Sanofi Pasteur product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination
    • Serious allergic reaction to a pervious pertussis vaccination
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)
    • Severe allergic reaction to any component of Pentacel, including neomycin and polymixin B (antibiotics).

NVIC NOTE: Some doctors only vaccinate children, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Pentacel. It is not known whether Pentacel can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Pentacel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About VAXELIS Vaccine in Brief

  • Ages: VAXELIS is a 6 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated poliomyelis, haemophilus influenzae b (Meningococcal Protein Conjugate) and Hepatitis B (recombinant) vaccines) for infants and children between 6 weeks through 4 years of age (prior to the 5th birthday) (see MCM company product insert for recommended schedule and other indications).
  • Estimated Efficacy: In VAXELIS pre-licensing clinical trials, efficacy was measured by examining antibody responses to the individual six disease components found in the vaccine. Immune responses were evaluated by the manufacturers one month following completion of the three dose VAXELIS vaccine series. The efficacy for diphtheria following three doses of VAXELIS was 82.4 percent. Tetanus antibodies were reported to be at 99.9 percent. Testing on the pertussis antibody efficacy examined the 4 components of pertussis. The anti-PT response was 98.1 percent, the anti-FHA response was 87.3 percent, the anti-PRN response was 79.3 percent and the anti-FIM response was 90.2 percent. Protective antibodies to all three types of poliomyelis in VAXELIS clinical trials were reported to be at 100 percent. 97.3 percent of clinical trial participants were found to have anti-PRP levels greater than or equal to 0.15 ug/mL while 85 percent were noted to have anti-PRP levels greater than or equal to 1.0 ug/mL. Anti-PRP levels greater than or equal to 1.0 ug/mL measured three weeks following Hib vaccination are considered to be predictive of protection for one year. Hepatitis B antibodies following the administration of three doses of VAXELIS were reported at 99.4 percent.
  • Use with Other Vaccines: In clinical trials, VAXELIS was given with pneumococcal (Prevnar 13) and rotavirus (RotaTeq) vaccines. There is no information in the package insert about the safety or effectiveness of giving VAXELIS simultaneously with inactivated or live influenza, hepatitis A, measles, mumps, rubella (MMR), varicella, or measles, mumps, rubella and varicella (MMR-V) vaccines.
  • Commonly Reported Adverse Events: Systemic reactions that occurred in clinical trials following any dose included injection site redness, swelling, and pain, fever, crying, decreased appetite, irritability, vomiting, and somnolence. In the 2 U.S. clinical trials, 6 deaths were reported but deemed unrelated to vaccination by trial investigators. The 6 deaths included sepsis, asphyxia, hydrocephalus, unknown cause, and two cases of sudden infant death syndrome.
  • Other Serious Reported Adverse Events: As VAXELIS is not currently available for use in the United States, post-marketing data on serious adverse events are limited to those events considered to have a causal link to the vaccines containing the antigens of VAXELIS. These include anaphylaxis, hypersensitivity, seizures, including febrile seizures, and excessive swelling of the injected limb
  • Contraindications (Some reasons why VAXELIS may not be given to a child – See product insert for complete list):
    • Temperature of 105 F. or higher within 48 hours of a previous pertussis vaccination, not attributable to another identifiable cause
    • Collapse or shock-like state (hypotonic-hyporesponsive episodes) within 48 hours of a previous pertussis vaccination
    • Persistent crying lasting 3 hours or more within 48 hours of a previous pertussis vaccination
    • Convulsions with or without fever, occurring within 3 days of a previous pertussis vaccination
    • Serious allergic reaction to a previous dose of VAXELIS, any ingredient found in VAXELIS, or any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, hepatitis B vaccine, inactivated poliovirus vaccine, or H. influenzae type b vaccine.
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause
    • Children with a progressive neurologic disorder (such as infantile spasms, uncontrolled epilepsy, or progressive encephalopathy)

NVIC NOTE: Some doctors only vaccinate children, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you do not want your acutely ill baby vaccinated and your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with VAXELIS. It is not known whether VAXELIS can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. VAXELIS has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Adacel in Brief:

  • Ages: Adacel is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis) used as a booster dose (Tdap) for children and adults 11 years and older (see Sanofi Pasteur product insert for recommended schedule and other indications).
  • Estimated Efficacy: The mechanism of protection from B. pertussis disease is not well understood. A serologic correlate of protection for pertussis has not been established. The estimated efficacy of the acellular pertussis vaccine component of Adacel is difficult to determine from available data. See product insert for more information.
  • Use with Other Vaccines: In clinical trials, Adacel was given with hepatitis B or inactivated influenza vaccine. There is no information in the product insert about the safety or effectiveness of giving Adacel simultaneously with live influenza, meningococcal, HPV, MMR, varicella, hepatitis A, inactivated polio or other vaccines.
  • Commonly Reported Adverse Events: In clinical trials, most common reactions were pain at the injection site, including swelling; fever (especially in adolescents); headache; body aches/muscle weakness; fatigue; chills, sore and swollen joints; nausea, lymph node swelling.
  • Other Serious Adverse Events: After licensure (post-marketing), adverse event reports include severe injection site swelling, bruising, sterile abscess; facial palsy; convulsion; syncope (fainting); parasthesia; Guillain-Barre syndrome; myelitis; anaphylactic reaction; hypersensitivity reaction (angioedema, rash, hypotension); urticaria; muscle spasm; myocarditis.
  • Contraindications (Some reasons why Adacel may not be given to a child or adult – See Sanofi Pasteur product insert for complete list):
    • Moderate or severe acute illness (with or without fever) until the illness resolves;
    • Serious allergic or hypersensitivity reaction to a pervious shot;
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause;
    • In adolescents, a progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (convulsions);
    • In adults, an unstable neurologic condition, such as cerebrovascular events and acute encephalopathic conditions;
    • Severe allergic reaction to any component of Adacel.

Animal reproduction studies have not been conducted with Adacel. It is not known whether Adacel can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Adacel has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

About Boostrix Vaccine in Brief

  • Ages: Boostrix is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis) used as a booster dose (Tdap) for children and adults 10 years and older (see GlaxoSmithKline product insert for recommended schedule and other indications).
  • Estimated Efficacy: The mechanism of protection from B. pertussis disease is not well established. A serologic correlate for protection from pertussis has not been established. The estimated efficacy of the acellular pertussis vaccine component of Boostrix is difficult to state from available data. See product insert for more information.
  • Use With Other Vaccines In clinical trials, Boostrix was given with inactivated influenza vaccine (Fluarix) and the meningococcal vaccine (Menactra). In both clinical trials the antibody level for the pertussis component was determined to be lowered. There is no information in the product insert about the safety or effectiveness of giving Boostrix simultaneously with live influenza, MMR, varicella, HPV, hepatitis B, hepatitis A, inactivated polio or other vaccines.
  • Commonly Reported Adverse Events: In pre-licensure clinical trials, pain, redness, and swelling at the injection site, increase in arm circumference of injected arm; headache; fatigue; gastrointestinal symptoms.
  • Other Serious Adverse Events: There was one case of diabetes that developed after Boostrix in clinical trials. After licensure (post marketing) adverse event reports have included extensive inflammation, swelling of injected limb, nodule, itching; encephalitis (brain inflammation); convulsion; facial palsy; lymphadenitis; lymphadenopathy; myocarditis; arthralgia; back pain; myalgia; urticaria; Henoch-Schonlein purpura.
  • Contraindications (Some reasons why Boostrix may not be given to a child or adult – See Sanofi Pasteur product insert for complete list):
    • Serious allergic or hypersensitivity reaction to a previous shot
    • Encephalopathy (coma, decreased level of consciousness, prolonged convulsions) within 7 days of a previous pertussis vaccination not attributable to another identifiable cause
    • In adolescents and adults, a progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy (convulsions).

NVIC NOTE: Some doctors only vaccinate children and adults, who are healthy and are not sick with a coinciding viral or bacterial infection at the time of vaccination. If you or your child are sick and do not want to get vaccinated but your doctor disagrees with you, you may want to consider consulting one or more other trusted health care professionals before vaccinating.

