Covid: UK health regulator backs Pfizer/BioNTech vaccine for babies as young as six months

The move opens the door to vaccinating the country’s youngest children should the Joint Committee on Vaccination and Immunisation agree
Infants as young as six months will be eligible for two Covid-19 vaccines in the US
Infants as young as six months are already eligible for two Covid-19 vaccines in the US
AFP via Getty Images
Michael Howie6 December 2022

A Covid-19 vaccine for infants as young as six months has been authorised by Britain’s health regulator.

The move announced on Tuesday opens the door to vaccinating the country’s youngest children should the Joint Committee on Vaccination and Immunisation (JCVI) agree.

The Medicines and Healthcare products Regulatory Agency (MHRA) authorised the vaccine - made by Pfizer and BioNTech - for children aged six months to four years old, after it was deemed safe and effective based on an ongoing clinical trial involving 4,526 participants.

Whether the vaccine is eventually deployed in this age group depends on a recommendation from the JCVI, which advises UK health departments on which shots should be used as part of the national vaccination programme.

The vaccine is tailored for use in this age group - it is a lower dose version than the one used in children aged five to 11 years. It is given as three injections in the upper arm, with the first two doses given three weeks apart, followed by a third dose administered at least two months after the second dose.

A statement released on the Government’s website on Tuesday morning said: “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 regulator’s 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.”

US officials rolled out this version of the Pfizer-BioNTech shot for the same age group earlier this year. Months ago, EU regulators also endorsed the use of Covid vaccines made by Pfizer-BioNTech and Moderna for under-fives.

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