The European Medicines Agency supports granting marketing authorisation to the updated Spikevax vaccine
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends the approval of the Spikevax XBB.1.5 coronavirus vaccine. The vaccine is used to prevent COVID-19 infection in adults and in children over 6 months of age.
The EMA and the European Centre for Disease Prevention and Control (ECDC) have previously together set out a policy that adults and children over the age of 5, 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. Children (6 months to 4 years of age) should be vaccinated with one or three doses, depending on the vaccine series they have previously received.
CHMP decided on the recommendation on the basis of all the information already available. In addition, the Committee assessed the new results of the laboratory study on the efficacy of the variant-tailored Spikevax vaccine to evoke immune response against XBB.1.5 and its adjacent virus lines.
Decisions on the marketing authorisation for the Spikevax Omicron XBB.1.5 vaccine are made by the European Commission at the recommendation of the European Medicines Agency, which means the marketing authorisation is valid simultaneously in all EU countries, including Finland.
National health authorities are responsible for making 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).
EMA press release 14 September 2023: Spikevax: EMA recommends approval of adapted COVID-19 vaccine targeting Omicron XBB.1.5
- Jukka Sallinen, Head of Unit, tel. +358 29 522 3410
- Marjo-Riitta Helle, Head of Unit, tel. +358 29 522 3320
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