Pfizer/BioNTech Covid-19 vaccine approved for use in 12 to 15-year-olds

The UK has approved the Pfizer/BioNTech coronavirus vaccine for use in children aged 12 to 15.

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

The Pfizer Covid-19 jab was the first to be authorised for use in the UK at the end of last year.

MHRA chief executive Dr June Raine said: “We have carefully reviewed clinical trial data in children aged 12 to 15 years and have concluded that the Pfizer/BioNTech Covid-19 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.

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

“It will now be for the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether this age group will be vaccinated as part of the deployment programme.”

A Department of Health spokeswoman said: “The Government has asked the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI) to advise whether routine vaccination should be offered to younger people aged 12 to 17.

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

The Government’s independent advisory body, the Commission on Human Medicines (CHM), also reviewed the safety, effectiveness and quality of the vaccine for use in the age group.

Chairman Professor Sir Munir Pirmohamed said the commission had been careful to take into consideration the younger age group and the benefits of them being vaccinated against any potential risk of side-effects.

He added: “There has been a thorough assessment and review of this data which was also looked at specifically by the CHM’s Paediatric Medicines Expert Advisory Group who are scientific experts within this age group, as well as the CHM’s Covid-19 Vaccines Benefit Risk Expert Working Group.

“We have concluded that, based on the data we have seen on the quality, effectiveness and safety of the vaccine, its benefits do outweigh any risk.

“The MHRA will continue to scrutinise all of the suspected side-effects data received through the rigorous surveillance programme in place through the Yellow Card scheme and other safety surveillance measures for all of the Covid-19 vaccines used in the UK.”

Health Secretary Matt Hancock said the UK had “enough supply” to offer the vaccine to children aged 12 and over if recommended to do so by the JCVI.

He also signalled it would be his “first duty” to see children in the UK vaccinated rather than donate doses to developing countries.

He told reporters: “My first role, my first duty as Health Secretary for the UK is to make sure that the UK is protected and safe.

“And while thankfully, children are very rarely badly affected by Covid themselves, they can still pass on the disease – and so that is my first duty.”

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.

“These are extremely positive results,” Sir Munir said.

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.