Pfizer’s 20-valent pneumococcal conjugate vaccine has taken a step toward approval in infants. After four doses, all 20 serotypes met the statistical noninferiority criteria in a study that compared the candidate to Prevnar 13.
The clinical 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.
“We are encouraged by today’s data which show that if approved for a pediatric indication, 20vPnC would have the potential to cover more of the clinically significant remaining burden of infant pneumococcal disease than any other available pneumococcal conjugate vaccine,” Annaliesa Anderson, Ph.D., chief scientific officer, vaccine research and development at Pfizer, said in a statement Friday morning.
All 20 serotypes elicited robust functional responses and increases in antibody responses after dose four, Pfizer said. 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.
Based on the data, Pfizer plans to seek approval in infants by the end of the year, subject to discussions with the FDA. The trial is one of four pediatric phase 3 studies of 20vPnC that have collectively enrolled around 4,700 infants and 800 toddlers. Pfizer expects to release additional top-line data from the trials in the second half of 2022.