Animal reproduction studies have not been conducted with Boostrix. It is not known whether Boostrix can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity. Boostrix has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Is the Pertussis Vaccine Mandated?

Federal health officials make recommendations for vaccine use and states enact laws that require vaccine use. Currently, there are mandates in every state that children receive 3 to 6 doses of pertussis vaccine to attend school. Medical exemptions to vaccination are allowed in every state but few medical conditions qualify for a medical exemption, which must be written by a medical doctor (M.D.) or Doctor of Osteopathy (D.O.).

Depending upon which state you live in, you may be legally allowed to exercise a religious or philosophical/conscientious belief exemption to vaccination, including pertussis vaccination. For more information about which vaccines your state requires and exemptions, go here on NVIC’s website.

If you are a health care worker, you may be required to get pertussis vaccine as a condition of employment.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

What is the History of Pertussis Vaccine use in America?

pertussis

In 1906, Octave Gengou and Jules Bordet of the Pasteur Institute of Brussels, were successful in growing pertussis bacterium using an artificial media.  As a result of the breakthrough, the pertussis bacterium was renamed Bordetella pertussis in honor of Jules Bordet. Following publication of research on the Bordet-Gengou technique, several scientists began development of a pertussis vaccine using whole cell killed pertussis. The first crude whole cell pertussis vaccine was licensed in 1914  but was not routinely used until after 1949, when it was combined with diphtheria and tetanus vaccines to become the DPT vaccine.  Prior to 1949, the crude whole cell pertussis vaccine was in limited use and reports of serious side effects, including deaths, following vaccination appeared in published medical research.   

A 1974 published study  reporting serious side effects following DPT vaccination received widespread publicity in Great Britain and DPT vaccination rates drop from 80 to 30 percent.  In 1975, Japan suspended the use of pertussis vaccine for several months in response to concerns over vaccine safety. The vaccine was reinstated for use but recommended for children ages 2 years and older only.  It was Japan that introduced the first acellular pertussis vaccine, the less reactive DTaP vaccine, in 1981, replacing the highly reactive whole cell pertussis vaccine. 

In 1982, the damaging effects of the highly reactive DPT vaccine was profiled in an award-winning television documentary DPT: Vaccine Roulette. This documentary led to the founding the organization known today as the National Vaccine Information Center and the publishing of the book DPT: A Shot in the Dark in 1985.  During the 1980’s, parents of DPT vaccine injured children worked tirelessly for over a decade to get the less reactive DTaP vaccine licensed in the United States. Since 1981, Japan had used the DTaP vaccine with far fewer serious reactions and no reported whooping cough outbreaks.  

It was the highly reactive whole cell DPT vaccine that caused many children to suffer permanent brain damage or death, which prompted vaccine makers in the United States to push Congress into giving pharmaceutical companies a partial product liability shield in 1986.  Parents of children who were severely injured or who died as a result of the whole cell DPT vaccine were suing vaccine manufacturers for damages, and as a result of the growing number of lawsuits, vaccine manufacturers were threatening to stop the sale of vaccines in the United States.   As a result, the National Childhood Vaccine Injury Act was passed by the 99th Congress in 1986.  The goal of the National Childhood Vaccine Injury Act was to restrict vaccine lawsuits against vaccine manufacturers and negligent doctors when vaccines such as the highly reactive DPT vaccine injure or kill to Americans. NVIC’s co-founders worked with Congress on the historic law and as a result, Congress acknowledged the reality of vaccine injuries and deaths, that safety reforms are needed, and that those who are harmed by vaccines should be financially compensated.  The National Vaccine Injury Compensation Program, set up in response to the passage of the National Childhood Vaccine Injury Act, was promised by Congress to be “a non-adversarial, expedited, less traumatic and less expensive administrative alternative to a lawsuit - not an exclusive legal remedy that prohibited all product liability lawsuits against vaccine manufacturers.” 

Between 1988 and 1995, following the passage of the National Childhood Vaccine Injury Act of 1986, DPT vaccine injured children were receiving awards through an administrative procedure.  However, in 1995, Health and Human Services Secretary Donna Shalala, officials at the CDC, and attorneys in the U.S. Department of Justice actively worked to substantially weaken the compensation and safety provisions of the National Childhood Vaccine Injury Act of 1986. Beginning in March of 1995, only anaphylaxis occurring within four hours and encephalopathy/encephalitis occurring within 72 hours of a DPT vaccination (or resulting in hospitalization) would be presumed to be associated with DPT vaccination. This rule change meant that any child who suffered classic pertussis vaccine reaction symptom such as collapse or shock, high pitched screaming, bulging fontanelle, or seizures within 72 hours of a DPT vaccination, and suffered permanent neurological damage (including residual seizure disorder), would no longer be presumed to have suffered a vaccine injury and be eligible for “no fault” compensation in the federal program. As a result of this change, attorneys representing children suffering these classic DPT vaccine reaction symptoms followed by permanent injury or death would have to prove causation in the U.S. Court of Claims whenever the Secretary of Health and the Justice Department refused to award compensation.  Since this change in 1995, it has become extremely rare for any vaccine injured child to qualify for uncontested compensation, and currently, most vaccine injury claims take many years to adjudicate because the Departments of Health and Justice fight against awarding compensation for the majority of children and adults who apply. 

In February 2011, the U.S. Supreme Court chose to inaccurately interpret the National Childhood Vaccine Injury Act of 1986, and removed the right of vaccine injured Americans to sue a vaccine maker, even when evidence existed that injuries could have been prevented if a pharmaceutical company had chosen to make a safer vaccine.  When the National Childhood Vaccine Injury Act passed in 1986, the Act protected a citizen’s right to sue drug companies when federal compensation was denied, or in the case that evidence existed that the company had the technological ability to make a vaccine safer but refused to do so. The February 2011 Supreme Court decision to remove this provision completely shielded pharmaceutical companies from all liability for harm caused by any vaccine. 

The Supreme Court decision was a result of a lawsuit filed by the attorneys and parents of Hannah Bruesewitz, a young woman who suffered from seizures within hours of her six month whole cell DPT vaccination that resulted in lifelong developmental delays. In 1995, one month prior to the hearing of her case in the federal compensation program, the injuries that Hannah suffered were removed from the vaccine injury table and Hannah was denied compensation by an administrative judge.  As a result of this denial, her parents filed a lawsuit against Wyeth, the company that had acquired the vaccine’s manufacturer, Lederle Laboratories, and provided evidence that Wyeth-Lederle had the technology to produce a less reactive, purified pertussis vaccine but declined to do so.  The case went all the way to the Supreme Court and in a 6-2 split decision, the Court ruled in favor of the pharmaceutical companies, protecting them against any lawsuits as a result of injuries and deaths resulting from the vaccines they design, manufacture and market. Only Justices Sotomayor and Ginsburg stood up for the American public by dissenting. 

Although the FDA approved the first acellular DTaP vaccines for use in the United States in 1991,  it took until 1996 for this less reactive vaccine to be granted approval for use in infants and children for all five of the recommended doses of pertussis, diphtheria, and tetanus vaccination.  Between 1991 and 1996, the DTaP vaccine was approved only for use in children ages 15 months to 6 years of age, following administration of three doses of the whole cell DPT vaccine.  In 1997, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the DTaP vaccine for use instead of the highly reactive whole cell DPT vaccine. 

In 2005, the FDA approved two additional pertussis-containing vaccines, Tdap, targeting adolescents and adults. Boostrix, initially approved for persons ages 10 through 18 years of age, and Adacel, approved for persons ages 11 through 64 years of age. Following FDA approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended all adolescents receive a dose of Tdap vaccine between the age of 11 and 12. This recommendation was made in response to high rates of pertussis outbreaks in adolescents as a result of waning vaccine-induced pertussis immunity. 

