BRITAIN'S medicines regulator on Friday (4) approved the Pfizer and BioNTech vaccine for use on 12- to 15-year-olds, saying it was safe and effective for use in younger people, with the benefits outweighing any risk.
“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," Medicines and Healthcare products Regulatory Agency (MHRA) chief executive June Raine said.
It is now up to the Joint Committee on Vaccination and Immunisation (JCVI) to decide whether to go ahead and inoculate this age group under Britain's ongoing vaccination roll-out plan.
The MHRA’s approval follows similar clearances given in the US and some European countries. Children aged 12-15 years are already receiving the Pfizer shot in the US, while France and Germany plan to start offering it to the age group this month.
Britain's Department of Health and Social Care said it will provide an update once the JCVI make its decision to vaccinate Brit teens for Covid-19. The Pfizer vaccine is already approved for use in people aged 16 and over.
Prof Munir Pirmohamed, chairman of the Commission on Human Medicines, who is advising the government, said the decision followed a trial involving 2,000 children aged 12 to 15.