Pfizer Announces Positive Phase 3 Results for Prevnar 20 Coadministered with Seasonal Influenza Vaccine in Adults Aged 65+

On September 29, 2021, Pfizer announced that a Phase 3 clinical trial of the 20-valent pneumococcal conjugate vaccine Prevnar 20 achieved positive topline results. The study evaluated the safety and immunogenicity of Prevnar 20 when co-administered with a seasonal influenza vaccine in adults aged 65 years and older. The trial results demonstrated that the immune responses elicited against all 20 serotypes by the co-administration of Prevnar 20 and the seasonal influenza vaccine met non-inferiority criteria compared to the immune responses elicited when the two vaccines were administered separately with a one-month interval. Additionally, the safety profile of Prevnar 20 during co-administration was similar to that of each vaccine when administered alone.

This trialA total of 1,796 subjects were enrolled, and 1,727 subjects completed the trial. Pfizer will release the detailed results of the clinical trial in the future.

Prevnar 20 is Pfizer's next-generation pneumococcal conjugate vaccine, containing capsular polysaccharide conjugates of the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) already included in Prevnar 13 (13-valent pneumococcal conjugate vaccine), as well as capsular polysaccharide conjugates of 7 additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that cause invasive pneumococcal disease, which are associated with high case-fatality rates, antibiotic resistance, and/or meningitis. On June 8, 2021, the U.S. FDA approved Prevnar 20 for the prevention of invasive disease and pneumonia in adults aged 18 years and older.

References:

[1] Positive Top-Line Results Of Pfizer’S Phase 3 Study Exploring Coadministration Of Prevnar 20™ With Seasonal Flu Vaccine In Older Adults Released. Retrieved September 29, 2021, from https://www.pfizer.com/news/press-release/press-release-detail/positive-top-line-results-pfizers-phase-3-study-exploring

(Original text abridged)

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