Drug major Pfizer Inc. (PFE) announced Friday positive top-line results from its pivotal U.S. Phase 3 study (NCT04382326) evaluating its 20-valent pneumococcal conjugate vaccine candidate or 20vPnC in infants.
The trial was for the prevention of invasive pneumococcal disease or IPD caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.
Based on the totality of positive safety and immunogenicity data, Pfizer plans to submit a supplemental Biologics License Application or sBLA by the end of this year, subject to discussions with the U.S. Food and Drug Administration.
Pfizer’s 20vPnC pediatric vaccine candidate includes 13 serotypes already included in Prevnar 13 – 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. The seven new serotypes included in 20vPnC are global causes of IPD, and are associated with high case-fatality rates, antibiotic resistance, and/or meningitis.
In 2020, Pfizer initiated the Phase 3 clinical trial program for the pediatric indication for 20vPnC.
The company now noted that the study had two co-primary objectives, associated with immunogenicity responses one month after the third and fourth doses of the four-dose vaccination series, respectively.
Overall, the safety profile of the 20vPnC candidate was consistent with Prevnar 13 given in the same schedule. The study also met non-inferiority objectives for responses to co-administered routinely used pediatric vaccines.
Pfizer said it will seek to present and publish outcomes from this clinical trial at a future date once safety and immunogenicity data have been fully analyzed.
Additional top-line results from other pediatric 20vPnC clinical trials are expected in the second half of 2022, with discussions with other regulatory bodies planned once those pivotal data become
Pfizer’s 20vPnC received the FDA’s Breakthrough Therapy Designation in August 2020 for the prevention of disease caused by Streptococcuspneumoniae serotypes in the vaccine in infants, children, and adolescents.
The FDA previously granted Fast Track Designation for 20vPnC for the pediatric indication in May 2017 .
In June, 2021, the FDA approved PREVNAR 20 for the prevention of invasive disease and pneumonia caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes in the vaccine in adults ages 18 years and older.
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