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

Spikevax, Moderna’s COVID-19 vaccine, is today licensed for use in children aged 6 months to 5 years.

The vaccine was authorized in this new age group after it was found to meet our standards for safety, quality and efficacy, with no new safety issues identified. This followed advice from the Commission for Medicinal Products for Human Use, which carefully reviewed the evidence.

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

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

To make their decision, MHRA experts carefully considered data from an ongoing clinical trial involving 6,388 children aged 6 months to 5 years. Common side effects (reactogenicity) were consistent with what one would expect from a vaccine in this age group.

It is up to the Joint Committee on Vaccination and Immunization (JCVI) to determine whether the vaccine will be recommended for use in this age group as part of the UK’s COVID-19 vaccination programme.

More information

• The Commission for Medicinal Products for Human Use (CHM) advises Ministers on the safety, efficiency and drug quality. The CHM is a non-departmental public consultative establishment, sponsored by the Ministry of Health and Social Action.
• This authorization granted by the MHRA is only valid in Great Britain and has been authorized via the Reliance Route decision of the European Commission (EC). This is when the marketing authorization application made by the company refers to the decision taken by the EMA’s Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA reviews the application with due regard to the EC decision, before making an independent decision on the quality, safety and efficacy of the vaccine.
• More information can be found in the product information.