A new age-appropriate formulation of the Covid-19 vaccine for use in children aged 5- to 11-years-old has been approved today.
The Medicines and Healthcare products Regulatory Agency (MHRA) approved the Pfizer BioNTech Covid-19 vaccine following a review of safety data.
The Joint Committee on Vaccination and Immunisation (JCVI) is advising that 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.
It added that further advice regarding Covid vaccination for other 5- to 11-year-olds will be issued in due course after consideration of additional data, and on the Omicron variant more broadly.
Tes reported on Friday that more than one in 20 primary school-age pupils tested positive for Covid-19 last week, based on figures released by the Office for National Statistics (ONS).
The ONS data published last week shows on 11 December, 5.56 per cent of those aged 2 to those in Year 6 tested positive.
Dr June Raine, chief executive at MHRA, said the vaccine is safe and effective for children 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,” she said.
“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.”
5- to 11-year-olds will be given a lower dose compared to that used in individuals aged 12 and above, with 10 micrograms, a third of the adult dose, compared with 30 micrograms for the latter.
The JCVI recommend eight weeks between the first and second doses.
Further advice regarding Covid vaccination for other 5- to 11-year-olds will be issued in due course after consideration of additional data, and on the Omicron variant more broadly.
The MHRA says it has worked with international regulators and public health bodies, and considered global data on the use of the vaccine in 5- to 11-year-olds, and says it demonstrates a favourable safety profile compared with that seen in other age groups.
Over 5.5 million dosages of the vaccine in 5 to 11s have now been administered in the United States.
Paul Whiteman, general secretary of the NAHT school leaders’ union, said: “NAHT has always said that the decision on whether or not to offer vaccinations for children is one for medical experts to take and that remains the case.
“We know that there are many families with medically vulnerable children who have been waiting for this decision and so they will be pleased that there is now a sense of clarity for them.
“Of course, vaccination for children, and particularly younger children, will always be a choice for parents to make.”
