Ask the Experts
Diphtheria, Tetanus, Pertussis
Diphtheria, tetanus, pertussis - disease issues
Is it true that pertussis in children is increasing? Are more infants dying from the disease?
Since the 1980s, the number of reported pertussis cases has increased. These increases have been noted in both infants younger than age 1 year, particularly among infants younger than age 6 months; adolescents age 11-18 years, and adults. An increase in the number of reported deaths from pertussis among very young infants has paralleled the increase in the number of reported cases. Reasons for the increases in pertussis are not completely clear; improvements in diagnosis and reporting of pertussis in adolescents and adults appear to be important factors contributing to the overall increase.
Can a child or an adult who has had pertussis get the disease again?
Reinfection appears to be uncommon, but does occur. Reinfection may present as a persistent cough rather than typical pertussis.
Should further doses of pertussis vaccine be given to an infant or child who has had culture-proven pertussis?
CDC's Advisory Committee on Immunization Practices (ACIP) states that a child who has had culture-proven pertussis does not need additional doses of pertussis vaccine. The series may be completed with pediatric DT. However, if there is any doubt about the diagnosis (i.e., if the diagnosis was made without a culture), the pertussis vaccine series should be completed on schedule.
 
If an adolescent or adult who has never received their one-time dose of Tdap is either infected with or exposed to pertussis, is vaccination with Tdap still necessary, and if so when?
Yes. Adolescents or adults who have a history of pertussis disease generally should receive Tdap according to the routine recommendation. In the U.S., two Tdap products are licensed for use. Adacel® (sanofi pasteur) is licensed for use in persons age 11–64 years, and Boostrix® (GlaxoSmithKline), is licensed for persons age 10–18 years. This practice is recommended because the duration of protection induced by pertussis disease is unknown (waning might begin as early as 7 years after infection) and because diagnosis of pertussis can be difficult to confirm, particularly with tests other than culture for B. pertussis. Administering pertussis vaccine to persons with a history of pertussis presents no theoretical risk. However, if the illness was recent (less than 5 years) and the diagnosis was certain (i.e., culture confirmed), it is reasonable to wait 3-5 years before administration of Tdap, unless tetanus and diphtheria toxoids are needed. For details, visit CDC's published recommendations on this topic at www.cdc.gov/vaccines/pubs/acip-list.htm
Vaccine products - choosing the right one
I'm confused about the various vaccines that contain tetanus, diphtheria, and pertussis. Can you explain?
There are two basic products that can be used in children younger than age 7 years (DTaP and DT) and two that can be used in older children and adults (Td and Tdap). Some people get confused between DTaP and Tdap and others get confused between DT and Td. Here's a hint to help you remember. The pediatric formulations usually have 3-5 times as much of the diphtheria component than what is in the adult formulation. This is indicated by an upper-case "D" for the pediatric formulation (i.e., DTaP, DT) and a lower case "d" for the adult formulation (Tdap, Td). The amount of tetanus toxoid in each of the products is equivalent, so it remains an upper-case "T."
Can we use the three DTaP products interchangeably?
There are three different DTaP products currently licensed for use in the primary series for children ages 2 months through 6 years (Daptacel® by sanofi pasteur, Infanrix® by GlaxoSmithKline, and Tripedia® by sanofi pasteur). ACIP has recommended that, whenever feasible, healthcare providers should use the same brand of DTaP vaccine for all doses in the vaccination series.

What should we do if we don't know which brand of DTaP a child had previously?
If the DTaP brand used for previous doses is not known or not in stock, use whatever DTaP vaccine you have available for all subsequent doses.
Someone gave Tdap to an infant instead of DTaP. Now what should be done?

This error sometimes happened because the packaging for the sanofi products (Daptacel® [DTaP] and Adacel® [Tdap]) was quite similar. You'll be glad to know that sanofi pasteur has changed their packaging and you should notice more distinct tabs, new package colors and vial labels, and clear use-descriptions next to the package logos.

If Tdap was inadvertently administered to a child, it should not be counted as either the first, second, or third dose of DTaP. The dose should be repeated with DTaP. Continue vaccinating on schedule. If the dose of Tdap was administered for the fourth or fifth DTaP dose, the Tdap dose can be counted as valid. Routinely submit a Vaccine Adverse Event Reporting System (VAERS) report for any vaccine administration error. And, please remind your staff to always check and double check the vaccine vial before administering any vaccine.

