MHRA authorises Pfizer/BioNTech’s COVID-19 vaccine for 12- to 15-year-olds

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has extended the authorisation of Pfizer/BioNTech’s COVID-19 vaccine for use in children aged 12 to 15 years old.

On Friday, the MHRA announced that it had concluded that the jab is safe and effectiveness in the younger age group, after conducting a ‘rigorous’ review of the vaccine alongside the Commission on Human Medicines (CHM) – the government’s independent advisory body.

The MHRA added that no new side effects were identified in 12- to 15-year-olds, with the safety data in children found to be comparable to that observed in young adults.

The majority of side effects in the younger age group – similar to young adults – were mild to moderate and related to reactogenicity, including a sore arm or tiredness.

“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,” said June Raine, chief executive of the MHRA.

“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,” she added.

In May, the US Food and Drug Administration (FDA) also expanded the emergency use authorisation for the Pfizer/BioNTech vaccine to included children aged 12 to 15 years old.

In a Phase III clinical trial, topline results showed that the vaccine had an efficacy of 100% in participants aged 12 to 15 years old, with and without prior COVID-19 infection, as well as ‘robust’ antibody responses.

The vaccine was also found to be generally well tolerated in this trial, with participants to be monitored for long-term protection and safety for an additional two years following their second dose.

“Following a robust review of the evidence, the MHRA has concluded that the Pfizer/BioNTech COVID-19 vaccine meets the high standards of safety, effectiveness and quality required and has authorised its use for young people aged 12 to 15,” said a Department of Health and Social Care (DHSC) spokesperson.

“The government has asked the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI) to advise whether routine vaccination should be offered to younger people aged 12 to 17. We will be guided by the expert advisors and will update in due course,” they added.