Pfizer jab to be offered to 5 – 11 year olds in “at-risk” group or in household with someone who is immunosuppressed

A new paediatric formulation of the Pfizer BioNTech COVID-19 vaccine has been approved for children aged 5 to 11 after meeting the required safety, quality and effectiveness standards.

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.”

In a written statement, Wales’ Health Minister Eluned Morgan said; “The Joint Committee for Vaccination and Immunisation (JCVI) has now recommended children aged 5 to 11, who are in an “at-risk” group or are the household contact of someone who is immunosuppressed should be offered two 10 micrograms doses of the Pfizer-BioNTech vaccine with an interval of eight weeks between the first and second doses.”

“At the current time, the JCVI considers the balance of potential benefits and harms is in favour of vaccination for this group.”

“The JCVI has not as yet advised whether children aged 5 to 11, who are not in an “at-risk” category should receive vaccination until more information and evidence is available.”

“The JCVI has also recommended offering a COVID-19 booster dose to all children and 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 17 years who are severely immuno-compromised and who have had a third primary dose.”

“The booster dose should be offered no sooner than three months after completion of their primary course.”

“As always, appropriate information about the potential benefits and risks of vaccination will be made available for children and young people, parents and guardians to make an informed decision on vaccination.”

“I have accepted this advice. Our intention, as it has been from the start of the pandemic, is to follow the clinical and scientific evidence.”

“NHS Wales will identify eligible 5 to 11-year-olds in the “at risk” groups and begin offering appointments in the New Year, and under 18s who are eligible for a booster dose will receive an appointment when they become eligible.”

Dr June Raine, Medicines and Healthcare products Regulatory Agency 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.”