In 2006, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended Tdap vaccination for all persons between the ages of 19 and 65 years, especially encouraging individuals to be vaccinated if they anticipate close contact with infants under one year of age. This recommendation was made without any scientific evidence to support the theory that vaccinating adults with Tdap would reduce the risk of pertussis in infants.  In fact, a 2013 published study found that baboons that were recently vaccinated carried the pertussis infection in their throats and spread the illness to others despite being asymptomatic themselves.   Recommendations also included women of childbearing age, recommending vaccine with Tdap vaccine prior to pregnancy or immediately postpartum if Tdap was not administered prior to pregnancy. Breastfeeding women who did not receive the Tdap prior to pregnancy were also included in this recommendation  despite a lack of information on whether Tdap is excreted in human milk and what implications this may have on the nursing infant.  The ACIP also recommended that health care personnel working in ambulatory care and hospital settings receive a Tdap vaccine as soon as possible, especially if their practice places them in direct contact with infants under the age of one year. 

In October 2011, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that health-care personnel implement a Tdap vaccine program for pregnant women after 20 weeks gestation, who had not been previously vaccinated with Tdap. The ACIP also continued to recommend vaccination all adolescents and adults, especially those who may come into close contact with infants.   One year later, in October of 2012, the CDC’s Advisory Committee on Immunization Practices (ACIP) updated its Tdap vaccination recommendations for pregnant women, recommending the vaccine be administered between 27 and 36 weeks gestation during each pregnancy.  This recommendation was made despite the fact that both available Tdap vaccines are FDA approved to be administered as a single dose, and the CDC’s recommendation that every pregnant woman receive a Tdap vaccination during every pregnancy - regardless of whether a woman has already received a dose of Tdap- is an off-label use of the vaccine.  In fact, product inserts for both Adacel and Boostrix, the two available Tdap vaccines for children and adults, including pregnant women, both state that safety and effectiveness have not been established in pregnant women.   Drug companies did not test the safety and effectiveness of giving Tdap vaccine to pregnant women before the vaccines were licensed in the U.S.   and almost no data exists on inflammatory or other biological responses to these vaccines that may have an effect on pregnancy and birth outcomes.   Further, a 2017 review of 15 published articles, including 2 randomized controlled trials and 13 observational studies determined that while Tdap vaccination boosted maternal antibodies, evidence was lacking on whether or not this had any impact on reducing the incidence of pertussis, serious complications from pertussis, or death in infants. 

Currently, the CDC recommends infants and children receive 5 doses of DTaP vaccination followed by a booster dose of Tdap vaccination in adolescence (age 11-12). Adults who have not received a Tdap vaccine are also recommended to receive a single dose. Pregnant women are recommended to receive Tdap vaccination with each pregnancy regardless of a previous history of Tdap vaccine. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

How Effective is Pertussis Vaccine?

vaccine effectiveness

After a century of pertussis vaccination programs, vaccinologists are still unsure how pertussis infections - or many other infections - stimulate long lasting cell mediated and humoral immunity in the body.   This lack of basic scientific knowledge relates directly to the inability of vaccine makers to develop and manufacture vaccines that provide long lasting artificial immunity and to the lack of correlates for immunity to accurately measure the kind of immunity vaccines do or do not provide.   

Most public health officials maintain that when pertussis vaccine is used on a widespread basis in a population, it appears to lessen the overall incidence of the disease and that vaccinated children have less severe cases of pertussis whooping cough.

However, studies published in the 1980’s reported that the highly reactive whole cell DPT vaccine licensed in 1949 did not prevent infection or transmission,  and provided only two to five years of temporary immunity at best.   The efficacy of whole cell pertussis vaccine in the DPT shot was measured to be between 30 and 85 percent, depending upon the type of DPT and vaccine manufacturer.     

The less toxic acellular DTaP vaccine, licensed in the U.S. in 1991, and currently in use in the United States and other developed countries, has also failed to prevent infection or transmission of pertussis.    Studies have also demonstrated that DTaP vaccine provides only between two and five years of temporary immunity from pertussis.    Acellular pertussis vaccine efficacy in clinical trials has been measured to be between 40 and 89 percent, depending upon the DTaP vaccine manufacturer.   

According to a 2005 study in the journal Pediatrics, pertussis containing DTP and DTaP vaccines were estimated to be from 83.6 percent to as much as 97.7 percent effective, depending on the number of doses administered, the combinations of vaccine used in the shot containing pertussis vaccine, and age of the child at which it was administered.  However, a 2010 analysis of a California whooping cough outbreak published in the medical literature revealed that more than 80% of those affected were fully vaccinated and the pertussis vaccine was found to be between 24 and 41 percent effective in children two to 18 years of age three years post-vaccination.  In 2010, the Tdap vaccine, recommended in 2006 for adolescents as a booster dose of acellular pertussis vaccine,   was found to be only about 66 percent effective. 

By 2012, the CDC acknowledged that pertussis vaccine immunity had waned in older children, that DTaP/Tdap immunity begins to wane within five years of vaccination, and that unvaccinated individuals and children with vaccine exemptions were not to blame for the ongoing whooping cough outbreaks. 

In fact, child pertussis vaccination rates in the U.S. have remained very high since 1961  and consistently more than 94 percent of kindergarten children have had four to five pertussis-containing vaccines.  As well, nearly 94 percent of all children have received at least three doses of DTaP vaccine,  and 88 percent of teenagers attending high school have received a sixth pertussis booster shot. 

However, reported numbers of pertussis cases differ substantially from the total number of actual cases of pertussis in the United States, as most pertussis cases are not being diagnosed or reported by doctors to the government.  Public health officials do not have reliable lab tests to measure pertussis immunity and are unable to agree about how to diagnose pertussis when infected people, especially vaccinated people, are seen in doctor’s offices with mild symptoms.   Further, there is evidence that millions of vaccinated children and adults living in the U.S. become infected with pertussis whooping cough but are never identified as doctors are not diagnosing or reporting them.     In fact, a person, vaccinated or unvaccinated, can develop a silent asymptomatic pertussis infection and transmit it to another person without even knowing it.    Both natural and vaccine acquired immunity is temporary  and while vaccination may prevent clinical symptoms, it does not block infection, carriage or transmission.  

In fact, a review of the medical literature has revealed that the experts are unhappy with their lack of knowledge of the B. pertussis microbe  and are disagreeing with each other about if, when, how and why pertussis vaccines have consistently failed to achieve herd immunity and prevent B. pertussis whooping cough from circulating in highly vaccinated populations around the world.   

In 1976, after only approximately 1,000 cases of pertussis were reported in the U.S. , pertussis rates began to climb. In the 1980’s and 1990’s, researchers became aware that the whole cell pertussis vaccine found in DPT was not capable of preventing infection and transmission of the disease.      Just like before the introduction of widespread DPT vaccination programs, pertussis increases continued to be reported in cycles of three to five years,        including in the U.S. where over 94 percent of children had gotten three to five DPT shots.   

In 1988, researchers began warning that the B. pertussis microbe had begun to evolve in order to evade the whole cell pertussis vaccine.        The evolving of the B. pertussis microbe had begun following the mass introduction of the DPT vaccine in 1950’s.     

In a fight to survive, the B. pertussis microbe has created new strains of pertussis that produce more toxin to suppress the human immune system and cause more serious disease. Today, the pertussis strains included in the vaccine no longer match the pertussis strains causing whooping cough disease.      There is compelling scientific evidence that B. pertussis bacteria have evolved to survive vaccine pressure and as a result, there are more virulent pertussis strains that are more efficiently transmitted by vaccinated children and adults with waning immunity. In 2014, public health officials at the CDC and around the world admitted that “most mutations in genes encoding acellular vaccine components arose in the period in which the whole cell vaccine was used.”  

Another Bordetella pertussis whooping cough disease, B. parapertussis is also circulating in the United States and elsewhere.  B. parapertussis whooping cough can look identical to B. pertussis whooping cough,  however symptoms are usually milder. B. parapertussis is increasing in the U.S. and other countries, which have had high pertussis vaccination rates for few decades. There are estimates that perhaps up to 30 percent of whooping cough disease in highly vaccinated populations may be caused by B. parapertussis organisms.  Pertussis vaccines widely used around the world do not protect against parapertussis and there is no vaccine for parapertussis. 

