The Pfizer BioNTech coronavirus vaccine has been approved for use in vulnerable primary school children.
The Joint Committee on Vaccination and Immunisation (JCVI) updated its advice after the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved the jab for five to 11-year-olds following a robust review of safety data.
In response to the Omicron variant, the committee has also advised that some older children be offered a booster dose.
A low-dose version of the vaccine has been approved for those 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. They should be offered a primary course of vaccination – typically two doses.
It is estimated that around 330,000 children are said to fall within the new category eligible.
The new age-appropriate vaccine formulation (Comirnaty) is made up of one-third of the adult dose, and it is recommended there should be eight weeks between the first and second doses.
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
Dr June Raine, MHRA chief executive
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 – thought to cover around half a million teenagers.
The committee has also advised boosters for 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 jab 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 of Covid-19 immunisation at the 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.”
However, one teaching union argues that the recommendations do not go far enough.
Kevin Courtney, joint general secretary of the National Education Union said: “This is good news for clinically vulnerable primary children and will offer some reassurance to their parents.
“However, it won’t impact on transmission rates in schools or make a significant difference to the turbulence that schools and colleges are experiencing due to Covid.
“This makes the case stronger for Government to introduce better mitigations.”
Meanwhile, Paul Whiteman, general secretary of school leaders’ union NAHT, said: “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.
“Of course, vaccination for children, and particular younger children, will always be a choice for parents to make.”
Professor Anthony Harnden, deputy chairman of the Joint Committee on Vaccination and Immunisation (JCVI), told the PA news agency: “Children on the whole don’t develop severe complications from Covid, so we looked at the data on hospitalisations and complications – admittedly most of this was pre-Omicron.
“The data shows that only those with severe underlying illnesses were more likely to get severe complications, even though that was quite rare even amongst that group of children.
“And of course, those who are living in a household with an immunosuppressed individual who may or may not have responded to the vaccine, and might be shielding, they were potentially at risk of transmitting an infection they brought into that household to that vulnerable member, and then having to live with the consequences that for the rest of their lives.
“So there was a direct benefit to those children as well from a mental health perspective.”
Asked if emerging Omicron data may also inform guidance for the adult population, Prof Harden added: The key thing for the adult population is to get vaccinated themselves.
“And we certainly don’t want to be vaccinating well children, who are at very low risk, to protect adults who decided not to get vaccinated – that would be wrong.
“And so we want all adults to take up the offer of a vaccine if they haven’t so far.”
Commenting on vaccine supply, Prof Harden said: “I don’t think vaccine supply is the problem at the moment.
“I think it’s just the capacity to vaccinate, which is pretty good in the UK, but obviously has a limitation to it.”