Vaccine Information

Entry last updated: May 28, 2004

- Understanding the Disease
- Available Vaccines
- History of the Vaccine
- Who Should and Should Not Receive the Vaccine
- Dose Schedule
- Effectiveness of the Vaccine
- Known Side Effects
- Related Issues
- Key References and Sources of Additional Information
- State Vaccine Requirements
- Important Facts for Parents to Know
- Frequently Asked Questions
- CDC Vaccine Information Statement

Understanding the Disease

Tetanus is caused by toxin-producing spores that inhabit the soil and the bowels of animals and humans. Unlike other vaccine-preventable diseases, it is not spread from person to person. Tetanus infection is most often the result of wound contamination in an unimmunized person. Tetanus may occur following delivery in newborn babies of unimmunized women (resulting from contamination of the umbilical cord), and in injection drug users. It may also occur following puncture wounds, animal bites, burns, abrasions and surgery.

Tetanus infection results in severe muscle contractions, or spasms. Fever, sweating, elevated blood pressure, and rapid heart rate may also occur. Spasms of the vocal cords or the muscles of respiration can interfere with breathing, and pneumonia is common. Contraction of muscles can be so severe that the spine or other bones are fractured.

Between 40-60 cases of tetanus are reported in the United States each year, and 30% of those infected with tetanus in the US die. Death is more likely in newborn infants of unimmunized mothers and patients over 50.

Available Vaccines

The tetanus vaccine is available as:

• DTaP (Diphtheria-Tetanus-Pertussis)�
• DTaP in combination with Haemophilus influenzae type b (Hib) vaccine�
• DTaP in combination with hepatitis B and inactivated polio vaccines
• DT or Td (in combination with diphtheria vaccine)�
• TT (alone)

Vaccines containing the whole cell pertussis component (DTP) are no longer recommended in the United States and are not listed here.

Product Name: Tetanus toxoid (TT)
Manufacturer: Aventis Pasteur
Year licensed: 1978

Product Name: Tetanus toxoid adsorbed (TT)
Manufacturer: Aventis Pasteur
Year licensed: 1978

Product Name: Diphtheria and tetanus toxoids adsorbed (DT)
Manufacturer: Aventis Pasteur
Year licensed: 1984

Product Name: Tetanus and diphtheria toxoids adsorbed for adult use (Td)
Manufacturers (Year licensed): Massachusetts Public Health Biologic Laboratories (1970); Aventis Pasteur (1978)

Product Name: Tripedia� (DTaP)
Manufacturer: Aventis Pasteur
Year licensed: 2001
Note: As of May 2001, Aventis was in the process of transitioning to their new preservative-free DTaP vaccine; however, some supplies of the original Tripedia� may still be in use.

Product Name: Infanrix�� (DTaP)
Manufacturer: GlaxoSmithKline
Year licensed: 1997

Product Name: TriHIBit� (DTaP and Hib conjugate vaccine)
Manufacturer: Aventis Pasteur
Year licensed: 2001
Note: As of May 2001, Aventis was in the process of transitioning to their new preservative-free DTaP and Hib conjugate vaccine; however, some supplies of the original TriHIBit��may still be in use.

Product Name: DAPTACEL^TM (DTaP)
Manufacturer: Aventis Pasteur
Year Licensed: 2002�

Product Name: Pediarix^TM (DTaP, hepatitis B, and inactivated polio vaccines)
Manufacturer: GlaxoSmithKline
Year licensed: 2002

For information on the thimerosal content in these vaccines, see the Food and Drug Administration at www.fda.gov/cber/vaccine/thimerosal.htm#t3
or Johns Hopkins University's Institute for Vaccine Safety at
www.vaccinesafety.edu/thi-table.htm

History of the Vaccine

In the mid-1940s, the tetanus vaccine was combined with vaccines against pertussis and diphtheria. The combined DTP vaccine soon was routinely used in the United States, but is no longer recommended.

