Questions
and Answers
NIP
Answers Your Questions
DTaP / DT / Td
(Diphtheria-Tetanus-Pertussis
/ Pediatric Diphtheria-Tetanus / Adult Tetanus-Diphtheria)
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General
Questions
Top
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Will
there be a pertussis vaccine for adults in the future?
There is a good chance that we will see a pertussis vaccine
licensed for persons beyond childhood somewhere in the future.
The hard questions to answer are: Who will get it? When will
they get it? and How often will they get it? Currently there
is no adult pertussis-containing vaccine licensed for this use
in this country, but there is in Canada. We will have to see
how the clinical trials go and how FDA and ACIP recommend its
use. (6/26/03)
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- We
have had several cases of pertussis in our county. Most of these
cases have been in very young children under one year of age who
have had only one or two doses of DTaP. How much protection does
one or two doses offer?
There isn’t much data on the efficacy and protection from
one or two doses of DTaP. Pertussis vaccine trials are difficult
to do. Virtually everyone who has looked at this issue uses 3
doses as the benchmark. We know that if you get 3 doses into a
child, you are looking at 80%-85% efficacy. We know that two doses
are better than one, and one dose is better than none. But I don’t
know of any data that would give us a feeling of how well one
or two doses would protect against pertussis.
(2/20/03) More Information
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-
Why
isn’t pertussis vaccine given after 7 years of age?
There is no pertussis-containing vaccine licensed by the FDA
for use in persons 7 years of age or older. The conclusion was
basically that pertussis was not a problem in older children
and adults. Now we know that is not true. We have no vaccine
that is properly built for older children and adults. The current
vaccine has a pediatric dose of diphtheria, which we would not
want to give to older children and adults because it is more
reactogenic than in children. What we need and may eventually
have is a dTaP like they have in Canada and some other countries
for use in older children and adults. Then we will have to figure
out who is going to get it and how often. (2/20/03)
- How
can we protect children over 7 years of age from pertussis if
they had not received a full series?
You cannot vaccinate these kids unless it is part of a controlled
study under a protocol. If a child has only had one or two doses
of DTaP and is in an environment, like school, where there is
an outbreak, they are not protected. The best advice is to remove
them from the situation until the outbreak settles down. They
should be watched closely for any signs and symptoms of cough
illness. (2/20/03)
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If
a person has culture-confirmed pertussis, are they immune for
life? If they have not completed their DTaP series, do they
need additional doses of DTaP or DT?
ACIP states that if you have had culture-confirmed pertussis,
which probably applies to PCR as will, then you are considered
immune. You are immune for a long time, but immunity for a lifetime
is questionable. There is evidence that pertussis has occurred
in adults who had pertussis as children.
Additional doses of pertussis-containing vaccine are not recommended
for these individuals. However, you do not need to stock DT
just for these patients. I don’t know of any data regarding
increased risk of side effects if pertussis-containing vaccine
is administered to someone who has had pertussis. Probably the
most that would happen is an additional local reaction. If there
is any doubt, err on the side of caution and vaccinate. (2/20/03)
- A
mother brings a 2½ year old child to the clinic with a
history of no immunizations. The mother states the child has recovered
from a cough that sounds much like pertussis. The mother insists
on only one shot and is very fearful of that. What vaccine would
you administer in this situation?
You don’t have a culture-confirmed case of pertussis even
if it sounds like that’s what the child had. Young children
are at increased risk for pertussis. Therefore I would recommend
a dose of DTaP, although one dose won’t offer much protection.
It also sounds like education and follow-up are certainly indicated
with this mother and child. (2/20/03)
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-
What
precautions should be followed for newborns when the mother
has not been immunized against tetanus since her childhood series?
The mother should be educated about the risk of tetanus, especially
regarding care of the cord stump and circumcision (if applicable).
