AstraZeneca will seek full FDA approval for the COVID vaccine rather than relying on the emergency-use status.
AstraZeneca said it plans to seek full regulatory approval for its COVID-19 vaccine from the US Food and Drug Administration in the second half of this year, bypassing the option of being certified for emergency use only.
Rather than applying for emergency-use authorisation, the drugmaker is requesting a Biologics License Application, which would allow the vaccine to be released in general use.
The FDA has requested data from clinical studies and real-world vaccination use from around the world, which CEO Pascal Soriot said could be delivered quickly.
On a conference call with reporters, Soriot said, “We have a great amount of data, clinical data, and all of the data coming from the work we’ve done around the world.” “A BLA submission is substantially larger than an emergency use approval.”
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The Anglo-Swedish pharmaceutical corporation disclosed the additional timeline while also announcing that it and its partners have delivered over 1 billion doses of the vaccine to over 170 countries where it is already approved for use.
Because the timeframe has slipped in recent months, the news on the US file is being eagerly followed. AstraZeneca officials indicated they anticipated to seek FDA approval in the first half of April when they released data from their vaccination study in the United States on March 22.
Reports that the vaccination may be connected to uncommon blood clots have prompted several governments to restrict its use in children are among the concerns AstraZeneca will have to answer.
Following clearance by regulators in the European Union, the World Health Organization, the United Kingdom, and other nations, the AstraZeneca vaccine is now widely used around the world.
Despite the fact that vaccinations are currently “well supplied” in the United States, AstraZeneca believes its injection could “play a role in the future,” according to Soriot.
He stated, “It’s a terrific vaccine, and we simply want to make sure it’s ready to use if it’s needed.”
In the first half of this year, AstraZeneca distributed 319 million doses of the vaccine, generating $1.17 billion in sales. For as long as the pandemic lasts, AstraZeneca has offered to provide the vaccine at no cost.
Despite the EU’s worries regarding its vaccination supplies, This is a condensed version of the information.