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Tetanus Overview

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Tetanus: The Disease

Tetanus (lockjaw) disease is caused by Clostridium tetani (C. tetani), an anerobic, gram-positive, bacteria that can develop into a spore. Tetanus spores can be found in soil, manure, and the digestive tracts of animals and humans. Additionally, tetanus has also been reportedly found in contaminated heroin and on skin surfaces. Tetanus bacteria do not survive in the presence of oxygen, however, are quite resistant to most chemicals and even heat. Puncture wounds, which do not bleed very much and are protected by tissue and skin from direct exposure to oxygen, can be the perfect environment for tetanus bacteria to multiply and cause infection.

The incubation period for tetanus infection, from exposure to the appearance of the initial symptoms, ranges from three days to three weeks. Initial symptoms include muscular stiffness of the jaw and neck, headache, seizures, changes in heart rate and blood pressure, fever, and chills. Complications include fractures, vocal cord spasms, impaired breathing, pulmonary embolism, pneumonia, infections acquired in the hospital during treatment, and death. Learn more about Tetanus…

Tetanus Vaccine

In the U.S. today, tetanus vaccine is available in combination with other vaccines. There are 10 different tetanus-containing vaccines available for use in the U.S. with differing use rules based on age groups. The U.S. Centers for Disease Control (CDC) currently recommends children receive 5 doses of tetanus-containing vaccines between two months of age and 12 years of age and a dose every ten years thereafter throughout adulthood. In an effort to reduce pertussis rates in infants, the CDC also recommends a dose of the tetanus-containing vaccine Tdap during each pregnancy, regardless of a previous history of Tdap vaccine. Learn more about Tetanus vaccine…

Tetanus Quick Facts

Tetanus

Since the early 1900s, reported tetanus deaths dramatically declined prior to the introduction of vaccines in the late 1940s. Factors contributing to the decline include improvements in wound care, use of tetanus immune globulin (TIG), and decreases in exposure due to population movement from rural to urban environments.
Tetanus is not contagious and cannot be transmitted from person to person. Tetanus bacteria can enter the body when a person sustains a deep cut, or even a burn. Rarely, it can also occur following abortions, elective surgeries, ear infections, pregnancy, dental infections, animal bites, and crush wounds. Continue reading quick facts…

Tetanus Vaccine

According to the CDC, common tetanus vaccine reactions include injection-site redness, pain, and swelling at the site of the injection. However, if the pain and swelling is significant and extends from the shoulder to the elbow, the CDC warns that additional tetanus toxoid vaccination should not be more frequent than every 10 years. Additional serious reported side effects following tetanus toxoid vaccination include anaphylaxis, brachial neuritis, Guillain-Barre Syndrome (GBS), acute disseminated encephalomyelitis (ADEM), arthritis and myocarditis.
The CDC reports that a single dose of tetanus toxoid will likely not protect a person from developing tetanus but that three tetanus toxoid vaccine doses should induce vaccine acquired blood antibody levels considered to be protective against tetanus disease in nearly all individuals. Vaccine acquired tetanus blood antibody levels, however, decrease with time and within 10 years, most individuals may only have blood antibody levels considered minimally protective against tetanus disease. Testing of antibodies in the blood can demonstrate the presence of an immune response to a particular pathogen such as tetanus, but it does not determine the level of protection that a person might have or how long protection might last. Continue reading quick facts…

NVIC encourages you to become fully informed about Tetanus and the Tetanus 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 Tetanus?

The tetanus bacteria, C. tetani, produces two exotoxins, tetanolysin, and tetanospasmin. At this time, the exact function of tetanolysin is unknown. However, tetanospasmin exotoxin is the neurotoxin responsible for the clinical symptoms of tetanus.

Tetanus bacteria do not survive in the presence of oxygen; however, the bacteria are quite resistant to most chemicals and heat. Puncture wounds, like animal bites that do not bleed very much and are protected by tissue and skin from direct exposure to oxygen can be the perfect environment to cause an infection.

Once infected, the tetanus spores multiply and produce toxins that spread throughout the body. The incubation period for tetanus infection, from exposure to the appearance of the first symptoms, ranges from three days to three weeks. Initial symptoms include muscular stiffness of the jaw and neck, headache, seizures, heart rate and blood pressure changes, fever, and chills. Complications include fractures, vocal cord spasms, impaired breathing, pulmonary embolism, pneumonia, infections acquired in the hospital during treatment, and death.

There are four recognized forms of tetanus disease. The most common form of tetanus is generalized tetanus, which is responsible for approximately 80 percent of cases. Initial symptoms involve jaw muscle spasms, frequently referred to as “lockjaw.” Muscle spasms involving the extremities, neck, and trunk may also occur. Complications of generalized tetanus can include severe muscle spasms and neurological abnormalities, resulting in prolonged hospital stays and even death.

