FDA grants priority review to Merck’s pneumococcal vaccine

Vaccine Injection Social

The U.S. Food and Drug Administration (FDA) has granted priority review to Merck’s experimental pneumococcal vaccine, with a decision to be made on approval by June 17, 2024.

The vaccine candidate, currently known as V116, met key endpoints in two phase III trials, Merck announced in July. Results from one of the trials, STRIDE-3, compared V116 against Pfizer’s pneumococcal 20-valent conjugate vaccine PCV20. V116 is a conjugate vaccine designed to protect against 21 strains of pneumococcal bacteria and is indicated for use in adults.

Pneumococcal disease presents greater risks to adults 65 and older and those who are immunocompromised. The firm noted that the 21 serotypes covered by V116 are responsible for 85% of invasive pneumococcal disease in individuals 65 and older. Merck also said in a statement that V116 includes eight strains that are responsible for about 30% of invasive pneumococcal disease cases in older adults but that are not currently covered by other approved pneumococcal vaccines.

If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.

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