On Sept. 29, 2021, Pfizer and BioNTech positive top-line results from a Phase 3 study (B7471004) evaluating the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in adults 65 years of age or older when administered at the same time as the seasonal influenza vaccine (SIIV, Fluad Quadrivalent [adjuvanted], 2020/2021 strains). Responses elicited by PREVNAR 20 for all 20 serotypes and by seasonal influenza vaccine when given together were noninferior (the study’s primary immunogenicity objectives) to those elicited by the vaccines when administered one month apart. The safety profile of PREVNAR 20 was similar when the vaccines were coadministered as compared to when each vaccine was administered separately, one month apart. Across 66 investigator sites in the United States, a total of 1,796 participants were enrolled and randomized, with 1,727 of participants completing the study.

PREVNAR 20 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 Prevnar 13^® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]). 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), and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis. PREVNAR 20 contains the broadest serotype coverage and helps protect against more strains of the bacteria that cause pneumococcal pneumonia than any other conjugate vaccine available.

On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved, based on accelerated approval and priority review, PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older. On February 26, 2021, the European Medicines Agency (EMA) accepted for review Pfizer’s Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate, as submitted for the prevention of invasive disease and pneumonia caused by S. pneumoniae serotypes in the vaccine in adults ages 18 years and older. The formal review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP) currently was ongoing.