UK Approves Pfizer/BioNTech COVID-19 Vaccine for 12 to 15-Year-Olds

A 15-year-old receives the Pfizer-BioNTech vaccine against the CCP virus in Bloomfield Hills, Mich., on May 13, 2021. Jeff Kowalsky/AFP via Getty Images

Britain’s medicines regulator said on Friday that it has approved the use of the Pfizer/BioNTech CCP virus vaccine in 12 to 15-year-olds.

The Medicines and Healthcare products Regulatory Agency (MHRA) said the decision follows a “rigorous review” of safety and effectiveness in that age group.

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- 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.”

The European Medicines Agency, the EU’s medicines regulator, has already recommended the Pfizer/BioNTech vaccine be extended to children aged 12 to 15.

Last month, the Pfizer jab became the first to be cleared for children as young as 12 in the United States.

The Commission on Human Medicines (CHM), a public body that advises the UK government on medicinal products, said more than 2,000 children were involved in the clinical trial to determine the safety of the Pfizer/BioNTech vaccine.

“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 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 years. These are extremely positive results,” said Professor Sir Munir Pirmohamed, chairman of CHM.

“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,” he said.

“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.”

He said the MHRA “will continue to scrutinise all of the suspected side effects data” for all of the CCP (Chinese Communist Party) virus vaccines used in the UK.

PA contributed to this report.