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The U.S. is holding onto tens of millions of AstraZeneca's COVID-19 vaccine doses in manufacturing facilities as scientists wait on clinical trial data to indicate the safety and efficacy of the vaccine, according to The New York Times.
Other countries that have authorized the AstraZeneca-University of Oxford vaccine are asking for the doses, which has become a major debate among White House and federal health officials, the newspaper reported. Some say the doses should go to other countries, but some disagree.
"We understand other governments may have reached out to the U.S. government about donation of AstraZeneca doses, and we've asked the U.S. government to give thoughtful consideration to these requests," said Gonzalo Viña, a spokesman for AstraZeneca, told the newspaper.
About 30 million doses are bottled at an AstraZeneca facility in Ohio, the newspaper reported. Tens of millions will soon be available in a Maryland manufacturing facility as well.
The AstraZeneca vaccine has been authorized in more than 70 countries, the company reported, but the U.S. clinical trial hasn't yet reported data or applied for FDA authorization. The company has asked the Biden administration to loan doses to the European Union, but so far, the request has been denied, The New York Times reported.
Officials have discussed sending the doses to Brazil or the UK, where coronavirus variants are spreading. On Friday, White House officials said the government is holding onto the doses so they can be given to Americans quickly if the vaccine is authorized by the FDA, according to Reuters.
"We have a small inventory of AstraZeneca so, if approved, we can get that inventory out to the American people," Jeffrey Zients, the White House COVID-19 response coordinator, said during a press call.
Last May, the Trump administration pledged $1.2 billion to AstraZeneca to develop and manufacture a vaccine and provide 300 million doses to the U.S.
In the fall, the U.S. clinical trial stopped for about 7 weeks after serious neurological side effects were identified in two participants. On Thursday, health officials in Denmark, Norway, and Iceland suspended the vaccine after reports of severe blood clots. The company said there wasn't evidence that the vaccine caused the clots, The New York Times reported.
Data from the U.S. clinical trial should be available in the coming weeks.
The AstraZeneca vaccine is considered less expensive and easier to store at refrigerated temperatures, but the doses shouldn't sit for longer than 6 months, officials told the newspaper.
The Biden administration wants to "make sure we have maximal flexibility, that we are oversupplied and over-prepared and that we have the ability to provide vaccines, whatever the most effective ones are, to the American public," Jen Psaki, the White House press secretary, said Friday during a press briefing.
"A number of countries have requested doses from the United States and we have not provided doses from the U.S. government to anyone," she said. "This is about our focus and our priority."
New York Times, "The U.S. Is Sitting on Tens of Millions of Vaccine Doses the World Needs."
Reuters, "White House says it's holding onto AstraZeneca COVID-19 shots for Americans."
Department of Health and Human Services, "Trump Administration's Operation Warp Speed Accelerates AstraZeneca COVID-19 Vaccine to be Available Beginning in October."
European Medicines Agency, "COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events - vaccine's benefits currently still outweigh risks."
C-SPAN, "White House Daily Briefing, March 12, 2021."
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Cite this: US Holds Millions of AstraZeneca Doses Requested Worldwide - Medscape - Mar 15, 2021.