MHRA approves new formulation of Pfizer BioNTech COVID-19 vaccine for 5-11 year olds

A new age-appropriate formulation of the Pfizer BioNTech COVID-19 vaccine (Comirnaty) for use in children aged 5 to 11 years old has been approved today by the Medicines and Healthcare products Regulatory Agency (MHRA) after finding that it is safe and effective. This approval was given following a robust review of safety data that shows a positive benefit-risk profile for this vaccine to be used in this age group.

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.”

Dr June Raine, MHRA Chief Executive

Today’s 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. It will be for the Joint Committee on Vaccination and Immunisation (JCVI) to make the final recommendation on the dosing interval.

In coming to this decision, the MHRA has liaised closely with other international regulators and public health bodies and carefully considered global data on use in 5-11-year olds. These data demonstrate a favourable safety profile compared with that seen in other age groups. Over 5.5 million dosages of the vaccine in 5-11s have now been administered in the US alone.