A new formulation of the Pfizer/BioNTech coronavirus vaccine has been approved for use in children aged five to 11.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) made the approval following a robust review of safety data that shows a positive benefit-risk profile for this jab to be used in the age group.
In light of the regulator’s approval, the Joint Committee on Vaccination and Immunisation (JCVI) is advising that children aged five 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.
A primary course vaccination for these children should be with two 10-microgram doses of the age appropriate Pfizer formulation (Comirnaty) – a third of the adult dose, with eight weeks between the first and second doses.
Further advice regarding Covid vaccination for other five to 11-year-olds will be issued in due course after consideration of additional data, and on the Omicron variant more broadly.
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 five 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.”
Separately, in response to the Omicron threat, the JCVI has advised that booster vaccinations should be offered to those aged 16 to 17 years, children aged 12 to 15 who are in a clinical risk group or who are a household contact of someone who is immunosuppressed, and children aged 12 to 15 years who are severely immunocompromised and who have had a third primary dose.
The booster for these groups should be 30 micrograms of the Pfizer/BioNTech vaccine, given no sooner than three months after completion of the primary course.
Professor Wei Shen Lim, chairman, Covid-19 immunisation, JCVI, said: “The majority of children aged five to 11 are at very low risk of serious illness due to Covid-19.
“However, some five 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.”
Why are you making commenting on The Herald only available to subscribers?
It should have been a safe space for informed debate, somewhere for readers to discuss issues around the biggest stories of the day, but all too often the below the line comments on most websites have become bogged down by off-topic discussions and abuse.
heraldscotland.com is tackling this problem by allowing only subscribers to comment.
We are doing this to improve the experience for our loyal readers and we believe it will reduce the ability of trolls and troublemakers, who occasionally find their way onto our site, to abuse our journalists and readers. We also hope it will help the comments section fulfil its promise as a part of Scotland's conversation with itself.
We are lucky at The Herald. We are read by an informed, educated readership who can add their knowledge and insights to our stories.
That is invaluable.
We are making the subscriber-only change to support our valued readers, who tell us they don't want the site cluttered up with irrelevant comments, untruths and abuse.
In the past, the journalist’s job was to collect and distribute information to the audience. Technology means that readers can shape a discussion. We look forward to hearing from you on heraldscotland.com
Comments & Moderation
Readers’ comments: You are personally liable for the content of any comments you upload to this website, so please act responsibly. We do not pre-moderate or monitor readers’ comments appearing on our websites, but we do post-moderate in response to complaints we receive or otherwise when a potential problem comes to our attention. You can make a complaint by using the ‘report this post’ link . We may then apply our discretion under the user terms to amend or delete comments.
Post moderation is undertaken full-time 9am-6pm on weekdays, and on a part-time basis outwith those hours.
Read the rules hereLast Updated:
Report this comment Cancel