The British drug regulator said on Friday that the Pfizer / BioNTech vaccine is safe for teenagers aged 12 to 15 after a “rigorous review”, following similar assessments in the European Union and the United States.
The Medicines and Health Products Regulatory Agency (MHRA) approved the follow-up twice clinical trials among younger age groups, saying the vaccine it had met the “expected standards” of safety, quality and effectiveness.
A government vaccination committee will now decide if and when to start administering doses in the age range. So far it has quickly followed all MHRA resolutions on vaccines offered by Pfizer and other companies.
“We have carefully reviewed data from clinical trials in children aged 12 to 15 years and 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 risks.” , said the executive director of MHRA. Said June Raine.
“No extension of an authorization would be approved unless the expected standards of safety, quality and effectiveness have been met.”
Raine added that the UK surveillance regime to monitor the safety of all approved COVID-19 vaccines would now include those aged 12 to 15 who receive doses.
The approval of the British regulator follows the approval of the European Medicines Agency and the US Food and Drug Administration last month for the younger cohort to receive the Pfizer / BioNTech blow.
The United States has begun administering the vaccine to teens, while EU members will do so this month.
Britain was the first Western country to launch a mass vaccination campaign in December. The government said on Thursday that more than half of the adults had already received the two doses of inoculation, mainly the Pfizer or AstraZeneca.
More than three-quarters of adults have received at least a single dose.
© 2021 AFP
Citation: UK regulator approves Pfizer jab for 12- to 15-year-olds (2021, June 4) retrieved June 4, 2021 at https://medicalxpress.com/news/2021-06-uk-pfizer -jab-year-olds.html
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