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EMA approval · 2026-04-29

EMA Authorised: Comirnaty (single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2) — BioNTech Manufacturing GmbH

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Summary

Comirnaty (BioNTech) has been authorised by the EMA for use in COVID-19, with the active substance being mRNA encoding the SARS-CoV-2 spike protein.

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Diseases / indications

Drugs mentioned

  • Comirnaty (tozinameran)

Snippet

Status: Authorised. Therapeutic area: COVID-19 virus infection. MAH: BioNTech Manufacturing GmbH. Decision date: 08/04/2026