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The New York Times
US takes tens of millions of doses of vaccines the world needs
WASHINGTON – Tens of millions of doses of the coronavirus vaccine made by Anglo-Swedish company AstraZeneca stand idly by at U.S. manufacturing facilities, awaiting the results of its U.S. clinical trial while countries that have cleared its use request access. The fate of these AstraZeneca vaccine doses is the subject of intense debate between the White House and federal health officials, with some saying the administration should let them go overseas where they are desperately needed, while others are not ready to abandon them, according to senior administration officials. AstraZeneca is involved in these conversations. Sign up for The Morning New York Times newsletter “We understand that other governments may have contacted the US government regarding the donation of doses of AstraZeneca, and we have asked the US government to give careful thought to these. requests, ”said Gonzalo Viña, 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, said a manager with knowledge of the stock. Emergent BioSolutions, a Maryland company that AstraZeneca contracted to manufacture its vaccine in the United States, also produced enough vaccine in Baltimore for tens of millions of additional doses once it was filled into vials and packaged. , said the official. But although AstraZeneca’s vaccine is already cleared in more than 70 countries, according to a company spokesperson, its clinical trial in the United States has yet to report results and the company has not requested. to the Food and Drug Administration an emergency use authorization. AstraZeneca has asked the Biden administration to let it loan American doses to the European Union, where it has failed to meet its initial supply commitments and the vaccination campaign has stumbled badly. The administration, for now, has rejected the request, an official said. Some federal officials have pushed the White House to make a decision in the coming weeks. Officials have discussed sending doses to the European Union, Britain and Brazil, all hit hard by the worsening coronavirus crisis. “If these donation efforts were to continue, we would seek advice from the US government on replacing doses for use in the US,” Viña said. The White House did not respond to a request for comment. The administration’s reluctance is at least in part linked to uncertainties over vaccine supply ahead of a late-May benchmark set by President Joe Biden – when he pledged enough doses of the vaccine to cover every adult to the United States. Vaccine production is notoriously complex and delicate, and problems such as mold growth can interrupt the progress of a plant. Last May, the Trump administration pledged AstraZeneca up to $ 1.2 billion to fund the development and manufacture of its vaccine, which it developed with the University of Oxford, and to provide to states -United 300 million doses if it proves effective. Last year, federal officials and public health experts rated the vaccine, which is cheaper and easier to store for long periods of time than some other vaccines, as the most likely to be among the first to receive. an authorization. This never happened, in part due to a pattern of AstraZeneca’s communication blunders that weakened the company’s relationship with U.S. regulators and slowed vaccine development. Last fall, the trial of AstraZeneca in the United States – the same one that will soon report results – was founded for almost seven weeks because the company was slow to provide the FDA with proof that the vaccine had failed. not caused serious neurological side effects in two volunteers. The company is now grappling with another fear of security. Acting as a precaution, Danish, Norwegian and Icelandic health authorities on Thursday suspended use of the AstraZeneca vaccine after several reports across the continent of severe blood clots. The EU official and the company said there was no evidence of a causal link. In the vast majority of cases, the appearance of such a medical condition has nothing to do with the vaccine. A certain percentage of people are expected to get sick by chance after being vaccinated, as would happen in any group of people. AstraZeneca also encountered other problems during the deployment of its vaccine. The lack of supplies has fueled tensions with European officials. Some people in Germany and other countries have been hesitant to take the vaccine for fear that it will be second-class due to its lower overall efficacy in clinical trials compared to Pfizer’s vaccine. South Africa ended plans to introduce the vaccine last month after a small clinical trial found the vaccine did not appear to protect against mild to moderate illnesses caused by a worrying coronavirus variant seen to the first time. In the United States, the decision of the Biden administration to order more than three vaccines authorized by the FDA further sidelined the AstraZeneca candidate. The United States may only briefly, if ever, require doses of AstraZeneca if