13 January 2022 - - US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) has posted positive top-line results from a Phase 3 study (B74710126) describing the safety and immunogenicity of Prevnar 20 (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo, the company said.

Responses elicited by Prevnar 20 for all 20 serotypes were similar whether given with a dose of the Pfizer-BioNTech COVID-19 Vaccine (n=190) or with placebo (n=191).

Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with Prevnar 20 or given with placebo (n=189).

The safety profile of co-administering Prevnar 20 with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine generally reflected that observed with the Pfizer-BioNTech COVID-19 Vaccine booster dose.

The initiation of the study exploring the coadministration of Prevnar 20 along with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine in older adults was announced in May 2021.

The study recruited adults from the pivotal Phase 3 Pfizer-BioNTech COVID-19 Vaccine clinical trial and included adults who received their second dose of the vaccine at least six months prior to entering the coadministration study.

Pfizer will seek to present and publish detailed outcomes from this clinical trial at a future date. At this time no coadministration data are included in the Prevnar 20 or Pfizer-BioNTech COVID-19 Vaccine prescribing information.

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, and have been associated with high case-fatality rates, antibiotic resistance, and/or meningitis.

According to Pfizer, Prevnar 20 contains the broadest conjugate 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 US Food and Drug Administration approved Prevnar 20, which is the US trade name, for the prevention of invasive disease and pneumonia in adults age 18 years or older.

On December 16, 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion to recommend the granting of a marketing authorization for the 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older in the 27 European Union member states plus Iceland, Lichtenstein and Norway.

The EMA had previously accepted review of Pfizer's Marketing Authorization Application for the 20-valent pneumococcal conjugate vaccine candidate on February 26, 2021.

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.