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The European Medicines Agency recommends granting marketing authorisation to the updated Nuvaxovid vaccine

1.11.2023 | Published in English on 3.11.2023 at 11.02

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends the approval of the Nuvaxovid XBB.1.5 coronavirus vaccine. The vaccine is used to prevent COVID-19 infection in adults and in adolescents over 12 years of age.

The EMA and the European Centre for Disease Prevention and Control (ECDC) have previously together set out a policy that adults and adolescents over the age of 12 who need protection from COVID-19 should be vaccinated again with a single dose of a variant-tailored vaccine, regardless of their previous vaccinations against COVID-19.

The CHMP decided on the recommendation on the basis of the laboratory results it assessed and the results of a previous study on adults vaccinated with the Nuvaxovid vaccine.

Decisions on the marketing authorisation for the Nuvaxovid XBB.1.5 vaccine are made by the European Commission at the recommendation of the European Medicines Agency, which means that the marketing authorisation is valid simultaneously in all EU countries, including Finland.

National health authorities are responsible for making the decisions on the use of vaccines and vaccinations. In Finland, the recommendations for vaccines are made by the Finnish Institute for Health and Welfare (THL).

Read more:

EMA press release, 31 October 2023: EMA recommends approval of adapted Nuvaxovid COVID-19 vaccine targeting Omicron XBB.1.5

Ask more

  • Jukka Sallinen, Head of Unit, tel. +358 29 522 3410
  • Marjo-Riitta Helle, Head of Unit, tel. +358 29 522 3320
  • E-mail addresses take the form [email protected]

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