I have a patient who received single-antigen tetanus (TT) in the emergency room rather than Td or Tdap. Should he be revaccinated?
ACIP recommends that patients always be given Td or, if appropriate, Tdap rather than TT, as long as there is no contraindication to the other vaccine components. However, since it's already been given, you can wait until the next scheduled booster dose is due and administer Td (or Tdap) at that time. There are exceptions (e.g., the patient plans to travel internationally, is a contact of an infant younger than age 12 months) in which case you should administer Td (or Tdap).
When should a person receive tetanus toxoid (TT) alone?
Single antigen tetanus toxoid should only be used in rare instances, for example when a person has had a documented severe allergic response to diphtheria toxoid.
In what year did tetanus toxoid first become available? At what age might most patients never have received a primary series?
Tetanus toxoid became commercially available in 1938, but was not widely used until the military began routine vaccination in 1941. Routine administration of tetanus toxoid was recommended by the AAP in 1944. Most World War II military personnel received at least one dose of tetanus toxoid, but civilian use, particularly for adults, did not increase until after the war. You should not assume the tetanus vaccination status for any person based on their age alone. Only a written record is acceptable proof of immunization. Persons without documentation should be assumed to be unimmunized.
Tdap for adolescents and adults
Please summarize the 2007 recommendations for the use of Tdap vaccine in adults.

The following recommendations for a single dose of Tdap (ADACEL®) apply to adults ages 19–64 years who have not yet received Tdap. After receiving Tdap, adults should receive the standard Td booster every ten years.
Routine: Adults should receive a single dose of Tdap to replace a single dose of Td for booster immunization against tetanus, diphtheria, and pertussis if they received their most recent tetanus toxoid-containing vaccine (e.g., Td) 10 or more years earlier.
Short intervals between Td and Tdap: Tdap can be administered at an interval of less than 10 years since the last dose of Td to protect against pertussis. The safety of intervals as short as approximately 2 years between administration of Td and Tdap is supported by a Canadian study of children and adolescents; shorter intervals may be used.
Prevention of pertussis among infants younger than age 12 months by vaccinating adult contacts: Adults who have or who anticipate having close contact with an infant younger than age 12 months (e.g., parents, grandparents, child-care providers, and healthcare personnel) should receive a single dose of Tdap. An interval as short as 2 years since the most recent tetanus toxoid-containing vaccine is suggested; shorter intervals can be used. Ideally, Tdap should be administered at least 2 weeks before beginning close contact with the infant. Women should receive a dose of Tdap in the immediate postpartum period if they have not previously received Tdap. Any woman who might become pregnant is encouraged to receive a single dose of Tdap.
Vaccination of healthcare personnel (HCP): HCP in hospitals and ambulatory care settings who have direct patient contact should receive a single dose of Tdap as soon as feasible if they have not previously received Tdap. An interval as short as 2 years from the last dose of Td is recommended. Other HCP should receive a single dose of Tdap according to the routine recommendation; they are encouraged also to receive Tdap at an interval as short as 2 years. Priority should be given to vaccination of HCP who have direct contact with infants younger than age 12 months. Hospitals and ambulatory-care facilities should provide Tdap for HCP and use approaches that maximize vaccination rates.
History of pertussis: Adults with a history of pertussis generally should receive Tdap according to the routine recommendations.
Tetanus prophylaxis in wound management: Adults ages 19–64 years who require a tetanus toxoid-containing vaccine as part of wound management should receive Tdap instead of Td if they have not previously received Tdap. If Tdap is not available or was administered previously, Td should be administered.
Incomplete or unknown vaccination history: Adults who have never received tetanus and diphtheria toxoid-containing vaccine should receive a series of three vaccinations. The preferred schedule is a single dose of Tdap followed by Td at least 4 weeks later and a second dose of Td 6–12 months after the previous dose. Tdap can substitute for Td for any one of the 3 doses in the series.
Pregnancy: Pregnancy is not a contraindication for Tdap or Td vaccination. Guidance on the use of Tdap during pregnancy is published separately in provisional recommendations for use of Tdap in pregnant women.

