Photographer: Alex Kraus / Bloomberg
Photographer: Alex Kraus / Bloomberg
The American reserve of the controversial The AstraZeneca Plc coronavirus vaccine has grown to more than 20 million doses, according to people familiar with the issue, although it seems unlikely that the shot will affect President Joe Biden’s internal vaccination campaign.
AstraZeneca has not yet applied for authorization from the Food and Drug Administration for the two-dose vaccine, and the company faces safety issues overseas and a scrutiny of U.S. regulators which has already been disproved by erroneous steps during clinical trials and partial publication of data.
Three other vaccines already authorized in the United States will end up in the arms of Americans at a rate of about 3 million doses a day, and hundreds of millions of additional doses are due to be delivered in August.
This raises Biden’s question: what to do with the AstraZeneca vaccine? The company has more than 20 million doses on hand, a share of a total of between 80 and 90 million at some stage of production for the U.S. order, according to people who knew the issue. U.S. allies have already sought doses from the U.S. AstraZeneca reserve, and the cheapest vaccine could inoculate people in dozens of low-income countries that cannot afford inoculations of Pfizer Inc. i Moderna Inc.
Read more: D’AstraZeneca The risks of the vaccine drama that prolong the pandemic
“Give them all. By the time we even think about authorizing it, we will be in an excessive situation nationwide, ”said Zeke Emanuel, a physician and vice-provost at the University of Pennsylvania who served as a senior policy advisor. health to the Obama administration and Biden’s.Covid transition advisory committee.
“We will never use them,” he said.
Celine Gounder, a doctor who was also part of a Covid advisory board for the Biden transition, agreed that the doses should be given after the company obtained FDA approval. “We have enough, we don’t even need it Johnson & Johnson, ”said the third authorized U.S. manufacturer.
“I would like to see the FDA continue its process, issue the emergency use authorization assuming tobacco passes and then give it away,” he added.
FDA clearance is “really important,” he said, “because of the various questions related to the AstraZeneca vaccine.”
Coagulation “association”
Earlier this week, the European Union’s drug regulator said it had established a “strong association” between AstraZeneca traits and rare blood clots, especially in younger patients. UK regulators said an alternative vaccine should be offered to people under the age of 30, if one is available.
More than 726 million shots fired: Covid-19 Tracker
This followed an unusual rebuke by U.S. regulators in March, who accused the company of posting “potentially misleading” data from a major U.S. clinical trial. AstraZeneca revised vaccine efficacy estimates slightly downward.
AstraZeneca is now looking for a new American manufacture of the active ingredient of the vaccine, after it agreed to vacate a Emerging plant of Biosolutions Inc. in Baltimore who had confused the production of his shot with Johnson & Johnson’s. The Biden administration brokered the acquisition of the plant by J&J.
The United States is about to have enough vaccine for its entire adult population by the end of next month, with 200 million more doses arriving from Moderna and Pfizer by the end of July. White House officials have said they want an overdose in part to vaccinate children once a dose is approved for children under 16. Given its problems with younger adults, it’s unclear whether AstraZeneca’s shot would be approved for young Americans.
The administration makes no decision on AstraZeneca until the FDA completes its review, said an official familiar with the matter, who, like other officials, was granted anonymity to discuss the matter.
Last year the U.S. government spent $ 1.2 billion to accelerate 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 hoped the first doses would be delivered as early as last October.
Biden did not change that order, so AstraZeneca began producing shots in the United States in anticipation of 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, AstraZeneca’s current total in the U.S. 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 reservation, but said in a statement that it “expects to have Until approximately 50 million doses available to the U.S. government at the time of emergency use authorization and millions of additional doses thereafter. “
There is no evidence at this time that AstraZeneca batches have 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. By contrast, Mexico has requested another shipment to the US.
Mexican President Andres Manuel Lopez Obrador said Thursday he would consider receiving the AstraZeneca shot.
– With the assistance of Riley Griffin and Suzi Ring