This spring, when the FDA pushed its target date for pediatric approval of Merck’s pneumococcal vaccine Vaxneuvance back by 90 days, it was a blow to the company’s hope to get its next-generation shot on the market as soon as possible in a key demographic.
But less than three months later, the FDA has blessed Vaxneuvance for children ages 6 weeks to 17 years, giving Merck a running start on its next-gen pneumococcal vaccine rival Pfizer.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to make its recommendations on the use of Vaxneuvance in the pediatric population.
The vaccines protect against bacteria that can cause pneumonia, meningitis and blood infections.
The endorsement is the first for a pediatric pneumococcal vaccine in nearly a decade. Merck scored its initial FDA nod for Vaxneuvance in July of last year. But that green light was for adults. Children are the important sector as they make up 80% of the pneumococcal vaccine market.
While Pfizer earned approval of its next-gen shot Prevnar 20 six weeks before Merck, it trails in its pursuit of a pediatric sanction. The longer Merck can offer the lone next-gen shot for kids, the more chance it has to attract new users and others interested in switching from Pfizer to gain an added measure of protection.
While Pfizer’s longtime stalwart Prevnar 13 covers 13 serotypes of pneumococcal disease, Vaxneuvance protects against 15, including all 13 covered by the Pfizer jab plus two key additional serotypes.
Those, F22 and F33, are among the top five serotypes that cause invasive pneumococcal disease (IPD) among children. IPD can lead to hospitalization or death as well as long-term neurological complications. Children under the age of 2 are particularly vulnerable to IPD.
“Our goal with Vaxneuvance is to expand coverage of key invasive disease-causing serotypes and provide a strong immune response to serotypes that pose substantial risk to infants and children,” Eliav Barr, M.D., senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said in a statement.
The approval was based on data from seven randomized, double-blind clinical studies that showed immune responses elicited by Vaxneuvance in infants, children and adolescents measured up to those of Prevnar 13 for their 13 shared serotypes.
In a secondary analysis, immune responses for Merck’s shot were superior to Prevnar 13 for shared serotype 3 and the two serotypes that are unique to Vaxneuvance.
Vaxneuvance was originally scheduled for a pediatric approval on April 1. But the FDA extended the deadline by three months, saying it needed more analyses of data from Merck.
Much is at stake in this large market. Prevnar 13 generated $5.3 billion in sales last year.