EMA
approval
· 2026-08-26
EMA Authorised: Spikevax (previously COVID-19 Vaccine Moderna) (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2) — Moderna Biotech Spain, S.L.
Summary
The EMA has authorised Spikevax (Moderna) for use in the EU; it is an mRNA vaccine encoding the SARS-CoV-2 spike protein for COVID-19.
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Diseases / indications
Drugs mentioned
Snippet
Status: Authorised. Therapeutic area: COVID-19 virus infection. MAH: Moderna Biotech Spain, S.L.. Decision date: 28/07/2026