WASHINGTON -- The U.S. will begin sharing its entire stock of AstraZeneca covid-19 vaccine with the world once it clears federal safety reviews, the White House said Monday, with as many as 60 million doses expected to be available for export in the coming months.
The move greatly expands on the Biden administration's action last month to share about 4 million doses of the vaccine with Mexico and Canada. The AstraZeneca vaccine is widely in use around the world but has not yet been authorized by the U.S. Food and Drug Administration.
The White House is increasingly feeling assured about the supply of the three vaccines being administered in the U.S., particularly after the restart of the single-dose Johnson & Johnson shot over the weekend. The U.S. has also been under pressure in recent weeks to share more of its vaccine supply with the world, as countries such as India experience surges of the virus and others struggle to obtain the doses needed to protect their most vulnerable populations.
President Joe Biden said last week that he was considering sending more vaccine doses overseas.
"We're looking at what is going to be done with some of the vaccines that we are not using," the president said. "We've got to make sure they are safe to be sent."
"Given the strong portfolio of vaccines that the U.S. already has and that have been authorized by the FDA, and given that the AstraZeneca vaccine is not authorized for use in the U.S., we do not need to use the AstraZeneca vaccine here during the next several months," said White House covid-19 coordinator Jeff Zients. "Therefore the U.S. is looking at options to share the AstraZeneca doses with other countries as they become available."
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More than 3 million people worldwide have died of covid-19, including more than 572,000 in the U.S. The U.S. has vaccinated more than 53% of its adult population with at least one dose of its three authorized vaccines from Pfizer, Moderna and Johnson & Johnson, and it expects to have enough supply for its entire population by early summer.
About 10 million doses of AstraZeneca vaccine have been produced but have yet to pass review by the FDA to "meet its expectations for product quality," Zients said, noting the U.S. regulator is recognized as the gold standard for safety around the world. That process could be completed in the next several weeks. About 50 million more doses are in various stages of production and could be available to ship in May and June, pending FDA sign-off.
The U.S. has yet to finalize where the AstraZeneca doses will go, Zients said. Neighbors Mexico and Canada have asked the Biden administration to share more doses, while dozens of other countries are looking to access supplies as well.
"We're in the planning process at this point in time," said White House press secretary Jen Psaki.
Psaki also cautioned at a news conference that the donations would not happen right away and were conditional on FDA approval.
"Right now we have zero doses available of AstraZeneca," Psaki said.
In a statement, a spokesperson for AstraZeneca said the company would not comment on specifics but that "the doses are part of AstraZeneca's supply commitments to the U.S. government. Decisions to send U.S. supply to other countries are made by the U.S. government."
The AstraZeneca doses will be donated by the government, which has contracted with the company for a total of 300 million doses -- though the company has faced production issues.
The administration's move to share vaccine drew praise from nongovernmental aid groups, which encouraged the White House to develop plans to share even more.
"The Biden administration's decision to begin sharing AstraZeneca vaccines is welcome news and an important first step towards the US sharing more of its massive vaccine stockpile," said Tom Hart, acting CEO at The ONE Campaign. "The Biden administration should build on this welcome first step and start sharing more vaccines as soon as possible."
In part because the AstraZeneca vaccine is not expected to play a significant factor in the U.S. virus response, the White House was also moving to share raw materials for the production of the vaccine with India -- which has emerged as a global hot spot for the virus -- by diverting some of its orders to the vaccine manufacturer Serum Institute of India.
Zients said the Biden administration was working to satisfy other "key requests" from the Indian government, namely for personal protective equipment, tests, therapeutics and supplies of oxygen and respiratory assistance devices.
"The administration's identified U.S. commercial suppliers of therapeutics that are immediately available to help relieve the suffering of the covid-19 patients in India," said Zients. "We've identified rapid diagnostic tests and supplies and PPE, and additional ventilators that are available to be transferred to India."
Epidemiologists from the Centers for Disease Control and Prevention are expected to travel to India soon to assist with its virus response.
The additional quality review before the U.S. shares the AstraZeneca doses is in order because of issues at the facility that produced them, White House officials said.
AstraZeneca's doses in the U.S. were produced at an Emergent BioSolutions plant in Baltimore that has come under increased regulatory and public scrutiny after it botched batches of the Johnson & Johnson vaccine. The U.S. pressed Johnson & Johnson to take over the plant and, as part of the effort to ensure the quality of newly produced vaccines, directed the facility to stop making the AstraZeneca shot. AstraZeneca is still looking to identify a new U.S. production facility.
The U.S. government ordered enough for 150 million Americans before issues with the vaccine's clinical trial held up clearance. The company's 30,000-person U.S. trial didn't complete enrollment until January, and it still has not filed for an emergency-use authorization with the FDA.
Monday's move came just a day after a spokesperson for the National Security Council announced a series of steps that were intended to help other nations but stopped short of actually providing the vaccine, including removing impediments to the export of raw materials for vaccines to India and supplying that country with therapeutics, rapid diagnostic test kits, ventilators and personal protective gear.
EU'S LEGAL ACTION
Meanwhile, the European Union's executive branch said Monday that it has launched legal action against AstraZeneca for failing to respect the terms of its contract with the 27-nation bloc.
The AstraZeneca vaccine has been central to Europe's immunization campaign and a linchpin in the global strategy to get vaccines to poorer countries. But the slow pace of deliveries has frustrated the Europeans, and they have held the company responsible for partly delaying their vaccine rollout.
European Commission spokesman Stefan De Keersmaecker said Brussels launched the legal action against AstraZeneca on Friday "on the basis of breaches of the advance purchase agreement."
He said the reason for the legal action was that "some terms of the contract have not been respected" and that "the company has not been in a position to come up with a reliable strategy to ensure a timely delivery of doses."
AstraZeneca's contract with the EU, which was signed by the commission on behalf of the member countries in August, foresaw an initial 300 million doses for distribution among member countries, with an option for a further 100 million.
The British-Swedish drugmaker had hoped to deliver 80 million doses of that in the first quarter of 2021, but only 30 million were sent. According to the commission, the company is now set to provide 70 million doses in the second quarter, rather than the 180 million it had promised.
AstraZeneca said it "regrets" the commission's decision to take legal action and that it will "strongly defend" itself in court.
"We believe any litigation is without merit and we welcome this opportunity to resolve this dispute as soon as possible," AstraZeneca said. It said deliveries are improving "following an unprecedented year of scientific discovery, very complex negotiations, and manufacturing challenges."
"We are making progress addressing the technical challenges and our output is improving, but the production cycle of a vaccine is very long which means these improvements take time to result in increased finished vaccine doses," it said.
Information for this article was contributed by Zeke Miller, Lorne Cook and Pan Pylas of The Associated Press; and by Sheryl Gay Stolberg and David E. Sanger of The New York Times.