The American stock of the controversial AstraZeneca Plc’s coronavirus vaccine has grown to more than 20 million doses, according to people familiar with the matter, even though it seems increasingly unlikely that the shot will play a role in President Joe Biden’s domestic vaccination campaign.
AstraZeneca has not yet filed for Food and Drug Administration authorization for the two-dose vaccine, and the company is facing security questions abroad and investigations from U.S. regulators who have already rebuked it for missteps during clinical trials and partial data releases.
Three other vaccines already approved in the US are going into the arms of Americans at the rate of about 3 million doses per day, and hundreds of millions of additional doses will be delivered by August.
That begs the question for Biden: what to do with the AstraZeneca vaccine? The company already has more than 20 million doses on hand, part of a total of between 80 and 90 million at a stage of production for the US order, the people familiar with the matter said. US allies have already sought doses from the US’s stock of AstraZeneca, and the cheaper vaccine could inoculate people in dozens of low-income countries that cannot afford vaccinations from Pfizer Inc. and From Moderna Inc.
Read more: AstraZenecas Vaccine Drama Risks Prolonging the Pandemic
‘Give them all away. By the time we even think about approving it, we’ll be in a plentiful situation domestically, ” said Zeke Emanuel, a physician and vice provost at the University of Pennsylvania who served as a senior health policy adviser in the Obama administration and Biden. Covid transition advisory board.
“We’re never going to use them,” he said.
Celine Gounder, a physician who was also a member of a Covid advisory board for the Biden transition, agreed that the doses should be donated after the company gets FDA approval. “We have enough – we don’t even need it Johnson & Johnson, ”the third authorized US manufacturer, she said.
“I would like to see the FDA continue its process, issue emergency use approval, assuming it passes snuff, and then donate it,” she added.
FDA authorization is “very important,” she said, “because of all the different questions with the AstraZeneca vaccine.”
Earlier this week, the European Union drug regulator said it had identified a “strong association” between AstraZeneca shots and rare blood clots, especially in younger patients. UK regulators said people under 30 should get an alternative vaccine, if available.
More than 726 million shots delivered: Covid-19 Tracker
That followed an unusual rebuke from US regulators in March, who accused the company of releasing “potentially misleading” data from a major US clinical trial. AstraZeneca has slightly downgraded the vaccine efficacy estimates.
AstraZeneca is now looking for new US manufacturing of the active ingredient in the vaccine after it had agreed to create one The factory of Emergent Biosolutions Inc. in Baltimore who had confused the production of his photo with that of Johnson & Johnson. Biden’s administration brokered the acquisition of the factory by J&J.
The US is on track to have enough vaccine for the entire adult population by the end of next month, with an additional 200 million doses of Moderna and Pfizer coming in by the end of July. White House officials have said they want excess doses, in part to vaccinate children, once a dose is approved for people under 16. Given the issues with younger adults, it’s unclear whether the AstraZeneca injection would ever be approved for use by American youth.
In any case, the government will not make any decisions on AstraZeneca until the FDA finalizes its review, said an official familiar with the matter who, like the other officials, was given anonymity to discuss the matter.
The US government spent $ 1.2 billion last year to accelerate research, development, production and delivery of 300 million doses of AstraZeneca’s vaccine. At the time, the Department of Health and Human Services under the Trump administration said it expected the first doses to be delivered as early as October.
Biden did not change that order, so AstraZeneca began filming in the US pending final FDA approval. Last month, the president agreed to send 4.2 million doses of AstraZeneca’s vaccine to Mexico and Canada, a scheme the government called a “loan.” When those doses are factored in, the current U.S. AstraZeneca total to date is nearly 30 million, the people said.
The company expects to have 50 million doses ready by the end of this month, one of the officials said.
AstraZeneca declined to comment directly on the US stock, but said in a statement until approximately 50 million doses available to the US government at time of emergency use authorization, and millions of additional doses thereafter. “
There is currently no evidence that all AstraZeneca batches were affected by problems at the Emergent Baltimore plant, a company spokesman said. Canadian and Mexican officials, who have been starving for the supply of vaccines, have not raised concerns. On the contrary, Mexico has asked the US for another shipment.
Mexican President Andres Manuel Lopez Obrador said on Thursday that he would consider receiving the shot from AstraZeneca himself.
– With help from Riley Griffin and Suzi Ring