It is possible to have both B. pertussis and B. parapertussis infections at the same time. B. parapertussis is often milder than B. pertussis but can also involve serious complications, which lead to pneumonia and death. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Can Pertussis Vaccine Cause Injury and Death?

The Institute of Medicine has acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons, but that vaccine providers cannot accurately predict prior to a vaccine’s administration who will suffer complications, injury or death from vaccination.  However, a person who has previously had a serious reaction to a vaccination or is acutely or chronically ill should become informed about all potential risks associated with vaccination and discuss any concerns with a trusted health care professional before receiving a DTaP/Tdap vaccine or any other vaccine.

B. pertussis bacteria, which cause pertussis whooping cough disease, and lab altered to make pertussis vaccine, contain several toxins that can cause inflammation in the body. Pertussis toxin (PT) is one of the most lethal toxins in nature and this toxin induces lymphocytosis, leukocytosis, stimulates insulin secretion and sensitizes histamine, which is involved in the immune system’s inflammatory response. 

Pertussis toxin is thought to be the main component of B pertussis bacteria responsible for stimulating the production of protective antibodies during natural whooping cough infection and after pertussis vaccination. Pertussis toxin is also thought to be the main component responsible for causing brain inflammation during B. pertussis whooping cough or after injection of pertussis-containing vaccines.  

Since the 1950’s, scientists have injected pertussis toxin into lab animals whenever they want to deliberately induce histamine, serotonin and endotoxin sensitivity or experimental autoimmune encephalomyelitis.    Because pertussis toxin can cross the blood brain barrier when conditions are right, brain inflammation (encephalitis) that causes permanent brain damage has always been the most dreaded serious complication of both whooping cough and pertussis vaccination.

Another toxin produced by B. pertussis bacteria during natural infection is endotoxin, which is also present in pertussis vaccines in varying amounts. When the immune system detects the presence of endotoxins, it produces a defensive inflammatory immune response, including the release of large amounts of histamine that can, under certain circumstances, lead to high fever, swelling, diarrhea, collapse, shock and death. 

The whole cell pertussis component of the DPT vaccine, the original pertussis containing vaccine in widespread use from 1949 until the late 1990’s, was found to be highly reactive, causing brain inflammation and encephalopathy.   

The authors of the 1981 British National Childhood Encephalopathy Study (NCES)  noted in 1993,  and the Institute of Medicine confirmed in 1994,  that brain inflammation and encephalopathy is associated with a broad range of long term brain dysfunction that affects the physical, social, behavioral and educational outcomes for children. Signs of brain inflammation in infants or very young children can include high fever; irritability; vomiting; high pitched screaming (encephalitic cry) with or without arching of back; prolonged, uncontrollable crying; collapse and unresponsiveness with pale skin and blue lips; crossing or wandering eyes; drowsiness/lethargy; convulsions (seizures) with or without fever; regression and loss of developmental milestones and negative changes in mental, emotional and physical health. Death or a diagnosis of mental retardation, medication resistant seizure disorders, learning disabilities, attention deficit disorder, autism and other chronic neurological and health problems may follow an acute brain inflammation. 

In 1991, the Institute of Medicine (IOM), National Academy of Sciences, published the first of four reports of expert committees, which reviewed the medical literature for evidence that vaccines can cause injury and death.  The literature review was mandated under the National Childhood Vaccine Injury Act of 1986. The 1991 IOM report on Adverse Effects of Pertussis and Rubella Vaccines  concluded that “evidence is consistent with a causal relation between DPT vaccine and acute encephalopathy (brain inflammation) and “unusual shock-like state”  (hypotonic/hyporesponsive episode): and that “evidence indicates a causal relation between DPT vaccine and shock (anaphylaxis) and protracted, inconsolable crying.” 

In 1994, the IOM published the report DPT Vaccine and Chronic Nervous System Dysfunction   after reviewing the 10-year follow up the British NCES study and concluded that “NCES data are consistent with the possibility that some children without underlying brain or metabolic abnormalities might experience serious acute neurologic illness within 7 days after receiving DPT and that acute illness could have chronic nervous system sequelae. The NCES data also are consistent with the possibility that some children with underlying brain or metabolic abnormalities (which foster a “triggering” by DPT of an acute neurologic illness) might go on to develop chronic nervous system dysfunction due to a DPT-triggered acute illness. Therefore the committee concludes that the balance of evidence is consistent with a causal relation between DPT and the forms of chronic nervous system dysfunction described in NCES in those children who experience a serious acute neurologic illness within 7 days after receiving DPT vaccine. This serious neurologic risk is a rare event. The estimated excess risk ranged from 0 to 10.5 per million immunizations.” 

Between 50 and 80 percent of babies who received the whole cell DPT vaccine ran fevers, and experienced pain, redness and swelling at the site of the injection, and many of them were fussier or lost their appetite for a day or two.   Published research also concluded that the whole cell pertussis vaccine had the ability to cause far more serious reactions such as high-pitched screaming,  hypotonic/hyporesponsive episodes,   febrile or afebrile convulsions,    and brain inflammation (also known as encephalitis, encephalomyelitis and encephalopathy).     Between 25 and 60 percent of children who develop acute encephalitis or encephalopathy or have convulsions, including febrile convulsions - for any reason - are left with personality changes, developmental delays, learning disabilities, ADHD, seizure disorders, lower IQ, speech, motor and behavior disorders and other disabilities.      

A 1981 U.S. study funded by the FDA and conducted at UCLA found that convulsion or collapse/shock occurred as frequently as 1 in every 875 DPT shots.  As well, some of the children who participated in this study were left with neurological problems and low IQs. The 1981 British National Childhood Encephalopathy Study (NCES) estimated that the risk of a previously healthy child developing a serious neurological problem within seven days of DPT vaccination was 1 in 110,000 DPT shots and the risk of chronic brain dysfunction was 1 in 310,000 DPT shots.   Again, some of the children involved in the study were left with brain damage manifested by “neurologic, motor, sensory, educational behavioral and self-care dysfunctions.”  

While a “safer” acellular pertussis vaccine (DTaP) was available and in wide-spread use in Japan by 1981, the FDA did not approve this vaccine until 1991, and only as an option for young children over the ages of 15 months to 6 years of age following administration of three doses of the whole cell DPT vaccine.  It was 1996 before the FDA approved the DTaP vaccine for administration in infants and children 6 weeks to 6 years of age  and 1997 before the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended the DTaP vaccine in lieu of the highly reactive whole cell DPT vaccine. 

The current acellular pertussis vaccine (DTaP/Tdap) vaccines still contain chemically inactivated pertussis toxin (10-25 mcg per dose) that retain varying amounts of bioactivity, which may induce brain inflammation in some individuals. Chiron, a company producing a genetically engineered DTaP vaccine in the early 1990’s, explained that one reason why chemically inactivated pertussis toxin will be a problem for some: “Genetic detoxification ensures than no active form of the pertussis toxin is present, while chemically detoxified pertussis toxins may revert to toxicity.” 

In the comprehensive report evaluating scientific evidence, Adverse Effects of Vaccines: Evidence and Causality, published in 2012 by the Institute of Medicine, 26 reported vaccine adverse events following DTaP/Tdap vaccine were evaluated by a physician committee.  These adverse events included encephalopathy, encephalitis, chronic urticarial, autism, serum sickness, SIDS, arthritis, Guillain Barre Syndrome, diabetes mellitus, immune thrombocytopenic purpura, transverse myelitis and more.

In 24 of the 26 DTaP/Tdap vaccine-related adverse events evaluated, the IOM committee concluded that there was inadequate evidence to support or reject a causal relationship between the DTaP/Tdap vaccine and the reported adverse event, primarily because there was either an absence of methodologically sound published studies or too few quality studies to make a determination.  The IOM committee concluded that the scientific evidence “convincingly supports” a causal relationship between anaphylaxis and DTaP/Tdap vaccine.  However, based on the evaluation of five epidemiological studies, the committee concluded that scientific evidence “favors rejection” of a relationship between Diabetes Type 1 and DTaP/Tdap vaccine. 