Localized tetanus is less common and more mild form of the disease that involves muscle spasms near a wound. This form of the disease is often associated with persons previously vaccinated against tetanus and can potentially progress into generalized tetanus.

Cephalic tetanus is a rare but serious form of the disease associated with ear infections or head wounds. Cephalic tetanus typically presents as a cranial nerve palsy and may progress to localized or even generalized tetanus.

Neonatal tetanus, while nearly non-existent in the United States, continues to be a threat to infants born in developing countries. Neonatal tetanus results primarily when childbirth occurs in unsanitary conditions and the umbilical cord becomes contaminated. Symptoms typically develop within one week, with infants noted to be irritable, difficult to feed, and may have rigidity with spasms.

Since the early 1900s, reported tetanus deaths dramatically declined prior to the introduction of vaccines in the late 1940s. Factors contributing to the decline include improvements in wound care, use of tetanus immune globulin (TIG), and decreases in exposure due to population movement from rural to urban environments.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Tetanus and the Tetanus 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 Tetanus contagious?

No, tetanus is not contagious and cannot be spread from person to person. There are no laboratory findings to confirm tetanus and a diagnosis is based clinical symptoms. Only about 30 percent of wounds in patients diagnosed with tetanus are found to be positive for the tetanus bacteria.

The disease that is contracted when a person becomes exposed to the tetanus bacterium (Clostridium tetani) through a break in the skin. As tetanus is unable to survive in the presence of oxygen, tetanus spores can only develop in the absence of oxygen. Wounds that do not bleed very much and are protected by tissue and skin from direct exposure to oxygen are more favorable environments for tetanus bacteria to multiple and spread throughout the body.

Puncture wounds, wounds contaminated with saliva, feces or dirt, crush wounds, burns, and injuries that result in tissue death are most frequently associated with tetanus.

Less commonly, a person can be exposed to tetanus from surgical wounds, compound fractures, intramuscular injections, intravenous drug use, insect bites, dental infections, chronic sores, and superficial wounds.

Tetanus is most commonly found in the soil as well as in the intestines of both animals and humans. Tetanus disease can occur anywhere in the world; however, it is more commonly found in regions that are hot, damp, highly populated, and have soil rich in organic matter. Tetanus disease occurs more frequently during the summer or wet season.

What is the history of Tetanus in America and other countries?

The first clinical description of tetanus disease dates back to records from 5^th century BC, however it was 1884 before experiments with tetanus were published and reported on within the medical community. In 1884, two Italian scientists were able to cause tetanus infections in animals by injecting them with pus originating from a case of fatal human tetanus disease. Also in 1884, German physician Arthur Nicolaier induced tetanus in mice by injecting them with tetanus contaminated soil.

In 1889, Japanese bacteriologist and physician Kitasato Shibasaburo isolated the tetanus bacteria from a human victim of the disease, confirmed its ability to cause the disease when injected into animals, and proved that the bacteria could only reproduce in environments that did not contain oxygen.

Following isolation of the tetanus bacteria, pharmaceutical companies began developing anti-serums against tetanus. By the early 1900’s, several pharmaceutical companies had tetanus anti-serums available for use against tetanus. Anti-serums were often produced in horses, and when antibodies developed, the horses were bled to harvest the serum antitoxins for use in the treatment of tetanus disease.

In World War I, soldiers were often administered tetanus anti-serums for both the prevention of as well as for the treatment of tetanus disease. World War I battles were frequently fought in fields and trenches, and soldiers often sustained shrapnel wounds which enhanced the risk of tetanus disease. Due to the significant risk of tetanus disease among enlisted men, military physicians felt it necessary to use tetanus anti-toxins and even experimented on soldiers using varying strengths and numbers of doses in the hopes of both treating and preventing tetanus disease in the battlefield. As a result, many soldiers suffered from serum sickness and even allergic reactions from the use of tetanus anti-serums. The first vaccine targeting tetanus disease, the tetanus toxoid (TT), was developed in 1924 but did not become commercially available until 1938.

Significant decreases in mortality rates from tetanus disease in the United States have been noted by public health officials since the early 1900’s, however, the disease did not become nationally notifiable until 1947. In 1948, there were 601 cases of tetanus reported in the U.S., the highest number of cases ever reported in a single year. After the 1940s, the incidence of tetanus disease declined steadily and by the mid-1970s, an average of 50–100 cases (~0.05 cases per 100,000) were reported annually.

Between 1982 and 1984, there were a total of 253 reported tetanus cases in the United States. Of the 224 reported cases where age demographic information was provided, 159 cases (71 percent) occurred in adults 50 years of age and older, while 56 cases (25 percent) occurred in adults 20 to 49 years of age. Six cases were reported in persons under the age of 19, including three cases of neonatal tetanus. Twenty-six percent of individuals who developed tetanus died and all deaths occurred in persons over the age of 30, with the majority of deaths (52 percent) occurring among adults 60 years and older. Eleven individuals who developed tetanus disease had previously received at least three doses of tetanus toxoid vaccine. Of the 56 individuals who received wound debridement following the injury but prior to the onset of tetanus, 55 were considered candidates to receive both the tetanus immune globulin (TIG) and the recommended tetanus-diphtheria (Td) vaccine, yet healthcare providers failed to administer the recommended TIG in all cases and administered Td vaccine in only 40 percent of the cases.