 
To access the Tdap recommendations for adults as issued by ACIP, either as a provisional or final statement, go to www.cdc.gov/vaccines/pubs/acip-list.htm

What is the difference between the two Tdap products - Boostrix® and Adacel®?
Both of these vaccines provide protection against pertussis, tetanus, and diphtheria. Boostrix® (GlaxoSmithKline) is licensed for persons ages 10–18 years, and Adacel® (sanofi pasteur) is licensed for persons ages 11–64 years. Both are approved for one dose only, not multiple doses in a series. The two vaccines also contain a different number of pertussis antigens and different concentrations of pertussis antigen and diphtheria toxoid.
Should I make an effort to give teenagers a Tdap dose, even if they've had a dose of Td at age 11–12 years?
Yes. All adolescents should receive one dose of Tdap vaccine to protect them from pertussis, even if they have already received Td. It is important to do this right away if they are in contact with an infant younger than age 12 months, work in a healthcare setting where they have direct contact with patients, or live in a community where pertussis is occurring.
What if we mistakenly gave Tdap to a child ages 7-9 years?
Use of Tdap in children ages 7-9 years is considered off-label and is not recommended; however, the dose can be counted and does not need to be repeated with Td.
 
Can a booster dose of Tdap be given to persons age 65 years and older?
No brand of Tdap is approved for persons age 65 years or older. ACIP does not recommend off-label use of Tdap for this age group. However, a clinician may choose to administer Tdap to a person age 65 years or older if both patient and clinician agree that the benefit of Tdap outweighs the risk of a local adverse event.
 
I am a 66-year-old pediatrician. To protect our patients, my aging colleagues (65 years and older) and I received Tdap vaccine, even though it isn't licensed for our age group. Regardless, I don't understand why this vaccine wasn't recommended or at least suggested for healthcare workers age 65 years and older who are in contact with young children.
There are no safety and efficacy data for this age group; FDA did not approve the vaccine for anyone older than age 64 years, and ACIP has not recommended off-label use of Tdap for this age group. However, there is no reason to believe that Tdap is any less safe for persons age 65 years and older than it is for younger adults. Clinicians may decide that the benefit of Tdap exceeds the hypothetical risk in these situations.
 
I want to protect pregnant women and their unborn children from pertussis. Can I give Tdap to pregnant women?
Tdap is not contraindicated during pregnancy. It should be administered to a pregnant woman who is in contact with an infant younger than age 12 months, is in an outbreak setting, or is a healthcare provider who sees children. If there is no risk to the pregnant woman of acquiring or transmitting pertussis, ACIP recommends that Tdap vaccination be deferred until the immediate postpartum period. AAP has endorsed preferential Tdap vaccination of pregnant adolescents who were not vaccinated with Tdap at age 11–12 years (Pediatrics 2006; 117:965-78). Providers can follow either the AAP or ACIP recommendations.
 
If a pregnant woman got a dose of Td during pregnancy, how soon after birth can she get her postpartum dose of Tdap?
The mother is taking home an infant who is susceptible to pertussis, so she should receive Tdap during the immediate postpartum period (e.g., before hospital discharge). There is no minimum interval between Td and Tdap.
 
Can Tdap be given at the same visit as other vaccines?
Yes. Tdap can be administered with all other vaccines that are indicated (e.g., meningococcal conjugate vaccine, hepatitis B vaccine, MMR). Each vaccine should be administered at a different anatomic site using a separate syringe.
 
How many doses of Tdap can we give to a patient?
The vaccine is licensed for just one dose for persons ages 10 through 64 years, depending on the age range of the product used. Subsequent doses, as well as vaccine given to children 7-9 years and adults ages 65 years and older, should be Td.
 
