Shots:
The CHMP has recommended mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (age≥12 yrs)
Opinion was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (age ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination
The trial met its 1EP with mNEXSPIKE showing 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in…
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Bavarian Nordic has reported topline P-II trial results evaluating two standard doses of the MVA-BN mpox/smallpox vaccine in 460 participants, incl. children (2–11 yrs) & adults (18–50 yrs) across 2 cohorts in the DRC & Uganda
In the trial, 227 children among 451 evaluable subjects showed a non-inferior immune response to adults (n=224) 2wks.…

