FDA approves first COVID-19 vaccine

The US Food and Drug Administration (FDA) yesterday approved Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorisation (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immuno-compromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved COVID-19 vaccine, the public can be confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said Janet Woodcock, MD, Acting Commissioner, FDA .

She added, “While millions of people have already safely received COVID-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US”

Since 11th December, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under EUA in individuals 16 years of age and older, and the authorisation was expanded to include those 12 through 15 years of age on 10th May, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.