Someone in our clinic gave DTaP to a 50-year-old instead of Tdap. How should this be handled?
The DTaP recipient received the appropriate amount of tetanus toxoid and MORE diphtheria toxoid and pertussis antigen than is recommended. Count the dose, but take measures to prevent this error in the future. Routinely submit a VAERS report for any vaccine administration error.
Vaccination scheduling issues
What schedule should I use to vaccinate adolescents or adults who never received the primary series of tetanus toxoid-containing vaccine?
Adolescents and adults who have never received tetanus-containing vaccines, or whose vaccination history is unknown, should receive the 3-dose series. In this situation, ACIP recommends Tdap for dose #1, followed 4 weeks later by Td for dose #2, followed at least 6 months later by Td for dose #3. Tdap can substitute for only one of any of the 3 Td doses in the series. The amount of protection provided by a single dose of Tdap in a person who has not previously received pertussis vaccine is not known. Booster doses of Td should be given every 10 years thereafter.
We are routinely scheduling the 4th dose of DTaP in children at 15-18 months, but occasionally would like to give it earlier. Is that okay?
The fourth dose of DTaP may be given as early as age 12 months if at least 6 months have passed since the third dose, and if, in the provider's opinion, the child might not return for another visit at 15-18 months of age.
When a child comes in for his vaccinations at age 4-6 years and presents with an incomplete history of 0-2 doses of DTaP vaccine, how do we determine how many more doses are needed?
You should try to achieve at least 4 total doses. Give additional doses of DTaP with 4 week intervals until you achieve 3 total doses. Then, give the 4th dose at least 6 months after the 3rd dose.
If a child didn't have the recommended 6-month interval between DTaP doses #3 and #4, should it be repeated?
If DTaP #4 is given with at least a 4-month interval after DTaP #3, it does not need to be repeated. Decreasing the interval to less than 6 months, however, is not recommended.
If a child has already received 5 doses of DTaP by their fourth birthday (with the appropriate 6 month intervals between #3 and #4 and also between #4 and #5), is a booster dose after the fourth birthday necessary?
In general, a child should receive no more than four doses of DTaP before 4 years of age (preferably by 2 years of age). The ACIP recommends that a dose of DTaP be given at 4-6 years of age. Many states have school immunization laws which also require at least one dose of DTP/DTaP on or after the fourth birthday. This dose is important to boost immunity to pertussis.
Is there a recommendation about how many doses of DTaP a child can receive by a certain age? Does this include half doses?
ACIP and AAP both recommend that children receive no more than 6 doses of diphtheria and tetanus toxoids (e.g., DT, DTaP, DTP) before the seventh birthday because of concern about adverse reactions, primarily local reactions. Half doses of DTaP are also not recommended under any circumstances, and should not be counted as part of the vaccination series. Only documented doses (those recorded on a written record) count toward the maximum of 6 doses.
What is the minimum interval between DTaP #4 and DTaP #5?
The minimum interval between DTaP #4 and DTaP #5 is six months. Remember that the minimum age for DTaP #5 is age 4 years.
How should we schedule DTaP for a child with a history of only DT?
If the child has not received all of the age-appropriate doses of pertussis-containing vaccine, it would be best to try to administer as many doses of DTaP as possible before the child reaches his 7th birthday in order to confer protection against pertussis. Give additional doses of DTaP with 4 week intervals until you achieve 3 total doses. Then, give additional doses with 6-month intervals, not to exceed 6 total doses of diphtheria- and tetanus-containing vaccine by the child's 7th birthday.
ACIP and AAP have different recommendations for spacing Tdap and MCV4 if they are not given simultaneously. Please discuss.
The ACIP Tdap recommendations published in the MMWR (www.cdc.gov/vaccines/pubs/acip-list.htm) state that Tdap or Td can be administered at any time before or after MCV4. AAP's Committee on Infectious Diseases (a.k.a., the "Red Book" Committee) took a somewhat more conservative approach and suggested these vaccines be separated by a month if not given at the same visit. Providers may use either approach.
Contraindications and precautions to vaccine
What are the contraindications for using DTaP, DT, Tdap, and Td?
