The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the emergency use authorisation (EUA) for Pfizer and BioNTech’s Covid-19 mRNA vaccine called BNT162b2 to include use in children aged 12 to 15 years.
The authorisation is based on a review of the safety, quality and effectiveness of the vaccine in this population by the Commission on Human Medicines (CHM), the UK’s independent advisory body, and the MHRA.
It follows the UK’s temporary EUA in December last year for the Covid-19 vaccine use in adults and adolescents aged 16 years and above.
BNT162b2 is indicated for active immunisation to prevent Covid-19 in individuals aged 12 years and above.
The UK Department of Health and Social Care and MHRA have authorised a temporary supply of this vaccine in the UK and Northern Ireland.
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.”
Trial data revealed no new side effects with the vaccine and its safety data in children was similar to that reported in young adults.
Most adverse events in both age groups were mild to moderate and associated with reactogenicity, including a sore arm or tiredness.
Commission on Human Medicines chair professor Munir Pirmohamed said: “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 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.”
The Joint Committee on Vaccination and Immunisation (JCVI) is yet to provide advice on adding this newly authorised age group to the UK’s vaccine deployment programme.