The U.S. stock of the controversial AstraZeneca Plc coronavirus vaccine has grown to more than 20 million doses, according to people familiar with it, even though it seems unlikely that the inclusion in President Joe Biden’s domestic vaccination campaign will contribute.
AstraZeneca has yet to seek the approval of the Food and Drug Administration for the two-dose vaccine, and the company faces overseas safety and investigation by U.S. regulators who have already punished it during clinical trials and partial release of reports.
Three other vaccines already approved in the US are going into the arms of Americans at about 3 million doses a day, with hundreds of millions of additional doses to be completed by August.
This begs the question for Biden: what to do with the vaccination of AstraZeneca? The people familiar with the matter already have more than 20 million doses on hand, a total of between 80 and 90 million at a stage of production for the US order. US allies have already sought doses from the US AstraZeneca stock, and the cheaper vaccine can vaccinate people in low-income countries with low incomes who cannot afford vaccinations Pfizer Inc. and Moderna Inc.
Read more: AstraZeneca’s The risks of vaccines prolong the pandemic
‘Give them all away. By the time we even think about authorizing it, we will be in a big situation domestically, ‘said Zeke Emanuel, a medical doctor and deputy provost of the University of Pennsylvania, as a senior health policy adviser in the Obama administration. government and at Biden’s. Advisory Board for Covid Transition.
“We’re never going to use it,” he said.
Celine Gounder, a physician who also served on Covid’s Biden Transition Advisory Board, agreed that the doses should be donated after the company obtained FDA approval. ‘We have enough – we do not even need Johnson & Johnson, ”she said, the third authorized U.S. manufacturer.
“I would like to see the FDA continue its process, issue the authorization for emergency use, assuming it is sniffed, and then donate it,” she added.
FDA authorization is ‘very important’, she said, ‘because of all the different issues with the AstraZeneca vaccine.’
Clotting Association
Earlier this week, the European Union’s Drug Regulator said it had established a ‘strong link’ between AstraZeneca’s shots and rare blood clots, especially in younger patients. UK regulators have said people under 30 should get an alternative vaccine, if one is available.
More than 726 million shots fired: Covid-19 Tracker
This followed an unusual reprimand from U.S. regulators in March, who accused the company of disclosing “potentially misleading” data from a major U.S. clinical trial. AstraZeneca has slightly revised downwards the estimates of the vaccine’s efficacy.
AstraZeneca is now looking for a new US manufacturer of the active ingredient of the vaccine, after agreeing to evacuate an upset Emergent Biosolutions Inc. plant in Baltimore that confused the production of its shot with Johnson & Johnson’s. The administration of Biden mediated J & J’s takeover of the plant.
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 coming from Moderna and Pfizer by the end of July. White House officials have said they want a surplus dose in part to vaccinate children once a dose is approved for people under 16. Given the problems with younger adults, it is unclear whether the AstraZeneca shot was ever approved. would be for use by American youth.
The government will not take any decisions on AstraZeneca until the FDA has completed its investigation, said an official familiar with the matter, who, like the 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’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 has not changed the order, so AstraZeneca began manufacturing shots in the US pending final FDA approval. Last month, the president agreed to send 4.2 million doses of AstraZeneca vaccine to Mexico and Canada, an arrangement the government calls a “loan.” If the doses are included, the current total of the US AstraZeneca so far is almost 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 did not want to comment directly on the US stock, but said in a statement that it “expects to to about 50 million doses available to the U.S. government at the time of emergency use authorization, and millions of additional doses thereafter. ”
There is at this stage no evidence that any AstraZeneca groups are affected by the 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. On the contrary, Mexico has asked the US for another shipment.
Mexican President Andres Manuel Lopez Obrador said on Thursday he would consider receiving the AstraZeneca shot himself.
– With the help of Riley Griffin and Suzi Ring