Some cultures use “belly bands” or earth-based healing
compounds. It is extremely important to caution these mothers
about keeping these sites clean and not introducing dirt/feces
into the site. These infants, who have little or no protection
from maternal antibodies, should begin their DTaP series at
the earliest possible age, which is 6 weeks. ACIP
DTP Recommendations (2/20/03)
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A
nurse on our staff inadvertently administered Td intradermally
instead of the PPD that should have been given. The patient
experienced a red blister-like area at the injection site with
burning and itching which lasted several months. It subsided
over a 6-month period, but even now there is a cyst-like lump
in the injection area. Can she receive a PPD on her other arm
and a tetanus shot administered at the correct site? Also, what
are the ramifications of having that dose given in the wrong
way?
I wish we could say this is uncommon, but unfortunately we hear
about situations like this too often. First, Td is a very immunogenic
vaccine. That is why it is given intramuscularly. You should
not count the Td dose that was given by the intradermal route.
She probably received 0.1 mL of Td, which is a very small fraction
of a dose.
She should receive her Td boosters on schedule and the PPD should
be given in the other arm or distal to the area where the incorrect
dose was given. She should be O.K. Presumably the inflammation
will go away with time, but there may be a scar that will hopefully
also resolve over time. (2/20/03)
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Is
it O.K. to administer tetanus vaccine to a pregnant woman. The
package insert says no unless there is an incident.
Td toxoid is an inactivated vaccine and is indicated routinely
for pregnant women. Previously vaccinated pregnant women who
have not received a Td vaccination ithin the last 10 years should
receive a booster dose. Pregnant women who are not immunized
or only partially immunized against tetanus should complete
the primary series. You don’t want to risk an infant being
born without maternal antibodies and susceptible to neonatal
tetanus. Although no evidence exists that tetanus and diphtheria
toxoids are teratogenic, some providers prefer waiting until
the second trimester of pregnancy to administer Td to minimize
any concern about the theoretical possibility of such reactions,
http://www.cdc.gov/nip/publications/preg_guide.htm#td.
(8/21/03)
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A
patient who was recently vaccinated with tetanus toxoid (TT)
is planning to travel to Russia and needs diphtheria protection.
What should we do?
We advise that you vaccinate the person with Td so that they
will have protection against diphtheria. You should tell this
person that their arm may be more sore than usual. If this person
were going to stay in the U.S., we would recommend that you
just wait until their next routine booster to give Td. (2/20/03)
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If
patients in a nursing home can't remember if they have had Td,
should we start vaccinating them?
A dose is only valid if it's documented. If you don't know what
they have, then, yes, you have to repeat the series or initiate
the series, and make sure it's documented. ACIP
General Recommendations (see page 8) (2/20/03)
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If
there is no diphtheria or very little of it in this country,
why do we even bother vaccinating against it?
You
don't have to go very far in order to be at risk for diphtheria.
In January 2004, there was an MMWR article published detailing
the account of a man in Pennsylvania who traveled to Haiti for
a weekend to help build a church in a rural area. He came back
to the United States ill with diphtheria and eventually died.
Also, diphtheria can be imported at any time. Just because it
is not common in the United States does not mean it can't occur.
We should all be protected from diphtheria with a booster every
10 years. (02/26/04)
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Combination
Vaccines
Top
- Since
we are now giving COMVAX at 1 year of age, do we still need to
make sure the DTaP #3 and Prevnar are given at 6 months exactly
or can they be given earlier than 6 months of age as long as we
observe the minimum intervals? Example: DTaP #1 at 6 weeks of
age, DTaP #2 at 3 months of age, and DTaP #3 at 5-6 months of
age?
There has been no change in the recommended schedules
for DTaP and Prevnar. Clinical studies have reported that recommended
ages and intervals between doses of multidose antigens provide
optimal protection or have the best evidence of efficacy. Minimum
ages and intervals between doses should only be used when there
is some reason to accelerate the schedule, such as when a child
is behind schedule or there is impending international travel.
