The UK government’s advisory body on vaccines has recommended giving low-dose Pfizer-BioNTech COVID-19 vaccine shots to vulnerable children as young as 5, and booster shots for some teenagers.
In a statement published on Wednesday, the Joint Committee on Vaccination and Immunisation (JCVI) said two 10 microgram doses of the Pfizer vaccine, also known as Comirnaty, should be offered to children aged 5 to 11 who are either in a clinical risk group or live with an immunosuppressed person.
It is estimated that around 330,000 children will be eligible for the shot.
The JCVI recommended an eight-week interval between the doses, and a four-week minimum interval between any vaccine dose and a recent COVID-19 infection.
Dr. June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency, sought to reassure parents and carers that “no new vaccine for children would have been approved unless the expected standards of safety, quality, and effectiveness have been met.”
Raine said the MHRA hasn’t identified any new safety concerns in 5- to 11-year-olds, and “there is robust evidence to support a positive benefit-risk for children in this age group.”
The regulatory body approved the Pfizer-BioNTech vaccine for use in 5- to 11-year-olds for the first time on Wednesday.
“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,” Raine said, adding that the UK has a “comprehensive safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines.”
The four nations’ health secretaries are yet to adopt the recommendation, but this is often just a formality.
The JCVI also recommended on Wednesday booster doses to all 16- and 17-year-olds and some 12- to 15-year-olds no sooner than three months after their second doses, making the UK the second country giving booster doses to children after Israel.
Children aged 12 to 15 who are in a clinical risk group, who are severely immunosuppressed, or who are a household contact of someone who is immunosuppressed are included in the recommendation.
The JCVI said its advice on whether to recommend the vaccine to other 5- to 11-year-olds will be issued in due course following consideration of additional data.
In September, the JCVI decided not to recommend the vaccine to healthy 12- to 15-year-olds as it considered “the benefits from vaccination are marginally greater than the potential known harms but … there is considerable uncertainty regarding the magnitude of the potential harms.”
But the UK government later offered the vaccines to the young teen group, after the chief medical officers recommended the move based on wider considerations, including the “impact on education.”
Pfizer-BioNTech are currently testing a lower-dose course of their COVID-19 vaccine in the United States on children aged 6 months to 5 years of age.
Should the study prove successful, the companies said they will apply for an emergency use authorization from the U.S. Food and Drug Administration sometime in the first half of 2022.
According to officials from the U.S. Centers for Disease Control and Prevention, eight cases of myocarditis, a type of heart inflammation, have been reported in children aged 5 to 11 years who received Pfizer-BioNTech’s COVID-19 vaccine by Dec. 16.
Jack Phillips and Katabella Roberts contributed to this report.