In 1987 and 1988, there were 101 reported cases of tetanus disease (48 cases in 1987 and 53 in 1988). Age demographics were reported in 99 cases, with 67 cases occurring in adults 50 years of age and older and six cases reported in children under 20 years of age. The case fatality rate was reported at 21 percent. Of the 48 cases where vaccine status was known, 29 reported no prior tetanus vaccination. In the tetanus cases involving persons under the age of 20, half (3 out of the 6 cases) had received at least three doses of tetanus toxoid vaccine. In the 14 cases where wounds were serious enough to warrant wound debridement, health care providers failed to administer the recommended tetanus immune globulin (TIG) in all cases and administered Td vaccine in only eight cases (57 percent).

Between 2001 and 2008, there were a total of 233 reported cases of tetanus disease (average of 29 cases per year). Of the 197 cases where outcomes were known, 26 (13.2 percent) were fatal. Vaccination status was known for 92 out of the 233 cases (39.5 percent). 55 individuals (59.3 percent) reported receiving at least one dose of a tetanus toxoid vaccine (TT), with 24 (26.1 percent) reported having received at least four or more doses. Of the 195 cases where medical information was known, 30 cases (15.4 percent) occurred in individuals with diabetes. In 176 cases where data was known in regards to injection drug use, 27 cases (15.4 percent) involved injection drug users. One third of persons with an acute wound sought medical treatment, however, fewer than four percent received the recommended treatment protocol of either tetanus toxoid (TT) vaccine or TT vaccine in combination with TIG.

From 2009 through 2017, there were an average of 29 tetanus cases and approximately two deaths each year. Tetanus cases occurred most frequently among adults between the ages of 20 and 29, however all tetanus related deaths were reported in persons over the age of 55. In 2019, there were 26 cases of tetanus reported in the United States.

In 2019, there were an estimated 34,684 tetanus-associated deaths globally, with approximately half of all deaths occurring in children under the age of five.

Can Tetanus cause injury and/or death?

Tetanus is a very serious disease requiring hospitalization and medical treatments. Symptoms of tetanus include:

Headache
Fever and sweating
Jaw cramping
Muscle spasms, commonly involving the stomach
Painful muscle stiffness throughout the entire body
Difficulty swallowing
Seizures
Blood pressure and heart rate changes

Complications of tetanus include:

Bone fractures
Vocal cord spasms
Infections acquired in the hospital during the course of treatment
Pulmonary embolism
Pneumonia
Breathing difficulties
Death

Tetanus is a rare disease in the United States and rates of the disease have decreased by 95 percent. Since 1947, tetanus associated fatalities have declined by 99 percent. While most people who develop tetanus recover fully from the disease, full recovery can take between two and four months.

Who is at highest risk for getting Tetanus?

Individuals most at risk for developing tetanus include:

Those injured with an item that may be contaminated with tetanus
Persons who undergo medical treatments in unsanitary conditions
Anyone who inject themselves with drugs, including diabetics
Intravenous (IV) drug users
Persons who are immunocompromised

Who is at highest risk for suffering complications from Tetanus?

Individuals who are more likely to have complications include:

Those who experience a disease onset within two days
Persons who have a tetanus incubation period of less than one week
A narcotics addiction
A diagnosis of generalized tetanus
Individuals who sustained tetanus through surgical wounds, abortion, burns, compound fractures, and intramuscular injection
Newborns who develop tetanus by means of their umbilical stump
Persons who develop fever greater than 104 F (40 C)
Individuals, including newborns, who experience elevated heart rates (tachycardia)

Cephalic and neonatal tetanus are considered the most serious and life-threatening forms of the disease and individuals who require mechanical ventilation as a result of tetanus have been noted to be at higher risk of death from the disease.

Can Tetanus be prevented and are there treatment options?

Prevention

Proper wound care is essential to preventing tetanus. If wounds are dirty or deep, prompt medical attention is recommended. Unclean wounds should not be covered with bandages as this may enhance the risk of wound infection by tetanus or other bacteria.

Medical treatment options for serious wounds where the presence of tetanus bacteria may be higher include: thorough wound care to remove any foreign objects, dirt, or dead tissue; administration of human tetanus immune globulin (TIG); and vaccination with a tetanus toxoid containing vaccine. Antibiotics are not recommended for use against tetanus, but can be used if a wound appears to be infected. A person who has sustained a wound considered to be at high risk for tetanus should receive a single dose of human TIG administered by intramuscular injection as quickly as possible. Human tetanus immune globulin (TIG), however, may only be effective at preventing tetanus if the tetanus toxin has not yet bonded to nerve endings.