The introduction of COMVAX has not changed these recommendations.
ACIP General
Recommendations (see pages 2-3) (2/20/03)
Back
-
Can
you interchange Pediarix with other DTaP vaccines for the primary
doses in the schedule?
ACIP’s
position is that, if possible, you should use the same brand
of DTaP for all doses in the series. This same recommendation
is made in the AAP Red Book. That means if Pediarix has been
used, it would be preferable to use Infanrix for the 4th and
5th DTaP doses, or for the 2nd or 3rd DTaP doses if Pediarix
is not available (remember, Infanrix is the DTaP component in
Pediarix).
However,
if you do not have the same brand or you do not know what brand
was used, you can use one of the other DTaP vaccines instead
of Pediarix to complete the first 3 doses in the primary series
or to complete the 4th and 5th DTaP doses. This includes the
use of TriHIBit for the 4th dose. (02/26/04)
Back
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Why
does TriHIBit exist? It causes confusion because most immunization
records don’t indicate if a child received TriHIBit or
single-antigen Hib for the primary series.
Vaccine manufacturers can build any kind of vaccine they want.
CDC does not control this. It is not that these children receive
no protection from the Hib component of TriHIBit, but the response
is less than the single antigen Hib vaccines. To be licensed,
FDA requires that the components of a combination vaccine perform
as well or better than the single antigen vaccines. Therefore,
to err on the conservative side, we recommend that if you know
a child received TriHIBit as the primary series, then the Hib
doses should be repeated. Hopefully in the future, the manufacturer
can work with the vaccine so that it will meet the FDA criteria
and it will be available for all 4 doses. (2/20/03)
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If
the first 3 doses of DTaP are given as TriHIBit, do they count
as valid?
TriHIBit
is licensed only for the 4th dose in the DTaP/Hib series. If
you encounter a child who received TriHIBit for one or more
of the first three doses of the series, you can count the DTaP
doses as valid as long as the minimum age and minimum intervals
were observed. You should revaccinate the child with single
antigen Hib vaccine appropriate for the child’s age. (02/26/04)
Back
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If
we use only Infanrix for doses 1 through 5 are we wrong? Do
we need to stock Tripedia for the fifth dose?
No, you are not wrong. You should use what you have in stock.
If all you have is Infanrix and someone is eligible for the
fifth dose, ACIP has recommended that you use what you have.
There really isn't a concern about the safety or efficacy. There
are just not extensive data. Certainly don't send the child
out without being vaccinated, and you don't need to stock certain
vaccines for certain doses. (2/20/03)
Back
Schedule/Intervals
Top
-
A
7 month old child received the 4th DTaP 6 weeks after the 3rd
DTaP and the 4th dose of Hib at the same time. Does this child
require any repeated doses?
Yes, the 4th doses of DTaP and Hib should not be administered
before the 1st birthday. Also, there must be a minimum of 2
months between the 3rd and 4th doses of Hib, and there must
be 6 months between the 3rd and 4th doses of DTaP. Doses administered
5 or more days earlier than the minimum interval or age should
not be counted as valid doses and should be repeated as age-appropriate.
The repeat doses should be spaced after the invalid doses by
the recommended minimum interval as provided in Table 1 of the
ACIP General Recommendations on Immunization. ACIP
General Recommendations (see page 4) (2/20/03)
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A
child receives the first 3 doses of DTaP on time and then does
not return until just before the 4th birthday. Should we give
a dose now and another in 6 months or wait until they turn 4
years and give one more dose?
Do not wait. Give a dose now and the 5th dose later. There should
be at least 6 months between the 4th and 5th doses, DTP
ACIP Recommendations (see Table 1 & “ Primary
Vaccination”). (2/20/03)
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If
a 17-month-old child has received five doses of DTaP, but two
doses were invalid because of interval problems, how many doses
will this child need?
