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Merck Says EU Regulator Panel Recommends Approval of Pneumonia Vaccine
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Merck Says EU Regulator Panel Recommends Approval of Pneumonia Vaccine
Jan 31, 2025 4:35 AM

07:10 AM EST, 01/31/2025 (MT Newswires) -- Merck ( MRK ) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of its Capvaxive vaccine to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae in adults 18 years and older.

The European Commission will review the recommendation for marketing authorization in the European Union, Iceland, Liechtenstein, and Norway, with a final decision expected by Q2, according to Merck ( MRK ).

The company said the recommendation is based on a phase 3 study comparing Capvaxive to PCV20 in adults who had not previously received a pneumococcal vaccine, along with other studies evaluating Capvaxive in vaccine-naive and vaccine-experienced adults.

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