Most pediatric neurologists acknowledge that vaccination, including use of vaccines for smallpox, rabies, influenza, mumps, measles, tetanus, polio and pertussis, can and does occasionally cause neurological complications that can lead to permanent brain dysfunction. 

Additional Reported Complications:

  • Allergic hypersensitive reactions occurring within minutes or hours of vaccination. These may include hives, sudden swelling of the mouth or throat, difficulty breathing, hypertension and shock.  
  • Thrombocytopenia and Hemolytic Anemia are two blood disorders, which have been reported to rarely follow pertussis vaccine containing shots.   Thrombocytopenia means a reduced number of platelets circulating in the blood and can cause "purpura" (blotchy red patches on the child’s body caused by the thinned blood seeping into the tissues beneath the skin). 
  • Diabetes and Hypoglycemia – The body’s glucose (sugar) metabolism is regulated by insulin, which is secreted by the pancreas. Researchers have detected increased insulin production in infants injected with pertussis vaccine.
      • In 1970, Pittman stated "the infant whose blood sugar level is influenced by food intake may be especially vulnerable to vaccine-induced hypoglycemia should a feeding be missed because of a feverish reaction following vaccinations." 
      • Hannik and Cohen in 1978 concluded, "infants who show serious reactions following pertussis vaccination suffer from failure to maintain glucose homeostasis." 
      • A 1982 study detailed the role the DPT vaccine played in causing diabetes in a 16-month old girl who was genetically predisposed to diabetes and who suffered from a viral infection that attacked her pancreas. 

The Pertussis Vaccine, Death, and SIDS

Death was the first reaction to be associated with pertussis vaccine. In 1933, the Danish vaccine researcher Madsen described the deaths of two babies within a few hours after they had been vaccinated. 

It is not known how many pertussis vaccine-related deaths occur in the US each year because sometimes the deaths of babies, who die after experiencing symptoms of reactions to DTaP, are misclassified as SIDS. Sudden Infant Death Syndrome (SIDS). SIDS usually involves the sudden, unexplained death of an infant, where there are no symptoms of any health problems before the baby is found lifeless.

Babies, who die after exhibiting pertussis vaccine reaction symptoms (such as high pitched screaming, collapse, extreme lethargy, convulsions) do not fit the general criteria of SIDS but are rarely reported as vaccine-related deaths.    

Reported Pertussis vaccine reactions

Using the MedAlerts search engine, as of October 31, 2022, there had been 180,025 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with pertussis-containing vaccines since 1990. Nearly half of those serious pertussis vaccine-related adverse events occurred in children under the age of three. Of these pertussis-vaccine related adverse event reports to VAERS, 3,286 were deaths, with nearly 86 percent of the deaths occurring in children under three years of age.

However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur develop after pertussis vaccination.

Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between one and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials, who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.      

As of November 1, 2022, there had been 5,987 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following pertussis-containing vaccination, including 864 deaths and 5,123 serious injuries. The pertussis vaccine is the vaccine with the most injury claims filed for death, and it is the second most compensated vaccine injury claim, with influenza vaccine now in first place.  

How to Recognize a Pertussis Vaccine Reaction

It cannot be emphasized enough that parents should monitor their children carefully day and night for at least 72 hours after vaccination.  The first 24-hour post-vaccination is an especially important time to be alert. Although identifying a severe vaccine reaction is the shared responsibility of parents and doctors, only parents can be with a child 24 hours a day.

Many children react to pertussis containing vaccines and recover without any apparent effects while others are left with chronic health problems. It is important to know how to recognize a potential vaccine reaction and to seek medical attention immediately if you suspect your child is suffering a severe vaccine reaction, such as unresponsiveness, convulsion (seizure), high pitched screaming (encephalitic cry) or other signs of brain inflammation. 

Pertussis vaccine has been documented to cause high fever; severe local reactions at the site of the injection  ; high pitched screaming and uncontrollable crying  ; collapse/shock (hypotonic/hyporesponsive episode)  ; lethargy (excessive sleepiness); convulsions with or without fever      ; and brain inflammation (encephalopathy).       

It is important for parents to know what constitutes a severe reaction to a pertussis vaccine containing shot because it is generally agreed by vaccine policy makers that those who react severely should not receive the "P" or pertussis portion of the DPT, DTaP or Tdap shot again. For subsequent boosters, only the "D" (diphtheria) and "T" (tetanus) portion of the shot should be administered. 

Following are descriptions of more serious vaccine reactions symptoms in the words of parents:

  • Collapse/Shock: “She turned white with a blue tinge around her mouth and went completely limp.”
  • Convulsion: “Her eyes twitched, her chin trembled, her body went rigid and then would shake.”
  • Behavior Changes: “She won’t sleep or eat. She throws herself down and screams for no reason. She was sweet and happy and is now out of control. She changed into a totally different child.”
  • High Fever: “His temperature was 105 degrees. I had to put cool towels on him to bring the fever down.”
  • Injection Site: “There was a big, hot swollen lump at the site of the shot that stayed for weeks.”
  • High Pitched Screaming: “It was a pain cry, a shrill scream and lasted for hours and nothing would help.”
  • Excessive Sleepiness: “He passed out and we couldn’t wake him to feed or do anything for over 12 hours.”
  • Brain Inflammation: “He just laid in his crib with his eyes wide open, then would arch his back and scream and go unconscious. Now he has seizures.”
  • Regression: “My 18 month old son stopped talking and walking after those shots. He developed severe allergies, constant diarrhea, ear infections and was sick all the time.”

If your child exhibits one or more of these symptoms or other dramatic change in physical, mental or emotional health/behavior within hours, days or weeks after vaccination, you should immediately have your child examined by your physician or go to the emergency room of your local hospital.

Make sure the date and time of the vaccination and the symptoms your child is having are recorded in your child’s medical record and that you do not leave the office or hospital without a written medical record that your child has been examined.

You can request that medical personnel make a formal vaccine adverse event report to the federal Vaccine Adverse Event Reporting System (VAERS).  If a doctor or medical worker will not make a vaccine reaction report to the government, you can make a report yourself. 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Who is at Highest Risk for Complications from Pertussis Vaccine?

vaccine complications

There is a gap in medical knowledge in terms of doctors being able to predict who will have an adverse reaction to pertussis vaccination, and who will not.

Since 1982, the co-founders of NVIC have been concerned about the lack of scientific studies investigating the biological mechanisms and high risk factors for pertussis vaccine, which has long been associated with reports of injury and death in more than 70 years of medical literature. Acknowledgement of biodiversity and genetic variation between individuals argues for a national scientific research agenda, which responsibly examines the biological factors that predispose some individuals to responding adversely to vaccination, including pertussis vaccination, and suffering brain and immune system damage or death.

In 1946, Werne and Garrow reported the deaths of identical twins within 24 hours of their second diphtheria-pertussis shot. The same outcome in identical twins following receipt of a pertussis vaccine-containing vaccine suggested genetic predisposition. The possibility of genetic predisposition to adverse responses to vaccination has been cited in the scientific literature. Additionally, there have been reports of two, three and four children in the same family, who have experienced serious reactions to pertussis-containing vaccines and suffered permanent brain damage. 

Following is a list of potential high risk factors for pertussis vaccine reactions, which are not acknowledged by public health officials, vaccine manufacturers or medical organizations, but which deserve serious scientific investigation.

Family History of Convulsions or Neurological Disease For most of the time that pertussis vaccine has been used, a personal history of convulsions or neurological disease has been listed as an absolute contraindication or serious precaution. In the past, some European countries have exercised caution and contraindicated pertussis vaccination if a member of the child’s immediate family (brother, sister, mother or father) has a history of convulsions or neurological disease. In 1985, CDC officials reported that children who experienced a neurological problem after DPT vaccination had a 7 times greater risk if they had a personal history of convulsions and a 4.5 times greater risk if they had a family history of convulsions.  

The product information circular accompanying DPT vaccine manufactured by Lederle Laboratories in 1985 stated, "Routine immunization with this product should not be attempted if the child has a personal or family history of central nervous system disease or convulsions."

