Notice to Readers
FDA Approval of a Fourth Acellular Pertussis Vaccine
for Use Among Infants and Young Children
On July 29, 1998, the Food and Drug Administration (FDA)
licensed
North American Vaccine, Inc. (Beltsville, Maryland) to distribute a
combined diphtheria and tetanus toxoids and acellular pertussis
vaccine
(DTaP) (CertivaTM *) ** for the first four doses of the diphtheria
and
tetanus toxoids and pertussis vaccination series administered to
infants
and children aged 6 weeks-6 years. CertivaTM is the fourth
acellular
pertussis vaccine to be licensed for use in infants and young
children in
the United States (1).
Vaccine doses should be administered at ages 2, 4, 6, and
15-20
months. Data are insufficient to evaluate the use of CertivaTM as a
fifth
dose among children aged 4-6 years who have received CertivaTM for
the
previous four doses. Additional information about the
immunogenicity and
safety of a fifth dose following four previous doses of the same
acellular
pertussis vaccine is being collected and should be available before
these
infants are aged 4-6 years and require a fifth dose.
The Advisory Committee on Immunization Practices (ACIP), the
Committee
on Infectious Diseases, the American Academy of Pediatrics, and the
American Academy of Family Physicians recommend that children
routinely
receive a series of five doses of vaccine against diphtheria,
tetanus, and
pertussis before age 7 years (1,2). The first four doses should be
administered at ages 2, 4, 6, and 15-18 months, and the fifth dose
at age
4-6 years.
The following evidence supports the use of CertivaTM for the
first
four doses of the diphtheria, tetanus, and pertussis vaccination
series:
The rates of local reactions, fever, and other common systemic
symptoms
following receipt of CertivaTM inoculations were significantly
lower than
those following whole-cell pertussis vaccination (administered as
diphtheria and tetanus toxoids and pertussis vaccine {DTP}) for
doses one
through three in controlled clinical studies (1,3).
Efficacy of three doses of CertivaTM against pertussis disease
was
assessed in a double-blind, randomized, placebo-controlled trial in
Sweden
using CertivaTM-EU, a vaccine containing the same amount of
pertussis
toxoid (40 ug) per dose as CertivaTM but more diphtheria toxoid (25
Lf
versus 15 Lf) and more tetanus toxoid (7 Lf versus 6 Lf) (4).
Infants were
randomly assigned to be vaccinated with either CertivaTM-EU or DT
(Diphtheria and Tetanus Toxoids Adsorbed Vaccine, Statens
Seruminstitut,
Copenhagen, Denmark) at ages 3, 5, and 12 months. The main
observation
period started 30 days after the third dose of vaccine and lasted a
mean of
17 months. In this trial, pertussis was defined according to the
World
Health Organization case definition (i.e., a paroxysmal cough
illness
lasting greater than or equal to 21 days and confirmed by culture,
serology, or epidemiologic link to a culture-positive household
contact).
Starting 1 month after the third dose, the vaccine efficacy of
CertivaTM-EU
against WHO-defined pertussis was 72% (95% confidence
interval=62%-78%)
(3). Although a serologic correlate of protection for pertussis has
not
been established, the antibody response to pertussis toxoid in U.S.
infants
after doses of CertivaTM at 2, 4, 6, and 15-20 months of age was
comparable
to that achieved in a previous trial among infants in Sweden in
whom
efficacy was demonstrated after three doses at 3, 5, and 12 months
of age.
Because of the reduced frequency of adverse reactions and
demonstrated
efficacy, the ACIP recommends a licensed DTaP for all five doses of
the
routine diphtheria, tetanus, and pertussis vaccination series and
for the
remaining doses in the series for children who have started the
vaccination
series with whole-cell DTP vaccine (1). The ACIP considers the data
to be
insufficient in terms of safety and efficacy to express a
preference
between different acellular pertussis vaccine formulations.
Whenever feasible, the same DTaP vaccine should be used
throughout the
entire vaccination series. No data exist on the safety,
immunogenicity, or
efficacy of different DTaP vaccines when administered
interchangeably in
the primary or booster vaccination of a child. However, if the
vaccine
provider does not know or have available the type of DTaP vaccine
the child
to be vaccinated had received previously, any of the licensed DTaP
vaccines
may be used to complete the vaccination series (1).
References
CDC. Pertussis vaccination: use of acellular pertussis vaccines
among
infants and young children: recommendations of the Immunization
Practices Advisory Committee (ACIP). MMWR 1997;46(no. RR-7).
American Academy of Pediatrics. Pertussis. In: Peter G, ed.
1997 Red
book: report of the Committee on Infectious Diseases. 24th ed.
Elk
Grove Village, Illinois: American Academy of Pediatrics
1997:394-407.
Diphtheria and tetanus toxoids and acellular pertussis vaccine
adsorbed
(CertivaTM) {Package insert}. Beltsville, Maryland: North
American
Vaccine, Inc., 1998.
Trollfors B, Taranger J, Lagergard T, et al. A
placebo-controlled trial
of a pertussis-toxoid vaccine. N Engl J Med 1995;333:1045-50.
* Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine,
Adsorbed,
CertivaTM, manufactured and distributed by North American Vaccine,
Inc.,
Beltsville, Maryland. Marketed by Ross Products Division, Abbott
Laboratories, Inc. The diphtheria and tetanus toxoid components are
produced by the Statens Seruminstitut, Copenhagen, Denmark. Final
formulation and release of CertivaTM are conducted by North
American
Vaccine, Inc.
** Use of trade names and commercial sources is for identification
only and
does not imply endorsement by CDC or U.S. Department of Health and
Human
Services.
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