The Pfizer COVID-19 vaccine has met the Medicines and Healthcare products Regulatory Agency’s required safety, quality and effectiveness standards to be authorised for use in children aged 6 months to 4 years.
It will now be for the Joint Committee on Vaccination and Immunisation (JCVI) to decide if the vaccine will be recommended for use in this age group as part of the UK’s COVID-19 vaccination programme.
The Medicines and Healthcare products Regulatory Agency (MHRA) authorised the vaccine for this age group after it was found to meet their standards and raised no new safety concerns. The decision has been endorsed by the Commission on Human Medicines, after a review of the evidence.
The vaccine would be given at a lower dose in this age group than for children aged 5 to 11 (3 micrograms compared with 10 micrograms) and would be given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose given at least eight weeks after the second dose.
In reaching their decision, the MHRA’s experts reviewed data from an ongoing clinical trial involving 4,526 participants. The common, expected side effects were in line with what would be expected from a vaccine in this age group.