The Medicines and Healthcare products Regulatory Agency (MHRA) have this afternoon approved the Pfizer Covid vaccine for use in vulnerable children aged five to 11-years-old.
A smaller dose of the Pfizer BioNTech COVID-19 vaccine, 10 micrograms rather than the current dose of 30 micrograms, has been especially designed for children and met the MHRA’s required safety, quality and effectiveness standards.
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.”
