Vaccine approval for 5 to 11 year olds

A new paediatric formulation of the Pfizer/BioNTech Covid-19 vaccine has been approved for children aged 5 to 11.

The Medicines and Healthcare products Regulatory Agency (MHRA) said the “age-appropriate” formulation had been found to be “safe and effective”.

The approval was given following a review of safety data that shows a positive benefit-risk profile for the vaccine.

However, the Joint Committee on Vaccination and Immunisation (JCVI) has said the vaccine will get a limited rollout initially, with only medically vulnerable children expected to be eligible.

Dr June Raine, MHRA chief executive, said: “Parents and carers can be reassured that no new vaccine for children would have been approved unless the expected standards of safety, quality and effectiveness have been met.

“We have concluded that the Pfizer/BioNTech Covid-19 vaccine is safe and effective for 5 to 11-year olds, with no new safety concerns identified.

“We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit risk for children in this age group.

“Our detailed review of all side-effect reports to date has found that the overwhelming majority relate to mild symptoms, such as a sore arm or a flu-like illness.

“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this includes children aged 5 to 11 years old.”

The approval is for a formulation specially designed for 5-11 year olds and given at a lower dose compared to that used in individuals aged 12 and above (10 micrograms compared with 30 micrograms).

As with other age groups, it is given as two injections in the upper arm.

The JCVI will make the final recommendation on the dosing interval.