Fri. 12 Aug 2022, 9:34am ET Benzinga Biotech, Large Cap, News, Health Care, General
- Pfizer Inc's (NYSE:PFE) 20-valent pneumococcal conjugate vaccine showed that after four doses, all 20 serotypes met the statistical noninferiority criteria in the Phase 3 study that compared the 20vPnC candidate to Prevnar 13.
- The trial randomized almost 2,000 healthy infants to receive the 20-valent candidate (20vPnC) or Prevnar 13.
- After three doses, Pfizer saw noninferiority for 14 of the 20 serotypes. According to the company, four of the serotypes "narrowly missed" while the other two fell short of noninferiority by a "wider margin." A fourth dose eliminated the gap, resulting in all 20 serotypes achieving noninferiority.
- Pfizer said that all 20 serotypes elicited robust functional responses and increases in antibody responses after dose four. The company thinks "the totality of data" supports the potential benefit of all serotypes in its 20-valent vaccine candidate.
- The safety profile of 20vPnC was consistent with Prevnar 13 when given in the same schedule. A similar percentage of infants in both cohorts experienced local reactions, such as pain at the injection site, fever, and other systemic events, including decreased appetite, drowsiness, and irritability.
- Pfizer plans to seek approval in infants by the end of 2022, subject to discussions with the FDA. Additional top-line results from other pediatric 20vPnC trials are expected to read out in 2H of 2022.
- Price Action: PFE shares are up 2.28% at $49.41 on the last check Friday.