The U.S. Is Sitting on Tens of Millions of Vaccine Doses the World Needs

 WASHINGTON — Tens of many doses of the coronavirus vaccine made by the British-Swedish company AstraZeneca are sitting idly in American manufacturing facilities, awaiting results from its U.S. clinical test while countries that have authorized its use beg for access.

The fate of these doses of AstraZeneca’s vaccine is that the subject of an intense debate among White House and federal health officials, with some arguing the administration should allow them to go abroad where they're desperately needed while others aren't able to relinquish them, consistent with senior administration officials.

AstraZeneca is involved in those conversations.

“We understand other governments may have reached bent the U.S. government about the donation of AstraZeneca doses, and we’ve asked the U.S. government to offer thoughtful consideration to those requests,” said Gonzalo Viña, a spokesman for AstraZeneca.

About 30 million doses are currently bottled at AstraZeneca’s facility in West Chester, Ohio, which handles “fill-finish,” the ultimate phase of the manufacturing process during which the vaccine is placed in vials, one official with knowledge of the stockpile said.

Emergent BioSolutions, a corporation in Maryland that AstraZeneca has contracted to manufacture its vaccine within us, has also produced enough vaccine in Baltimore for tens of millions more doses once it's filled into vials and packaged, the official said.

But although AstraZeneca’s vaccine is already authorized in additional than 70 countries, consistent with a corporation spokesman, its U.S. clinical test has not yet reported results, and therefore the company has not applied to the Food and Drug Administration for emergency use authorization. AstraZeneca has asked the Biden administration to let it loan American doses to the ECU Union, where it's fallen in need of its original supply commitments and where the vaccination campaign has stumbled badly.

The administration, for now, has denied the request, one official said.

Some federal officials have pushed the White House to make a decision within the next few weeks. Officials have discussed sending doses to Brazil, which has been hard hit by a worsening coronavirus crisis, or the ECU Union or Britain.

“If those donation actions were to proceed, we might seek guidance from the U.S. government on replacement of doses to be used within the U.S.,” Mr. Viña said.

The White House didn't answer an invitation for comment.

The administration’s hesitation is a minimum of partly associated with uncertainties with vaccine supply before a benchmark lately May laid down by President Biden when he promised enough vaccine doses to hide every adult within us. Vaccine production is notoriously complex and delicate, and problems like mold growth can interrupt a plant’s progress.

Last May, the Trump administration pledged up to $1.2 billion to AstraZeneca to finance the event and manufacturing of its vaccine, which is developed with the University of Oxford, and to provide us with 300 million doses if it proved effective. Federal officials and public health experts last year viewed the vaccine, which is a smaller amount expensive and easier to store for long periods than another vaccine, as presumably to be among the primary to receive authorization.

That never happened, partially due to a pattern of communication blunders by AstraZeneca that weakened the company’s relationship with American regulators and slowed the vaccine’s development. Last fall, AstraZeneca’s trial within us — an equivalent one which will soon report results — was grounded for nearly seven weeks because the corporate was slow to supply the F.D.A. with evidence that the vaccine had not caused serious neurological side effects in two volunteers.

The company is now grappling with another safety scare. Acting out of precaution, health authorities in Denmark, Norway, and Iceland suspended the utilization of AstraZeneca’s vaccine on Thursday after several reports across the continent of severe blood clots.

European official and therefore the company said there was no evidence of any causal link. within the overwhelming majority of cases, the emergence of such medical conditions has nothing to try to do with the vaccine. Some percentage of individuals are expected to fall ill accidentally after getting vaccinated, as would happen in any group of individuals.

AstraZeneca has also run into other problems as its vaccine has unrolled. The shortfall in supply has fueled tensions with European officials. Some people in Germany and other countries have balked at taking the vaccine, for fear it's second-class due to its lower overall efficacy in clinical trials compared with the vaccine from Pfizer. South Africa last month halted its plans to introduce the vaccine after a little clinical test found that the vaccine didn't appear to be protective against mild to moderate illness caused by a concerning coronavirus variant first seen there.

