Pfizer Reports European Approval for Label Update Related to Prevenar 13

Pfizer Inc. (NYSE: PFE) announced today that the European Commission approvedupdates to the Summary of Product Characteristics (SmPC) for the company'spneumococcal conjugate vaccine Prevenar 13* (pneumococcal polysaccharideconjugate vaccine [13-valent, adsorbed]), regarding its use in certainpopulations at high risk of pneumococcal disease. The updated label nowincludes information describing the use of the vaccine in preterm infants,children and adolescents with sickle cell disease who were previouslyvaccinated with the 23-valent pneumococcal polysaccharide vaccine, and adultswith human immunodeficiency virus (HIV) infection who were previouslyvaccinated with the 23-valent pneumococcal polysaccharide vaccine.^1“People with conditions that compromise the immune system, such as HIV, thosewith sickle cell disease, and infants born prematurely are all at an increasedrisk of pneumococcal disease,^2,3,4,5,6” said Luis Jodar, Ph.D., vicepresident, Vaccines, Global Medicines Development Group and ScientificAffairs, Pfizer. “The Prevenar 13 label in the European Union now includesimportant information about appropriate use of the vaccine for the preventionof pneumococcal disease for health care professionals who care for thesepatients.^1”The decision to approve the SmPC for Prevenar 13 followed the EuropeanMedicines Agency's review of data submitted by Pfizer from several studiesassessing immunogenicity and safety of vaccination with Prevenar 13 in thesethree risk groups.^7,8,9 These data are under review by the U.S. Food and DrugAdministration.Prevenar 13 received an expanded indication in the European Union (EU) in July2013 to include adults aged 18 to 49 years for active immunization for theprevention of invasive disease caused by vaccine-type Streptococcus pneumoniae(S. pneumoniae). Previously approved in the EU for use in infants, youngchildren and adolescents aged 6 weeks to 17 years, and adults 50 years of ageand older, Prevenar 13 is now the only pneumococcal vaccine in the EU thatoffers protection against invasive pneumococcal disease from infancy throughadulthood.“Pfizer is dedicated to improving public health through vaccination, and tosupporting health care professionals in their efforts to reduce the impact ofpneumococcal disease among those most at risk,” said Susan Silbermann,president, Vaccines at Pfizer.Preterm InfantsPreterm infants (gestational age 19 to 36 weeks) have an increased risk forpneumococcal disease compared with infants born full term (gestational age 37to 42 weeks), according to studies. A Phase 4 study of Prevenar 13administered 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 preterminfants compared to term infants. An acceptable safety profile wasdemonstrated. Adverse events were generally consistent with those expectedin this study population.Sickle Cell DiseaseIndividuals with sickle cell disease are 30 to 600 times more likely tocontract invasive pneumococcal disease than healthy individuals. A Phase 3,open-label, single-arm study evaluated the safety, tolerability andimmunogenicity of two doses of Prevenar 13 given six months apart in 158children and adolescents aged 6 years to 17 years with sickle cell disease whowere previously vaccinated with one or more doses of the 23-valentpneumococcal polysaccharide vaccine. The study showed that Prevenar 13elicited antibody levels after the first dose that were statisticallysignificantly higher when compared with levels prior to vaccination. Antibodylevels after the second dose were comparable to those after the first dose. Anacceptable safety profile was demonstrated. Adverse events were generallyconsistent with those expected in this study population.HIV InfectionHIV-infected individuals are more vulnerable to invasive pneumococcal disease,with an incidence that has been reported to be 6 to 324 times that ofuninfected adults. Studies estimating the risk in the current setting ofantiretroviral therapy use suggest the risk remains 20 to 40 times higher inHIV-infected adults than the general population.A Phase 3, open-label, single-arm study assessed the safety, tolerability andimmunogenicity of three doses of Prevenar 13 given six months apart in 331individuals with HIV infection (with a CD4 count of ≥200 cells/µL, HIV viralload