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Pfizer’s Pneumococcal Vaccine Shows Great Promise in European Study
This week, Pfizer announced incredibly positive results from their Phase III study in 20-valent pneumococcal conjugate vaccine candidate (20vPnC) in infants. The data suggests that 20vPnC will most likely be able to defend against all 20 vaccine serotypes in a three-dose series, the broadest serotype coverage of any pneumococcal conjugate vaccine (PCV). News of this success in the European trial comes just a month after Pfizer’s triumph in their four-dose clinical trial conducted in the US.
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20vPnC contains 13 serotypes which are already found in Prevenar 13, the new vaccine candidate’s predecessor. The seven new serotypes included in 20vPnC are causes of invasive pneumococcal disease (IPD) which are closely associated with high case-fatality rates, antibiotic resistance, and/or meningitis. According to Pfizer, the 20 serotypes are deemed responsible for “the majority of currently circulating pneumococcal disease in the EU and globally”.
The EU 20vPnC trial saw over 1200 infants enrolled and given either 20vPnC or Prevenar 13 to allow Pfizer to compare the results produced by the old and new vaccines. The 20vPnC is a three-dose vaccination series, with doses administered at approximately 2, 4, and 11-12 months of age.
The three co-primary outcomes for the EU study corresponded to immunogenicity responses one month after both the second and third doses. For the noninferiority (NI) co-primary objective of immunoglobin G concentrations one month after the second dose, 16 of the 20 serotypes met the NI criteria. This gap was closed for the NI co-primary one month after dose three, where 19 out of the 20 serotypes met NI criteria. Pfizer reported that the outstanding serotype “narrowly” missed the criteria.
20vPnC had “the most comprehensive pneumococcal serotype coverage of any available PCV”
Moreover, all 20 serotypes showed increased booster responses post-dose two and again after dose three. These results, which resemble the first two iterations of Prevenar 13, indicate immunological memory and therefore the capacity for long-term protection.
Overall, the positive results from the 20vPnC data, in conjunction with prior clinical experience of Prevenar 13, suggest that 20vPnC will be able to protect against all 20 PVC serotypes. Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development at Pfizer, commented that this would mean that 20vPnC had “the most comprehensive pneumococcal serotype coverage of any available PCV”.
Pfizer plans to file these data with the European Medicines Agency before the end of 2022. They also intend to present and publish the outcomes from this clinical trial at a future date once the safety and immunogenicity data have been fully analysed.
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