AstraZeneca delays submitting for US authorization of COVID shot

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AstraZeneca delays filing for US authorization of COVID shot

South Korean President Moon Jae-in (left) will receive his second dose of the AstraZeneca COVID-19 vaccine on Friday, April 30, 2021 at a health center in Seoul, South Korea. (Lee Jin-wook / Yonhap via AP)

AstraZeneca announced on Friday that it intends to apply for US approval for its COVID-19 vaccine in the "coming weeks" and acknowledged that the eagerly awaited filing had been delayed until mid-April.

The Anglo-Swedish drug maker announced the new schedule when it released its first quarter financial results, which show it had shipped 68 million doses of the vaccine to the UK, European Union and other countries in the first three months of the year Has.

The company said it was continuing to work on its application to the US Food and Drug Administration, noting that the "substantial size of the file" would include data from US studies, as well as all other completed studies and real-world data Use of the vaccine in other countries.

Problems that are likely to be addressed include evidence that the vaccine has been linked to rare blood clots, especially in younger people. Several countries have recommended that the shot should only be given to the elderly because of possible side effects. Vaccine experts say the blood clots are very rare, less than the risk of blood clots in women taking birth control.

When AstraZeneca released data from its U.S. vaccine study on March 22, company officials said they would likely file for FDA approval in the first half of April. Once the application is submitted, an FDA advisory committee will publicly discuss the evidence behind the shots before the agency decides whether emergency use is acceptable.

Ruud Dobber, executive vice president of AstraZeneca, said at the time that the company would dispose of 30 million doses immediately if the FDA approves the vaccine, followed by another 20 million within the first month.

The White House said earlier this week that the US would begin sharing its entire inventory of AstraZeneca vaccines with the world once federal security clearances are completed. Up to 60 million cans are expected to be available for export in the coming months. The move extends the Biden government's decision in March to share approximately 4 million doses of the vaccine with Mexico and Canada.

The White House is increasingly confident that the three vaccines that are already being used in the US – Pfizer, Moderna and Johnson & Johnson – will be delivered. The U.S. is also under increasing pressure to share more of its vaccine supply with the world as infection rates rise in countries like India and other countries in order to receive enough doses to protect its most vulnerable residents.

More than 3.1 million people have died of COVID-19 worldwide, including more than 572,000 in the United States. More than half of adults in the United States have received at least one dose of vaccine, and the government expects the early population will be adequately cared for by early summer.

AstraZeneca had first quarter revenues of $ 275 million from the supply of 68 million doses of the vaccine. AstraZeneca has promised to make the vaccine charitable for as long as the pandemic continues.

The company said 30 million doses went to the EU, 26 million to the UK, 7 million to Gavi, an alliance securing vaccines for low-income countries, and 5 million to other nations.

To date, AstraZeneca and partners like the Serum Institute of India and Fiocruz in Brazil have shipped more than 300 million COVID-19 vaccine doses to over 165 countries, according to the Anglo-Swedish drug maker.

The vaccine was developed by Oxford University researchers who licensed the technology to AstraZeneca to leverage the company's global manufacturing and distribution capabilities. AstraZeneca in turn authorizes other companies to produce the recordings worldwide.

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