Merck Secures FDA Decision Date for Pneumococcal Vaccine, Race Heats Up with Pfizer

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Pictured: Merck building in California/iStock, Sun

Merck is looking to challenge Pfizer in the pneumococcal vaccine space with Tuesday’s announcement that the FDA has granted priority review for a Biologics License Application for V116, Merck’s investigational 21-valent pneumococcal conjugate vaccine.

The regulator has set a Prescription Drug User Fee Act date of June 17, 2024.

If the V116 vaccine is approved, it would be the first pneumococcal conjugate vaccine that is “specifically designed to address the serotypes that cause most adult invasive pneumococcal disease,” according to Merck CMO Eliav Barr.  

The BLA for the vaccine is based on data from the Phase III STRIDE-3 trial which put Merck’s vaccine up against Pfizer’s Prevnar 20. In November 2023, Merck announced the results from the STRIDE-3 study , revealing that in adults 50 and over the vaccine produced “non-inferior immune responses” compared to PCV20 for all 10 serotypes of both vaccines at day 30. Immune responses to the vaccine “were superior” for 10 of the 11 serotypes included in the V116 vaccine but not in PCV20.

For adults 18 to 49 years of age, the vaccine had “non-inferior immune responses” compared to adults aged 50 to 64. For both groups of patients, V116 had a safety profile that was “comparable” to PCV20. While Merck initially gave no other detailed figures, according to the CDC, the serotypes covered by the V116 vaccine are responsible for an estimated 83% of invasive pneumococcal disease in people 65 and older.  

“These results provide strong evidence to support the immunogenicity of V116 compared to the standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults,” Barr said at the time.

In July 2023, the STRIDE-3 and STRIDE-6 trials showed that V116 outperformed a standard 20-valent vaccine  providing an immune response in those who have not been immunized before. 

“Invasive forms of pneumococcal disease can cause severe and sometimes life-threatening complications, such as pneumococcal pneumonia, pneumococcal meningitis and bacteremia, especially for older or immunocompromised adults,” Sady Alpizar, principal investigator at the Clinical Research Trials of Florida, who serves as a principal investigator of the study, said in a statement. 

Pfizer had its 20-valent vaccine Prevnar 20 approved by the FDA in infants and children from six months to age 17 in April 2023. The vaccine was approved in adults in 2021. The Prevnar family of vaccines saw a 15% boost in sales in the third quarter of 2023, bringing in over $4.8 billion in revenue. 

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

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