LONDON: Britain's top medicine regulator on Friday announced that it has extended approval of the COVID-19 vaccine developed by Pfizer and BioNTech so it can be used on children aged between 12 to 15 years.
"We have carefully reviewed clinical trial data on 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," June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), said.
United Kingdom approves Pfizer/BioNTech COVID shot for 12- to 15-year-olds: Reuters pic.twitter.com/LL2wSXAZrn
— ANI (@ANI) June 4, 2021
Dr Raine also said the safety of the vaccine in children aged between 12 to 15 years would be carefully monitored. "No extension to an authorisation would be approved unless the expected standards of safety, quality and effectiveness have been met," she said.
She added that it would now be up to the Joint Committee on Vaccination and Immunisation to decide whether this age group would come under the vaccine deployment programme.
It may be noted that the Pfizer vaccine is already approved for use in people aged 16 and over.
US pharmaceutical giant Pfizer has recently told the Indian government that its COVID-19 vaccine is suitable for all aged 12 and above and can be stored at 2-8 degrees for over a month.
The firm also said that is ready to supply 50 million COVID-19 vaccines to India in 2021, albeit with a few conditions. The US drugmaker has also asked for relaxations in some clauses, including indemnification for its shots, sources said.
Pfizer officials and the government also reportedly discussed the indemnity protection against liabilities and the firm asked for relaxation in some clauses before the company brings its COVID-19 vaccines to India.