As with all vaccines, a severe allergic reaction to a vaccine component or to a prior dose is a contraindication to further doses of that vaccine. A history of encephalopathy within 7 days of receiving a previous pertussis-containing vaccine that is not due to another identifiable cause is a contraindication to both DTaP and Tdap. Use of DTaP should also be deferred in children with a progressive neurologic disorder (including infant spasms), uncontrolled epilepsy, progressive encephalopathy until the child is stable.
What precautions should be observed when giving DTaP, DT, Tdap, or Td?
A history of Guillain-Barré syndrome (GBS) within 6 weeks of receiving a tetanus-containing vaccine and the presence of a moderate or severe acute illness with or without fever are the two basic precautions to any of these vaccines. A history of Arthus-type reaction after receiving a previous tetanus- or diphtheria-containing vaccine is a precaution to further Tdap vaccine. As with all vaccines, moderate or severe illness is a precaution. Several additional precautions apply only to DTaP (see next question).
Do the same precautions that apply to DTaP also apply to Tdap?
No, many of the precautions to DTaP (e.g., temperature of 105°F or higher, collapse or shock-like state, persistent crying lasting 3 hours or longer, seizure with or without fever) do not apply to Tdap. This issue is discussed in the Tdap ACIP recommendations, available at www.cdc.gov/vaccines/pubs/acip-list.htm
When assessing for precautions for administering DTaP in an infant, is the 105°F cutoff for DTaP a rectal, oral, or axillary temperature?
A temperature of 105°F or higher recorded from any of these body sites following a dose of DTaP without another known cause constitutes a precaution to further doses of any pertussis-containing vaccine.
A 2-month old received her first dose of DTaP and then had inconsolable crying for greater than 3 hours. Should we give additional doses of DTaP or should we give just DT?
Persistent crying following DTaP (as well as other vaccines) has been observed far less frequently than it was following the use of DTP. When it occurred after DTP, it was considered to be an absolute contraindication to further doses of pertussis-containing vaccine. When it occurs following DTaP, it is considered a "precaution" (or warning). If you believe the benefit of the pertussis vaccine exceeds the risk of more crying (which, although unnerving, is otherwise benign), you can administer DTaP. Many providers choose to administer pertussis-containing vaccine if this is the only precaution the child has experienced. You and the parent will need to make this judgment.
Can we give further doses of DTaP to an infant who had an afebrile seizure within 3 hours of a previous dose?
An infant who experiences an afebrile seizure following a dose of DTaP requires further evaluation. An infant with a recent seizure or an evolving neurologic condition should not receive further doses of DTaP, or DT until the condition has been evaluated and stabilized. Other indicated vaccines may be administered on schedule. To assure that the child is at least protected against tetanus and diphtheria, the decision to give either DTaP or DT should be made no later than the first birthday.
Does tetanus toxoid contain horse serum?
Tetanus toxoid has never contained horse serum or protein. Equine tetanus antitoxin (horse derived) was the only product available for the prevention of tetanus prior to the development of tetanus toxoid in the 1940s. Equine antitoxin was also used for passive postexposure prophylaxis of tetanus (e.g., after a tetanus-prone wound) until the development of human tetanus immune globulin in the late 1950s. Equine tetanus antitoxin has not been available in the U.S. for at least 40 years.
Can Tdap be given to a pregnant teen or woman?
ACIP and AAP have different recommendations on the use of Tdap in pregnancy. ACIP voted to recommend using Td (not Tdap) during pregnancy if the woman is due for a routine tetanus booster. If she is not due for the routine booster (i.e., the previous Td booster was given within the preceding 10 years), the new mother should receive Tdap immediately postpartum. However there are situations when a clinician can consider the use of Tdap for a pregnant woman, such as if there is a risk of exposure because of a pertussis outbreak. Tdap is not contraindicated for pregnant women. The infant's other household contacts ages 10 through 64 years should also receive 1 dose of Tdap, if not already given. AAP has endorsed preferential use of the Tdap vaccine during pregnancy in adolescents who were not vaccinated at the visit at age 11-12 years (Pediatrics 2006; 117:965-78). Providers can follow either the AAP or ACIP recommendation.
Tetanus and wound management issues
If an adolescent or adult needs wound prophylaxis, should Td or Tdap be given?
Adolescents and adults ages 11–64 years who require a tetanus toxoid-containing vaccine as part of wound management should receive a single dose of Tdap instead of Td, if they have not previously received Tdap. If Tdap is not available, or was previously administered, these persons should receive Td.
