News story

MHRA approves Moderna’s adapted COVID-19 vaccine (Spikevax) that targets Omicron XBB.1.5

The vaccine was approved after it was found to meet the MHRA’s standards of safety, quality and effectiveness.

An adapted COVID-19 vaccine from Moderna (Spikevax) that targets the Omicron XBB 1.5 subvariant, has today been authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.

The vaccine has been approved for use in individuals from 6 months of age.

The adapted vaccine works in the same way as the original vaccine by causing the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19. All approved adapted COVID-19 vaccines help to improve the protection obtained from earlier doses of the vaccine and help give longer-term protection against getting seriously ill from COVID-19.

Further information:

  • This new line extension was approved via the National licensing route. This marketing authorisation has been endorsed by the government’s independent Commission on Human Medicines after review of the data submitted on the quality, safety and effectiveness of the vaccine.
  • More information can be found in the vaccine decision page on mhra.gov.uk
  • The Public Assessment Report will be published shortly.

Updates to this page

Published 15 September 2023