The product information circular accompanying DPT vaccine manufactured by Connaught Laboratories in 1989 stated, "Use of this product is also contraindicated if the child has a personal or family history of a seizure disorder.”

In 1975, a World Health Organization-sponsored international meeting of pertussis vaccine experts recommended that "children from families with a history of neurological disorders should not be vaccinated."  

In 1977, the Department of Health and Social Security in England stated that children should not be given pertussis vaccine if they have a "family history of epilepsy or other diseases of the central nervous system.”  

In a 1987 recommendation published in the Morbidity and Mortality Weekly Report, the CDC stated "recent studies suggest that infants and children with a history of convulsions in the first degree family members (i.e. siblings and parents have a 3.2 fold increase risk for neurologic events compared with those without such histories (CDC, unpublished data)."  The CDC went on to recommend, however, that these children should still receive pertussis vaccine. 

Premature Birth or Low Birth Weight – Babies who are born prematurely may have neurological, respiratory, and immunological systems that are not as fully developed as those who are full-term. Premature and low weight babies are at high risk for dying from pertussis whooping cough disease but may also be at higher risk for adverse responses to pertussis vaccination.

A 2006 study of preterm infants (defined as newborns born before or at 32 weeks gestation) found an increase in adverse cardiorespiratory events such as desaturations, bradycardia, and apnea in the first 72 hours following the first dose of a combination Diphtheria, tetanus, pertussis, inactivated polio and HIB vaccine. The risk was determined to be similar for acellular pertussis vaccine versus whole cell pertussis vaccine.  Lower current weight was found to be a risk for adverse events and the study suggested that vaccination should occur at least 72 hours prior to discharge from the hospital.  

A 2012 Dutch study found that nearly 25 percent of preterm infants born before 33 weeks gestation experiences bradycardia or a slight decrease in oxygen saturation following vaccination at 2 months. 7 percent, however, experienced a moderate cardiorespiratory event requiring stimulation. The study found that younger and lower birth weight infants experienced higher adverse events following vaccination. 

Several pertussis containing vaccines on the market today, list apnea as a reported adverse event and also advise caution when vaccinating premature babies with some pertussis containing vaccines. 

Cerebral Irritation in the Neonatal Period – Newborn babies can exhibit cerebral irritation following birth, including high pitched screaming (encephalitic cry) with arching of the back, depressed consciousness and other neurological signs. A difficult labor and birth can cause cerebral irritation as can inflammation of the brain from meningitis or other infection. An infant with symptoms of cerebral irritation after birth may be manifesting evidence of a weakened or damaged neurological system that may be especially vulnerable to the inflammatory effects of the pertussis vaccine. 

In years past, the British department of Health and Social Security stated that pertussis vaccination "should not be carried out in children who have … a history of cerebral irritation or damage in the neonatal period."

A Personal or Family History of Severe Allergies and Autoimmune Disorders – A healthy, mature immune system requires an equal balance of cellular (Th1 - innate) and humoral (Th2 - learned) immune system responses to prevent inflammatory responses from remaining unresolved and causing chronic illness. A disruption in immune function can lead to chronic inflammation and development of allergy or autoimmune disorders. 

Vaccination does not exactly mimic the natural infection process and often bypasses cellular immunity in favor of humoral immunity (measured by antibodies in the blood). There have been persistent reports that some individuals may be at risk for developing autoimmune disorders after vaccination. 

In more than 70 years of scientific literature reporting complications of pertussis vaccine, there have been reports by some researchers that a history of severe allergies or autoimmune disorders in a child or his family (eczema, asthma, hay fever, milk allergy) may predispose a child to reacting to the pertussis vaccine. In England in past decades, a personal or family history of allergies was considered a contraindication.

Dow Chemical Company’s DPT product insert in the 1960s stated "fractional doses are recommended in infants with cerebral injury, asthma, a strong family history of allergy …"

In 1961, Hopper found that in a group of babies who reacted strongly to the pertussis vaccine, there was twice as much eczema, asthma, hay fever, and allergic skin rashes in the child, his brothers and sisters, parents, and grandparents as there was in a control group of the same size.  

In 1969, Hannik found a positive family history of allergies in a significant proportion of infants who reacted with high-pitched screaming, shock and convulsions. 

In 2000, a study comparing the health of vaccinated and unvaccinated children between 1988 and 1994 found that a child who received DPT or tetanus vaccination was 50 percent more likely to experience severe allergic reactions, more than 80 percent more likely to experience sinusitis, and twice as likely to experience asthma as those who were not vaccinated. The conclusion of the authors was that “asthma and other allergic hypersensitivity reactions and related symptoms may be causes, in part, by the delayed effects of DTP or tetanus vaccination.”  

A healthy, mature immune system requires an equal balance of cellular (innate) and humoral (learned) immune system responses so that inflammatory responses do not remain unresolved and cause chronic illness. A disruption in immune function can lead to development of allergy and autoimmune disorders. Vaccination does not exactly mimic the natural infection process and often bypasses cellular immunity in favor of humoral immunity. There have been persistent reports of development of autoimmune disorders and allergy after vaccination, including pertussis vaccination.  

Milk Allergy (Casein Intolerance) – Studies have identified genetic susceptibility to pertussis vaccine induces encephalopathy involving genes of the major histocompatibility complex correlating to genetic regulation of antibody responses to bovine serum albumin (a cow’s milk protein).  

A personal or family history of allergies, particularly milk (casein) allergy, may be one high risk factor for reacting to pertussis vaccine. There were many cases of pertussis vaccine injury documented in the 1985 book DPT: A Shot in the Dark   of children, who had milk allergy before or developed milk allergy after suffering a serious DPT vaccine reaction. Casein is a protein in milk and symptoms of milk allergy include frequent spitting up of milk after bottle or breast feeding; projectile vomiting of milk; frequent diarrhea; constipation; gas and abdominal pain; persistent crying after feedings (colic); eczema or recurrent skin rashes. 

Is Tdap vaccine safe during pregnancy?

For many years, pregnancy was also a contraindication to pertussis vaccine but, today, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC) recommends pertussis vaccine for all pregnant women. Currently, the ACIP recommends that pregnant women receive a dose of Tdap vaccine between 27 and 36 weeks gestation, during each pregnancy, regardless of a previous history of Tdap vaccine.  However both Tdap vaccines are FDA approved to be administered as a single dose, and the CDC’s recommendation that every pregnant woman receive a Tdap vaccination during every pregnancy - regardless of whether a woman has already received a dose of Tdap- is an off-label use of the vaccine. 

Drug companies did not test the safety and effectiveness of giving Tdap vaccine to pregnant women before the vaccines were licensed in the U.S.   and there is almost no data on inflammatory or other biological responses to these vaccines that could affect pregnancy and birth outcomes.  In fact, product inserts for both Adacel and Boostrix, the two available Tdap vaccines for children and adults, including pregnant women, both state that safety and effectiveness have not been established in pregnant women.  

Adacel vaccine is considered a Pregnancy Category C biological. According to the U.S. Department of Health and Human Services, Category C biologicals are products where ” Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.”   No animal reproduction studies have been completed on Adacel and it is unknown if this vaccine can cause fetal harm or impair reproduction.  Sanofi Pasteur, the manufacturer of Adacel, warns that this vaccine should “be given to a pregnant woman only if clearly needed.” 

Boostrix vaccine is considered a Pregnancy Category B biological. According to the U.S. Department of Health and Human Services, Category B biologicals are products where “Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.”  Toxicity studies performed on female rats found no evidence of fetal harm, however, no well-controlled and adequate studies have been completed on pregnant women.  GlaxoSmithKline, the manufacturer of Boostrix, also warns that this vaccine should “be given to a pregnant woman only if clearly needed.” 

There are ingredients in the pertussis containing Tdap vaccines that have not been fully evaluated for potential genotoxic  or other adverse effects on the human fetus developing in the womb that may negatively affect health after birth, including aluminum adjuvants and many more bioactive and potentially toxic ingredients.          As well, there are no published biological mechanism studies that assess pre-vaccination health status and measure changes in brain and immune function and chromosomal integrity after vaccination of pregnant women or their babies developing in the womb. 

