With a pediatric approval in June for its next-generation pneumococcal vaccine, Merck leads a high-stakes race with Pfizer to capture the competition’s key demographic.
But Pfizer is quickly gaining ground with its next-gen shot that offers more protection. Friday, the FDA designated Prevnar 20 for priority review in children aged 6 weeks through 17 years.
Acceptance of the priority review slices four months off the approval timeline, setting Prevnar 20 up for a potential nod in April of this year. The vaccine won an approval in adults in June 2021, six weeks before Merck gained its endorsement for Vaxneuvance to protect adults.
With Prevnar 13 and 20, Pfizer has the dominant franchise on the market, generating $5.3 billion in sales in 2021.
But with its pediatric approval seven months ago for Vaxneuvance, Merck gained an advantage—offering a shot that defends against 15 serotypes of the virus versus the 13 strains covered by Prevnar.
Now, that edge could be short-lived as Prevnar’s next-generation vaccine protects against 20 serotypes.
The vaccines offer protection against bacteria that can cause pneumonia, meningitis and blood infections. The Centers for Disease Control and Prevention recommends that infants receive doses at ages 2 months, 4 months, 6 months and 12 through 15 months. Children make up 80% of the pneumococcal vaccine market.
In phase 2 and 3 studies that support the submission, Prevnar 20 was tested in more than 4,300 children, including 3,500 infants.
Though not imminent, pneumococcal vaccine competition is coming for Merck and Pfizer. Last May, in an effort to crack the market, GSK acquired Affinivax and its 24-valent vaccine in a $3.3 billion buyout. A phase 3 trial is underway for AFX3772.
Just yesterday, California biotech Vaxcyte received FDA breakthrough therapy designation for its pneumococcal vaccine VAX-24, which is in phase 2 testing for adults. In August, Seattle-based Inventprise launched a phase 1/2 trial of its 25-valent vaccine IVT PCV-25.