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Moderna Receives EMA's CHMP Positive Opinion Recommending Conditional Marketing Authorization of Spikevax (COVID-19 vaccine) for COVID-19

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Moderna Receives EMA's CHMP Positive Opinion Recommending Conditional Marketing Authorization of Spikevax (COVID-19 vaccine) for COVID-19

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  • The EMA’s CHMP has adopted a positive opinion recommending CMA for Spikevax in adolescents aged ≥12yrs. to treat COVID-19
  • The P-II/III (KidCOVE) study evaluates the safety, tolerability, reactogenicity & effectiveness of Spikevax (mRNA-1273) in healthy children. The study is being conducted in collaboration with NIAID
  • The results from ~4,000 children showed that 50μg mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing Ab responses over P-III (COVE) study in patients aged 18-25yrs. & the efficacy of two 50 μg doses was observed & was well tolerated. The booster dose will be given for patients aged ≥18yrs. at 2mos. after the second dose

 Ref: Accesswire | Image: Moderna

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