In us, the Biden administration’s moves to order more supply of the three vaccines authorized by the F.D.A. has further sidelined AstraZeneca’s candidate. We may only briefly, or never, need the AstraZeneca doses if they're cleared for emergency use.

“If we have a surplus, we’re getting to share it with the remainder of the planet,” Mr. Biden told reporters on Wednesday, speaking generally about the U.S. vaccine supply. “We’re getting to begin ensuring Americans are taken care of first.”

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Johnson & Johnson, which has authorization for its vaccine within us but fell behind on its production targets in both us and Europe, recently asked us to loan 10 million doses to the ECU Union, but the Biden administration also denied that request, consistent with American and European officials.

The European Union has come under fierce criticism for “vaccine nationalism” and protectionism, which intensified last week when Italy blocked a little shipment of doses to Australia, stepping up a tug of war over badly needed shots. Still, the ECU Union exported 34 million doses of coronavirus vaccines in recent weeks to dozens of nations, whilst it faced shortages reception.

As frustrations simmer, some European officials are blaming us. the ECU Council president, Charles Michel, said us, alongside Britain, “has imposed an outright ban on the export of vaccines or vaccine components produced on their territory.” Asked on Thursday about the American supply of the AstraZeneca vaccine, Jen Psaki, the White House press secretary, told reporters that vaccine manufacturers were liberal to export their products made within us while also fulfilling the terms of their contracts with the govt.

But because AstraZeneca’s vaccine was produced with help from the Defense Production Act, Mr. Biden has got to approve shipments of doses overseas. Such a move could have huge negative political repercussions as long as Americans are still clamoring for shots.

AstraZeneca is additionally likely to require liability protection for doses shipped overseas love it would have within us if the vaccine is cleared.

Meantime, regulators within us are expecting new AstraZeneca data, expected within the next few weeks, from a Phase 3 trial that enrolled 32,000 participants mostly within us. AstraZeneca isn't likely to report results from an early check out its data, as other vaccine makers have done. it'll instead await more statistically meaningful results after trial participants are monitored longer for side effects and more people within the vaccine and placebo groups may have gotten sick, federal officials said. Experts believe the vaccine is unlikely to hold a better efficacy rate than the shot made by Johnson & Johnson, which uses similar technology and requires just one dose.

The potential for those results means AstraZeneca’s vaccine won't have a clear advantage within us over the vaccines currently authorized. Johnson & Johnson’s vaccine is straightforward to distribute and protects against severe disease and hospitalizations. The two-dose vaccines made by Pfizer-BioNTech and Moderna, which use different technology, have efficacy rates of around 95 percent.

Federal officials have also emphasized within the discussions that AstraZeneca’s vaccine shouldn't be stored indefinitely in Ohio or Maryland, since it, like all vaccines, features a limited time period. The vaccine is often kept at refrigerator temperatures for 6 months, and a few countries are giving the 2 doses spaced up to 3 months apart — raising the danger that the doses could go bad if they sit too long.

Mr. Biden is taking steps to build up vaccine production, and therefore the administration may have quite a billion doses available by the top of this year, with most ready by summer. that's much more than is important to vaccinate the roughly 260 million adults within us or maybe the whole population, once children and adolescents become eligible for shots. last, the administration has focused on Johnson & Johnson’s one-shot vaccine, brokering a deal to possess the pharmaceutical giant Merck manufacture and bottle the shot and announcing plans to secure 100 million additional doses.

Before the Merck deal was announced, administration officials discussed whether Johnson & Johnson should take over AstraZeneca’s manufacturing space in Baltimore, which the corporate shares with Johnson & Johnson. the method of stopping the assembly of vaccines takes weeks. and since AstraZeneca features a contract with Emergent, the Maryland manufacturer, White House intervention would be difficult. the thought was dropped once the Merck partnership was sealed.

The administration says it's increasing the availability to eventually vaccinate children and possibly to form booster doses or to protect against emerging variants that will be ready to escape the protection conferred by some vaccines. But privately, two senior administration officials said that by helping Johnson & Johnson proportion with the Merck deal, the White home is laying the groundwork for the corporate to eventually make its vaccine available overseas.

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