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Notice to Readers: FDA Approval of Diphtheria and Tetanus Toxoids
and Acellular Pertussis Vaccine Adsorbed,
(INFANRIX®) for Fifth Consecutive DTaP Vaccine Dose
On July 8, 2003, the U.S. Food and Drug Administration (FDA) approved the use of Diphtheria and Tetanus Toxoids
and Acellular Pertussis Vaccine Adsorbed (DTaP)
(INFANRIX®, SmithKline Beecham Biologicals, Rixensart, Belgium) as a
fifth dose for children aged 4--6 years after 4 previous doses of
INFANRIX®.
INFANRIX® had been previously approved for
the first 4 doses in the DTaP vaccination series. Sufficient data are now available to establish the frequency of adverse events after a fifth dose of INFANRIX® at age 4--6 years in children who have received 4 previous doses of INFANRIX® (1).
The frequency of local injection site reactions (erythema and swelling) increases with successive doses of INFANRIX® (1). In two German studies, 93 and 390 children, respectively, received a fifth dose of INFANRIX® at age 4--6 years after
4 previous doses of INFANRIX®. Among solicited adverse events, swelling
>5 cm (2 inches) in the injected limb within the
3 days after vaccination was reported in 15% and 20% of the vaccinees, respectively
(1). Extensive swelling of the injected
limb was reported spontaneously by parents of nine (9.7%) and 25 (6.4%) vaccinees, respectively, in these two studies
(1).
The Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics, and the
American Academy of Family Physicians recommend that children routinely receive a series of 5 doses of vaccine against
diphtheria, tetanus, and pertussis before age 7 years. ACIP recommends that the first 4 doses be administered at ages 2, 4, 6, and 15--18 months and the fifth dose at age 4--6 years
(2--4).
Data are limited on the safety, immunogenicity, and efficacy of using DTaP vaccines from different manufacturers
for successive doses of the DTaP series. ACIP recommends that, whenever feasible, the same brand of DTaP should be used for
all doses of the series but that vaccination should not be deferred because the type of DTaP used for previous doses is
not available or is unknown. In such situations, any of the available licensed DTaP vaccines can be used to continue or
complete the series (3,4).
References
SmithKline Beecham Biologicals.
INFANRIX® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) Prescribing
information. SmithKline Beecham Biologicals, Rixensart, Belgium, July 2003.
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Health and Human Services.References to non-CDC sites on the Internet are
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