No new side effects were identified and safety data was comparable with young adults, MHRA says
The coronavirus vaccine developed by Pfizer and BioNTech has been approved for children aged 12 to 15 in the UK, with Britain’s medicines regulator saying on Friday the jab’s benefits outweigh any risk for those in the age bracket.
It follows a rigorous review of the safety, quality and effectiveness of the vaccine for children, which was carried out by the Medicines and Healthcare products Regulatory Agency (MHRA).
“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,” Dr June Raine, MHRA’s chief executive, said.
She continued: “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.”
Over 2,000 children aged 12 to 15 were studied as part of the randomised, placebo-controlled clinical trials. Results showed there were no cases of coronavirus 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 to 25. “These are extremely positive results,” said Prof Munir Pirmohamed, chair of the Commission on Human Medicines, which assisted MHRA.
Following the announcement earlier, the government released a statement to say it was now calling on the JCVI to determine how this development should influence the UK’s vaccination programme.
“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,” a Department of Health spokeswoman said.
“We will be guided by the expert advisors and will update in due course.”
No new side effects were identified during the review and the safety data in children was comparable with that seen in young adults, MHRA said. As in young adults, the majority of adverse events were mild to moderate and related to reactogenicity, with the most common ailments being a sore arm or tiredness.