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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).1 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,2 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”.3 4

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.5 This vaccine was replaced with a purified, less reactive acellular DTaP vaccine in 1996.6 (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.7

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,8 and contains neurotoxic aluminum9 and mercury10 along with shock-inducing endotoxin,11 12 and brain damaging bioactive pertussis toxin.13 14 15

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.16

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).17

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.18

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 eight 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.
  • 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-BarrĂ© 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 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.

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References

1 CDC Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Apr. 27, 2018 / 67(2);1–44

2 Ibid

3 FDA Boostrix Product Insert. Apr. 25, 2016

4 FDA Adacel Product Insert Sept. 29, 2017

5 Institute of Medicine. Pertussis and Rubella Vaccines: A Brief Chronology (Appendix B, pp. 320) In: Adverse Effects of Pertussis and Rubella Vaccines. The National Academies Press 1991.

6 CDC Pertussis Vaccination: Use of Acellular Pertussis Vaccines Among Infants and Young Children Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. Mar. 28, 1997  46(RR-7);1-25

7 Patel MK, Patel TK, Tripathi CB. Diphtheria, pertussis (whooping cough) and tetanus vaccine induced recurrent seizures and acute encephalopathy in a pediatric patients: Possibly due to pertussis fraction. J Pharmacol Pharmacother 2012; 3(1): 71-73.

8 US National Library of Medicine. Formaldehyde (formalin). PubChem Open Chemistry Database Sept. 1, 2018.

9  Mold M, Shardlaw E, Exley C. Insight into the cellular fate and toxicity of aluminum adjuvants used in clinically approved human vaccinations. Sci Rep 2016; 6: 31578.

10 Burbacher TM, Shen DD et al. Comparison of Blood and Brain Mercury Levels in Infant Monkeys Exposed to Methylmercury or Vaccines Containing ThimerosalNational Center for Biotechnology Information, U.S. National Library of Medicine Apr. 21, 2005.

11  Geier DA, Geier MR. Clinical Implications of Endotoxin Content in Vaccines. Ann Pharmacother 2002; 36(5).

12  Brito LA, Singh M. Acceptable Levels of Endotoxin in Vaccine Formulations During Preclinical Research. J. Pharm. Sci 2011; 100(1): 34-37.

13 Steinman L, Weiss A et al. Pertussis toxin is required for pertussis vaccine encephalopathy. Proc Natl Acad Sci 1985; 82(24): 8733-8736.

14 Munoz JJ, Arai H. Biological Activity of Crystalline Pertussigen from Bordetella pertussis. Infect Immunity 1981; 33(3): 820-826.

15 Donnelly S, Loscher CE et al. Whole cell but Not Acellular Pertussis Vaccines Induce Convulsive Activity in Mice: Evidence for a Role for Toxin-Induced Interleukin-1B in a New Murine Model for Analysis of Neuronal Side Effects of Vaccination. Infect Immun 2001; 69(7): 4217-4223.

16 CDC. Vaccine Excipients & Media Summary (Vaccine Ingredients).Appendix B.The Pink Book, 13th Edition, June 2018

17 Ibid

18 FDA Vaccines Licensed for Use in the United States. Mar. 29. 2018


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