Spikevax, Moderna’s COVID-19 vaccine, is licensed for use in children ages 6 months to 5 years.
The vaccine was licensed in this new age group after it was shown to meet our standards for safety, quality and efficacy, with no new safety concerns identified. This followed advice from the Human Medicines Committee, which has carefully reviewed the evidence.
This is the second COVID-19 vaccine to be authorized in this age group; Pfizer/BioNTech (Comirnaty) vaccine, licensed 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 an initial series of two 25-mcg injections into the upper arm or thigh, about a month apart.
To reach their decision, MHRA experts carefully reviewed data from an ongoing clinical trial involving 6,388 children ages 6 months to 5 years. The common side effects (interaction) were consistent with what would be expected from a vaccine in this age group.
It is up to the Joint Committee on Vaccination and Immunization (JCVI) to decide whether the vaccine would be recommended for use in this age group as part of the UK’s COVID-19 vaccination programme.
- The Committee on Human Medicines (CHM) advises ministers on safety, effectiveness The quality of medical products. The Clearing House is a non-departmental advisory public body, sponsored by the Department of Health and Welfare.
- This authorization granted by the MHRA is valid in Great Britain only and authorized through the European Commission (EC) Decision-Making Path. This is when the company’s marketing authorization application refers to the decision made by the EMA Committee for Medicinal Products for Human Use (CHMP). In such cases, the MHRA considers the application together with due regard to the decision of the European Commission, before making an independent decision on the quality, safety and efficacy of the vaccine.
- More information can be found in the product information.