The Medicines and Healthcare products Regulatory Agency (MHRA) has today approved the use of Comirnaty for children aged 5 to 11 years old. It is a formula produced specifically for youngsters. Its 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.
Experts want more real-world evidence before recommending wider use of the drug of young children.
The Joint Committee on Vaccination and Immunisation (JCVI) has said it wants more real-world evidence before recommending the jab, after it found that a million doses among five to 11-year-olds would prevent only two healthy children from requiring intensive care.
However, around 330,000 children with underlying health conditions in this age group will be offered two reduced doses of the Pfizer/BioNTech vaccine, eight weeks apart.
Included in this group are also children who are household contacts of people who are immunosuppressed.
Dr June Raine, chief executive of the MHRA, 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 five 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 five to 11 years old.”
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