Europe Approves Next-Generation 20-Valent Pneumococcal Conjugate Vaccine

New York-based Pfizer Inc. announced that the European Medicines Agency (EMA) approved the company's next-generation 20-valent pneumococcal conjugate vaccine (PCV20), which will be marketed in the European Union (EU) under the brand name APEXXNAR.

The PCV20 vaccine is known as Prevnar 20® in the U.S.

The EMA approved APEXXNAR for active immunization to prevent invasive disease and pneumonia caused by Streptococcuspneumoniae in individuals 18 years of age and older.

The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein, and Norway.

"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, in a press statement issued on February 15, 2022.

"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."

This authorization follows the recent positive opinion from the EMA's Committee for Medicinal Products for Human Use announced on December 17, 2021. The EMA had previously accepted a review of Pfizer's Marketing Authorization Application for the 20-valent pneumococcal conjugate vaccine candidate in February 2021.

APEXXNAR / PREVNAR 20 includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), known as PREVNAR 13® in the U.S.

The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that cause invasive pneumococcal disease (IPD),1,2,3,4,5 and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis.

APEXXNAR contains the broadest serotype coverage of any available conjugate vaccine and helps protect against the 20 Streptococcus pneumoniae serotypes in the vaccine.

To learn more, visit www.Pfizer.com.