The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) made the approval following a robust review of safety data that shows a positive benefit-risk profile for this jab to be used in the age group.
In light of the regulator’s approval, the Joint Committee on Vaccination and Immunisation (JCVI) is advising that children aged five to 11, who are in a clinical risk group, or who are a household contact of someone (of any age) who is immunosuppressed, should be offered a primary course of vaccination.
A primary course vaccination for these children should be with two 10-microgram doses of the age appropriate Pfizer formulation (Comirnaty) – a third of the adult dose, with eight weeks between the first and second doses.
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
Dr June Raine, MHRA chief executive
Further advice regarding Covid vaccination for other five to 11-year-olds will be issued in due course after consideration of additional data, and on the Omicron variant more broadly.
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.
“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.”
Separately, in response to the Omicron threat, the JCVI has advised that booster vaccinations should be offered to those aged 16 to 17 years, children aged 12 to 15 who are in a clinical risk group or who are a household contact of someone who is immunosuppressed, and children aged 12 to 15 years who are severely immunocompromised and who have had a third primary dose.
The booster for these groups should be 30 micrograms of the Pfizer/BioNTech vaccine, given no sooner than three months after completion of the primary course.
Professor Wei Shen Lim, chairman, Covid-19 immunisation, JCVI, 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.
“For children and young people who have completed a primary course of vaccination, a booster dose will provide added protection against the Omicron variant.”