AstraZeneca to Seek Full FDA Approval for COVID Vaccine, Forgo Emergency-Use Status

AstraZeneca said it intends to seek full regulatory approval from the U.S. Food and Drug Administration for its COVID-19 vaccine in the second half of this year, forgoing the option to be approved for emergency use only.

The drugmaker is seeking a Biologics License Application, which would allow its vaccine to be introduced in general use, rather than taking the fast-track approach for status as emergency-use authorization.

The FDA has requested data from clinical trials and real world use of the vaccine from across the globe, which CEO Pascal Soriot said could be easily provided.

"We have an enormous amount of data, clinical data and all of the data coming from the work we've done around the world," Soriot said on a conference call with reporters. "A BLA is a much bigger submission than the emergency use approval."

For more reporting from the Associated Press, see below.

The Anglo-Swedish drugmaker announced the new timetable as it said the company and its partners have delivered more than 1 billion doses of the vaccine to over 170 countries where it is already authorized for use.

The news on the U.S. filing is being closely watched because the timetable has slipped in recent months. When AstraZeneca released data from its U.S. trial of the vaccine on March 22, company officials said they expected to seek FDA authorization in the first half of April.

Among the concerns AstraZeneca will have to address are reports that the vaccine may be linked to rare blood clots, which have caused some countries to limit its use in younger people.

The AstraZeneca vaccine is already in widespread use around the world following approval by regulators in the European Union, World Health Organization, U.K. and other countries.

While the U.S. is currently "well supplied" with vaccines, AstraZeneca believes its shot could "play a role in the future," Soriot said.

"It's a good vaccine, and we just want to make sure it's ready to be used if needed," he said.

AstraZeneca said Thursday that it delivered 319 million doses of the vaccine in the first half of this year, $1.17 billion in revenue. AstraZeneca has pledged to deliver the vaccine on a non-profit basis as long as the pandemic lasts.

Despite complaints from the EU about its vaccine supply, the 27-nation bloc received more doses directly from AstraZeneca than any other single entity in the six months through June. The company shipped 97 million doses to the EU, while Brazil got 65 million and the U.K. 52 million, AstraZeneca said. Gavi, an alliance that secures vaccines for low-income countries, received 49 million doses, and another 57 million doses went to other countries.

Sub-licensees, including the Serum Institute of India, supplied millions more doses.

The vaccine was developed by Oxford University researchers, who licensed the technology to AstraZeneca in an effort to tap into the company's global manufacturing and distribution capacity. AstraZeneca, in turn, authorizes other companies to produce the shots around the world.