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Merck’s V116 Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Invasive Pneumococcal Disease & Pneumococcal Pneumonia

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Merck’s V116 Receives the US FDA’s Breakthrough Therapy Designation for the Prevention of Invasive Pneumococcal Disease & Pneumococcal Pneumonia

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  • The US FDA has granted BTD to V116 (21-valent pneumococcal conjugate vaccine) for the prevention of IPD and pneumococcal pneumonia caused by multiple Streptococcus pneumoniae serotypes in adults aged ≥18yrs. The P-III trial of V116 is expected to be initiated in 2022
  • The designation was based on the results from the two-part P-I/II (V116-001) study to evaluate the safety, tolerability, and immunogenicity of a single dose of V116 in pneumococcal vaccine-naïve adults aged 18-49yrs. (P-I) study and ≥50yrs. (P-II) study. The full results will be presented at the upcoming ISPPD in June
  • V116 was designed to target serotypes that account for 85% of IPD in patients aged ≥65yrs. in the US

Sukamenak

Ref: Businesswire | Image: Merck

Click here to­ read the full press release 

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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.

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