Policy & Regulation
Pfizer reports positive top-line results from Phase 3 study of IPD vaccine candidate
12 August 2022 -

US biopharmaceutical company Pfizer Inc (NYSE:PFE) announced on Friday positive top-line results from its a Phase 3 study of its 20-valent pneumococcal conjugate vaccine candidate, 20vPnC.

The trial evaluated 20vPnC for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the paediatric population.

Results show that 20vPnC elicited robust immune responses to all 20 serotypes, meeting the statistical non-inferiority (NI) criteria for the co-primary objective after Dose 4.

Additionally, 14 of the 20 serotypes met the co-primary objective of NI of the percentage of participants with predefined immunoglobin G (IgG) levels after Dose 3, and all serotypes met NI for the key secondary objective of IgG geometric mean concentrations (GMCs) after Dose 3. All 20 serotypes elicited robust functional responses and increases in antibody responses after Dose 4.

20vPnC also demonstrated a favourable safety and tolerability profile similar to Prevnar 13.

Pfizer said that it plans to submit a supplemental Biologics License Application (sBLA) by the end of this year, subject to discussions with the US Food and Drug Administration.

If approved, a four-dose series of the new vaccine would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants, Pfizer noted.

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