Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s Approval for the Prevention of Invasive Pneumococcal Disease
Shots:
- The approval is based on seven P-III clinical studies assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in infants, children, and adolescents 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 and unique serotypes 22F and 33F
- The approval follows the FDA’s Priority Review of Merck’s application. Vaxneuvance is the first PCV to be approved in almost a decade 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