The
child will need two more doses. The 6 doses before 7 years of
age rule applies to valid doses. The concern about the number
of doses is the risk of an Arthus reaction (an exaggerated local
reaction in the limb where the injection is administered). This
can happen when too many doses of tetanus- and diphtheria-containing
vaccines are given too close together. However, it is important
to ensure that the child has adequate protection against pertussis.
Any time you go beyond the 6 doses, as in this situation, you
need to at least explain carefully to the parents that the child
can have a stronger local reaction, but that the extra doses
are necessary for protection against pertussis. If they know
this, they can handle it better. Tell them how to take care
of a local reaction and that should take care of it. (02/26/04)
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An
autistic child has not had any of the primary immunizations
but receives a dose of Td when injured. This child has had two
doses of Td four years apart. How much protection would this
child have?
The immune system doesn’t forget, so the child has the
benefit of immune memory from the first two doses, but needs
the 3rd primary dose for adequate immunity, as well as routine
boosters since immunity does wane with time. Hopefully you can
convince the parent to give the protection that vaccines offer.
(2/20/03)
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A
14-year-old received one dose of DTaP at 6 years of age. How
many Td doses are needed to complete the series?
This depends on the child’s age when the 1st dose was
administered. If the 1st dose was given before one year of age,
then ACIP recommends a total of 4 doses to complete the primary
series. If the 1st dose is administered after one year of age,
then the primary series should consists of 3 doses. This child
needs 2 doses of Td spaced 6-12 months apart followed by a routine
booster every 10 years. Unfortunately this child currently has
no protection against pertussis. DTP
ACIP Recommendations (See “Children with contraindications
to pertussis vaccination”) (2/20/03)
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My
patient was given single antigen tetanus rather than Td. Should
I revaccinate? If so, when?
The
recommended vaccine for anyone 7 years of age and older is Td
rather than TT as long as there are no contraindications to
the diphtheria component. If you encounter a patient who inadvertently
received TT, just wait to give Td until their next scheduled
dose if no international travel is planned. If travel is planned,
then they should receive a dose of Td. If there is time, allow
for the minimum interval between the dose of TT and Td. (6/26/03)
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Considering
waning immunity for pertussis in the teen years, is there any
discussion regarding middle school boosters?
It is being discussed and it is likely that we will have an
adult/older child booster dose of probably a pertussis/Td combination.
There is already a vaccine like that in Canada, but it is not
yet approved in the U.S. It likely will be. Recommendations
regarding which adults and adolescents will receive the vaccine
is yet to be decided. This is a big issue of discussion and
you will be hering more about this in the months and years to
come. (8/21/03)
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Please
clarify on the minimum interval table in Appendix A of the Pink
Book, the minimum interval between DTaP #3 and DTaP #4. Is it
6 months or 4 months?
This
refers to "Recommended
and Minimum Ages and Intervals Between Vaccine Doses”
(which also appears in the ACIP "General Recommendations").
This table says there is a 6 month interval between the 3rd
and 4th doses and the minimum age for the 4th dose is 12 months
of age. However, the 5th footnote (**) says that a 4th dose
given >4 months after the 3rd dose needn't be repeated.
The issue is when should you schedule the 4th dose vs. when
can you count a 4th dose as valid after it has been given. Ideally,
the 4th dose should be scheduled 6 to 12 months after the 3rd
dose, which is the RECOMMENDED interval, and it should always
be given after the 1st birthday.
However, a few years ago we ran into a situation where some
children had gotten the 4th DTaP sooner than 6 months after
the 3rd dose. We took this issue to the ACIP. The committee
felt the benefit of revaccinating those children was not worth
the risk of local reactions from having too many DTaP close
together. Therefore, if on a record review you find someone
who received a 4th dose of DTaP on or after the first birthday
and the dose was AT LEAST 4 months after the
3rd dose, you don't have to repeat it. The main thing to remember
is when you schedule doses; don't schedule them for 4 months
apart. You need to schedule the 4th dose 6 to 12 months after
the 3rd dose and the child must be at least 12 months of age.
