The New York Times
The US puts on tens of millions of vaccines the world needs
WASHINGTON – Tens of millions of doses of the coronavirus vaccine made by the British-Swedish company AstraZeneca are sitting idle in US manufacturing plants awaiting the results of the US clinical trial, while countries that have approved its use are asking for access. The fate of the doses of AstraZeneca’s vaccine is the subject of intense debate among White House and federal health officials, and some argue that the government should let them go abroad where they are urgently needed, while others are unwilling to to waive it, according to officials of the senior administration. AstraZeneca is involved in the talks. Sign up for The Morning Newsletter of the New York Times “We understand that other governments may have reached out to the U.S. government about donations of AstraZeneca doses, and we have asked the U.S. government to consider these requests carefully,” Gonzalo Viña said. said. , a spokesman for AstraZeneca. About 30 million doses are currently being bottled at the AstraZeneca plant in West Chester, Ohio, which handles the “filling finish”, the final phase of the manufacturing process, during which the vaccine is placed in vials, said one official with knowledge of the stock said. Emergent BioSolutions, a Maryland company that contracted AstraZeneca to manufacture its vaccine in the United States, also produced enough vaccine in Baltimore for another ten million doses once it was filled and packaged in vials, the official said. However, although the AstraZeneca vaccine has already been approved in more than 70 countries, the U.S. clinical trial has not yet reported the results, and the company has not yet applied to the Food and Drug Administration for approval for emergency use. AstraZeneca has asked the Biden government to lend US doses to the European Union, where it did not have the original supply commitments and where the vaccination campaign stumbled. The administration has provisionally rejected the request, one official said. Some federal officials urged the White House in the next few weeks to make a decision. Officials have discussed sending doses to the European Union, Britain and Brazil, all of which have been hit hard by a worsening coronavirus crisis. “If the donation actions were to continue, we would ask the US government for replacement doses for use in the US,” Viña said. The White House did not respond to a request for comment. The government’s reluctance is at least partly related to uncertainties with the provision of vaccines ahead of a late May benchmark 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 such as mold growth can disrupt the progress of a plant. Last May, the Trump administration pledged up to $ 1.2 billion to AstraZeneca to fund the development and manufacture of its vaccine, which it developed with the University of Oxford, and to deliver 300 million doses to the United States as it seems to be effective. Federal officials and public health experts last year considered the vaccine, which is cheaper and easier to store for long periods of time than some other vaccines, to be probably the first to receive authorization. This never happened, in part because of a pattern of communication errors by AstraZeneca that weakened relations with US regulators and slowed the development of the vaccine. 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 FDA evidence that the vaccine did not cause serious neurological side effects in two volunteers. not. The company is now struggling with another safety concern. From health care, the health authorities in Denmark, Norway and Iceland suspended the use of the AstraZeneca vaccine on Thursday after several reports across the continent of serious blood clots. European official and the company said there was no evidence of any causal link. In the vast majority of cases, the onset of such medical conditions has nothing to do with the vaccine. It is expected that a certain percentage of people will accidentally become ill after being vaccinated, as would happen to any group of people. AstraZeneca has also experienced other problems as its vaccine has been rolled out. The shortage of supply has fueled tensions with European officials. Some people in Germany and other countries do not like to take the vaccine, for fear that it is second-class because of its overall efficacy in clinical trials, compared to the Pfizer vaccine. South Africa stopped its plans to introduce the vaccine last month after a small clinical trial found that the vaccine did not look protective against mild to moderate diseases caused by a coronavirus variant first seen there. In the United States, the bid of the Biden government to provide more for the three FDA-approved vaccines has further sidelined the AstraZeneca candidate. The United States may only require short, or never, doses of AstraZeneca if it is cleaned for emergency use. “If we have a surplus, we’re going to share it with the rest of the world,” Biden told reporters on Wednesday, speaking in general about the U.S. vaccine supply. “We’re going to make sure Americans are cared for first.” Johnson & Johnson, which has permission for the 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 government of Praying also denies it according to US and European officials. The European Union has come under heavy criticism for “vaccine nationalism” and protectionism, which intensified last week when Italy blocked a small amount of doses to Australia, which intensified a tug of war over much-needed shots. Yet in the past few weeks, the European Union has exported 34 million doses of coronavirus vaccines to dozens of countries, even though it has been short of home. While frustrations are simmering, some European officials are blaming the United States. European Council President Charles Michel said the United States, along with Britain, had “imposed a direct ban on the export of vaccines or vaccine components into its territory.” Asked on Thursday about the US offering of the AstraZeneca vaccine, White House press secretary Jen Psaki told reporters that vaccine manufacturers are free to export their products made in the United States while also comply with the terms of their contracts with the government. Because AstraZeneca’s vaccine was produced using the Defense Production Act, Biden must approve the delivery of doses overseas. Such a move could have major negative political consequences, as long as Americans continue to seek shots. AstraZeneca is also likely to want liability protection for doses sent overseas, such as in the United States when the vaccine is cleared. Meanwhile, regulators in the United States are awaiting new AstraZeneca data, which is expected in the next few weeks, from a phase 3 trial that enrolled 32,000 participants mostly in the United States. AstraZeneca is unlikely to report the results of an early investigation into its data as other vaccine manufacturers have done. It will instead wait for more statistically meaningful results after trial participants were longer monitored for side effects and more people in the vaccine and placebo groups became ill, federal officials said. Experts believe that the vaccine is unlikely to carry a higher efficacy rate than the survey conducted by Johnson & Johnson, which uses a similar technology and requires only one dose. The potential for these results means that the AstraZeneca vaccine will not have a clear advantage in the United States over current vaccines. The Johnson & Johnson vaccine is easy to distribute and protects against serious diseases and hospitalizations. The two-dose vaccines manufactured by Pfizer-BioNTech and Moderna, which use a different technology, have an efficacy of approximately 95%. Federal officials also stressed in the discussions that the AstraZeneca vaccine should not be stored indefinitely in Ohio or Maryland, as it, like all vaccines, has a limited shelf life. The vaccine can be kept at refrigerator temperatures for six months, and some countries give the two doses at a distance of three months apart, which increases the risk that the doses can go bad if left for too long. Biden is taking steps to increase vaccine production, and the administration could have more than 1 billion doses available by the end of this year, most of which are ready by summer. It is much more than necessary to vaccinate the approximately 260 million adults in the United States or even the entire population once children and adolescents are eligible for shots. Recently, the administration focused on the vaccine vaccine from Johnson & Johnson, which entered into an agreement to have the pharmaceutical giant Merck manufactured and bottled and to announce plans to receive 100 million extra doses. Prior to the announcement of the Merck agreement, administrative 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, the White House intervention will be difficult. The idea was abandoned once the Merck partnership was closed. The administration says it is increasing the supply to eventually vaccinate children and possibly make increased doses or to guard against emerging variants that could potentially escape the protection offered by some vaccines. But privately, two administration officials said the White House, through Johnson & Johnson’s helping to sharpen the Merck deal, lays the groundwork for the company to eventually make its vaccination available overseas. This article originally appeared in The New York Times. © 2021 The New York Times Company