Britain’s medicines regulator said on Friday it had extended approval of the Covid-19 vaccine developed by Pfizer and BioNTech so it can be used on 12- to 15-year-olds.
“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 Dr June Raine, the chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA).
She added it would be up to the Joint Committee on Vaccination and Immunisation to decide whether this age group would come under the vaccine deployment programme.
More than 2,000 children were involved in the clinical trial to determine the safety of the Pfizer vaccine, the chair of the Commission on Human Medicines, Prof Sir Munir Pirmohamed, said. “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.
“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. The MHRA will continue to scrutinise all of the suspected side-effects data received through the rigorous surveillance programme in place through the yellow card scheme and other safety surveillance measures for all of the Covid-19 vaccines used in the UK.
“Over 2,000 children aged 12 to 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 to 25 years. These are extremely positive results.”