One shot vaccine against measles, mumps, rubella
and chickenpox approved in US
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BY OUR PHARMA CORRESPONDENT
8 September,2005: The US Food and Drug
Administration has approved a combination vaccine
against measles, mumps, rubella and varicella.
Branded Proquad, the vaccine can be used for
simultaneous vaccination against all the four
infections in children 12 months to 12 years of
age, vaccine maker Merck & Co said in a release.
Proquad is the first and only vaccine approved in
the United States to help protect against these
four diseases in a single shot. It is also
approved for use in children 12 months to 12 years
of age if a second dose of measles, mumps, and
rubella vaccine is to be administered.
Until now, a young child had to undergo two
separate vaccinations against these diseases. The
approval of Proquad makes it more likely that more
children can gain protection against these four
diseases because fewer shots can potentially mean
better compliance, the release stated.
Leading U.S. authorities on vaccination -- such as
the American Academy of Pediatrics (AAP), American
Academy of Family Physicians (AAFP) and the Center
for Disease Control and Prevention's (CDC's)
Advisory Committee on Immunization Practices (ACIP)
-- recommend routine vaccination against measles,
mumps, rubella and varicella. As a combination
vaccine indicated for simultaneous vaccination
against all four of these diseases in children 12
months to 12 years of age, Proquad can help
physicians meet these vaccination recommendations.
Moreover, according to the report "Combination
Vaccines for Childhood Immunization," issued by
the ACIP in 1999, "the use of licensed combination
vaccines is preferred over separate injection of
their equivalent component vaccines."
Potential advantages of combination vaccines
include reducing multiple injections, improving
timely vaccination coverage, reducing the costs of
stocking and administration of separate vaccines
for health care providers and reducing health care
costs for extra health visits, according to the
report.
Merck's Biologics License Application for Proquad
included results from studies that evaluated the
immunogenicity, antibody persistence and safety of
Proquad compared to its component vaccines.
Immunogenicity was studied in 5,835 healthy
children 12 months to six years of age with a
negative clinical history of measles, mumps,
rubella and varicella who participated in five
randomized trials. In these trials, the
immunogenicity of Proquad was similar to that of
its individual component vaccines, M-M-R II and
Varivax.
In four randomized trials in which 5,446 healthy
children aged 12 to 23 months received Proquad,
vaccine response rates for Proquad were similar to
the rates induced by the concomitant
administration of single doses of M-M-R II and
Varivax at separate injection sites in 2,038
children. Results showed that following a single
dose of Proquad, the immune response rates were
97.4 percent for measles, 95.8 to 98.8 percent for
mumps, 98.5 percent for rubella and 91.2 percent
for chickenpox. The duration of protection from
measles, mumps, rubella and chickenpox infections
after vaccination with Proquad is unknown.
In clinical trials, the safety of Proquad was
compared with the safety of M-M-R II and Varivax
given concomitantly at separate injection sites.
PROQUAD was administered to 4,497 children 12 to
23 months of age without concomitant
administration with other vaccines. Children in
these studies were monitored for up to 42 days
post-vaccination. The safety profile for PROQUAD
was similar to the component vaccines.
Injection-site adverse experiences reported in
greater than or equal to 1 percent of children 12
to 23 months of age who received one dose of
Proquad were: pain/tenderness/soreness (22
percent); erythema (abnormal redness of the skin)
( 14.4 percent); swelling (8.4 percent);
ecchymosis (bruising) (1.5 percent); and rash (2.3
percent). Pain/tenderness/soreness at the
injection site was reported at a statistically
lower rate in individuals who received PROQUAD
than in individuals who received M-M-R II and
Varivax concomitantly at separate injection sites.
Proquad is a combined attenuated live virus
vaccine indicated for simultaneous vaccination
against measles, mumps, rubella and chickenpox in
children 12 months to 12 years of age. No clinical
data are available on the safety, immunogenicity
and efficacy of Proquad in children less than 12
months of age. Proquad may be used in children 12
months to 12 years of age if a second dose of
measles, mumps and rubella vaccine is to be
administered. At least one month should elapse
between a dose of a measles-containing vaccine,
such as M-M-R II, and a dose of PROQUAD. If for
any reason a second dose of varicella-containing
vaccine is required, at least three months should
elapse between administration of the two doses.
Proquad should not be administered to individuals
with a history of anaphylactic reactions to
neomycin. Proquad should not be administered to
individuals with a history of hypersensitivity to
any component of the vaccine, including gelatin.
The vaccine should not be administered to
individuals with certain medical conditions,
including blood dyscrasias, leukemia, lymphomas of
any type, or other malignant neoplasms affecting
the bone marrow or lymphatic system, or
individuals with any immunodeficient condition or
receiving immunosuppressive therapy. The vaccine
also should not be used in individuals with active
untreated tuberculosis or active febrile illness
with fever (> 101.3 F) or those who are pregnant.
Proquad may be used in individuals who are
receiving topical corticosteroids or low-dose
corticosteroids for asthma prophylaxis or
replacement therapy (e.g., for Addison's disease),
but should not be given to individuals receiving
immunosuppressive doses of corticosteroids, the
release warned.
BY OUR PHARMA CORRESPONDENT |
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