Positive top-line Phase III study results from Pfizer’s major 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) indicate that it could help prevent invasive pneumococcal disease (IPD) and pneumonia.
The trial, conducted with 4,700 infants and 800 toddlers and children of all ages (NCT04546425), measured the vaccine’s immunogenicity and safety parameters against Prevenar 13®, a common paediatric vaccine.
The vaccine’s ability to inhibit the 20 Streptococcus pneumoniae (pneumococcus) serotypes was determined during the trial. Findings suggested that the 20vPnC vaccine offered the broadest serotype coverage of any pneumococcal conjugate vaccine (PCV) available on the market today – and that 20vPnC was as safe as Prevenar 13®.
The seven serotypes included in 20vPnC vaccine cause most cases of invasive pneumococcal disease (IPD) worldwide. The illness causes increased fatality rates, antibiotic resistance, as well as meningitis. Thus, the positive results offer tangible solutions for paediatric patients in the EU.
Referencing the paediatric program, Dr Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development at Pfizer explained: “Based on the totality of immunogenicity and safety data, we feel confident that 20vPnC is likely to be protective against all vaccine serotypes in a three-dose series.”
The study had three main outcomes, testing how the three-dose vaccination performed one month after patients were given second and third doses. The non-inferiority (NI) co-primary objective of immunoglobulin G (IgG) geometric mean concentrations (GMCs) one month after dose three at 11-12 months of age, 19 of the 20 serotypes met the NI criteria with only one serotype narrowly missing. For the NI co-primary objective of IgG GMCs one month after dose two, 16 of the 20 serotypes met NI. The third NI co-primary objective of the percentage of participants with predefined serotype-specific IgG concentrations one month after dose two, nine of the 20 serotypes met the NI criteria.
Every serotype that was tested demonstrated enhanced booster and antibody responses after the third dose versus after the second dose, compared to Prevenar® and Prevenar 13®, demonstrating the vaccine offered substantial long-term protection against pneumococcus serotypes.
Pfizer will provide the clinical data of the studies to European Medicines Agency (EMA). Additionally, the firm will publish outcomes from the clinical trial once full analysis of safety and immunogenicity data has been performed.
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