FDA approves Emergency use of Pfizer-BioNTech covid vaccine in adolescents

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The US Food and Drug Administration (FDA) on Monday, 10 May, approves the emergency use of Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12 to 15 years.

In an article posted on its website, the FDA analysed that the Pfizer-BioNTech COVID-19 vaccine is in accordance with the statutory criteria to alter the emergency use authorisation (EUA), which was originally issued on 11 December 2020. The detected potential benefits of this vaccine in individuals 12-15 years of age is said to outweigh the known and potential risks.

FDA commissioner Janet Woodcock asserted that FDA’s expansion of Pfizer’s vaccine emergency use authorisation in the younger generation is a remarkable move to battle the infection.

With the scientific data getting evaluated, FDA can now assure the public and medical community that it would meet the rigorous standards for EU authorization in adolescent population said Peter marks, director of the FDA’s center for Biologics evaluation and research.

Nevertheless, it was suggested by health experts that use of Pfizer-BioNTech covid vaccine should be restricted in patients with a history of known allergic reaction in addition to prophylaxis.

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