All wounds should be completely rinsed out with water and thoroughly washed with soap. Topical antibiotics can also be applied to the wound to prevent bacterial growth. Wounds can be covered with a bandage to keep out bacteria, however, wounds may heal quicker if they remain exposed to air. Bandages and dressings applied to wounds should be changed at least one time per day or if dirty or wet. Medical attention is advised if debris is present or in the event that there are concerns about the wound.

Treatment

Any person suspected of having tetanus requires hospitalization and immediate treatment with human tetanus immune globulin (TIG). Additional treatments of tetanus include wound care, antibiotics, and medications to control muscle spasms. Mechanical ventilation and sedation may also be required.

Vitamin C may also be an effective treatment option to reduce tetanus mortality rates. A 2013 Cochrane review reported on one study from Bangladesh that found a 100 percent reduction in tetanus-related deaths among children between the ages of 12 months and 12 years, and a 45 percent reduction in tetanus-related deaths among persons between the ages of 13 and 30 years of age. While study authors cautioned the use of vitamin C based on this study, they did recommend that further research should be conducted on the use of vitamin C as a treatment option for tetanus disease.

What is Tetanus vaccine?

The tetanus toxoid vaccine is available in the U.S. only in combination with other routinely administered vaccines and most frequently combined with diphtheria (Td) and acellular pertussis vaccines (DTaP, Tdap). It can also be found in combination with vaccines for polio, haemophilus influenzae B (HIB), and hepatitis B (see below for descriptions).

The CDC’s Advisory Committee on Immunization Practices (ACIP) currently recommends administration of a tetanus 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 11-12 years of age (Tdap). After a booster dose of Tdap vaccine, booster doses with tetanus - diphtheria toxoid vaccine (Td) or Tdap vaccine are recommended every ten years throughout a person’s life. 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.

Tetanus Toxoid Vaccines Licensed for Use in the U.S.

The U.S. Food and Drug Administration has approved 11 different combination vaccines that include tetanus toxoid vaccine; however, only 10 are available for use. There are different rules for use of these vaccines by different aged groups.

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 tetanus vaccine but would prefer a 3 in 1 combination shot (diphtheria, tetanus, and 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 tetanus-containing vaccines have been studied in clinical trials to prove the safety and efficacy 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.

No tetanus-containing vaccines have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Package inserts links for each vaccine are located on the Tetanus Quick Facts Page. Click on a vaccine below to learn more about each vaccine.

Infanrix

Infanrix is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccine) given to children under age seven (see GlaxoSmithKline product insert for recommended schedule and other indications).

Vaccine ingredients: Aluminum hydroxide, sodium chloride, polysorbate 80 (Tween 80), formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein.

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.

Daptacel

Daptacel is a 3 in 1 shot (diphtheria, tetanus, acellular pertussis vaccines) given to children under age seven (see Sanofi Pasteur product insert for recommended schedule and other indications).

Vaccine ingredients: Aluminum phosphate, formaldehyde, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, glutaraldehyde, 2-phenoxyethanol, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin, Mueller’s growth medium.

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.

Pediarix

Pediarix is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and recombinant hepatitis B vaccines) given to children under age seven (see GlaxoSmithKline product insert for recommended schedule and other indications).

Vaccine Ingredients: Aluminum hydroxide, aluminum phosphate, aluminum salts, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B, yeast protein, VERO cells, a continuous line of monkey kidney cells, calf serum and lactalbumin hydrolysate, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein, formaldehyde, glutaraldehyde, modified Stainer-Scholte liquid medium.

Use with Other Vaccines: In clinical trials, Pediarix was given with HIB conjugate vaccine (no longer licensed in the U.S.) or pneumococcal vaccines (PCV7). 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.

Kinrix

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).

Vaccine Ingredients: Aluminum hydroxide, VERO cells, a continuous line of monkey kidney cells, calf serum, lactalbumin hydrolysate, fenton medium containing a bovine extract, modified Latham medium derived from bovine casein, formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde, sodium chloride, polysorbate 80 (Tween 80), neomycin sulfate, polymyxin B.

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.

Quadracel

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).

Vaccine Ingredients: Aluminum phosphate, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin, MRC-5 cells, normal human diploid cells, CMRL 1969 medium supplemented with calf serum, modified Mueller’s growth medium, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, formaldehyde, 2-phenoxyethanol, polysorbate 80, glutaraldehyde, neomycin, polymyxin B sulfate.

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 A, or hepatitis B vaccines.

Pentacel

Pentacel is a 5 in 1 shot (diphtheria, tetanus, acellular pertussis, inactivated polio and haemophilus influenzae b conjugate vaccines) for children under age five (see Sanofi Pasteur product insert for recommended schedule and other indications).

