AstraZeneca to seek US approval for Covid vaccine by year-end

AstraZeneca to seek US approval for Covid vaccine by year-end

LONDON – AstraZeneca on Thursday announced its intention to seek clearance from the United States for its Covid-19 vaccine in the second half of this year, offering a new timeline for the much delayed application.

The Anglo-Swedish drugmaker announced the schedule when releasing second quarter financial results, which showed the company and its sublicensees had delivered more than 700 million doses of the vaccine to more than 170 countries during the year. first semester of this year. This includes 80 million doses that have been donated to the COVAX initiative for low- and middle-income countries.

News on the US filing is being closely watched as the deadline has slipped.

When AstraZeneca released data from its U.S. vaccine trial on March 22, company officials said they expected to seek approval from the Food and Drug Administration in the first half of April. In April, the company said it planned to submit an application to the United States in the “coming weeks.”

The United Kingdom, the European Union and the World Health Organization have already authorized the use of the AstraZeneca vaccine.

AstraZeneca reported first-half revenue of $ 1.17 billion from the delivery of 319 million doses of vaccine supplied directly by the company. AstraZeneca has pledged to deliver the vaccine to a nonprofit for as long as the pandemic lasts.

Despite complaints from the EU about its vaccine supply, the 27-country bloc received more doses directly from AstraZeneca than any other entity in the first half of the year. The company shipped 97 million doses to the EU, while Brazil received 65 million and the UK 52 million,

says AstraZeneca. Gavi, an alliance that secures vaccines for low-income countries, has received 49 million doses, and an additional 57 million doses have gone to other countries.

Sub-licensees, including the Serum Institute of India, provided millions of additional doses, bringing global deliveries to more than 700 million doses.

The vaccine was developed by researchers at the University of Oxford, who licensed the technology to AstraZeneca with the aim of harnessing the company’s global manufacturing and distribution capacity. AstraZeneca, in turn, allows other companies to produce the images around the world.