NEW YORK– Pfizer Inc. (NYSE:PFE) today announced that the European Medicines Agency (EMA) has approved the company’s 20-valent pneumococcal conjugate vaccine (PCV20), which will be marketed in the European Union (EU) under the brand name APEXXNAR. The vaccine is approved for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
“The EMA’s authorization of APEXXNAR for adults continues Pfizer’s ongoing commitment to help prevent certain potentially-serious infectious respiratory diseases, including invasive pneumococcal disease and pneumonia,” said Nanette Cocero, Ph.D., Global President of Pfizer Vaccines. “APEXXNAR helps protect against the 20 serotypes in the vaccine, and today’s approval offers adults — through a single dose — the broadest serotype protection of any available pneumococcal conjugate vaccine in Europe.”
Today’s authorization follows the recent positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) announced on December 17, 2021. The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein, and Norway. The EMA had previously accepted review of Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate in February 2021.
The EMA authorization for APEXXNAR is based on evidence from a clinical program in adults, including Phase 1 and 2 trials, and three Phase 3 trials (NCT03760146, NCT03828617, and NCT03835975) describing the safety and evaluating the immunogenicity of the vaccine. More than 6,000 adult subjects 18 years and older participated in the three Phase 3 trials, including adults 65 years of age and older. The populations included adults with stable chronic medical conditions, pneumococcal vaccine-naïve adults, and adults with a history of prior pneumococcal vaccination.
