Photographer: Alex Kraus / Bloomberg
Photographer: Alex Kraus / Bloomberg
The controversial American stock AstraZeneca Plc’s coronavirus vaccine has risen to more than 20 million doses, according to people familiar with the issue, even though the shooting seems less and less likely to take into account President Joe Biden’s vaccination campaign.
AstraZeneca has not yet applied for authorization from the Food and Drug Administration for the two-dose vaccine, and the company is facing overseas safety and control issues from U.S. regulators who have already reprimanded it for mistakes during clinical trials and publication. partial data.
Three other vaccines already authorized in the US enter the arms of the Americans at a rate of about 3 million doses per day, hundreds of millions of additional doses to be administered by August.
This raises the question for Biden: What to do with the AstraZeneca vaccine? The company already has more than 20 million doses at hand, part of a total of between 80 and 90 million at a certain stage of production for the US order, said people familiar with the problem. US allies have already sought doses from US stock AstraZeneca, and the cheaper vaccine could inoculate people in dozens of low-income countries who cannot afford inoculations from Pfizer Inc. and Moderna Inc.
Read more: AstraZeneca’s The dramatic risks of vaccines that prolong the pandemic
“Give them all. Until we even think about authorizing him, we will be in an insensitive situation internally, “said Zeke Emanuel, a physician and deputy prefect at the University of Pennsylvania who was a senior health policy adviser to the Obama administration and Biden’s. . Covid Transition Advisory Committee.
“We will never use them,” he said.
Celine Gounder, a doctor who also served on a Covid advisory board for the Biden transition, agreed that doses should be donated after the company obtains FDA approval. “We have enough – we don’t even need it Johnson & Johnson “, the third authorized manufacturer in the USA, she said.
“I would like to see the FDA continue its process, issue the emergency use authorization, assuming it goes snuff and then donate it,” she added.
FDA authorization is “really important,” she said, “because of various questions about the AstraZeneca vaccine.”
Coagulation “Association”
Earlier this week, the European Union’s drug regulator said it had established a “strong association” between AstraZeneca strokes and rare blood clots, especially in younger patients. The UK regulators have said that people under the age of 30 should be offered an alternative vaccine if one is available.
More than 726 million photos given: Covid-19 Tracker
This was followed by an unusual rebuke from US regulators in March, who accused the company of releasing “potentially misleading” data from a large US clinical trial. AstraZeneca has revised the vaccine efficacy estimates slightly downwards.
AstraZeneca is now looking for a new US manufacture of the active ingredient in the vaccine, after agreeing to release a Emerging Plant Biosolutions Inc. from Baltimore who confused the production of his photo with Johnson & Johnson’s. The Biden administration brokered the takeover of the plant by J&J.
The US is on track to have enough vaccine for its entire adult population by the end of next month, with another 200 million doses arriving from Moderna and Pfizer by the end of July. White House officials said they want extra doses in part to vaccinate children, once a dose is approved for people under 16. Given its problems with younger adults, it is unclear whether the AstraZeneca shot would ever be approved for use by young Americans.
The administration will not make any decision regarding AstraZeneca until the FDA completes the review, said an official familiar with the matter, who, like other officials, was granted anonymity to discuss the issue.
The US government spent $ 1.2 billion last year to accelerate the research, development, production and delivery of 300 million doses of AstraZeneca vaccine. At the time, the Trump administration’s Department of Health and Human Services said it expected the first doses to be given as early as last October.
Biden did not change this order, so AstraZeneca began producing photos in the US pending possible FDA approval. Last month, the president agreed to send 4.2 million doses of AstraZeneca vaccine to Mexico and Canada, an agreement the administration called a “loan.” When these doses are included, the current US total AstraZeneca is nearly 30 million so far, people said.
The company expects to have 50 million doses ready by the end of this month, one official said.
AstraZeneca declined to comment directly on the US stock, but said in a statement that it “expects to have up to approximately 50 million doses available to the US government at the time of emergency use authorization and millions of additional doses thereafter. ”
There is no evidence at this time that any AstraZeneca batches were affected by problems at the Emergent plant in Baltimore, a company spokesman said. Canadian and Mexican officials, who are starving for the vaccine supply, have not expressed concern. On the contrary, Mexico has asked the United States for another shipment.
Mexican President Andres Manuel Lopez Obrador said on Thursday that he would consider receiving AstraZeneca.
– With the assistance of Riley Griffin and Suzi Ring