GovWire

Authorisation has today been granted for a new presentation of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) for use in infants and children aged 6 months to 4 years.

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the vaccine in this new age group after it has been found to meet the UK regulators standards of safety, quality and effectiveness, with no new safety concerns identified. This decision has been endorsed by the Commission on Human Medicines, after a careful review of the evidence.

This presentation is specially designed for this new age group and given at a lower dose compared to that used in individuals aged 5 to 11 years (3 micrograms compared with 10 micrograms). It is given as three injections in the upper arm, with the first two doses given 3 weeks apart, followed by a third dose given at least 8 weeks after the second dose.

In reaching their decision, the MHRAs experts carefully reviewed data from an ongoing clinical trial involving 4,526 participants. The common, expected side effects (reactogenicity) were in-keeping with what can be anticipated from a vaccine in this age group.

It will be 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 UKs COVID-19 vaccination programme.

Notes to editors:

• 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 new line extension granted by the MHRA is valid in Great Britain only and was authorised via the European Commission (EC) Decision Reliance Route. This is when the marketing authorisation application made by the company references the decision made by the EMAs 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 for the Pfizer/BioNTech bivalent v

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