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 Streptococcuspneumoniae 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.
About PCV20
PCV20 - known as APEXXNAR in the EU and PREVNAR 20TM in the US -- is Pfizer's next-generation pneumococcal conjugate vaccine that 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 PREVENAR 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,6,7,8,9 antibiotic resistance,10,11,12 and/or meningitis.13,14 APEXXNAR contains the broadest serotype coverage of any available conjugate vaccine and helps protect against the 20 Streptococcus pneumoniae serotypes in the vaccine.
On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved PREVNAR 20, which is the U.S trade name for PCV20, for the prevention of invasive disease and pneumonia in adults age 18 years or older. Pfizer has recently submitted to the FDA a supplemental Biologics License Application to include data in the PREVNAR 20 prescribing information for adults age 18 years or older regarding coadministration of PREVNAR 20 with a seasonal inactivated influenza vaccine.
Pivotal Phase 3 studies of the 20-valent pneumococcal conjugate vaccine candidate in infants are expected to read out in the second half of 2022 and, if positive, form the basis of potential regulatory submissions to the FDA and EMA later this year.
U.S. INDICATIONS FOR PREVNAR 20™
- PREVNAR 20™ is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
- This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
U.S. IMPORTANT SAFETY INFORMATION
- PREVNAR 20™ should not be given to anyone with a history of severe allergic reaction to any component of PREVNAR 20™ or any diphtheria toxoid-containing vaccine
- Some adults with weakened immune systems may have a lower response to PREVNAR 20™. Safety data are not available for these groups. Your healthcare provider can tell you if PREVNAR 20™ is right for you
- In adults 18 years of age and older, the most common side effects were pain at the injection site, muscle pain, fatigue, and headache
- Ask your healthcare provider about the risks and benefits of PREVNAR 20™. Only a healthcare provider can decide if PREVNAR 20™ is right for you
Please see full prescribing information for PREVNAR 20™.
