AstraZeneca delays US application for COVID vaccine | Business and Economy News


The Anglo-Swedish pharmacist said he intends to apply for US clearance for his shot in the coming weeks.

AstraZeneca said Friday that it intends to apply for U.S. authorization for its COVID-19 vaccine in the “coming weeks,” acknowledging a delay in the long-awaited submission that was expected in mid-April. .

The Anglo-Swedish pharmacist unveiled the new schedule as it released first-quarter financial results, which showed the company delivered 68 million doses of the vaccine to the European Union, the United Kingdom and other countries during the first three months of the year.

The company said it would continue to work on its application to the U.S. Food and Drug Administration (FDA), noting the “substantial file size” that will include data from U.S. trials, as well as all the other studies conducted so far and the real world. data collected from vaccine use in other countries.

Among the problems that are likely to be treated are indications that the vaccine is related to rare blood clots, especially in younger people. Several countries have recommended that the vaccine be given only to the elderly because of the possible side effects. Vaccine experts say blood clots are very rare, less than the risk of blood clots in women taking birth control pills.

When AstraZeneca released data from its vaccine trial in the United States on March 22, company officials said they expected to apply for FDA approval in the first fortnight of April. Once the application is submitted, an FDA advisory committee will publicly discuss the evidence behind the shootings before the agency decides whether emergency use is allowed.

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

The White House said earlier this week that the United States would begin sharing its entire stock of AstraZeneca vaccine with the world once it clears federal safety reviews, with up to 60 million doses expected to be available for export in the coming months. The move is extended by the decision of the administration of the President of the United States, Joe Biden, in March, to share about four million doses of the vaccine with Mexico and Canada.

The White House is increasingly confident of supplying the three vaccines that are already being administered in the U.S.: Pfizer, Moderna, and Johnson & Johnson. The United States has also come under increasing pressure to share more vaccines with the world, as infection rates rise in countries like India and other countries struggling to get enough doses to protect their vaccines. most vulnerable residents.

More than 3.1 million people worldwide have died from COVID-19, including more than 572,000 in the US. More than half of American adults have received at least one dose of vaccine and the government hopes to have enough supply for the entire population in early summer.

AstraZeneca reported revenue of $ 275 million for deliveries of 68 million vaccine doses during the first quarter. AstraZeneca has pledged to administer the nonprofit vaccine for the duration of the coronavirus pandemic.

The company said 30 million doses were destined for the EU; 26 million in the UK; 7 million to Gavi, the Vaccine Alliance, which insures vaccines for low-income countries; and 5 million to other nations.

To date, AstraZeneca and partners such as the Serum Institute of India and Fiocruz in Brazil have supplied more than 300 million doses of COVID-19 vaccine to more than 165 countries, the Anglo-Swedish pharmacist said.

The vaccine was developed by researchers at Oxford University, who licensed the technology to AstraZeneca in an effort to leverage the company’s global manufacturing and distribution capacity. In turn, AstraZeneca authorizes other companies to produce photographs worldwide.

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