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The New York Times
For Biden, a new viral dilemma: how to deal with an impending vaccine glut
WASHINGTON – Biden administration officials predict that the supply of the coronavirus vaccine will exceed U.S. demand by mid-May, if not sooner, and wonder what to do with looming surpluses when the vaccine shortage hits. turns into glut. President Joe Biden has pledged enough doses by the end of May to immunize all of the country’s estimated 260 million adults. But between that date and the end of July, the government blocked commitments from manufacturers for enough vaccines to cover 400 million people, about 70 million more than the entire population of the country. Whether to hold onto, modify or redirect those orders is a question that has significant implications, not only for the nation’s efforts to contain the virus, but also for how quickly the pandemic can end. Of the vaccine doses administered worldwide, about three-quarters went to just 10 countries. At least 30 countries have yet to inject a single person. Sign up for The Morning New York Times newsletter And the global shortage is likely to worsen as countries and regions crack down on vaccine exports. With the outbreak of infections, India, which had been a major distributor of vaccines, is now withholding almost all of the 2.4 million doses manufactured daily by a private company in that country. The move follows the European Union’s decision this week to propose emergency legislation that would limit vaccine exports over the next six weeks. Officials in the Biden administration who are keen on keeping the U.S. surplus ahead highlight unmet need and growing uncertainty: Children and teens still go unvaccinated, and no one knows if or when immunity might wane , which could require tens of millions of recalls. blows. “A lot of us want to be part of the global solution here,” White House press secretary Jen Psaki said this week. But she added: “There are still a number of unpredictable factors that we need to plan to the best of our ability, including variations and impact and what will be most effective, as well as what will work best with. children. . Vaccine makers and some senior federal officials say decisions on what to do with additional orders need to be made within weeks, or the uncertainty could slow production lines down. The manufacturing process can take up to 10 weeks and changes for a foreign market take time. Another hurdle is the regulatory rules that govern vaccine shipments, as is the limited shelf life of the drug substances that make up the vaccine. Bottles from Michigan and Indiana bottling plants are labeled for home use. If their destination is unclear, either the production line needs to take a break or vials destined for overseas may need to be relabelled. Once doses are shipped to states, federal regulations prohibit recalling them even if they are not needed domestically. And the vials cannot be stored indefinitely: While the vaccine itself can last up to a year in a frozen state, once bottled, it should be used within four to six months. All of these variables threaten to complicate what has been relatively fluid for the Biden administration. Thanks in part to determined support from the federal government over many months, vaccine makers steadily increased production and states purchased new doses as quickly as the government could supply. Where to go from now on is a matter of intense debate. Clinical trials to find out which vaccines work for teens and children nationwide are ongoing and likely won’t end perfectly at the same time. In late spring, for example, Moderna and Pfizer are hoping for interim results on how their vaccines would work for the nation’s roughly 30 million teens. But Moderna, at least, isn’t expecting results for children under 12 before the school year begins next fall. The administration could hang on to doses from these two manufacturers while awaiting results, only to find out later that another vaccine whose trials started later – say Johnson & Johnson – is a better option. If one or more of the three licensed vaccines are found to provide only brief protection against COVID-19, tens of millions of additional doses may be needed for booster shots. But when that answer will come is also uncertain. Federal health officials have also discussed the cancellation or reduction of some orders from Moderna and Pfizer in exchange for the promise of a new supply this fall of either pediatric doses or injections of a new vaccine. which has been reconfigured to work against the fast-spreading variants. There is some pressure for this from manufacturers, whose vaccines are coveted by other high-income countries. But it would also deprive federal officials of the power to decide which countries will receive the excess doses, as well as the humanitarian and diplomatic credit they would get from sending the vaccine to countries that need it most. For all these reasons, say senior officials, the administration tends to maintain the doses it ordered and then at some point direct the surplus to other countries under bilateral agreements or give it to COVAX. , an international non-profit organization backed by the World Health Organization that tries to coordinate equitable distribution