AstraZeneca delays application for COVID vaccine in the US Business and Economy News

The Anglo-Swedish drug maker has said he plans to get permission to shoot in the U.S. in the coming weeks.

AstraZeneca said on Friday that it intends to seek permission to obtain its COVID-19 vaccine in the “coming weeks” in the United States, acknowledging the delay in the file expected by mid-April.

The Anglo-Swedish drug maker unveiled a new calendar when it released economic results for the first quarter, which showed the company delivered 68 million doses of the vaccine to the European Union, the United Kingdom and other countries in the first three months of the year.

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

Among the issues that will probably be addressed are signs that the vaccine is associated with rare blood clots, especially in younger people. Several countries have recommended that the shot be given only to older people because of potential side effects. Vaccine experts say blood clots are very rare, with women taking birth control medications having a lower risk of developing blood clots.

When AstraZeneca released U.S. vaccine test data on March 22, company officials said they expected to apply for FDA approval in the first fortnight of April. Once the petition is filed, an FDA advisory committee will publicly discuss the evidence behind the shootings before the agency decides whether to allow emergency use.

AstraZeneca executive vice president Ruud Dobber said then that if the FDA authorized the vaccine, the company would deliver 30 million doses immediately, and another 20 million in the first month.

The White House said earlier this week that the U.S. will begin sharing the entire stock of the AstraZeneca vaccine with the world after clearing federal safety reviews, with 60 million doses expected to be exported in the coming months. The move was expanded with a decision by the U.S. President Joe Biden’s administration to share about four million doses of the vaccine with Mexico and Canada in March.

The White House is increasingly confident about the supply of three vaccines that are already being administered in the US – Pfizer, Moderna and Johnson & Johnson -. The US has also come under a lot of pressure to share more vaccine supplies with the world as infection rates in India and other countries increase to get enough doses to protect its most vulnerable residents.

As a result of COVID-19, more than 3.1 million people have died worldwide, more than 572,000 in the United States. More than half of U.S. adults have received at least one dose of vaccine, and the government hopes to have enough supplies for all residents by early summer.

AstraZeneca had revenue of $ 275 million in the first quarter as a result of delivering 68 million doses of the vaccine. AstraZeneca has pledged to provide the vaccine nonprofit for the duration of the coronavirus pandemic.

The company said 30 million doses have gone to the EU; 26 million to the United Kingdom; 7 million Gavi, the Vaccine Alliance, which certifies vaccines for low-income countries; and 5 million to other nations.

To date, partners such as AstraZeneca and the Indian Serum Institute and Brazil’s Fiocruz have donated more than 300 million COVID-19 vaccine doses to more than 165 countries, the Anglo-Swedish doctor said.

The vaccine was developed by researchers at Oxford University and licensed the technology to AstraZeneca in an effort to gain the company’s global manufacturing and distribution capability. AstraZeneca, in turn, allows other companies to make plans around the world.