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.
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.”
In late October, the US Food and Drug Administration approved for the jab’s use – although with lower doses than older age groups.
Since then some experts, including the American Academy of Pediatrics, have pushed strongly for even younger children to be vaccinated.
But the UK has held off expanding its Covid vaccination programmes to children as experts weighed up whether the health gains from vaccinating this group were greater than the risks.
Now, the MHRA is satisfied that they do.
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Dr Raine added: “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.”
They have approved 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.
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It comes after the European Medicines Agency (EMA) approved the use of lower-dose vaccine on the 5-11 age group last month.
Several countries across the European Union have started vaccinating children in that age group.
On Monday, France’s Haute Autorite de Sante (HAS) health regulator approved its use as well.
Scientists hope it will help in the fight against a coming wave of Omicron cases.