mcloudy.png
Sunday June 20th, 2021 6:00PM

AstraZeneca delays filing for US authorization of COVID shot

By The Associated Press
Related Articles
  Contact Editor

LONDON (AP) — AstraZeneca said Friday that it intends to seek U.S. authorization for its COVID-19 vaccine in the “coming weeks," acknowledging a delay in the much-anticipated filing that had been expected by mid-April.

The Anglo-Swedish drugmaker revealed the new timetable as it released first-quarter financial results, which showed that the company delivered 68 million doses of the vaccine to the U.K., 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 U.S. Food and Drug Administration, noting the “substantial size of the file" that will include data from U.S. trials as well all other studies completed so far and real-world data collected from use of the vaccine in other countries.

Among the issues that will likely be addressed are indications that the vaccine is linked to rare blood clots, particularly in younger people. Several countries have recommended that the shot be given only to older people because of the potential side effect. Vaccine experts say the blood clots are very rare, less than the blood clot risks of women taking birth control.

When AstraZeneca released data from its U.S. vaccine trial on March 22, company officials said they expected to apply for FDA authorization 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 to allow emergency use.

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

The White House said earlier this week that the U.S. would begin sharing its entire stock of AstraZeneca vaccine with the world once it clears federal safety reviews, with as many as 60 million doses expected to be available for export in the coming months. The move expands on the Biden administration’s March decision to share about 4 million doses of the vaccine with Mexico and Canada.

The White House is feeling increasingly confident about the supply of the three vaccines already being administered in the U.S. — Pfizer, Moderna and Johnson & Johnson. The U.S. has also been under mounting pressure to share more of its vaccine supply with the world, as infection rates surge in countries like India and other countries struggle to get enough doses to protect their most vulnerable residents.

More than 3.1 million people worldwide have died of 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 vaccine, and the government expects to have enough supply for the entire population by early summer.

AstraZeneca reported revenue of $275 million from deliveries of 68 million doses of the vaccine during the first quarter. AstraZeneca has pledged that it will deliver the vaccine on a non-profit basis as long as the pandemic lasts.

The company said 30 million doses went to the EU, 26 million to the U.K., 7 million to Gavi, an alliance that 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 COVID-19 vaccine doses to over 165 countries, the Anglo-Swedish drugmaker said.

The vaccine was developed by researchers at Oxford University, who licensed the technology to AstraZeneca in an effort to tap into the company’s global manufacturing and distribution capacity. AstraZeneca in turn authorizes other companies to produce the shots around the world.

—-

Follow more of AP’s pandemic coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/hub/coronavirus-vaccine.

  • Associated Categories: Associated Press (AP), AP World News, AP Business, AP Business - Industries, AP Business - Health Care
© Copyright 2021 AccessWDUN.com
All rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
AstraZeneca delays filing for US authorization of COVID shot
AstraZeneca says it intends to seek U.S. authorization for its COVID-19 vaccine in the “coming weeks,” acknowledging a delay in the the much-anticipated filing that had been expected by mid-April
2:49PM ( 2 minutes ago )
White House completes North Korea policy review
The Biden administration says it has completed a review of U.S. policy toward North Korea and suggests it has limited hopes of brokering a “grand bargain” to persuade the North to give up its nuclear weapons program
2:48PM ( 3 minutes ago )
Determined volunteers still search for capsized ship missing
A team of volunteers is still searching for survivors of a platform ship that capsized in the Gulf of Mexico
2:45PM ( 7 minutes ago )
Associated Press (AP)
Russia targets lawyer over media comments on treason case
Russian authorities have launched a criminal probe against a lawyer representing a former Russian journalist accused of treason and the team of imprisoned opposition leader Alexei Navalny
1:29PM ( 1 hour ago )
The Latest: US will send Pfizer vaccines to Canada next week
Canada will get Pfizer vaccines doses from the United States starting next week
1:25PM ( 1 hour ago )
The Latest: Dr. Fauci: Be sure to get 2nd dose of vaccines
About 8% of Americans who have received one dose of either the Pfizer or Moderna COVID-19 vaccines have not returned for their second shot
12:49PM ( 2 hours ago )
AP Business
The Latest: Turkey grants emergency use of Sputnik V vaccine
Turkish authorities have granted Russia’s Sputnik V vaccine approval for its emergency use in Turkey
10:56AM ( 3 hours ago )
Pfizer, BioNTech seek EU's OK to use COVID vaccine on kids
Pfizer and BioNTech have submitted a request to the European drug regulator for the approval of their coronavirus vaccine to be extended to include children aged 12 to 15 years old, in a move that could offer younger and less at-risk populations in Europe access to the shot for the first time
8:49AM ( 6 hours ago )
The Latest: India sets record of 386,000 daily virus cases
India has set another global record with 386,452 daily coronavirus cases
8:38AM ( 6 hours ago )
AP Business - Industries
India's COVID-19 human crisis spirals with record new cases
India’s coronavirus cases have climbed again, prompting the army to open up its hospitals in a desperate bid to control a massive humanitarian crisis created by an acute shortage of beds, medicines and oxygen
12:50AM ( 14 hours ago )
The Latest: Wash. state alters vaccine system as demand ebbs
Washington state is changing the way it allocates coronavirus vaccine as demand for the shots declines in some places
9:30PM ( 17 hours ago )
The Latest: Costa Rica tightens restrictions as virus surges
A record surge in COVID-19 infections in Costa Rica forced the government to announce new restrictions Thursday that will dial back the country’s economic reopening
7:19PM ( 19 hours ago )
AP Business - Health Care
Determined volunteers still search for capsized ship missing
A team of volunteers is still searching for survivors of a platform ship that capsized in the Gulf of Mexico
2:45PM ( 7 minutes ago )
Prosecutor in Daunte Wright's death not swayed by critics
As activists in Minnesota press for murder charges against the police officer who shot Daunte Wright, the prosecutor is sticking by the manslaughter charge he filed
2:19PM ( 33 minutes ago )
Mars helicopter gets extra month of flying as rover's scout
NASA's little Mars helicopter is getting an extra month of flying
2:07PM ( 44 minutes ago )
Number of Americans fully vaccinated tops 100 million
Disneyland has reopened in Southern California
2:07PM ( 44 minutes ago )
Steep drop in national security surveillance during pandemic
The number of targets of secretive surveillance in national security investigations fell sharply last year in large part because of the coronavirus pandemic
1:46PM ( 1 hour ago )