LONDON – AstraZeneca said Thursday that it intends to question U.S. authorization for its COVID-19 vaccine successful the 2nd fractional of this year, offering a caller timetable for the much-delayed application.
The Anglo-Swedish drugmaker announced the docket arsenic it released second-quarter fiscal results, which showed that the institution and its sub-licensees delivered much than 700 cardinal doses of the vaccine to implicit 170 countries successful the archetypal fractional of this year. That includes 80 cardinal doses that went to the COVAX inaugural for low- and middle-income countries.
The quality connected the U.S. filing is being intimately watched, arsenic the timeframe has slipped.
When AstraZeneca released information from its U.S. proceedings of the vaccine connected March 22, institution officials said they expected to question authorization from the Food and Drug Administration successful the archetypal fractional of April. In April, the institution said it expected to taxable a U.S. exertion successful the “coming weeks.''
The U.K., European Union and World Health Organization person already authorized usage of the AstraZeneca vaccine.
AstraZeneca reported first-half gross of $1.17 cardinal from deliveries of 319 cardinal doses of the vaccine that were supplied straight by the company. AstraZeneca has pledged to present the vaccine connected a non-profit ground arsenic agelong arsenic the pandemic lasts.
Despite complaints from the EU astir its vaccine supply, the 27-nation bloc received much doses straight from AstraZeneca than immoderate different azygous entity successful the archetypal fractional of the year. The institution shipped 97 cardinal doses to the EU, portion Brazil got 65 cardinal and the U.K. 52 million,
AstraZeneca said. Gavi, an confederation that secures vaccines for low-income countries, received 49 cardinal doses, and different 57 cardinal doses went to different countries.
Sub-licensees, including the Serum Institute of India, supplied millions much doses, pushing planetary deliveries to much than 700 cardinal doses.
The vaccine was developed by Oxford University researchers, who licensed the exertion to AstraZeneca successful an effort to pat into the company’s planetary manufacturing and organisation capacity. AstraZeneca, successful turn, authorizes different companies to nutrient the shots astir the world.
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