Vaccines

Understanding the Disease

Tetanus (Lockjaw) is caused by toxin-producing spores of a bacterium Clostridium tetani 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 may occur following delivery in the newborn babies of unimmunized women. Tetanus infection is most often the result of wound contamination in an unimmunized person or someone who has not had vaccine boosters in many years. It may also occur following puncture wounds, animal bites, burns, abrasions and surgery.

The tetanus toxin causes 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
• DTaP in combination with Hib, hepatitis B and inactivated polio vaccines
• Tdap (Diphtheria-Tetanus-Pertussis)
• DT or Td (in combination with diphtheria vaccine)
• TT (alone)

Vaccines containing the whole cell pertussis component (DTP) are no longer recommended for use in the United States and are not listed here although they are used in many other countries. Vaccines containing lower amounts of diphtheria toxoid—abbreviated with a small d—are utilized in persons 7 years of age or older. Pertussis component-containing vaccines are not available for children 7-9 years of age.

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

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

Product Name: Diphtheria and tetanus toxoids adsorbed (DT)
Manufacturer: Sanofi 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: Sanofi Pasteur
Year licensed: 2001

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

Product Name: TriHIBit® (DTaP and Hib conjugate vaccine)
Manufacturer: Sanofi Pasteur
Year licensed: 2001

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

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

Product Name: DECAVAC^TM (Tetanus and Diphtheria Toxoids Adsorbed for Adult Use - preservative free)
Manufacturer: Sanofi Pasteur
Year licensed: 2004

Product Name: BOOSTRIX^TM (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed for use in 10-18 year old persons - preservative free) (Tdap)
Manufacturer: GlaxoSmithKline Biologicals
Year licensed: 2005

Product Name: ADACEL^TM (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) (Tdap)
Manufacturer: Sanofi Pasteur
Year licensed: 2005

Product Name: Pentacel^TM (DTap, Hib conjugate, hepatitis B, and inactivated polio vaccines)
Manufacturer: Sanofi Pasteur
Year licensed: 2008

All DTaP vaccines are available containing no or only trace amounts of thimerosal. DT & Td are both available as vaccines containing thimerosal preservative, containing trace amounts of thimerosal, or as thimerosal-free vaccines. TT is only available containing thimerosal preservative. For information on the thimerosal content in these vaccines, see the Food and Drug Administration.

History of the Vaccine

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

In 1991, the Food and Drug Administration licensed the DTaP (diphtheria-tetanus-acellular pertussis) vaccine. While DTP vaccine was made using whole cells of the pertussis germ, DTaP is made using only small, purified pieces of the germs. Fewer side effects have been reported with the DTaP vaccine 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.

Two tetanus vaccines containing acellular pertussis vaccine and reduced amounts of diphtheria toxoid were licensed by the Food and Drug Administration for use in older individuals in 2005. These vaccines are abbreviated Tdap.

There are 3 licensed vaccines that combine DTaP with other vaccine components, permitting a reduction in injections.

Who Should and Should Not Receive the 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.
• For children who are younger than 7 years of age for whom there is a reason to not give a pertussis-containing vaccine, the TD can be administered.
• For children seven to nine years of age, the Td vaccine can be administered for initial catch-up immunization.
• For persons seven years of age and older, the Td vaccine should be administered every 10 years to provide continued immunity against diphtheria and tetanus and for tetanus prophylaxis for a tetanus prone injury if more than 5 years have elapsed since the last dose of a tetanus toxoid-containing vaccine.
• 11-18 year olds should receive a single dose of Tdap instead of a Td booster if they have completed the recommended childhood DTP/DTaP immunization series and have not received Td or Tdap. The preferred age for Tdap vaccination is 11-12 years. If they have already received a Td booster, it is recommended that there be an interval of at least 5 years before Tdap is administered to reduce the likelihood of local and systemic reactions. Detailed recommendations for the use of Tdap for preteens and adolescents are available from the CDC.
• Adults 19-64 years of age should also receive a single dose of Tdap (ADACEL®) to replace a single dose of Td for booster immunization if their most recent tetanus toxoid-containing vaccine was 10 or more years earlier. Tdap may be given at an interval shorter than 10 years since the last tetanus toxoid-containing vaccine in order to protect against pertussis, especially for:
  • Women <65 years of age who are planning to become pregnant.
  • Adults <65 years of age who have or anticipate having close contact with an infant aged <12 months should receive a single dose of Tdap and trivalent inactivated influenza vaccine. Ideally the vaccines should be given at least 2 weeks before contact.
  • Health-care personnel who have direct patient contact should receive a single dose of Tdap.