Prior to the late 1940's, when tetanus vaccine became part of the routine childhood immunization schedule, there were 500 to 600 reported cases of tetanus annually in the United States. The striking value of the vaccine against tetanus was demonstrated among U.S. World War II casualties. U.S. troops were routinely immunized against tetanus and, as a result, only 12 cases of tetanus (half of them in soldiers who had received no tetanus vaccine) were documented. In contrast, thousands of unimmunized enemy troops, as well as civilians, died of tetanus-associated wounds. Only 33 cases of tetanus were reported in the United States in 1999.

In 1991, the Food and Drug Administration licensed the DTaP (diphtheria-tetanus-pertussis) vaccine. While the DTP vaccine was made using whole cells of the pertussis germ, DTaP is made using only small, purified snippets of the germs. Fewer side effects have been reported with DTaP than with DTP. In 1991, DTaP was licensed for only the fourth and fifth doses in the series, and in 1997 it was licensed for all five doses.

Who Should and Should Not Receive this Vaccine

Who should receive the vaccine?�

• Most infants and children younger than�seven years of age should receive DTaP beginning at�two months of age.�
• Pregnant women should ensure they are protected against tetanus, and may receive the vaccine during pregnancy.
• For children�seven years of age and older, the Td vaccine can be administered every 10 years to provide continued immunity against diphtheria and tetanus.

Who should not receive the vaccine?

• Pertussis vaccines (including the DTaP vaccine) currently are not recommended for children after they reach age seven because pertussis is not a life-threatening disease in older children and adults though they often spread the disease to infants and young children. Studies are currently being undertaken to determine the safety and efficacy of DTaP when given after age six; preliminary data suggests that the vaccine is safe and effective in adolescents and adults.

People with the following conditions should discuss with their health care professional whether they should receive DTaP vaccine:

• Moderate or serious reaction after receiving DTP or DTaP in the past
• Seizure or have a parent or sibling who has had a seizure
• Brain problem that is unstable or is getting worse
• People who are moderately or severely ill should consult with their physician before receiving any vaccine.

This vaccine is recommended by:

• Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention
• American Academy of Pediatrics
• American Academy of Family Physicians

The complete childhood immunization schedule can be found at:
www.cdc.gov/nip/recs/child-schedule.PDF�

The summary of adolescent/adult immunization recommendations can be found at: www.cdc.gov/nip/recs/adult-schedule.pdf

Dose Schedule

The DTaP vaccine�or DTaP, hepatitis B, and inactivated polio vaccines (Pediarix^TM1, GlaxoSmithKline)�is given to most children at two, four, and�six months of age.� Pediarix^TM can only be given for the first three doses a child receives.

A fourth dose of DTaP�or DTaP and Hib conjugate vaccine (TriHIBit�, Aventis Pasteur)�is given between 15 and 18 months, and a fifth dose is given at age�four to six years.� If the fourth dose was given after age four years, then no fifth dose is needed.� TriHIBit� can only be given for these booster doses, not for the initial three doses.

Receiving combination vaccines from different manufacturers, which may include different component vaccines, can make the dose schedule more complex.� However, since giving combination vaccines means fewer shots overall for a child, healthcare providers will usually choose to administer them.� Healthcare professionals should attempt to select vaccines for their patients, especially children who have been seen by other practices, based on what they have already been given.��

Children younger than age�seven who should not receive the pertussis vaccine should receive the DT (diphtheria-tetanus) vaccine. At age seven or older, Td (tetanus-diphtheria), which contains the same amount of tetanus vaccine as in DTaP or DT, but contains much less diphtheria toxoid, is given to protect against tetanus and diphtheria.

The Td vaccine is given to unimmunized children age seven and older instead of DTaP (or any combination vaccine that includes a pertussis component).� Two doses are given�one to�two months apart, and a third dose should be given 6 to 12 months after the second dose.

At age 11-12 years, a booster shot of tetanus-diphtheria (Td) is needed. It should be given no later than 16 years of age. Every 10 years thereafter, a booster of Td is needed to maintain protection against diphtheria and tetanus.