it is cleared for emergency use. “If we have a surplus, we’ll share it with the rest of the world,” Biden told reporters Wednesday, speaking generally about the vaccine supply in the United States. “We’re going to start by making sure Americans are taken care of first.” Johnson & Johnson, which has clearance for its vaccine in the United States but has fallen behind on its production targets in the United States and Europe, recently asked the United States to lend 10 million doses to the European Union, but the Biden administration has also denied the request, according to U.S. and European officials. The European Union has come under fierce criticism for “vaccine nationalism” and protectionism, which escalated last week when Italy blocked a small dose shipment to Australia, stepping up a standoff on essential vaccines. Yet the European Union has exported 34 million doses of coronavirus vaccines in recent weeks to dozens of countries, even as it faced shortages in its country. As frustrations simmer, some European officials blame the United States. The President of the European Council, Charles Michel, said that the United States, as well as Great Britain, “had imposed an outright ban on the export of vaccines or vaccine components produced on their territory”. Asked about the US supply of the AstraZeneca vaccine on Thursday, Jen Psaki, the White House press secretary, told reporters that vaccine makers were free to export their products made in the United States while respecting the terms of their contracts with the government. Since AstraZeneca’s vaccine was produced with the help of the Defense Production Act, Biden must approve dose shipments overseas. Such a move could have huge negative political repercussions as long as Americans still clamor for blows. AstraZeneca is also likely to want liability protection for doses shipped overseas, as it would in the United States if the vaccine were licensed. Meanwhile, regulators in the United States were awaiting new AstraZeneca data, expected in the coming weeks, from a Phase 3 trial that enrolled 32,000 participants mostly in the United States. AstraZeneca is not likely to report the results of an initial review of its data like other vaccine manufacturers have. Rather, it will wait for more statistically significant results after trial participants have been monitored longer for side effects and more people in the vaccine and placebo groups may have fallen ill, federal officials said. Experts believe the vaccine is unlikely to have a higher rate of effectiveness than Johnson & Johnson’s vaccine, which uses similar technology and only requires a single dose. The potential of these results means that AstraZeneca’s vaccine may not have a clear advantage in the United States over currently licensed vaccines. Johnson & Johnson’s vaccine is easy to distribute and protects against serious illness and hospitalization. The two-dose vaccines manufactured by Pfizer-BioNTech and Moderna, which use different technology, have efficacy rates of around 95%. Federal officials also stressed during discussions that AstraZeneca’s vaccine should not be stored indefinitely in Ohio or Maryland because it, like all vaccines, has a limited shelf life. The vaccine can be stored at refrigerator temperature for six months, and some countries give the two doses up to three months apart, which increases the risk that the doses will spoil if left too long. Biden is taking steps to speed up vaccine production, and the administration could have more than a billion doses available by the end of this year, with most of them ready by the summer. This is far more than what is needed to immunize the roughly 260 million adults in the United States, or even the entire population, once children and adolescents become eligible for the vaccines. More recently, the administration has focused on Johnson & Johnson’s single-dose vaccine, negotiating a deal for pharmaceutical giant Merck to manufacture and bottle the vaccine and announcing plans to get an additional 100 million doses. Before the deal was announced with Merck, administration officials discussed whether Johnson & Johnson should take over the AstraZeneca manufacturing space in Baltimore, which the company shares with Johnson & Johnson. The process of shutting down vaccine production takes weeks. And since AstraZeneca has a contract with Emergent, the Maryland maker, White House intervention would be difficult. The idea was abandoned once the Merck partnership was sealed. The administration says it is increasing the supply to possibly vaccinate children and possibly to do booster doses or to guard against emerging variants that might escape the protection conferred by certain vaccines. But privately, two senior administration officials said that by helping Johnson & Johnson scale up the Merck deal, the White House was paving the way for the company to eventually make its vaccine available to the United States. ‘foreign. This article originally appeared in The New York Times. © 2021 The New York Times Company
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