The Pfizer/BioNTech coronavirus vaccine has been approved for use in children aged 12 to 15 years old. 

The Medicines and Healthcare products Regulatory Agency (MHRA) authorised the use of the jab in the younger age group on Friday June 4 following a review of its safety, quality and effectiveness.

MHRA chief executive Dr June Raine said the vaccine is “safe and effective” in this age group and that “the benefits of this vaccine outweigh any risk”.

“We have in place a comprehensive safety surveillance strategy for monitoring the safety of all UK-approved Covid-19 vaccines and this surveillance will include the 12- to 15-year age group,” she said.

“No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met.”

Pfizer was the first jab to be authorised for use in the UK. The vaccines currently issued in the UK are suitable for different age groups. The Pfizer/BioNTech vaccine is suitable for people aged 16 and over, while the AstraZeneca/Oxford vaccine and Moderna vaccines should be given to over-18s. 

Dr Raine said it’s now down to the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group will be vaccinated as part of the deployment programme.

What did trials of the jab find?

More than 2,000 children aged 12 to 15 were studied as part of the randomised, placebo-controlled clinical trials.

There were no cases of the virus from seven days after the second dose in the vaccinated group, compared with 16 cases in the placebo group.

In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16-25. No new side-effects were identified and the safety data in children was comparable with that seen in young adults.

As in young adults, the majority of adverse events were mild to moderate and related to reactogenicity, such as a sore arm or tiredness.

What happens now?

The government has asked the JCVI to advise whether routine vaccination should now be offered to younger people aged 12 to 17 years old, a Department of Health and Social Care (DHSC) spokesperson said. “We will be guided by the expert advisers and will update in due course,” they said.

Are other countries vaccinating kids?

The United States began inoculating young adolescents in May after its Centre for Disease Control and Prevention (CDC) approved the Pfizer jab for those aged 12-15. More than 600,000 children have been vaccinated so far.

The jab has also been approved for emergency use in Chile, Canada, Japan, the Philippines, Israel and Dubai and the European Union.

What are the side effects?

The most common side effects in children aged 12 to 15 are similar to those in people aged 16 and over. They include pain at the injection site, tiredness, headache, muscle and joint pain, chills and fever.

These effects are usually mild or moderate and improve within a few days.

Recipients can report any side effects they experience via the MHRA’s existing Yellow Card scheme found on its website.

Do children need the vaccine?

Children rarely develop severe forms of Covid-19, and deaths from the disease are rarer still (fewer than two out of every million worldwide).

But, on rare occasions, those who have been infected can later develop a dangerous condition called multi-system inflammatory syndrome in children (MIS-C), which can damage the brain and cause hallucinations.

We also know that some children suffer with long Covid symptoms, which can impact their quality of life and education. 

Evidence is building that jabs can block coronavirus transmission, so vaccinating children could save other people’s lives and help contribute to herd immunity – the point at which most of a population is immune to an infectious disease.

What do experts say about rolling out the vaccine to kids?

Professor Adam Finn, professor of paediatrics at the University of Bristol, said the key question to address now is whether it’s necessary to immunise children in order to protect them from the infection and prevent further disruption to their education and social development, or whether vaccinating adults only would be sufficient to control spread of infection.

In the short term, he said giving available vaccine doses to children would mean diverting them from adults who are “at higher personal risk and who probably represent a higher onward transmission risk”.

Professor Dominic Wilkinson, a consultant paediatrician and professor of medical ethics at the University of Oxford, said for the time being we “shouldn’t extend Covid vaccination programmes” to include children.

“There are ethical reasons for thinking that it would be premature to extend our vaccine rollout to those under 16,” he said. “First, it is not yet clear that Covid vaccines are in the best interests of children and young people. A vaccine can be in someone’s best interests if the benefit outweighs any side effects.  Children have much less severe illness from coronavirus than adults. 

“Secondly, and perhaps even more importantly, there is a serious problem of vaccine supply globally. There are current surges in Covid cases in a number of poorer countries where only a very small proportion of the population has been vaccinated. 

“It is unethical to give vaccines to people at very low risk in our own country when there are others overseas at much higher risk who are dying.”