Since licensure of Tdap vaccines in the U.S., there have been no well-designed prospective case controlled studies comparing the health outcomes of large groups of women who get pertussis containing Tdap vaccines during pregnancy either separately or simultaneously with influenza vaccine, compared to those who do not get the vaccines, and no similar health outcome comparisons of their newborns at birth or in the first year of life have been conducted. Safety and effectiveness evaluations that have been conducted are either small,  or have been performed by drug company or government health officials using unpublished data. 

A 2017 review of 15 published articles, including 2 randomized controlled trials and 13 observational studies determined that while vaccination boosted maternal antibodies, evidence was lacking on whether or not this had any impact on reducing the incidence of pertussis, serious complications from pertussis, or death in infants. 

Vaccine manufacturers, doctors, and other vaccine providers are shielded from vaccine injury lawsuits , however, it is unclear whether injuries sustained by an unborn child in the womb will qualify for federal vaccine injury compensation.  The Health Resources & Services Administration (HRSA) is seeking public comment until October 1st pertaining to “Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table.” 

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Who Should Not Get Pertussis Vaccine?

For the first 40 years of use of whole cell pertussis (DPT) vaccine, ABSOLUTE CONTRAINDICATIONS to pertussis vaccination included :

  • Temperature of 103 F. or higher within 48 hours after getting a DPT shot;
  • Seizure within 3 days after getting a DPT shot;
  • Collapse or shock-like state (hypotonic hyporesponsive episode) with 48 hours of getting a DPT shot;
  • High pitched screaming or inconsolable crying within 48 hours of getting a DPT shot;
  • Acute illness with fever

After the 1986 National Childhood Vaccine Injury Act was passed by Congress creating a federal vaccine injury compensation program and shielding vaccine manufacturers and doctors giving vaccines from civil vaccine injury lawsuits, by 1991, these absolute CONTRAINDICATIONS to receipt of pertussis containing vaccines were re-categorized as “PRECAUTIONS” and parents were told to speak with their doctor about further vaccinations.  

In general, the same high risk factors and contraindications for whole cell pertussis vaccine (DPT) are also considered high risk factors and contraindications for DTaP, Tdap or other combination shots containing acellular pertussis vaccine. There may be other circumstances, which could place a child or adult at higher risk for reacting to pertussis vaccine that are not officially recognized by the CDC’s Advisory Committee on Immunization Practices (ACIP), the vaccine manufacturers or the American Academy of Pediatrics. You may want to do your own research and access medical studies on the Internet or visit a medical library at a community hospital or university to gain access to the medical literature.

The vaccine manufacturer product information inserts contain the most complete information about contraindications and precautions for use of pertussis vaccine. However, federal health officials at the CDC also publish information about what they consider to be contraindications and precautions for use of pertussis containing vaccines, including DTaP and Tdap.

The CDC lists the following CONTRAINDICATIONS to getting pertussis containing (DTP, DTaP, Tdap) vaccines:  

  • Those who have had a life-threatening allergic reaction after a previous dose of DPT, DTaP or Tdap should not get another dose.
  • Persons who have a severe allergy to any vaccine component
  • Those who have suffered a brain or nervous system disease (brain inflammation, coma, convulsions, encephalopathy) within 7 days after a dose of DPT or DTaP should not another dose of pertussis containing vaccine.

The CDC lists the following PRECAUTIONS to getting a pertussis containing vaccine (DTP, DtaP/Tdap):  

  • Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy; defer DTaP until neurologic status clarified and stabilized.
  • Temperature of ≥105° F (≥40.5° C or higher) within 48 hours after vaccination with a previous dose of DTP or DTaP
  • Collapse or shock-like state (i.e., hypotonic hyporesponsive episode) within 48 hours after receiving a previous dose of DTP/DTaP
  • Seizure ≤3 days after receiving a previous dose of DTP/DTaP
  • Persistent, inconsolable crying lasting ≥3 hours within 48 hours after receiving a previous dose of DTP/DTaP
  • GBS <6 weeks after a previous dose of tetanus toxoid-containing vaccine
  • History of arthus-type hypersensitivity reactions after a previous dose of tetanus or diphtheria-toxoid containing vaccines (including MCV4); defer vaccination until at least 10 years have elapsed since the last tetanus toxoid-containing vaccine
  • Moderate or severe acute illness with or without fever

It is important for parents to know what constitutes a severe reaction to a pertussis vaccine containing shot because it is generally agreed by vaccine policy makers that those who react severely should not receive the "P" or pertussis portion of the DPT, DTaP or Tdap shot again. For subsequent boosters, only the "D" (diphtheria) and "T" (tetanus) portion of the shot may be given.  While the CDC currently recognizes the capability of pertussis vaccination to cause serious reactions and has issued a list of contraindications and precautions to vaccination, the World Health Organization (WHO) has opted to eliminate nearly all contraindications to giving children any pertussis containing vaccine. In 2015, the World Health Organization published a new pertussis vaccine position and in doing so, global public health officials rejected nearly a century of scientific evidence documenting the toxicity and risks of whole cell pertussis vaccine, stating that except for anaphylaxis, no contraindications exist to giving children any type of pertussis-containing vaccine.  Positions such as these ones make it even more important for individuals and parents to educate themselves to determine the personal risk that pertussis vaccination may have on themselves and their children.

Sickness at Time of Vaccination – When a person has a coinciding viral or bacterial infection at the time of vaccination, the body may not mount an antibody response and fail to provide any protection. In addition, when a child or adult is sick at the time of vaccination and an even more serious health problem develops following vaccination, there may be confusion about whether the new health problem is related to the vaccination, to the infection present at the time of vaccination, or a combination of the two.

In order to ensure that your child is healthy at the time of vaccination, make sure a doctor gives your child a careful physical exam before giving shots. This should include taking a temperature and a thorough exam of your child’s throat and ears. Be sure to mention any illness, however slight, that your child has had in the previous months or if you or a member of your family may have an infection to which your child has been exposed.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

What Questions Should I ask my Doctor About the Pertussis Vaccine?

questions

NVIC’s If You Vaccinate, Ask 8! Webpage downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your child. If you review these questions before your appointment, you will be better prepared to ask your doctor questions.  Also make sure that the nurse or doctor gives you the relevant Vaccine Information Statement (VIS) for the vaccine or vaccines you are considering well ahead of time to allow you to review it before you or your child gets vaccinated. Copies of VIS for each vaccine are also available on the CDC's website and there is a link to the VIS for DTaP, Tdap and Multi vaccines on NVIC's “Quick Facts” at the top of this page.

The pertussis (whooping cough) vaccine is included as a component in “combination” shots that may include tetanus and diphtheria (DPT, DTaP, Tdap) or polio, hepatitis B, and/or Haemophilus Influenza B (Hib). Check with the person who will give the shot containing pertussis vaccine to make sure which vaccine(s) you or your child are being given.

It is also a good idea to read the vaccine manufacturer product insert that can be obtained from your doctor or public health clinic because federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts that may not be available in other published information. Vaccine product inserts are located on the Food and Drug Administration’s website. A review of the vaccine product insert to determine whether any contraindications and/or precautions to vaccination exists is also important. More information on contraindications and precautions to vaccination can be found here.

Other questions that may be useful to discuss with your doctor before getting the pertussis (DTaP/Tdap) vaccine are: 

  • If other vaccines in addition to DTaP/Tdap vaccine are scheduled for my child at this office visit, am I allowed to modify the schedule so fewer vaccines are given at once?
  • What should I do if my child has a high fever or appears very ill after vaccination?
  • What other kinds of reaction symptoms should I call to report after DTaP/Tdap vaccination?
  • If the DTaP/Tdap vaccine doesn’t protect my child, do I have any other options for preventing pertussis infection?

Under the National Childhood Vaccine Injury Act of 1986, doctors and all vaccine providers are legally required to give you vaccine benefit and risk information before vaccination; record serious health problems following vaccination in the permanent medical record; keep a permanent record of all vaccines given, including the manufacturer’s name and lot number; and report serious health problems, injuries and deaths that follow vaccination to VAERS.


Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination, and keep vaccination records in a file you can access easily.  

It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS). NVIC’s Report Vaccine Reactions—It’s the Law webpage can help you file a vaccine reaction report yourself to VAERS if your doctor fails or refuses to make a report.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

NVIC Press Releases, Statements & Commentaries Related to Pertussis

Report Harassment to NVIC

Has your doctor or a vaccine provider refused to report a serious health problem after vaccination to the federal Vaccine Adverse Event Reporting System (VAERS), or discouraged you from reporting a vaccine reaction you or your child experienced?

Have you been threatened or harassed for making vaccine decisions that does not conform with your doctor’s opinion?

NVIC supports your right to make informed, voluntary health care decisions. To make a report of harassment for making informed vaccination choices to NVIC, click here.

NVIC Reports & Referenced Video Commentaries

The Vaccine Reaction

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Pertussis (Whooping Cough) Disease & Vaccine Quick Facts

Pertussis (whooping cough)

  • Pertussis, commonly referred to as whooping cough, is a respiratory disease caused by the Bordetella (B.) pertussis bacterium. B. pertussis bacteria attach themselves to the mucus membranes of the respiratory tract and cause inflammation in the body.  Only a lab test will positively confirm the exact organism causing the whooping cough symptoms. 
  • Pertussis whooping cough is highly contagious. Whooping cough disease circulates all year long, however, in North America, more cases are diagnosed in the summer and fall. 
  • Whooping cough disease is transmitted from person to person through coughing, sneezing and by coming into direct contact with nasal secretions and mucus from the respiratory tract of a person who is actively contagious. People are most contagious in the early stages when symptoms may be mild and include only a stuffy or runny nose and nagging, dry cough. 
  • The major symptom of B. pertussis whooping cough disease is uncontrollable coughing. In advanced stages, thick mucous develops in the lungs and clogs air passages, triggering violent episodes of coughing, choking and vomiting up of mucous followed by a high-pitched intake of breath that sounds like "whoop." With whooping cough disease, it is possible to have such violent coughing spells, especially at night,   where large amounts of mucous are vomited up through the mouth and nose and interfere with breathing. The fatality rate for B. pertussis whooping cough disease is highest in infants under six months of age.  Older children and adults can suffer rib fractures from violent coughing fits.  Permanent health problems resulting from whooping cough disease can include brain inflammation,  seizure disorders,  mental retardation, learning disabilities, ADD/ADHD and other chronic illness. 
  • There are no prescription drugs that cure pertussis, but many doctors routinely prescribe antibiotics to try to reduce a person’s ability to transmit the disease to others. Antibiotics are also given to help prevent secondary infections such as bronchitis, pneumonia, and otitis media (inner ear infection). In the past, these complications caused many of the deaths following whooping cough.   
  • In 1922, there were 107,473 pertussis cases reported in the U.S. with 5,099 deaths.  In the United States, deaths from pertussis infections dropped by more than 75% between 1922 and 1948, the year beforethe DPT vaccine was licensed. Mortality associated with pertussis declined dramatically in the 1940’s as living conditions improved. 

Pertussis Vaccine

  • In the U.S. today, pertussis vaccine is administered only in a combination shot (DTaP, Tdap) that contains vaccines for diphtheria (D), tetanus (T), and pertussis (whooping cough) (P). A pertussis vaccine containing shot is routinely given in the U.S. six times: at two, four, and six months old; between 15 and 18 months old; and between four and six years old. Another booster dose is given at 12-13 years of age (Tdap). The ACIP also recommends that pregnant women receive a dose of Tdap vaccine during each pregnancy, between 27 and 36 weeks gestation, regardless of a previous history of Tdap vaccine.  However, this recommendation contradicts the information provided by the vaccine manufacturers statement that the safety and effectiveness of vaccination has “not been established in pregnant women”.   
  • There are currently nine different pertussis vaccines licensed in United States.  DTaP/Tdap vaccines packaged in single dose vials contain reduced bioactive pertussis toxin, less endotoxin than the DTP vaccine, and may contain trace amounts of mercury, along with an aluminum adjuvant. Depending upon the vaccine manufacturer, vaccines containing pertussis may contain varying amounts of inactivated pertussis toxin, filamentous hemagglutinin (FDA), pertactin, fimbriae, formaldehyde, polysorbate 80 (Tween 80), gluteraldehyde, 2-phenoxoyethanol, aluminum and thimerosal (mercury). 
  • IMPORTANT: Parents should monitor their children carefully day and night for at least 72 hours after vaccination.  Pertussis vaccine has been documented to cause high fever; severe local reactions at the site of the injection; high pitched screaming and uncontrollable crying; collapse/shock (hypotonic/hyporesponsive episode); lethargy (excessive sleepiness); convulsions with or without fever; and brain inflammation (encephalopathy). 
  • According to the CDC, in 2017, out of a U.S. population of 326 million people, there were 15,808 reported cases of pertussis including 13 deaths, with 4 deaths occurring in infants under age one year.  Out of 3,663 cases occurring in children from six months of age through six years of age, 44 percent of cases occurred in children who had completed the primary DTaP series  and there are reported increases in whooping cough disease in the U.S. and other countries, no matter how high the vaccination rate. 
  • As of November 1, 2022, there had been 5,987 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following pertussis-containing vaccination, including 864 deaths and 5,123 serious injuries.
  • Using the MedAlerts search engine, as of October 31, 2022, there had been 180,025 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with pertussis-containing vaccines since 1990. Nearly half of those serious pertussis vaccine-related adverse events occurring in children under the age of three. Of these pertussis-vaccine related adverse event reports to VAERS, 3,286 were deaths, with nearly 86 percent of the deaths occurring in children under three years of age.

Food & Drug Administration (FDA)

Centers for Disease Control (CDC)

National Institute of Allergy & Infectious Diseases (NIAID)

Search for Vaccine Reactions

NVIC hosts MedAlerts, a powerful VAERS database search engine. MedAlerts examines symptoms, reactions, vaccines, dates, places, and more.

Reporting a Vaccine Reaction

Since 1982, the NVIC has operated a Vaccine Reaction Registry, which has served as a watchdog on VAERS. Reporting vaccine reactions to VAERS is the law. If your doctor will not report a reaction, you have the right to report a suspected vaccine reaction to VAERS.

Vaccine Reaction Symptoms & Ingredients

Our Ask 8, If You Vaccinate webpage contains vaccine reaction symptoms and more.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

Bibliography & Resource Links

Manufacturer Product Information Inserts:

  • GlaxoSmithKline Infanrix (Diphtheria, Tetanus, Pertussis combined)
  • Sanofi Pasteur DAPTACEL (Diphtheria, Tetanus, Pertussis combined)
  • GlaxoSmithKline Pediarix (Diphtheria, Tetanus, Pertussis, Hepatitis B, Inactivated Polio combined)
  • GlaxoSmithKline KINRIX (Diphtheria, Tetanus, Pertussis, Inactivated Polio combined)
  • Sanofi Pasteur Pentacel (Diphtheria, Tetanus, Pertussis, Inactivated Polio, Haemophilus B combined)
  • Sanofi Pasteur Quadracel (Diphtheria, Tetanus, Pertussis, Polio combined)
  • MCM Vaccine Company VAXELIS (Diphtheria, Tetanus, Pertussis, Inactivated Polio, Haemophilus b conjugate, Hepatitis B combined)
  • Sanofi Pasteur Adacel Tdap (Tetanus, Diphtheria, Pertussis combined)
  • GlaxoSmithKline Boostrix (Tetanus, Diphtheria, Pertussis combined)

Books

  • DPT: A Shot in the Dark by Harris L. Coulter and Barbara Loe Fisher (Harcourt Brace Jovanovich, 1985; Warner, 1986; Avery 1991; Penguin Books)
  • Vaccines, Autism & Chronic Inflammation: The New Epidemic by Barbara Loe Fisher (2008)

World Health Organization

Selected Medical Literature

IMPORTANT NOTE: NVIC encourages you to become fully informed about Pertussis and the Pertussis vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

 

 

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