If a person gets a puncture wound or laceration on Friday night, does the person need to receive tetanus wound management that night or can it wait until Monday?
ACIP has not addressed this issue specifically. Puncture wounds, however, should be attended to as soon as possible. The decision to delay a booster dose of tetanus toxoid-containing vaccine following an injury should be based on the nature of the injury and likelihood that the injured person is susceptible to tetanus. The more likely the person is to be susceptible, the more quickly that tetanus prophylaxis should be administered. A person with a tetanus-prone wound (e.g., punctures, wounds contaminated with soil or fecal material) and who has no history of tetanus immunization must be vaccinated (and given tetanus immune globulin or TIG) as soon as possible. A person with a documented series of at least three tetanus toxoid-containing products, with a booster dose within the previous 10 years ago is less likely to be susceptible to tetanus, and the need for a booster dose is not as urgent, particularly if the wound can be thoroughly cleaned. The more likely a person is to be completely susceptible to tetanus (i.e., unvaccinated or incompletely vaccinated), the sooner that TIG (and Td/Tdap) should be administered, even if it means a trip to the emergency department.
When should tetanus immune globulin (TIG) be administered as part of wound management?
TIG is recommended for any wound other than a clean minor wound if the person's vaccination history is either unknown, or s/he has had less then a full series of 3 doses of Td vaccine. TIG should be given as soon as possible after the injury.
How long after a wound occurs is tetanus immune globulin no longer recommended?
In the opinion of the tetanus experts at the CDC, for a person who has been vaccinated but is not up to date, there is probably little benefit in giving TIG more than a week or so after the injury. For a person believed to be completely unvaccinated, we would suggest increasing this interval to 3 weeks (i.e., up to day 21 post injury). Td or Tdap should be given concurrently.
Combination vaccines containing DTaP
What is the dosing schedule for the DTaP-IPV-HepB combination vaccine (Pediarix® by GSK)?
Pediarix®, the combination vaccine from GlaxoSmithKline, contains the vaccine components DTaP, IPV, and hepatitis B. The primary series is 3 doses (0.5 mL) given intramuscularly at 2, 4, and 6 months of age. It should not be given to infants younger than 6 weeks of age nor to children 7 years or older.
Can Pediarix® is given to infants born to mothers who are HBsAg-positive?
Yes, although the package inserts states that Pediarix should only be given to infants born to mothers who are HBsAg-negative, the ACIP voted on February 26, 2003, to expand its recommendations for use to also include infants born to mothers whose HBsAg status is positive or unknown beginning no earlier than age 6 weeks. In expanding the use of Pediarix beyond FDA-prescribing information, ACIP remained consistent with its 1997 vote, which permitted the use of Comvax (Merck's Hib-hepatitis B combination vaccine) to complete the hepatitis B vaccine series in infants born to HBsAg-positive mothers and mothers whose HBsAg status is unknown.
Can Pediarix® is used in infants and children who have fallen behind?
Yes. As with any combination vaccine, it may be used when any of the components are indicated and none are contraindicated. Providers must observe spacing intervals such that the minimum interval between doses is equal to the greatest interval of any of the individual antigens. The vaccine may only be used in children less than 7 years of age.
How should the combination DTaP-Hib vaccine be used?
The combination DTaP-Hib vaccine (TriHIBit® by sanofi pasteur) is currently licensed only for the fourth dose of the DTaP and Hib series given at age 12 months or older, as long as it has been 6 months since the third dose of DTaP and 2 months since the previous dose of Hib vaccine. It should not be used for the first three doses of the series regardless of the child's age. There are data that suggest that response to the Hib component may be reduced if given combined with DTaP for the first three doses of the series.
Vaccine storage and handling
How should DTaP, DT, Tdap, and Td vaccines be stored?
Each of these products must be stored at 35° to 46°F (2° to 8°C). They should not be frozen or exposed to freezing temperatures.
What are the special considerations for preparing the combination Hib-DTaP (TriHIBit by sanofi)?
TriHIBit® is formed when ActHib® (sanofi's Hib) is reconstituted with Tripedia® (sanofi's DTaP). Once it is reconstituted, it must be discarded if not used within 30 minutes.
Reviewed on 4/08
Immunization Action Coalition  |  1573 Selby Avenue  |  St. Paul MN 55104
contact: admin@immunize.org  |  www.immunize.org
tel: 651.647.9009  |  fax: 651.647.9131