Vaccine Ingredients: Aluminum phosphate, polysorbate 80, sucrose, formaldehyde, glutaraldehyde, bovine serum albumin, 2-phenoxyethanol, MRC-5 cells (a line of normal human diploid cells), CMRL 1969 medium supplemented with calf serum, Medium 199 without calf serum, modified Mueller and Miller medium, neomycin, polymyxin B sulfate, modified Mueller’s growth medium, ammonium sulfate, modified Mueller-Miller casamino acid medium without beef heart infusion, Stainer-Scholte medium, casamino acids, dimethyl-beta-cyclodextrin.

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.

VAXELIS

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 four years of age (prior to the 5^th birthday) (see MCM company product insert for recommended schedule and other indications).

Vaccine Ingredients: Aluminum, polysorbate 80, glutaraldehyde, formaldehyde, bovine serum albumin, neomycin, streptomycin sulfate, polymyxin B sulfate, yeast protein, ammonium thiocyanate, Mueller’s growth medium, Mueller-Miller casamino acid medium without beef heart infusion, ammonium sulfate, aluminum phosphate, Stainer-Scholte medium, Vero cells, extract of yeast, soy peptone, dextrose, amino acids, mineral salts, amorphous aluminum hydroxyphosphate sulfate.

Use with Other Vaccines: In clinical trials, VAXELIS was given with pneumococcal (Prevnar 13) and rotavirus (RotaTeq) vaccines. There is no information in the product 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.

Diphtheria and Tetanus Toxoids Adsorbed

Diphtheria and Tetanus Toxoids Adsorbed is a 2 in 1 shot (diphtheria and tetanus) for children six weeks to six years of age (see Sanofi Pasteur product insert for recommended schedule and other indications). It is used in cases where pertussis vaccine should not be administered. (Discontinued by the manufacturer in 2023)

Vaccine Ingredients: aluminum phosphate, isotonic sodium chloride, uracil, inorganic salts, vitamins, dextrose, formaldehyde, casein, cystine, maltose.

Use With Other Vaccines No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.

Animal reproduction studies have not been conducted with Diphtheria and Tetanus Toxoid Adsorbed. It is not known whether Diphtheria and Tetanus Toxoid Adsorbed can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity.

Adacel

Adacel is a 3 in 1 shot (tetanus, diphtheria, and acellular pertussis) used as a booster dose (Tdap) for children and adults 10 years and older (see Sanofi Pasteur product insert for recommended schedule and other indications).

Vaccine Ingredients: Aluminum phosphate, formaldehyde, 2-phenoxyethanol, Stainer-Scholte medium, casamino acids, ammonium sulfate, modified Mueller’s growth medium, dimethyl-beta-cyclodextrin, glutaraldehyde, modified Mueller-Miller casamino acid medium without beef heart infusion.

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.

Boostrix

Boostrix is a 3 in 1 shot (tetanus, diphtheria, and 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).

Vaccine ingredients: Aluminum hydroxide, sodium chloride, polysorbate 80, modified Latham medium derived from bovine casein, Fenton medium containing a bovine extract, formaldehyde, modified Stainer-Scholte liquid medium, glutaraldehyde.

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.

TDVAX

TDVAX is a 2 in 1 shot (tetanus and diphtheria) for persons over the age of seven (see MassBiologics product insert for recommended schedule and other indications). (Discontinued by the manufacturer in 2024)

Vaccine Ingredients: Thimerosal, aluminum phosphate, formaldehyde, modified Mueller's media which contains bovine extracts.

Use with Other Vaccines: No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.

Animal reproduction studies have not been conducted with TDVAX. It is not known whether TDVAX can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity.

TENIVAC

TENIVAC is a 2 in 1 shot (tetanus and diphtheria) for persons over the age of seven (see Sanofi Pasteur product insert for recommended schedule and other indications).

Vaccine Ingredients: Aluminum phosphate, formaldehyde, ammonium sulfate, sodium chloride, modified Mueller-Miller casamino acid medium without beef heart infusion, water.

Use with Other Vaccines: No clinical trials examined the safety or effectiveness of administering the vaccine with any other U.S. licensed vaccine.

Animal reproduction studies have not been conducted with TENIVAC. It is not known whether TENIVAC can cause fetal harm when administered to a pregnant woman, or can affect reproductive capacity.

What is the history of Tetanus vaccine use in America?

The protective effect of utilizing passive tetanus antitoxin (tetanus anti-serum) in the treatment of tetanus resulted from the combined research and work of Edmond Nocard, Emil von Bering, and Shibasaburo Kitasato. Experimentation on the use of tetanus anti-serum for both the prevention and treatment of tetanus occurred among soldiers serving in World War I, as fatality rates from the disease were high and soldiers were considered to be at high risk of disease development related to field battles and shrapnel wounds. Hundreds of soldiers administered varying doses of tetanus anti-serums developed adverse reactions that included both acute allergic reactions and serum sickness.

