Spikevax approved for use in children aged 6 months to 5 years

Spikevax, the COVID-19 vaccine from Moderna, has today been authorized for use in children aged 6 months to 5 years.

The vaccine has been authorized in this new age group after it has been found to meet our standards of safety, quality and effectiveness, with no new safety concerns identified. This followed advice from the Commission on Human Medicines, which carefully reviewed the evidence.

This is the second COVID-19 vaccine to be authorized in this age group; the Pfizer/BioNTech vaccine (Comirnaty), was authorized in Great Britain for infants and children aged 6 months to 4 years on 6 December 2022.

For this age group, the vaccine is given as a primary series of two 25-microgram injections in the upper arm or in the thigh, approximately one month apart.

In reaching their decision, the MHRA's experts carefully reviewed data from an ongoing clinical trial involving 6,388 children aged 6 months to 5 years. The common side effects (reactogenicity) were in-keeping with what can be anticipated from a vaccine in this age group.

It is for the Joint Committee on Vaccination and Immunisation (JCVI) to determine if the vaccine will be recommended for use in this age group as part of the UK's COVID-19 vaccination program.

Further information

• The Commission on Human Medicines (CHM) advises ministers on the safety, efficacy and quality of medicinal products. The CHM is an advisory non-departmental public body, sponsored by the Department of Health and Social Care.
• This authorization granted by the MHRA is valid in Great Britain only and was authorized via the European Commission (EC) Decision Reliance Route. This is when the marketing authorization application made by the company references the decision made by the EMA's Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA considers the application together with due consideration of the EC decision, before making an independent decision on the quality, safety and effectiveness of the vaccine.
• More information can be found in the product information.