E-Paper
FDA grants full approval to Pfizer's Covid-19 vaccine
However, the vaccine will remain available available to children in the 12-15 age group under Emergency Use Authorisation (EUA).
The coronavirus vaccine developed by American pharmaceutical firm Pfizer in partnership with Germany's BioNTech SE has been granted full approval in the United States, the US Food and Drug Administration (USFDA) said in a statement on Monday. The announcement follows reports from last week that the full approval may be granted soon.
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Janet Woodcock, the FDA's acting commissioner, described this as a "milestone" in the battle against the Covid-19 pandemic. "While millions have already safely received Covid-19 vaccines, we recognise that for some, an approval from us may now instill additional confidence to get vaccinated," Woodcock said.
The full approval of Pfizer's Covid-19 vaccine candidate means that the jab can now be branded under the brand name of "Comirnaty." It also becomes the first shot to receive such an approval in the United States. Though the vaccine will continue to be available under Emergency Use Authorisation (EUA) for children in the 12-15 age group, it may now be prescribed by physicians for children aged below 12 if they think it will be beneficial.
FDA granted EUA to the jab on December 11 last year.
In medical terms, a full approval is known as "biologics license application" (BLA). FDA approves EUA on the basis of results of an interim trial if it is of the opinion that benefits outweigh the risks. For BLA, on the other hand, data should be submitted only after the completion of clinical trials.
The regulator's approval of Pfizer's submission for BLA was on the basis of an updated data from the vaccine's clinical trial, during which its safety and efficacy was evaluated among more than 40,000 participants.
With the country witnessing a fresh surge of the coronavirus pandemic due to the Delta variant, authorities last week approved a Covid-19 booster shot, from September 20. According to Johns Hopkins University, the US has thus far seen more than 37 million Covid-19 cases and nearly 630,000 related fatalities, the highest globally on both counts.
(With agency inputs)
