Open access article
The Royal Pharmaceutical Society has made this article free to access in order to help healthcare professionals stay informed about an issue of national importance.
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The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised the Pfizer/BioNTech COVID-19 vaccine for use in children aged 12–15 years — the first to be approved for this age group in the UK.
In a statement on 4 June 2021, the MHRA said that it had authorised the extension to the current UK approval of the vaccine after “rigorous review” of the safety, quality and effectiveness of the vaccine in those aged 12–15 years.
The Pfizer/BioNTech COVID-19 vaccine is already approved for use in adults and adolescents aged 16 years and over.
“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,” said June Raine, chief executive of the MHRA.
“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.”
She added that it would now be for the Joint Committee on Vaccination and Immunisation (JCVI) to advise on whether the age group will be vaccinated as part of the NHS’s COVID-19 vaccination programme.
According to the Department of Health and Social Care, the JCVI’s current advice is that those aged 16–18 years should be offered a vaccination if they are in a priority Phase 1 group or they are the household contacts of someone who is immunosuppressed.
The results of a randomised, placebo-controlled trial in adolescents, published in the New England Journal of Medicine on 27 May 2021, found that the Pfizer/BioNTech vaccine had 100% efficacy in more than 2,000 participants aged 12–15 years, with 18 cases of COVID-19 in the placebo group and 0 in the vaccine group.
The authors concluded that the vaccine had a favourable safety profile, produced a greater immune response than in young adults, and was “highly effective” against COVID-19.
As in young adults, the majority of adverse events were mild to moderate and related to reactogenicity, such as a sore arm or tiredness.
“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,” said Sir Munir Pirmohamed, chair of the Commission on Human Medicines (CHM).
“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.”
Pirmohamed added that the MHRA would “continue to scrutinise” all of the suspected side effects data received through the Yellow Card scheme and other safety surveillance measures for all COVID-19 vaccines used in the UK.