In the mid- 1920’s, vaccine researchers developed a tetanus toxoid vaccine by inactivating the tetanus toxin using both formaldehyde and heat. Two individuals were injected with the tetanus toxoid and then exposed themselves to tetanus on at least two separate occasions. Prior to exposing themselves, their blood antibody levels were tested and reported to be 0.01 and 0.007 of American units of Tetanus toxoid per ml. Neither injected individual developed tetanus after exposure. In 1950, the World Health Organization (WHO) determined that a minimum blood antibody level of 0.01 IU/mL following the administration of the tetanus toxoid vaccine could be considered protective against tetanus disease.

The first tetanus toxoid vaccine became commercially available in 1938 and in the mid 1940’s, the tetanus toxoid was combined with diphtheria toxoid to create the tetanus- diphtheria (Td) toxoid vaccine and additionally combined with whole cell pertussis to create the diphtheria-tetanus-pertussis vaccine (DTP). The newly created DTP combination vaccine was then absorbed onto aluminum salts when researchers discovered aluminum’s ability to enhance blood immune responses to both diphtheria and tetanus. Numerous companies held licenses for tetanus toxoid vaccines in the mid 1940’s, however, product licensing was not indicative of product endorsement. Safety, purity, and potency (if tests were available to determine potency) were tested as part of licensing approval, however, product efficacy was not, and not required for product licensing. Companies that held tetanus toxoid vaccine licenses in 1945 included Parke Davis and Co., Sharp and Dohme, Cutter Laboratories, Lederle Laboratories and more.

In 1966, the Public Health Service Advisory Committee on Immunization Practices (now the CDC’s Advisory Committee on Immunization Practices) published its first tetanus, diphtheria and pertussis vaccine recommendations as well as recommendations for tetanus disease prevention pertaining to wound management. These recommendations formally stated that all infants receive three doses of diphtheria, tetanus, and pertussis vaccine (DTP) beginning between two and three months of age at intervals of 4 to 6 weeks. Additional booster doses were also recommended at one year of age and between the age of three and six years, preferably prior to school entry. School children and adults not previously vaccinated with DTP were recommended to receive two doses of tetanus-diphtheria (Td) vaccine at four to six weeks intervals with a booster dose one year later and routine booster doses every 10 years. The Td vaccine was recommended for use among schoolchildren and adults instead of the DTP vaccine. This recommendation was made due to the significant increase in adverse reactions that were noted to occur following full doses of the diphtheria toxoid found in the DTP vaccine as age increased. For wound management, when a tetanus toxoid vaccine booster dose had previously been administered more than one year prior or when a person was not previously vaccinated against tetanus, Td vaccination was recommended. However, tetanus toxoid booster doses administered more frequently than every 10 years were not recommended by ACIP as they were reported to be associated with more frequent and severe reactions.

In September of 1984, the CDC’s ACIP published its first adult vaccination guidelines. In this publication, adults not previously vaccinated with tetanus toxoid vaccine were recommended to receive two doses of Td vaccine at least four weeks apart, followed by a booster dose one year later and routine booster doses every 10 years. In the case of wound management, Td vaccine was recommended if a person had not received a Td vaccine within five years. Persons previously vaccinated with the DTP primary series were recommended to receive the first booster dose of Td vaccine between the age of 14 and 16.

The FDA approved the first acellular pertussis combination vaccine (DTaP) for use in the United States in 1991, however, between 1991 and 1996, the whole cell diphtheria, tetanus, and pertussis (DPT) vaccine continued to be recommended for the first three primary doses at 2, 4, and 6 months of age. The DTaP vaccine was only approved for use in children between the ages of 15 months and 6 years after completion of three primary doses of DPT.

In 1995, the American Academy of Pediatrics (AAP) and the CDC’s ACIP published a harmonized childhood vaccine schedule and decreased the recommended age of the adolescent booster dose of tetanus-diphtheria (Td) vaccine from 14-16 years, to age 11-12 years. In this recommendation, ACIP stated that blood antibody levels considered to be protective against tetanus declined with age, and reported that 28 percent of children and teenagers between the ages of six and 16 years of age, despite previous vaccination, were found to have tetanus antibodies below minimally acceptable levels considered protective against tetanus disease. Further, ACIP stated that lowering the recommended age of the Td booster dose to 11-12 years of age would encourage a routine preadolescent healthcare visit where health care practitioners could administer additional vaccines such as a second MMR dose, recommended in 1989 following a resurgence in measles cases related to MMR vaccine failure, and the hepatitis B vaccine, in children not previously vaccinated.

The CDC’s ACIP updated its diphtheria, tetanus, and acellular pertussis vaccine (DTaP) recommendation in 1997, and recommended that all children receive five doses of DTaP vaccine, at 2, 4, 6, 15-18 months and 4-6 years of age, in lieu of the highly reactive whole cell DPT vaccine.