Effectiveness of the Vaccine

The DTaP vaccine is 95% effective in preventing all three diseases that it immunizes against--diphtheria, tetanus and pertussis. It is virtually 100% effective in preventing tetanus, while the protection rates for diphtheria and pertussis are lower. Immunity against tetanus lasts about 10 years; therefore a booster dose of Td (tetanus-diphtheria) vaccine is needed every 10 years to maintain immunity.

Known Side Effects

The DTP vaccine is no longer recommended in the United States. DTaP is now recommended because the rate of serious reactions to the DTaP vaccine is lower than with DTP; however, if a person has had a serious adverse reaction related to DTP, they should not be given DTaP.

Half of those vaccinated with DTaP will experience no side effects at all. About half of those vaccinated will experience mild reactions such as soreness where the shot was given, fever, fussiness, reduced appetite, tiredness, or vomiting. These mild reactions are more likely to occur in those who have received frequent doses of the tetanus vaccine. Some children may experience a temporary swelling of the arm or leg where DTaP was given; this reaction is more common after the fifth dose of DTaP.

In rare cases (about 100 children out of 10,000 shots given, or about 1%) children have moderate reactions such as prolonged crying, fever of 105 degrees or higher, seizure, or the child becoming limp, pale, and less alert.

In very rare cases (less than 1 out of every 10,000 shots given, or about .003%) children have serious reactions such as breathing difficulty, shock, or severe brain reaction (brain inflammation, long seizure, coma or lowered consciousness). These adverse reactions are usually due to the vaccine's pertussis component; therefore, doctors advise that infants and children who experience these adverse reactions to DTaP should receive DT for each of the remaining doses in the primary series.

Studies have shown that children who receive the Hib vaccine in combination with or at the same time as the DTaP vaccine are no more likely to experience side effects than children who only receive the DTaP vaccine.

Related Issues

Questions about the relationship between the DTP vaccine and the incidence of Sudden Infant Death Syndrome (SIDS) have arisen. Scientific investigations have shown no causal relationship between the DTP or DTaP vaccines and Sudden Infant Death Syndrome (SIDS).

For more information, see:
www.cdc.gov/nip/vacsafe/concerns/SIDS/default.htm

Key References and Sources of Additional Information

• American Academy of Pediatrics, Committee on Infectious Diseases. (2003). Red Book: Report of the Committee on Infectious Diseases (26th ed.). Elk Grove Village, IL: Author.
• Atkinson W, Wolfe C, Humiston S, and Nelson R (Eds.). (2004). Tetanus. In Epidemiology and prevention of vaccine-preventable diseases. (The Pink Book). (8th ed.). Atlanta: Centers for Disease Control and Prevention.
• Centers for Disease Control and Prevention (CDC). (1991). Diphtheria, tetanus, and pertussis: Recommendations for vaccine use and other preventive measures: Recommendations of the Immunization Practices Advisory Committee (ACIP). Morbidity and Mortality Weekly Report (MMWR), 40(RR-10), 1-28.
• CDC. (1997). Vaccine Information Statement (VIS).�
• CDC. (2000). Recommended childhood immunization schedule--United States, January-December, 2001 (Approved by the ACIP, AAP, and AAFP). MMWR, 49(2), 35-38, 47.
• CDC. (2001). Notice to readers: Update on the supply of tetanus and diphtheria toxoids and of diphtheria and tetanus toxoids and acellular pertussis vaccine. MMWR, 50(10), 189-90.
• CDC, National Immunization Program. (2000). Vaccine-preventable childhood diseases--Tetanus.�
• Combination Vaccines for Childhood Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP), The American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). (1999). Pediatrics, 103(5).
• Food and Drug Administration. (2002). Product approval information � Licensing action.�
• Humiston SG and Good C. (2000). Vaccinating your child: Questions and answers for the concerned parent. Atlanta: Peachtree Publishers.
• Offit PA and Bell LM. (1999). Vaccines: What every parent should know (revised edition). New York: IDG Books.

Also see our image gallery of diseases.