American stocks controversial The AstraZeneca Plc coronavirus vaccine has risen to more than 20 million doses, according to people familiar with the issue, although the shot appears unlikely to affect President Joe Biden’s domestic vaccination campaign.
AstraZeneca has not yet sought approval from the Food and Drug Administration for the two-dose vaccine, and the company faces overseas safety issues and oversight by U.S. regulators who have already resented it for erroneous steps during clinical trials and partial disclosure.
Three other vaccines already approved in the U.S. are going into the arms of Americans at a rate of about 3 million doses a day, and hundreds of millions of additional doses are to be delivered by August.
This begs the question for Biden: What to do with the AstraZeneca vaccine? The company already has more than 20 million doses available, which is part of a total of between 80 and 90 million at some stage of production for a U.S. order, people familiar with the matter said. U.S. allies have already sought doses from U.S. stockpiles of AstraZeneca, and a cheaper vaccine could vaccinate people in a multitude of low-income countries who cannot afford inoculations Pfizer Inc. i Modern Inc.
Read more: AstraZeneca Risks of vaccine drama prolonging the pandemic
“Give them all. As long as we even think about approving it, the natives will be in a position to sow, ”said Zeke Emanuel, MD and vice president of the University of Pennsylvania, who served as senior health policy adviser to the Obama administration and Biden’s Covid Transition Advisory Board. .
“We will never use them,” he said.
Celine Gounder, a physician who was also a member of Covid’s advisory board for Biden’s transition, agreed that the doses should be donated once the company receives FDA approval. “We have enough – we don’t need to Johnson & Johnson, “the third authorized U.S. manufacturer,” she said.
“I would like to see the FDA continue its process, issue an emergency authorization assuming the snout passes, and then donate it,” she added.
FDA approval is “really important,” she said, “because of all the different questions about the AstraZeneca vaccine.”
Earlier this week, the European Union’s drug regulator said it had established a “strong link” between AstraZeneca injections and rare blood clots, especially in younger patients. British regulators have said that people under the age of 30 should be offered an alternative vaccine, if available.
More than 726 million shots given: Covid-19 Tracker
This followed an unusual reprimand by U.S. regulators in March, who accused the company of publishing “potentially misleading” data from a large U.S. clinical trial. AstraZeneca has revised the vaccine efficacy evaluations slightly downwards.
AstraZeneca is now seeking new production of the active ingredient in the vaccine in the US, after agreeing to leave the problematic Emergent Biosolutions Inc. a plant in Baltimore that confused the production of its shot with Johnson & Johnson’s. The Biden administration mediated the takeover of the J&J plant.
The U.S. is on the verge of having enough vaccines for the entire adult population by the end of next month, with another 200 million doses arriving from Moderna and Pfizer in late July. White House officials said they want excess doses in part to vaccinate children, once the dose is approved for people under 16. Given the problems with younger adults, it is unclear whether the shooting from AstraZeneca will ever be approved for use by American youth.
The administration in no case makes decisions on AstraZeneca until the FDA completes its review, said an official familiar with the matter, who, like other officials, was given anonymity to discuss the issue.
The U.S. government spent $ 1.2 billion last year to accelerate research, development, production and delivery of 300 million doses of AstraZeneca vaccine. At the time, the Ministry of Health and Social Services under the Trump administration said it expected the first doses to be delivered as early as last October.
Biden did not change that order, so AstraZeneca began producing the footage in the U.S. pending possible FDA approval. Last month, the president agreed to send 4.2 million doses of AstraZeneca vaccine to Mexico and Canada, an arrangement the administration called a “loan.” When those doses are included, the total American AstraZeneca so far is almost 30 million, people said.
The company expects 50 million doses to be ready by the end of this month, one official said.
AstraZeneca declined to comment directly on U.S. stocks, but said in a statement that “it expects to have to approximately 50 million doses available to the U.S. government at the time of emergency approval, and millions of additional doses thereafter. “
At this time, there is no evidence that any AstraZeneca series has been affected by problems at the Emergent plant in Baltimore, a company spokesman said. Canadian and Mexican officials, who are hungry for the supply of vaccines, have not expressed concern. In contrast, Mexico requested another shipment from the United States.
Mexican President Andres Manuel Lopez Obrador said on Thursday that he would consider receiving a bullet from AstraZeneca.
– With the help of Riley Griffin and Susie Ring