AstraZeneca Delays Filing of US Approval Application for COVID Vaccine | Business and economic news

The Anglo-Swedish drugmaker has said it intends to seek US clearance for its injection in the coming weeks.

AstraZeneca said on Friday it intended to seek US clearance for its COVID-19 vaccine in the “next few weeks,” acknowledging a delay in the much-anticipated 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 European Union, UK and other countries during the first three months of the year.

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

Among the issues that will likely be addressed are the indications that the vaccine is linked to rare blood clots, especially in young people. Several countries have recommended that the vaccine be given only to the elderly because of the potential side effects. Vaccine experts say blood clots are very rare, less than the chances of blood clots in women taking contraceptive drugs.

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 start sharing its entire AstraZeneca vaccine stockpile with the world once it approves federal safety reviews, with up to 60 million doses which should be available for export in the coming months. The move is in line with the decision taken in March by the administration of US President Joe Biden to share around four million doses of the vaccine with Mexico and Canada.

The White House is feeling increasingly confident about the supply of the three vaccines already administered in the United States – Pfizer, Moderna and Johnson & Johnson. The United States has also come under increasing pressure to share its vaccine supply more with the world, as infection rates rise in countries like India and other countries struggling to 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 United States. More than half of American 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 coronavirus pandemic lasts.

The company said 30 million doses were destined for the EU; 26 million in the United Kingdom; $ 7 million to Gavi, the Vaccine Alliance, which secures 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 drug maker said.

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.

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