WASHINGTON — Tens of millions of doses of the coronavirus vaccine made by British-Swedish company AstraZeneca are sitting idly in U.S. manufacturing facilities, awaiting results from its U.S. clinical trial while countries that have authorized its use beg for access.
The fate of those doses of AstraZeneca’s vaccine is the subject of an intense debate among White House and federal health officials, with some arguing the administration should let them go abroad where they are desperately needed, while others are not ready to relinquish them, according to senior administration officials.
AstraZeneca is involved in those conversations.
“We understand other governments may have reached out to the U.S. government about donation of AstraZeneca doses, and we’ve asked the U.S. government to give thoughtful consideration to these requests,” said Gonzalo Viña, a spokesperson for AstraZeneca.
About 30 million doses are currently bottled at AstraZeneca’s facility in West Chester, Ohio, which handles “fill-finish,” the final phase of the manufacturing process, during which the vaccine is placed in vials, one official with knowledge of the stockpile said.
Emergent BioSolutions, a company in Maryland that AstraZeneca has contracted to manufacture its vaccine in the United States, has also produced enough vaccine in Baltimore for tens of millions more doses once it is filled into vials and packaged, the official said.
But although AstraZeneca’s vaccine is already authorized in more than 70 countries, according to a company spokesperson, its U.S. clinical trial has not yet reported results, and 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 U.S. doses to the European Union, where it has fallen short 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 in the next few weeks. Officials have discussed sending doses to the European Union, Britain and Brazil, all hit hard by a worsening coronavirus crisis.
“If those donation actions were to proceed, we would seek guidance from the U.S. government on replacement of doses for use in the U.S.,” Viña said.
The White House did not respond to a request for comment.
The administration’s hesitation is at least partly related to uncertainties with vaccine supply before a bench mark of late May laid down by President Joe Biden — when he promised enough vaccine doses to cover every adult in the United States. 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 development and manufacturing of its vaccine, which it developed with the University of Oxford, and to supply the United States with 300 million doses if it proved effective. Federal officials and public health experts last year viewed the vaccine, which is less expensive and easier to store for long periods than some other vaccines, as most likely to be among the first to receive authorization.
That never happened, in part because of a pattern of communication blunders by AstraZeneca that weakened the company’s relationship with U.S. regulators and slowed the vaccine’s development. Last fall, AstraZeneca’s trial in the United States — the same one that will soon report results — was grounded for nearly seven weeks because the company was slow to provide the FDA 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 use of the AstraZeneca’s vaccine Thursday after several reports across the continent of severe blood clots.
European official and the company said there was not evidence of any causal link. In the vast majority of cases, the emergence of such medical conditions has nothing to do with the vaccine. Some percentage of people are expected to fall ill by chance after getting vaccinated, as would happen in any group of people.
AstraZeneca has also run into other problems as its vaccine has rolled out. 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 is second-class because of 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 small clinical trial found that the vaccine did not appear to be protective against mild to moderate illness caused by a concerning coronavirus variant first seen there.
In the United States, the Biden administration’s moves to order more supply of the three vaccines authorized by the FDA has further sidelined AstraZeneca’s candidate. The United States may only briefly, or never, need the AstraZeneca doses if they are cleared for emergency use.
“If we have a surplus, we’re going to share it with the rest of the world,” Biden told reporters Wednesday, speaking generally about the U.S. vaccine supply. “We’re going to start off making sure Americans are taken care of first.”
Johnson & Johnson, which has authorization for its vaccine in the United States but fell behind on its production targets in both the United States and Europe, recently asked the United States to loan 10 million doses to the European Union, but the Biden administration also denied that request, according to 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 small shipment of doses to Australia, stepping up a tug of war over badly needed shots. Still, the European Union exported 34 million doses of coronavirus vaccines in recent weeks to dozens of countries, even as it faced shortages at home.
As frustrations simmer, some European officials are blaming the United States. The European Council president, Charles Michel, said the United States, along with Britain, “have imposed an outright ban on the export of vaccines or vaccine components produced on their territory.” Asked Thursday about the U.S. supply of the AstraZeneca vaccine, Jen Psaki, the White House press secretary, told reporters that vaccine manufacturers were free to export their products made in the United States while also fulfilling the terms of their contracts with the government.
Because AstraZeneca’s vaccine was produced with help from the Defense Production Act, Biden has 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 also likely to want liability protection for doses shipped overseas, like it would have in the United States if the vaccine is cleared.
Meantime, regulators in the United States have been waiting for new AstraZeneca data, expected in the next few weeks, from a phase 3 trial that enrolled 32,000 participants mostly in the United States. AstraZeneca is not likely to report results from an early look at its data as other vaccine-makers have done. It will instead wait for more statistically meaningful results after trial participants have been monitored longer for side effects and more people in the vaccine and placebo groups may have gotten sick, federal officials said. Experts believe the vaccine is unlikely to carry a higher efficacy rate than the shot made by Johnson & Johnson, which uses a similar technology and requires only one dose.
The potential for those results means that AstraZeneca’s vaccine might not have an obvious advantage in the United States over the vaccines currently authorized. Johnson & Johnson’s vaccine is easy to distribute and protects against severe disease and hospitalizations. The two-dose vaccines made by Pfizer-BioNTech and Moderna, which use a different technology, have efficacy rates around 95%.
Federal officials have also emphasized in the discussions that AstraZeneca’s vaccine should not be stored indefinitely in Ohio or Maryland since it, like all vaccines, has a limited shelf life. The vaccine can be kept at refrigerator temperatures for six months, and some countries are giving the two doses spaced up to three months apart — raising the risk that the doses could go bad if they sit too long.
Biden is taking steps to ramp up vaccine production, and the administration may have more than 1 billion doses available by the end of this year, with most ready by summer. That is far more than are necessary to vaccinate the roughly 260 million adults in the United States or even the entire population, once children and adolescents become eligible for shots. Most recently, the administration has focused on Johnson & Johnson’s one-shot vaccine, brokering a deal to have 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 company shares with Johnson & Johnson. The process of stopping the production of vaccines takes weeks. And because AstraZeneca has a contract with Emergent, the Maryland manufacturer, White House intervention would be difficult. The idea was dropped once the Merck partnership was sealed.
The administration says it is increasing the supply to eventually vaccinate children and possibly to make booster doses or to guard against emerging variants that may be able to escape the protection conferred by some vaccines. But privately, two senior administration officials said that by helping Johnson & Johnson scale up with the Merck deal, the White House is laying the groundwork for the company to eventually make its vaccine available overseas.