In 2005, the FDA approved two tetanus, diphtheria and acellular pertussis vaccines (Tdap), targeting adolescents and adults. Boostrix vaccine received initial approval for use in persons between 10 and 18 years of age, and Adacel received approval for use in individuals aged 11 through 64 years. Following FDA approval, the CDC’s Advisory Committee on Immunization Practices (ACIP) promptly recommended that all 11-12-year olds receive a dose of Tdap vaccine. This recommendation was made in response to the high number of pertussis cases and outbreaks occurring among adolescents due to the waning of vaccine acquired pertussis immunity. ACIP recommended that all 11 to 18-year-old adolescents receive a dose of Tdap, including those already vaccinated with the previously recommended booster dose of tetanus-diphtheria (Td) vaccine at age 11-12. While ACIP recommended a five-year interval between Tdap and Td vaccine administration related to the increased risk of both local and systemic reactions, they stated that vaccination at an interval of less than five years was still acceptable. Additionally, ACIP encouraged health care practitioners to administer the newly FDA approved Tdap vaccine at the same time as the newly licensed meningococcal conjugate vaccine (MCV4). This recommendation was made even though no safety or immunogenicity data existed to support the administration of both vaccines simultaneously.

In 2006, ACIP recommended that all adults between the ages of 19 and 65 years receive a dose of Tdap vaccine. The Tdap vaccine was recommended to be administered one time in lieu of the Td vaccine and given if more than 10 years had passed since administration of Td vaccine had occurred. ACIP, however, reported that the Tdap vaccine could be administered at an earlier interval, to protect a person against pertussis. In their report, ACIP admitted that pre-licensing clinical trials of Adacel vaccine, the only Tdap vaccine FDA approved at the time for use in adults between 19 and 64 years of age, had purposely excluded all persons previously vaccinated with any vaccine containing tetanus or diphtheria toxoid and/or pertussis vaccine within the preceding five years, and that it was not known if vaccinating at an earlier interval than 10 years was, in fact, safe. ACIP also acknowledged that adult safety studies of Adacel vaccine were not sufficient enough to be able to detect rare adverse events that might occur following vaccination. Tdap vaccine was also recommended for all women of childbearing age, and vaccination was encouraged prior to pregnancy or immediately postpartum. As well, all health care providers with direct patient contact were also recommended to receive Tdap vaccine if at least 2 years had passed since a previous dose of Td vaccine had been administered.

In October of 2012, the ACIP recommended that all pregnant women receive a Tdap vaccine during each pregnancy, between 27 and 36 weeks gestation. At the time of this recommendation, ACIP acknowledged that a theoretical risk exists for severe local reactions in pregnant women vaccinated frequently due to multiple pregnancies spaced closely together, but reported that current tetanus toxoid containing vaccines contained less tetanus toxin than previously recommended tetanus toxoid vaccines and stated that the potential benefit of preventing pertussis morbidity and mortality in infants outweighs the theoretical concerns of possible severe adverse events.

In this recommendation, ACIP also acknowledged that no studies had ever examined the safety of administering Tdap vaccine to pregnant women during subsequent pregnancies, but reported that going forward, they planned to monitor both the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) to assess for adverse events, maternal adverse pregnancy outcomes and birth outcomes.

In October 2022, the FDA approved Boostrix Tdap vaccine for use during the third trimester of pregnancy based on a reanalysis of data from a non-US formulation of the vaccine. According to the FDA, the use of Boostrix during the third trimester of pregnancy would likely offer vaccine acquired protection against pertussis to infants under two months. Adacel Tdap vaccine received FDA approval for use in women during the third trimester of pregnancy in January 2023 for the prevention of pertussis in infants under two months of age. This approval was also based on a reanalysis of data pertaining to pertussis that was not specific to the Adacel Tdap vaccine.

In 2023, Sanofi-Pasteur discontinued manufacturing of the Diphtheria-tetanus (DT) vaccine and there is currently no diphtheria or tetanus vaccine available in the U.S. for infants and children who can’t receive DTaP vaccine due to a contraindication to acellular pertussis vaccine. In February 2024, the CDC recommended that infant and children with a contraindication to acellular pertussis vaccine receive the tetanus-diphtheria (Td) vaccine in place of DTaP. As Td vaccine is licensed for individuals seven years of age and older, this recommendation is considered an “off-label” use of the vaccine.

The CDC currently recommends that all children receive five doses of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) at 2, 4, 6, 15-18 months, and 4-6 years, with an adolescent booster dose of tetanus, diphtheria, and acellular pertussis vaccine (Tdap) at age 11-12. Adults not previous vaccinated with Tdap are recommended to receive one dose of the vaccine, and then continue to receive booster doses of Td or Tdap vaccine every 10 years.

