Although Pfizer beat Merck to sell its next-generation pneumococcal vaccination, it lost a more important battle in June when the FDA said its competitor may provide its next-generation shot to new-borns and young children.
Two months later, Pfizer, playing catch-up, has reacted with clinical evidence that might pave the way for the approval of its injection, Prevnar 20, for use in babies. According to a news statement, Pfizer stated it hopes to submit its Biologics License Application to the FDA for Prevnar 20 clearance before the end of the year.
Prevnar 20 is roughly a year behind Merck’s next-generation shot in the paediatric population. In August of last year, Merck released its phase 3 findings for Vaxneuvance usage in newborns. An unforeseen roadblock occurred in March when the FDA postponed its decision over Vaxneuvance, delaying the clearance by three months.
Pfizer may be able to beat Merck once their vaccine is licenced because Vaxneuvance offers protection from 15 serotypes.
All 20 of the serotypes covered by Prevnar 20 met the study’s non-inferiority criteria, triggering immunological responses in the phase 3 trial. In addition, the trial assessed immunological responses following the third Prevnar 20 treatment in a four-dose series, with 14 of the 20 serotypes qualifying. According to the statement, of the six that didn’t, two fell short more severely and four missed by a significant margin.
In July 2021, Merck received the first approval for the use of Vaxneuvance in adults. However, given that they make up 80% of the profitable market, children are the crucial demographic. Prevnar 13 sales last year totalled $5.3 billion.