The New York Times

For Biden, a New Virus Dilemma: How to Handle a Looming Glut of Vaccine

WASHINGTON — Biden administration officials are anticipating the supply of coronavirus vaccine to outstrip U.S. demand by mid-May if not sooner, and are grappling with what to do with looming surpluses when vaccine scarcity turns to glut. President Joe Biden has promised enough doses by the end of May to immunize all of the nation’s roughly 260 million adults. But between then and the end of July, the government has locked in commitments from manufacturers for enough vaccine to cover 400 million people — about 70 million more than the nation’s entire population. Whether to keep, modify or redirect those orders is a question with significant implications, not just for the nation’s efforts to contain the virus but also for how soon the pandemic can be brought to an end. Of the vaccine doses given globally, about three-quarters have gone to only 10 countries. At least 30 countries have not yet injected a single person. Sign up for The Morning newsletter from the New York Times And global scarcity threatens to grow more acute as nations and regions clamp down on vaccine exports. With infections soaring, India, which had been a major vaccine distributor, is now holding back nearly all of the 2.4 million doses manufactured daily by a private company there. That action follows the European Union’s decision this week to move emergency legislation that would curb vaccine exports for the next six weeks. Biden administration officials who are inclined to hold on to the coming U.S. surplus point to unmet need and rising uncertainty: Children and adolescents are still unvaccinated, and no one is certain if or when immunity could wear off, which could require scores of millions of booster shots. “We want to, largely, be a part of the global solution here,” Jen Psaki, the White House press secretary, said this week. But she added, “There are still a number of factors that are unpredictable that we need to plan for to the best of our ability, including the variants and the impact and what will be most effective, as well as what will work best with children.” Vaccine manufacturers and some top federal officials say decisions about what to do with extra orders must be made within weeks, or the uncertainty could slow production lines. The manufacturing process can take up to 10 weeks, and changes for a foreign market need time. The regulatory rules that govern vaccine shipments present another hurdle, as does the limited storage life of the drug substances that make the vaccine. Vials in the nation’s bottling plants in Michigan and Indiana are being labeled for use at home. If their destination is unclear, either the production line must pause or vials directed for overseas may need to be relabeled. Once the doses are shipped out to states, federal regulations prohibit recalling them even if they are not needed domestically. And vials cannot sit in storage forever: While vaccine itself can last up to a year in a frozen state, once bottled it must be used within four to six months. All these variables threaten to complicate what has been relatively smooth sailing for the Biden administration. Thanks in part to the federal government’s determined assistance over many months, vaccine manufacturers have been steadily increasing their output, and states have snapped up new doses as fast as the government could deliver them. Where to go from here is a matter of intense debate. Clinical trials to determine which vaccines work for the nation’s adolescents and children are continuing and most likely will not neatly wind up at the same time. By the end of spring, for example, Moderna and Pfizer are hoping for interim results on how their vaccines would work for the nation’s 30-some-million adolescents. But Moderna, at least, does not expect results for children under 12 until after the school year starts next fall. The administration could hang on to doses from those two manufacturers while it awaits findings, only to discover later that another vaccine whose trials began later — say Johnson & Johnson’s — is a better option. If one or more of the three authorized vaccines turn out to provide only brief protection against COVID-19, scores of millions of more doses could be required for booster shots. But when that answer will come is also uncertain. Federal health officials have also discussed canceling or reducing some orders from Moderna and Pfizer in return for the promise of a fresh supply this fall of either pediatric doses or shots of a new vaccine that has been reconfigured to work against the fast-spreading variants. There is some push for that from the manufacturers, whose vaccines are coveted by other high-income countries. But it would also deprive federal officials of the power to decide which nations get the surplus doses, as well as the humanitarian and diplomatic credit it would reap from sending the vaccine to countries in greater need. For all these reasons, senior officials say, the administration is leaning toward keeping the doses it has ordered then at some point directing the excess to other nations in bilateral deals or giving it to COVAX, an international nonprofit organization backed by the World Health Organization that is trying to coordinate equitable distribution of vaccine. The