The Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that the Pfizer/BioNTech COVID-19 vaccine is safe to use in 12-15-year-olds
The Pfizer/BioNTech COVID-19 vaccine has already been approved for use in adolescents aged 16-over and today the MHRA has extended the current UK approval to allow its use in 12-15-year-olds.
The MHRA and the Government’s independent advisory body, the Commission on Human Medicines (CHM), conducted a rigorous review of the safety, quality and effectiveness of the vaccine in this age group and found no new side effects. The majority of adverse events were mild to moderate and relating to reactogenicity, such as a sore arm or tiredness.
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 (JCVI) to advise on whether this age group will be vaccinated as part of the deployment programme.”
Side effects
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 2000 children aged 12-15 years were studied as part of the randomised, placebo-controlled clinical trials. There were no cases of COVID-19 from 7 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.”