(02/20/04)
- DAPTACEL™
has not been approved for the 5th DTaP dose. What are the ramifications
and/or implications of using it for this dose?
From time to time ACIP will make “off-label” recommendations
for a vaccine based on data the committee has available beyond
the data that was obtained during clinical trials and presented
to the FDA when the vaccine was licensed. This is one such case.
ACIP recommends that it is preferable to complete the 5-dose
DTaP series with the same vaccine based on available safety
and efficacy data. ACIP also recommends that if DAPTACEL is
the only DTaP you have on hand and a child presents for the
5th dose, it is better to use the vaccine you have on hand than
to miss the opportunity to vaccinate. (03/04/04)
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Wound
Management
Top
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Is
a Td booster still recommended for dirty injuries if the last
documented Td is more than 5 yrs old?
Yes.
The recommendations for tetanus prophylaxis in wound management
from the 1991 Diphtheria, Tetanus and Pertussis ACIP recommendations
(http://www.cdc.gov/mmwr/preview/mmwrhtml/00041645.htm)
are still valid. See Table 5 in this document, also. (6/26/03)
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How
long can a person wait after a wound to get a Td booster?
There
is no simple answer to your question. The urgency of tetanus
prophylaxis is a function of several factors, including the
nature and location of the wound and the person's previous vaccination
status.
The
incubation period of tetanus can be as short as 1 day, or as
long as several months. Most cases occur within 3 days to 3
weeks of the injury. Once the disease starts it must run its
course.
Factors
that increase the urgency of prophylaxis include lack of prior
vaccination with tetanus toxoid, or vaccination in the remote
past without a booster dose within the last 10-20 years; unknown
vaccination status (you should always assume the worst case
scenario, and assume the person is unvaccinated unless they
can prove otherwise); and a wound contaminated with dirt or
feces. The situation is most urgent when the person is unvaccinated
or inadequately vaccinated, and the wound is contaminated and
on or near the head. Puncture wounds are dangerous because of
the anaerobic condition that results.
Factors
that reduce the urgency are evidence of primary vaccination
with a booster dose within the prior 10-20 years, or a clean
wound (i.e., uncontaminated with dirt or feces).
The
decision of whether or not to recommend an ED visit is a judgment
call by the person doing the triage. Tetanus is unlikely (but
not impossible) to result from a clean wound in a person who
has been vaccinated. The other end of the scale (come in right
now) is an unvaccinated person with a dirty head puncture wound.
We don't know of any formula or algorithm to guide the urgency
level for situations that lie between these two extremes. If
there is any doubt about the person's vaccination status, get
them in sooner rather than later. Puncture and contaminated
wounds need to be seen immediately for treatment of the wound
itself. And because the incubation period of tetanus can be
very long, it is never "too late" to receive prophylaxis.
(6/26/03)
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Additional
Information
Pertussis
in the Community
In
a situation where you have pertussis in the community, one thing
that should be done is to try to get the vaccine into the children
as quickly as you can, particularly young infants who are by far
the most likely to have complications or die from pertussis. You
can accelerate the pertussis vaccine schedule to 6, 10, and 14 weeks
of age, using the minimum age and intervals to get doses in as early
as possible. Don’t let any infants fall behind if there is
pertussis in your community. You definitely have a problem if you
have adults with persistent coughs caring for infants. They may
have undiagnosed pertussis and can act as a source of infection
in the infants. If you have pertussis cases in your area, you can
put out some kind of alert for adults, particularly those around
children, to get treatment and stay away from young children if
they have a persistent cough. Pertussis outbreaks are difficult
to deal with because the disease can circulate among adults and
older children, compounded by the fact that we don’t have
a vaccine we can offer to try to extend protection beyond 7 years
of age. (02/20/03) Back
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