Pfizer/BioNTech COVID-19 vaccine approved for paediatric use

A new lower-dose presentation of Comirnaty has been recommended for use in children 5-11 years.

A young boy wearing a face mask looks away as a doctor's blue-gloved hands are seen injecting a vaccine into the boy's upper arm.
An age-appropriate formulation of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) has been approved for use in children. | GETTY IMAGES

Children aged 5 to 11 who are in a clinical risk group or who are a household contact of someone who is immunosuppressed should be offered the new paediatric formulation of the Comirnaty Pfizer/BioNTech COVID-19 vaccine, the Joint Committee on Vaccination and Immunisation (JCVI) has advised.

Further information

View Comirnaty drug record

The new formulation contains a third of the vaccine dose given to people aged 12 and above (10 microgram compared with 30 microgram). As for other age groups, it is given as two injections in the upper arm. The JCVI recommends an interval of 8 weeks between the first and second doses.

Professor Wei Shen Lim, Chair, COVID-19 immunisation, JCVI, said: 'The majority of children aged 5 to 11 are at very low risk of serious illness due to COVID-19. However, some 5 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 JCVI said advice regarding COVID-19 vaccination for other 5- to 11-year-olds will be issued in due course 'following consideration of additional data relevant to this age group, and on the Omicron variant more broadly'.

MHRA approval

The JCVI's recommendation was issued following regulatory approval of the new Comirnaty formulation by the MHRA. 

Dr June Raine, MHRA Chief Executive said: “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.'

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