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you recommend Pediarix in spite of the higher risk of fever?
This question refers to information released by the FDA when
the vaccine was approved for use on December 16, 2002. The clinical
trials did show a slightly higher rate of fever after vaccination
with Pediarix than with other DTaP vaccines. The temperatures
were slightly higher and not significant. If FDA had considered
this to be a significant problem then they would not have approved
the vaccine for use. FDA
Talk Paper on Pediarix (2/20/03)
you start the DTaP series with Pediarix, do you have to complete
the series with Infanrix?
Whenever feasible, use same brand of DTaP for all doses of the
primary series. We do not have efficacy or safety data for a
primary series using multiple brands of DTaP. However, there
is no reason to believe, based on the data we have, that using
another brand of DTaP would compromise either safety or efficacy.
So do not let a child go out of your office without a dose just
because you don’t have Infanrix. Use what you have in
we use Pediarix to complete the primary series if the child received
DTaP from another manufacturer?
Whenever feasible, the same brand of DTaP should be used for
all doses of the primary series. However, if this isn't possible,
use a different manufacturer's product rather than defer vaccination.
you start the IPV, DTaP, and Hepatitis B series with the individual
vaccines, can you still use Pediarix for subsequent doses?
Yes, if the child received Infanrix as the DTaP vaccine. It
is preferable to use the same manufacturer's DTaP vaccine for
all doses in the primary series. But if you do not know whether
a child received Infanrix for prior doses, or if Pediarix is
the only DTaP-containing vaccine available, Pediarix may still
be used to complete the series. (8/21/03)
comment on the thimerosal used in the manufacture of Pediarix
and the implications for giving the vaccine.
does not contain thimerosal as a preservative. Thimerosal is
used during the early stages of production, and subsequently
removed, leaving only a clinically insignificant trace. (8/21/03)
Pediarix vaccine made from fetal embryos?
None of the components of Pediarix are produced using human
cell cultures. For information about the components of Pediarix
components and its manufacturing process, see the manufacturer’s
product information. (8/21/03)
clarify whether or not Pediarix may be used for infants whose
mothers are HBsAg-positive.
not labeled for this indication by FDA, Pediarix may be used
in infants whose mothers are HBsAg-positive or whose HBsAg status
is not known. ACIP approved this off-label use of the vaccine
in February 2003. (02/26/04)
is Pediarix not recommended for booster doses?
is not FDA approved for doses four or five of the DTaP series.
This makes sense because using Pediarix for the 4th and 5th
doses would result in a lot of extra doses of Hepatitis B. If
the child received a birth dose of Hepatitis B vaccine and then
4 or 5 doses of Pediarix, that would mean the child received
5 or 6 doses of Hepatitis B vaccine, which is far more than
is recommended and far more than anyone needs. (02/26/04)
older children, less than 7 years of age, with no immunization
record or an incomplete record, can Pediarix be used for the
first three doses?
Yes, Pediarix is licensed for the 3-dose primary series of DTaP,
IPV, and Hepatitis B for a child 6 weeks up to 7 years of age.
have been told that the minimum interval between doses one and
two of Pediarix is 6 weeks. You mentioned on a satellite broadcast
that the minimum interval is 4 weeks. Please clarify?
The minimum interval between any two doses is equivalent to
the longest interval recommended for any of
the individual components for those doses. The minimum interval
between the first and second doses of DTaP, IPV, or Hepatitis
B is 4 weeks, so 4 weeks is the minimum interval for Pediarix.
The minimum interval between the second and third doses is dictated
by the Hepatitis B component. There must be 8 weeks between
the second and third doses AND at least 16 weeks between the
first and third doses. The same guideline applies to the minimum
Pediarix is now available, should we continue to give a birth
dose of Hepatitis B vaccine?
Yes, CDC and AAP still encourage parents to get their children
the first dose of hepatitis B vaccine at birth. (8/21/03)
a child gets his 3rd dose of Pediarix before 6 months, will he
need an additional dose at 6 months of age?
The March 14, 2003 MMWR announcement of Pediarix states that
the third dose should not be given before age 24 weeks. In General
Recommendation on Immunization, ACIP states that vaccine doses
administered 5 or more days before the minimum age should be
repeated on or after the child reaches the minimum age and 4
or more weeks after the invalid dose. http://www.cdc.gov/mmwr/PDF/rr/rr5102.pdf
is ACIP’s stand on informing parents that using Pediarix
for 3 doses is O.K. for children who have already had a birth
dose of Hepatitis B vaccine?
It is reasonable to disclose the fact that the child is going
to receive a fourth dose. You should also add that ACIP and
the American Academy of Pediatrics (AAP) consider this an acceptable
practice. It is not a problem. In fact, you could argue that
it will make their antibody titers even higher. Inform the parent
that this practice has been considered very carefully by the
ACIP and the AAP and in their opinion there is really no harm
and no problem with giving the extra dose. We do want to continue
to give the birth dose of hepatitis B vaccine. That is a very
important intervention. Therefore, four doses are not an issue
and the ACIP and NIP have included this in a footnote on the
2004 immunization schedule, which you can use as a reference,
a child did not receive the birth dose of Hepatitis B vaccine
should you start Pediarix on the first office visit?
Yes, you can. We would prefer that the first dose be given as
Hepatitis B vaccine in the hospital as a birth dose. However,
if for some reason the did not get it – for instance,
you documented that the mother was Hepatitis B surface antigen
negative – it is appropriate to use Pediarix or Comvax
for that matter. Remember, both of these vaccines (Pediarix
and Comvax) should not be given before 6 weeks of age. These
are not vaccines that you can give at one month of age. You
wait until they are at least 6 weeks of age. (8/21/03)
a child receives a birth dose of Hepatitis B vaccine and Comvax
at 2 months of age, can the child receive Pediarix at 4 months
Yes, as long as you observe the minimum ages and minimum intervals,
both vaccines can be used. (8/21/03)
it necessary to give an additional dose of Hepatitis B vaccine
if Pediarix is given prior to 6 months of age?
When administering combination vaccines you should still apply
the minimum ages and minimum intervals for the individual components.
ACIP recommends that 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
dose should be spaced after the invalid dose by the recommended
minimum interval for that dose. The 3rd dose of PEDIARIX™
should be given at least 16 weeks after the first dose, preferably
at 6 months of age but not before 24 weeks of age. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5210a8.htm
dose one in the vaccination series is Pediarix (DTaP, IPV, Hepatitis
B) and the second dose in the series is separate DTaP, IPV,
and Hepatitis B vaccines, does the IPV count since it is a different
IPV than the one in the combined Pediarix vaccine?
Yes, all doses in the combined vaccine and the separate vaccines
can be counted as valid doses as long as none of the doses violates
minimum age and minimum interval guidelines. These vaccines
are all licensed by FDA. (2/20/03)