British-Swedish drugmaker AstraZeneca says it intends to hunt U.S. authorization for its COVID-19 vaccine within the second half of this 12 months
LONDON — AstraZeneca mentioned Thursday that it intends to hunt U.S. authorization for its COVID-19 vaccine within the second half of this 12 months, providing a brand new timetable for the much-delayed software.
The Anglo-Swedish drugmaker introduced the schedule because it launched second-quarter monetary outcomes, which confirmed that the corporate and its sub-licensees delivered greater than 700 million doses of the vaccine to over 170 international locations within the first half of this 12 months. That features 80 million doses that went to the COVAX initiative for low- and middle-income international locations.
The information on the U.S. submitting is being carefully watched, because the timeframe has slipped.
When AstraZeneca launched knowledge from its U.S. trial of the vaccine on March 22, firm officers mentioned they anticipated to hunt authorization from the Meals and Drug Administration within the first half of April. In April, the corporate mentioned it anticipated to submit a U.S. software within the “coming weeks.”
The U.Ok., European Union and World Well being Group have already licensed use of the AstraZeneca vaccine.
AstraZeneca reported first-half income of $1.17 billion from deliveries of 319 million doses of the vaccine that had been equipped instantly by the corporate. AstraZeneca has pledged to ship the vaccine on a non-profit foundation so long as the pandemic lasts.
Regardless of complaints from the EU about its vaccine provide, the 27-nation bloc obtained extra doses instantly from AstraZeneca than another single entity within the first half of the 12 months. The corporate shipped 97 million doses to the EU, whereas Brazil received 65 million and the U.Ok. 52 million,
Sub-licensees, together with the Serum Institute of India, equipped tens of millions extra doses, pushing international deliveries to greater than 700 million doses.
The vaccine was developed by Oxford College researchers, who licensed the expertise to AstraZeneca in an effort to faucet into the corporate’s international manufacturing and distribution capability. AstraZeneca, in flip, authorizes different firms to supply the pictures world wide.
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