A new formulation of ‘lower dose’ Pfizer BioNTech COVID-19 vaccine (Comirnaty) has been approved for use in children aged 5 to 11 years old with the Joint Committee on Vaccination and Immunisation (JCVI) recommending it is offered to those in a clinical risk group or who are a household contact of someone who is immunosuppressed.
The approval by the Medicines and Healthcare products Regulatory Agency (MHRA) 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,” says the MHRA.
The formulation designed for 5-11 year olds will be given at a lower dose compared to that used in individuals aged 12 and above (10 micrograms compared with 30 micrograms). The JCVI says there should be 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.
The JCVI says this will be based on updated estimates of the proportion of children aged 5 to 11 years who have already been infected; the level of protection afforded against COVID-19 disease due to the Omicron variant; any reports of adverse reactions and considerations from the Department of Health and Social Care (DHSC) and other government departments on the potential educational impacts of COVID-19 vaccination in those aged 5 to 11 years
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.”
In all instances, the offer of vaccination must be accompanied by appropriate information to enable children, and those with parental responsibility, to provide informed consent prior to vaccination.
The JCVI has also recommended a booster be offered to young people aged 16 to 17 years; children and young people aged 12 to 15 who are in a clinical risk group or who are a household contact of someone who is immunosuppressed and children and young people aged 12 to 15 years who are severely immunosuppressed and who have had a third primary dose.
Professor Wei Shen Lim, Chair of 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.”