Detailed recommendations for the use of Tdap in adults are available from the CDC.

Who should not receive the vaccine?

• Those with a history of a serious allergic reaction (such as anaphylaxis) to any of the vaccine components.
• Those with a history of encephalopathy (e.g. coma or prolonged seizures) not attributable to an identifiable cause within 7 days of administration of a vaccine with pertussis components should not receive a pertussis-containing vaccine.
• Pertussis-containing vaccines (including the DTaP vaccine) are not currently recommended for children who are 7-9 years of age.
• Tdap is not recommended to be administered within 2 years after the most recent tetanus toxoid-containing vaccine.

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 (the risk of fever and seizure is much less with the new DTaP vaccines than with DTP).
• Brain problem that is unstable or 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:
http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm

Dose Schedule

A DTaP vaccine is given to most children at two, four, and six months of age. A fourth dose of DTaP is given between 15 and 18 months, and a fifth dose is given at age four to six years. PediarixTM can only be given for the first three doses a child receives. TriHIBit® is only licensed for use as a booster dose for children 15-18 months of age. Pentacel is not licensed for use in children over 4 years of age.

If the fourth dose was given after age four years, then no fifth dose is needed.

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 others, 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. Between the ages of seven and nine, 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 to nine years of age instead of DTaP (or any combination vaccine that includes a pertussis component) because there is no pertussis-containing vaccine licensed for this age group. 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-acellular pertussis (Tdap) 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.

One booster dose of Tdap is recommended for adults to replace a Td booster. 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 DTaP vaccine is 95% effective in preventing all three diseases that it immunizes against—diphtheria, tetanus and pertussis. It is also about 95% effective in preventing diphtheria, while the protection rates are lower for pertussis and higher for tetanus. Immunity against diphtheria lasts about 10 years; therefore a booster dose of Td (tetanus-diphtheria) vaccine is needed every 10 years to maintain immunity. If exposed to diphtheria, partially immunized individuals can acquire the disease, although generally it is less severe than in unimmunized people.

Related Issues

Tetanus in newborn infants, once common throughout the Americas, is prevented if the mother has been immunized. This is because an immune mother passes antibodies to the baby across the placenta. The mother is immune if she has been immunized before becoming pregnant or during pregnancy. An expectant mother whose tetanus immunization status is uncertain or whose last immunization was more than 10 years ago should be immunized against tetanus.

This is usually given combined with diphtheria toxoid vaccine (a product called Td). Recently a new vaccine that also contains vaccine for pertussis for adults, Tdap, has been licensed for use for women in the child-bearing age group. Pregnancy is not a contraindication to Tdap immunization. However, at this time, CDC recommends that pregnant women who received the last tetanus toxoid-containing vaccine less than 10 years ago receive Tdap in the post-partum period according to the routine vaccination recommendations, and if the last dose of tetanus toxoid-containing vaccine was more than 10 years previously, that they would give preference to her being immunized with Td during the second and third trimester in preference to Tdap.

Key References and Sources of Additional Information

• American Academy of Pediatrics, Committee on Infectious Diseases. (2006). Red Book: Report of the Committee on Infectious Diseases (27th ed.). Elk Grove Village, IL..
• Centers for Disease Control and Prevention (CDC). Vaccine Information Statements (VIS).
• CDC. (1997). Pertussis vaccination: Use of acellular pertussis vaccines among infants and young children: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 46(RR-7),1-25.
• CDC. (2000). Use of diphtheria toxoid-tetanus toxoid-acellular pertussis vaccine as afive-dose series: Supplemental recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 49 (RR-#13).
• CDC (2006). Preventing tetanus, diphtheria, and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 55(No. RR-3).
• CDC (2006). Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel.. MMWR 55(RR-#17).
• CDC. (2008). Licensure of a diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, and Haemophilus b conjugate vaccine and guidance for use in infants and children. MMWR 57(39); 1079-80.
• CDC. (2008). Recommended immunization schedules.
  • For infants and children: http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm.
  • For preteens and adolescents: http://www.cdc.gov/vaccines/recs/schedules/child-schedule.htm.
  • For adults: http://www.cdc.gov/vaccines/recs/schedules/adult-schedule.htm

CDC Information

http://www.cdc.gov/nip/publications/VIS/vis-dtp.pdf