Vaccinations are to be offered to 5 to 11 year olds who are at higher risk from coronavirus (COVID-19).
Following extensive assessment of the risks and benefits of vaccinations for 5 to 11 year olds, including analysis of clinical trial results and real-world international data, the Joint Committee on Vaccination and Immunisation (JCVI) has updated its advice for this age group.
Children aged 5 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.
Primary course vaccination for these children should be with 2 10-microgram doses of the Pfizer-BioNTech COVID-19 vaccine (a third of the adult dose), with an interval of 8 weeks between the first and second doses.
Further 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.
Separately, in response to the threat from the Omicron variant, the JCVI has advised that booster vaccinations should be offered to persons aged:
- 16 to 17 years
- 12 to 15 who are in a clinical risk group or who are a household contact of someone (of any age) who is immunosuppressed
- 12 to 15 years who are severely immunocompromised and who have had a third primary dose
The booster vaccination for these age groups should be with 30 micrograms of the PfizerBioNTech COVID-19 vaccine, given no sooner than 3 months after completion of the primary course.
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.
For children and young people who have completed a primary course of vaccination, a booster dose will provide added protection against the Omicron variant.
The new age-appropriate formulation of the Pfizer BioNTech COVID-19 vaccine (Comirnaty) for use in children aged 5 to 11 years old has been approved today by the Medicines and Healthcare products Regulatory Agency (MHRA) after finding that it is safe and effective. This 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. 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.”
Today’s approval is for 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).