The United States Food and Drug Administration has fully approved the world’s first Covid-19 vaccine from American company Pfizer and its German collaborator BioNTech.

The approval comes eight months after the Pfizer-BioNTech mRNA vaccine received an emergency use authorisation (EUA), in December 2020. The final approval is expected to be a confidence-booster of sorts, getting fence-sitters to take the vaccine as more data has now been reviewed.

The vaccine’s final approval is expected to herald similar US clearances for vaccines from fellow-American companies Moderna and Johnson and Johnson, as well. However, in India, the vaccine awaits a regulatory green light, as it seeks clarity from the authorities on issues, including indemnity from local litigation.

In the US, the vaccine will be marketed as Comirnaty for the prevention of Covid-19 disease in individuals 16 years of age and older, the regulator said, adding it would continue to be available under an EUA, including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

Additional Confidence

As the first FDA-approved Covid-19 vaccine, “the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock. “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,” she added.

The vaccine contains messenger RNA (mRNA), a kind of genetic material that is used by the body to make a mimic of one of the proteins in the virus that causes Covid-19.

“The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes Covid-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into — nor does it alter — an individual’s genetic material,” the FDA explained. The vaccine is administered in two doses, three weeks apart.

BLA

The regulator said Comirnaty’s Biologics License Application (BLA) built on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, details on the manufacturing process, vaccine-testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. “The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval,” it added.

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