Covid vaccines have been licensed for use with children as young as five in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) today issued approval for a new "age-appropriate formulation" of the Pfizer/BioNTech covid vaccine "following a robust review of safety data".
The agency said it had concluded there is a "positive benefit-risk profile" for the jab in that age group.
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The jabs are currently available to anyone aged over 12.
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 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."
Dr Raine said a "detailed review" of all side-effect reports found the overwhelming majority relate to mild symptoms, such as a sore arm or a flu-like illness.
She 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."
However the Joint Committee on Vaccination and Immunisation (JCVI), which decides who should get vaccines once they are licensed and how they will be administered, has so far recommended that the vaccines should only be given to clinically vulnerable children of primary school age.
Professor Wei Shen Lim, chair of the JCVI’s Covid panel, said: “The majority of children aged five to 11 are at very low risk of serious illness due to Covid-19.
"However, some five to 11 year olds have underlying health conditions that put them at higher risk, and we advise these children to be vaccinated in the first instance."
The MHRA said the new vaccine formula is 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 will be given as two injections in the upper arm.
The MHRA said would be for the JCVI to make the final recommendation on the dosing interval.
The agency said it had liaised closely with other international regulators and public health bodies and "carefully considered global data" on use in 5-11-year olds.
It said the data demonstrated 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.
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