Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Pneumococcal Disease


The approval is based on seven P-III clinical studies assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in 1720 adults aged 6wks. through 17yrs. with IPD caused by 15 serotypes
Results: Vaxneuvance showed a non-inferior immune response to PCV13 for 13 shared serotypes based on serotype-specific IgG GMCs, following a four-dose pediatric series & superior immune responses for shared serotypes 3, 22F & 33F
The approval follows the FDA’s Priority Review of Merck’s application. Vaxneuvance marks the first pneumococcal conjugate vaccine approved to protect pediatric populations against IPD & has also received BTD from the US FDA for the pediatric indication

Ref: Businesswire | Image: Merck

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