of the vaccine. The Biden administration has already donated $ 4 billion to this international effort. Biden has stressed that his top priority is to protect Americans, but the pressure is increasing to share American stocks. The United States has ordered 1 billion doses from the three federally licensed manufacturers and AstraZeneca, whose vaccine is not yet cleared for emergency use in the United States but has been cleared by more than 70 countries . He recently announced that he is negotiating a deal with Johnson & Johnson for doses sufficient to cover an additional $ 100million. Taken together, the supply would be enough to immunize 650 million people, nearly double the U.S. population. With the highest death toll from COVID-19 in the world, the United States has fully immunized 14% of its population. Last week, the White House announced it would share 4 million doses of the AstraZeneca vaccine with Mexico and Canada, but stressed that no American would be a loser because the vaccine has yet to be rolled out here. That’s a net from the 300 million doses of AstraZeneca the federal government has ordered, enough to cover 150 million people on the two-dose regimen. Senior administration officials say tens of millions of these doses may be released now or imminently, and tens of millions of unbottled doses could also be distributed. Brazil is particularly keen to help. With over 300,000 lives lost, the country has the second highest death rate and has fully immunized less than 2% of its population. “Once we take care of the really difficult situation that we have experienced in our own country with more than 535,000 deaths, we will obviously have a surplus of vaccine in the future, and it is certainly possible to make this possible. vaccine available to countries in need, ”Dr Anthony Fauci, the government’s top infectious disease specialist, said at a White House press conference on Wednesday. He chose in early May, when the Biden administration wants states to open up vaccination to all adults, as a turning point. In an interview this week, he said it was likely that anyone who wanted a vaccine could get one by then. Some will not want to be vaccinated, even if their numbers seem to be decreasing. According to a Pew Research Center poll this month, 69% of the public intend to get a vaccine or have already done so. During the summer, production prospects in the United States brighten further. Pfizer and Moderna have jointly pledged enough doses to cover an additional 100 million people by the end of July. Pfizer continues to strengthen its production lines. And Moderna hopes to get regulatory approval to increase the number of doses in each vial by at least 40%, although shortages of specialized syringes could hamper that plan. Johnson & Johnson has been slower to ramp up manufacturing in the United States and is now rushing to deliver up to 24 million manufactured doses at its Dutch factory by the end of the month, according to federal officials. The Food and Drug Administration has just certified its new bottling operation in Indiana and is expected to approve overnight its vaccine production lines at a plant in Baltimore. But while Johnson & Johnson has lagged behind other manufacturers, its technology holds great promise for mass production as it can deliver many more doses per batch. Later this year, when Merck & Co. is expected to start producing Johnson & Johnson’s vaccine, it could produce 100 million doses per month – that’s as many as Pfizer and Moderna together deliver each month. The White House has welcomed the deal between Johnson & Johnson and Merck, but by the time production levels up, those doses could be destined for a growing surplus or for export. One option is to ship the frozen vaccine that will be manufactured at the Merck plant overseas, where it can be bottled at a lower cost. Of the $ 10 the federal government has agreed to pay for a dose of Johnson & Johnson’s vaccine, the drug substance itself is only about 30 cents, federal officials said. The rest corresponds to the so-called filling and finishing cost. If AstraZeneca gets emergency use clearance from US regulators, that will throw even more hits into the mix. Authorities expect around 50 million doses to be ready for delivery in May. But officials in the Biden administration are worried about AstraZeneca’s vaccine. It appears to be about as efficient as that of Johnson & Johnson, but requires additional fire, which means a more complicated deployment. Some health officials fear that if there are already enough doses in the pipeline to cover every adult who wants a vaccine, the introduction of a fourth vaccine will only create confusion. On the other hand, if the administration decides to give the doses of AstraZeneca without offering any to its own citizens, other countries could conclude that the United States lacks confidence in the safety or effectiveness of the vaccine. . “As we gain confidence in the doses we have and the ability or the need or not to increase, then we can make a more definitive statement about the role of the AZ product in the United States.” it’s gaining clearance, Fauci said in an interview this week, “but at the moment 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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