Biden administration has already donated $4 billion to that international effort. Biden has stressed that his top priority is to protect Americans, but pressure is growing to share the U.S. stock. The United States has ordered 1 billion doses from the three federally authorized manufacturers and AstraZeneca, whose vaccine is not yet cleared for emergency use in the U.S. but has been authorized by more than 70 countries. It recently announced that it was negotiating a deal with Johnson & Johnson for enough doses to cover another 100 million. Taken together, the supply would be enough to vaccinate 650 million people — nearly twice the U.S. population. With the world’s highest death toll from COVID-19, the United States has fully vaccinated 14% of its population. Last week, the White House announced that it would share 4 million doses of AstraZeneca’s vaccine with Mexico and Canada, but emphasized that no Americans would lose out because the vaccine has not been deployed here yet. That is a trickle compared with the 300 million AstraZeneca doses the federal government has ordered, enough to cover 150 million people with the two-dose regimen. Senior administration officials say tens of millions of those doses can be released now or imminently, and tens of millions of unbottled doses possibly could also be given away. Brazil is particularly eager for help. With more than 300,000 lives lost, the country has the second-highest death toll and has fully vaccinated less than 2% of its population. “After we do take care of the really difficult situation we’ve had in our own country with over 535,000 deaths, we will obviously, in the future, have surplus vaccine, and there certainly is a consideration for making that vaccine available to countries that need it,” Dr. Anthony Fauci, the government’s top infectious disease expert, said at a White House news conference Wednesday. He has cast early May, when the Biden administration wants states to open up vaccinations to all adults, as a turning point. In an interview this week, he said it was likely that anyone who wants a vaccine would be able to get one then. Some will not want to be vaccinated, although their numbers appear to be dwindling. According to a Pew Research Center poll this month, 69% of the public intends to get inoculated or already has. In the summer, the U.S. production outlook brightens further. Pfizer and Moderna together have promised enough doses to cover another 100 million people by the end of July. Pfizer continues to beef up its production lines. And Moderna is hoping to win regulatory approval to increase the number of doses in each vial by at least 40%, although shortages of specialized syringes might hinder that plan. Johnson & Johnson has been slower to scale up its manufacturing in the United States and is now racing to deliver as many as 24 million doses manufactured at its Dutch plant by the end of the month, according to federal officials. The Food and Drug Administration just certified its new bottling operation in Indiana and is expected any day to approve its vaccine production lines at a Baltimore plant. But while Johnson & Johnson has lagged behind the other manufacturers, its technology carries enormous promise for mass production because it can deliver many more doses per lot. Later this year, when Merck & Co. is expected to begin producing Johnson & Johnson’s vaccine, it could churn out 100 million doses a month — or as much as Pfizer and Moderna together deliver monthly. The White House hailed the deal between Johnson & Johnson and Merck, but by the time production gets up to speed, those doses may be bound for a growing surplus or for export. One option is to ship the frozen vaccine that will be manufactured in Merck’s plant overseas, where it can be bottled much more cheaply. Of the $10 that the federal government has agreed to pay for a dose of Johnson & Johnson’s vaccine, the drug substance itself accounts for only about 30 cents, federal officials said. The rest is the so-called fill-and-finish cost. If AstraZeneca wins emergency use authorization from U.S. regulators, that will throw still more shots into the mix. Officials expect about 50 million doses to be ready for delivery in May. But Biden administration officials are skittish about AstraZeneca’s vaccine. It appears to be roughly as effective as Johnson & Johnson’s but requires an additional shot, meaning a more complicated rollout. Some health officials worry that if there are already enough doses in the pipeline to cover every adult who wants a shot, introducing a fourth vaccine will just confuse people. On the other hand, if the administration decides to donate the AstraZeneca doses without offering any to its own citizens, other countries might conclude that the United States lacks confidence in the vaccine’s safety or effectiveness. “As we gain more confidence in the doses that we have and the ability or the need or not to be boosting, then we can make a more definitive statement about what the role of the AZ product is going to be in the United States” should it gain clearance, Fauci said in an interview this week, “but right now I think it’s too premature to say anything.” This article originally appeared in The New York Times. © 2021 The New York Times Company

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