AstraZeneca delays filing of U.S. clearance for Covid shot – Times of India

LONDON: AstraZeneca said on Friday that he intended to seek US clearance for its Covid-19 vaccine in the “next few weeks,” acknowledging a delay in the long-awaited filing that was expected in mid-April.
The Anglo-Swedish drugmaker revealed the new schedule by releasing first quarter financial results, which showed the company had delivered 68 million doses of the vaccine to the UK, European Union and other countries in the first three months of the year.
The company said it was continuing to work on its application to the US Food and Drug Administration, noting the “substantial file size” which will include data from trials in the United States as well as all other studies done so far and actual data collected on vaccine use in other countries.
Among the issues that will likely be addressed are indications that the vaccine is linked to rare blood clots, especially in younger people. Several countries have recommended that the vaccine be given only to the elderly because of the potential side effect. Vaccine experts say blood clots are very rare, less than the chances of blood clots in women taking birth control.
When AstraZeneca released data from its U.S. vaccine trial on March 22, company officials said they planned to seek FDA clearance in the first half of April. Once the application is filed, an FDA advisory committee will publicly debate the evidence behind the shots before the agency decides whether or not to allow emergency use.
Ruud Dobber, executive vice president of AstraZeneca, said at the time that if the FDA cleared the vaccine, the company would deliver 30 million doses immediately, followed by an additional 20 million in the first month.
the White House said earlier this week that the United States will begin sharing its entire AstraZeneca vaccine stockpile with the world once it approves federal safety reviews, with up to 60 million doses expected to be available for export in the coming months. The move extends the Biden administration’s decision in March to share about 4 million doses of the vaccine with Mexico and Canada.
The White House feels increasingly confident about the supply of the three vaccines already administered in the United States – Pfizer, Modern and Johnson & Johnson. The United States has also come under increasing pressure to share more of its vaccine supply with the world, as infection rates rise in countries like India and other countries struggle. get enough doses to protect their most vulnerable residents.
More than 3.1 million people worldwide have died from Covid-19, including more than 572,000 in the U.S. More than half of U.S. adults have received at least one dose of the vaccine and the government expects to have sufficient supplies for the entire population by early summer.
AstraZeneca reported sales of $ 275 million from shipments of 68 million doses of the vaccine in the first quarter. AstraZeneca has pledged to deliver the vaccine to a nonprofit as long as the pandemic lasts.
The company said 30 million doses went to the EU, 26 million to the UK, 7 million to Gavi, an alliance that secures vaccines for low-income countries, and 5 million to other countries.
To date, AstraZeneca and partners such as Serum Institute of India and Fiocruz in Brazil have supplied more than 300 million doses of the Covid-19 vaccine to more than 165 countries, the Anglo-Swedish drug maker said.
The vaccine was developed by researchers from Oxford University, which licensed AstraZeneca to harness the company’s global manufacturing and distribution capacity. AstraZeneca in turn allows other companies to produce the images around the world.

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