Covid: Pfizer vaccine approved for 12- to 15-year-olds in UK

No new side effects were identified and safety data was comparable to that for young adults, MHRA says

The coronavirus vaccine developed by Pfizer and BioNTech has been approved for use in children aged 12 to 15 by Britain’s medicines regulator, which said the jab was safe and highly effective in that age group.

The announcement follows a “rigorous review” of the safety, quality and efficaciousness of the vaccine for children, carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).

The UK’s vaccines committee will now advise on whether children in the age group should receive the jab, which has been used since December to inoculate people aged 16 and over.

Under the current policy, 16- to 18-year-olds who are in a priority group or live with a clinically vulnerable individual qualify for vaccination, but there is no routine programme in place across Britain for children aged under 18.

The question of extending the rollout to these age groups carries many ethical considerations, including matters of safety and necessity, which will be discussed by the Joint Committee on Vaccination and Immunisation (JCVI).

Scientists independent of the JCVI have warned against rushing any decision on the matter, with some arguing that “it is not yet clear” whether the Covid vaccines “are in the best interests of children and young people”.

The Department of Health and Social Care said the government has asked the JCVI to “advise whether routine vaccination should be offered to younger people aged 12 to 17”.

A spokesperson added: “We will be guided by the expert advisers and will update in due course.”

The MHRA said its “comprehensive safety surveillance” will be extended to cover 12- to 15-year-olds, should they be vaccinated with the Pfizer jab.

Dr June Raine, chief executive of the MHRA, said: “No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met.”

The EU has approved the Pfizer vaccine for 12- to 15-year-olds, while both Canada and the US have already started administering doses to this group.

In a study overseen by Pfizer earlier this year, more than 2,000 children aged 12 to 15 were recruited for the randomised, placebo-controlled clinical trials.

Results showed that there were no cases of coronavirus from seven days after the second dose in the vaccinated group, compared with 16 cases in the placebo group.

This suggests that the vaccine is 100 per cent effective in preventing symptomatic Covid-19, Pfizer said.

In addition, data on neutralising antibodies showed the vaccine working at the same level as seen in adults aged 16 to 25.

“These are extremely positive results,” said Prof Sir Munir Pirmohamed, chair of the Commission on Human Medicines, which assists the MHRA.

No new side effects were identified during the review and the safety data in children was comparable to that seen in young adults, the MHRA said.

As in young adults, the majority of adverse events were mild to moderate in nature, with the most common ailments being a sore arm or tiredness.

The green light of approval provided by the MHRA will now prompt ethical questions about whether the UK’s rollout should be extended to children and adolescents.

Dominic Wilkinson, a consultant paediatrician and professor of medical ethics at the University of Oxford, said he was against offering the vaccine to Britain’s children.

He explained that the Pfizer trials conducted on children, while “reassuring”, were too small to properly identify “rare events” that may follow vaccination in this age group.

“If there is a risk, we simply cannot say yet whether that risk is higher or lower than the risk that young people face from Covid-19,” he added.

Prof Wilkinson also warned that globally there are millions of people who remain at risk of dying from Covid but do not have access to effective vaccines.

“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,” he said, adding that vulnerable individuals in high-risk countries have “the greatest need”.

Others believe that the Pfizer jab should be used among young children to help combat the spread of the Delta variant, first identified in India, which has been linked to a number of school-based outbreaks across England.

Prof Dominic Harrison, the director of public health in Blackburn with Darwen, has called for 12- to 18-year-olds to be vaccinated as quickly as possible in order to limit transmission in the region, with recent data from Public Health England suggesting that the Delta variant increases the risk of hospitalisation.

Russell Viner, a professor of adolescent health at University College London, said the JCVI would also have to take into consideration side effects among children, including myocarditis – inflammation of the heart – which has been reported among some young male recipients of the vaccine in Israel.

“The early reports … provide a warning that we should not rush into these decisions,” he said.

Currently, the UK is offering vaccines to everyone aged 30 and over, with the latest government data showing that half of all British adults have now had both doses of a jab.