Children aged 12-15 who are at high risk of Covid-19 to be invited for Pfizer vaccine

Children aged between 12 and 15 who are at high risk of Covid-19 or live with someone who is more likely to contract it are now being invited for a Pfizer vaccine locally.

Approval for the vaccine’s use in 12-15-year-olds was authorised in June 2021 by the Medicines and Healthcare products Regulatory Agency (MHRA).

Children aged 12 to 15 who are clinically vulnerable to Covid will be contacted by the NHS and invited for their vaccine. Those who are eligible include those with Down’s syndrome, or undergoing many cancer treatments, have had organ or bone marrow transplants or who are on the learning disability register.

The Covid vaccine will also be offered to children aged 12 years and over who live with someone who is immunosuppressed, such as those receiving chemotherapy or who have had a transplant.

This follows all 16 and 17-year-olds being offered one dose of the vaccine.

The National Booking Service (NBS) is currently open to anyone aged 18 or over, and to people within three months of their 18th birthday.

Speaking in June, Dr June Raine, MHRA Chief Executive 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 12-15-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 to advise on whether this age group will be vaccinated as part of the deployment programme.”

Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said: “We have been very careful to take into consideration the younger age group and the benefits of this population being vaccinated against any potential risk of side effects.

“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.

“Over 2,000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials.

“There were no cases of Covid-19 from sevendays 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 years.

“These are extremely positive results.”

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 relating to reactogenicity, such as a sore arm or tiredness.