2023-05-01| Trials & Approvals

Pfizer Racks Up Infant Indication for Pneumococcal Vaccine

by Reed Slater
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After traversing through clinical trials, Pfizer announced that the FDA approved its pneumococcal vaccine, Prevnar 20, for infants and children. The 20-valent vaccine is now in direct competition with Merck’s 15-valent pneumococcal vaccine approved last year, indicated for the same infant population. 

A New and Improved Pneumococcal Vaccine

Prior to Prevnar 20, Pfizer developed Prevnar 13, which is approved for infants and children. Now, the new and improved 20-valent vaccine adds some additional protection, with seven extra serotypes found in pneumococcal cases. 

Pneumococcal disease encompasses a broad range of infections caused by the bacteria, Streptococcus pneumoniae. Infections under the pneumococcal umbrella can range from ear infections to pneumonia to bloodstream infections. Children with certain conditions like sickle cell disease, HIV infection, and diabetes are at a higher risk of developing pneumococcal-related infections. 

Pfizer is touting Prevnar 20 as offering the broadest serotype protection of any pneumococcal vaccine for infants after its most recent approval. The company said the seven added serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) account for approximately 37% of pneumococcal disease cases in children under five years old in the U.S. each year.

Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer of Vaccine Research and Development of Pfizer, said, “Today’s FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children.”

Related Article: Pfizer and GSK Neck and Neck for First FDA-Approved RSV Vaccine 

Clinical Data Supporting the Approval

The Phase 3 clinical trial used to support the FDA’s decision consisted of nearly 2,000 healthy infant participants. The trial compared Prevnar 20’s safety and efficacy to Prevnar 13’s over the course of several months. 

In August last year, Pfizer announced results from the trial before submitting a Biologics License Application to the FDA. The study met its two co-primary objectives of non-inferiority of the percentage of participants with predefined serotype-specific immunoglobulin G concentrations after Dose 3 and NI of IgG geometric mean concentrations after Dose 4.

The data convinced the FDA and led to Prevnar 20’s most recent approval for infants and children. Pfizer can now set Prevnar 20 up against Merck’s 15-valent vaccine, VAXNEUVANCE, which gained approval last June for the same infant indication that Prevnar 20 just received.

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