All pregnant women are recommended by the CDC to receive a Tdap vaccine between 27- and 36-weeks’ gestation, during each pregnancy, regardless of any previous Tdap vaccination.

In 2018, the CDC reported that 58.9 percent of adults 65 years and older, 62.8 percent of adults 50 to 64 years, 64.5 percent of adults 19 to 49, and 62.9 percent of adults 19 and younger had received a tetanus containing vaccine within the previous 10 years. When Tdap vaccination rates could be assessed among adults, 22.2 percent of adult 65 years and older, 33.5 percent of adults 19 to 64 years, and 31.2 percent of adults 19 and older had reported receiving a dose Tdap vaccine within the previous 10 years. Whites were found to have a higher tetanus vaccination rates when compared to Hispanics, blacks, and Asians. The CDC also reported that between 2010 and 2018, Tdap vaccination rates increased from 6.9 percent to 31.2 percent.

In 2023, the CDC reported that 94.2 percent of all children born in 2018-2019 had received at least three doses of the tetanus toxoid containing DTaP vaccine and 81.9 percent had received at least four DTaP vaccine doses. As well, in 2021, the CDC also reported that 90.1 percent of all adolescents had received a booster dose of Tdap vaccine in 2020.

How effective is Tetanus vaccine?

There is very little data on what can be considered the minimal level of blood anti-tetanus antibodies believed to be protective against tetanus disease. Testing of antibodies in the blood can demonstrate the presence of an immune response to a particular pathogen such as tetanus, but it does not determine the level of protection that a person might have or how long protection might last. A tetanus antibody level of 0.01 IU/mL and above, however, is considered indicative of protection against tetanus disease. No randomized control studies (considered the gold standard for efficacy) demonstrating the efficacy of the tetanus toxoid have ever been completed.

The CDC reports that a single dose of tetanus toxoid will likely not protect a person from developing tetanus but that three tetanus toxoid vaccine doses should induce vaccine acquired blood antibody levels considered to be protective against tetanus disease in nearly all individuals. Vaccine acquired tetanus blood antibody levels, however, decrease with time and within 10 years, most individuals may only have blood antibody levels considered minimally protective against tetanus disease. As a result, the CDC recommends tetanus vaccination every 10 years, however, in the event that a serious wound occurs and the previous dose of tetanus toxoid vaccine is greater than five years earlier, a booster dose of tetanus toxoid vaccine is recommended.

There are several published case studies reporting on the incidence of tetanus disease among vaccinated persons, including severe and fatal tetanus cases among persons found to have blood anti-tetanus antibodies considered to be well above the minimum level considered to be protective against tetanus.

Neonatal tetanus cases have also been reported in newborns found to have significantly elevated tetanus blood antibody levels. In one study, seven newborns diagnosed with neonatal tetanus were found to have antibody levels between 4 and 13 times the minimally accepted level (0.01 IU/ml) considered to be protective against tetanus disease. The mothers of all but one infant had received a dose of tetanus toxoid vaccine (TT) during pregnancy. Two additional newborns diagnosed with neonatal tetanus, born to mothers who had received multiple doses of tetanus toxoid during pregnancy, were found to have antibody levels at 100 and 400 times the minimal protective level. Researchers hypothesized that the administration of the tetanus toxoid vaccine (TT) during pregnancy might produce tetanus disease by overwhelming the pre-existing tetanus anti-toxin levels and that multiple doses of tetanus toxoid vaccine administered during pregnancy could also result in an ineffective immune response.

Between 2001 and 2008, there were a total of 233 reported cases of tetanus (average of 29 cases per year). Of the 197 cases where outcomes were known, 26 (13.2 percent) were fatal. Tetanus vaccination status was known in 92 out of 233 cases (39.5 percent), with 55 individuals (59.3 percent) reported receiving at least one dose of a tetanus toxoid vaccine (TT), and 24 (26.1 percent) reported having received at least 4 or more tetanus toxoid vaccine doses.

Between 2009 and 2017, there were 264 cases and 19 deaths associated with tetanus disease. Tetanus vaccination status was reported on a total of 72 cases (27 percent). Of cases where vaccination status was reported, 18 cases of tetanus disease (25 percent) occurred in individuals reporting a history of receiving at least three doses of tetanus toxoid vaccine.

The Adacel (Tdap) vaccine package insert reports that in clinical studies examining the concomitant administration of Adacel with the trivalent inactivated influenza vaccine, Fluzone, tetanus booster response rates were significantly lower in the group receiving the vaccines concurrently when compared to those who received the vaccines separately. In both groups, however, more than 98 percent of vaccine recipients were found to have blood immune levels considered to be protective against tetanus.

Can Tetanus vaccine cause injury & death?

The Institute of Medicine (IOM) 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/Td vaccine or any other vaccine.

Adverse reactions reported by vaccine manufacturers as listed in the vaccine product inserts: