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Pfizer Inc.
announced today that the European Commission approved
updates to the Summary of Product Characteristics (SmPC) for the company's
pneumococcal conjugate vaccine Prevenar 13* (pneumococcal polysaccharide
conjugate vaccine [13-valent, adsorbed]), regarding its use in certain
populations at high risk of pneumococcal disease. The updated label now
includes information describing the use of the vaccine in preterm infants,
children and adolescents with sickle cell disease who were previously
vaccinated with the 23-valent pneumococcal polysaccharide vaccine, and adults
with human immunodeficiency virus (HIV) infection who were previously
vaccinated with the 23-valent pneumococcal polysaccharide vaccine.^1
“People with conditions that compromise the immune system, such as HIV, those
with sickle cell disease, and infants born prematurely are all at an increased
risk of pneumococcal disease,^2,3,4,5,6” said Luis Jodar, Ph.D., vice
president, Vaccines, Global Medicines Development Group and Scientific
Affairs, Pfizer. “The Prevenar 13 label in the European Union now includes
important information about appropriate use of the vaccine for the prevention
of pneumococcal disease for health care professionals who care for these
patients.^1”
The decision to approve the SmPC for Prevenar 13 followed the European
Medicines Agency's review of data submitted by Pfizer from several studies
assessing immunogenicity and safety of vaccination with Prevenar 13 in these
three risk groups.^7,8,9 These data are under review by the U.S. Food and Drug
Administration.
Prevenar 13 received an expanded indication in the European Union (EU) in July
2013 to include adults aged 18 to 49 years for active immunization for the
prevention of invasive disease caused by vaccine-type Streptococcus pneumoniae
(S. pneumoniae). Previously approved in the EU for use in infants, young
children and adolescents aged 6 weeks to 17 years, and adults 50 years of age
and older, Prevenar 13 is now the only pneumococcal vaccine in the EU that
offers protection against invasive pneumococcal disease from infancy through
adulthood.
“Pfizer is dedicated to improving public health through vaccination, and to
supporting health care professionals in their efforts to reduce the impact of
pneumococcal disease among those most at risk,” said Susan Silbermann,
president, Vaccines at Pfizer.
Preterm Infants
Preterm infants (gestational age 19 to 36 weeks) have an increased risk for
pneumococcal disease compared with infants born full term (gestational age 37
to 42 weeks), according to studies. A Phase 4 study of Prevenar 13
administered at 2, 3, 4 and 12 months to approximately 100 preterm infants
(born at 26 to 36 weeks) found a less robust immune response among preterm
infants compared to term infants. An acceptable safety profile was
demonstrated. Adverse events were generally consistent with those expected
in this study population.
Sickle Cell Disease
Individuals with sickle cell disease are 30 to 600 times more likely to
contract invasive pneumococcal disease than healthy individuals. A Phase 3,
open-label, single-arm study evaluated the safety, tolerability and
immunogenicity of two doses of Prevenar 13 given six months apart in 158
children and adolescents aged 6 years to 17 years with sickle cell disease who
were previously vaccinated with one or more doses of the 23-valent
pneumococcal polysaccharide vaccine. The study showed that Prevenar 13
elicited antibody levels after the first dose that were statistically
significantly higher when compared with levels prior to vaccination. Antibody
levels after the second dose were comparable to those after the first dose. An
acceptable safety profile was demonstrated. Adverse events were generally
consistent with those expected in this study population.
HIV Infection
HIV-infected individuals are more vulnerable to invasive pneumococcal disease,
with an incidence that has been reported to be 6 to 324 times that of
uninfected adults. Studies estimating the risk in the current setting of
antiretroviral therapy use suggest the risk remains 20 to 40 times higher in
HIV-infected adults than the general population.
A Phase 3, open-label, single-arm study assessed the safety, tolerability and
immunogenicity of three doses of Prevenar 13 given six months apart in 331
individuals with HIV infection (with a CD4 count of ≥200 cells/µL, HIV viral
load <50,000 copies/mL) aged 18 years or older who had been previously
vaccinated with at least one dose of 23-valent pneumococcal polysaccharide
vaccine. The study showed that Prevenar 13 elicited antibody levels after the
first dose that were statistically significantly higher when compared with
levels prior to vaccination. After the second and third doses of Prevenar 13,
immune responses were comparable or higher than those after the first dose. An
acceptable safety profile was demonstrated. Adverse events were generally
consistent with those expected in this study population.
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