WASHINGTON – In a sharp break with the Trump administration, President-elect Joseph R. Biden Jr. plans to release almost all available doses of the coronavirus vaccine soon after taking office, instead of retaining millions of vials to ensure that the second doses will be accessible.
The decision is part of an aggressive effort to “make sure the Americans who need it most can get it as quickly as possible,” Biden’s transition team said on Friday. The vaccination plan, to be formally released next week, will also include vaccination sites administered by the federal government in places like high schools and sports stadiums, and mobile units to reach high-risk populations.
The president-elect promised to carry “at least 100 million Covid vaccines in the arms of the American people” during his first 100 days in office.
The decision to release the vast majority of vaccine doses sparked a heated debate among public health experts. The two vaccines that received emergency approval require two doses each, and the Trump administration has so far withheld about half of its supply to ensure that booster doses are available to those already inoculated.
Officials at Operation Warp Speed, the Trump administration’s vaccine program, noted that doses would stop being hijacked after the first few weeks of implantation. But the Biden administration’s announcement establishes the clearest reference so far for initial photos and then distributing them as they become available. And Warp Speed officials on Friday criticized the president-elect’s decision.
The Food and Drug Administration – whose Biden council has pledged to follow – has spoken out vehemently against changing the dosing schedule, as some other countries have chosen to do, calling such a move “premature and not firmly rooted in the available evidence. ”Some public health experts fear that second doses will be delayed by the decision.
But others considered it a smart move and said it was imperative to vaccinate as many people as soon as possible – as long as the second doses are not long in coming. Biden’s team said they were confident that the supply would be sufficient and that Biden would invoke the Defense Production Act, if necessary, to reinforce the supply of second doses.
“The president-elect believes that we must accelerate the delivery of the vaccine while continuing to ensure that Americans who need it most receive it as quickly as possible,” said TJ Ducklo, spokesman for the Biden transition team.
The announcement that Biden plans to release extra doses coincided with a letter from eight Democratic governors – including Andrew M. Cuomo of New York and Gretchen Whitmer of Michigan, both of whom clashed with President Trump – pleading with the current government to release all the doses available to the states as soon as possible.
“Failure to distribute these doses to states requesting them is unfair and unacceptable,” wrote the governors in the letter, obtained by The New York Times and sent Friday to Health Secretary Alex M. Azar II and General Gustave F Perna, responsible for the distribution of vaccines.
“We demand that the federal government start to distribute these doses reserved to the states immediately,” said the letter.
Biden’s promise of 100 million gunshots is ambitious, and the difficult implementation of the Trump administration – which Biden called “a scam” on Friday – has not made his task any easier. On Thursday, the Trump administration dispatched more than 21 million doses of vaccines and millions more were already in the hands of the federal government.
However, only 5.9 million people received a dose. State and local public health officials, already overwhelmed by the rise in infections, have struggled to administer the vaccine to hospital staff and at-risk seniors, while most people remain in the dark about when they can be protected.
The Presidential Transition
The biggest problem so far has not been the lack of a vaccine, but the difficulties that state and municipal governments face in distributing the doses they have. Capacity and logistics, not scarcity, are preventing vaccines from being administered.
Dr. Leana S. Wen, an emergency physician and public health specialist at the George Washington University School of Public Health, said she was surprised and concerned by Biden’s new strategy.
“This is not the problem we are trying to solve right now,” said Dr. Wen.
Operation Warp Speed officers were also critical.
Speaking at a news conference on Friday, Dr. Stephen M. Hahn, the FDA commissioner, asked states that used only a small portion of their supply to start vaccinating low-priority groups, while still observing the guidelines of the government. Most states still prioritize frontline healthcare professionals and older Americans in residential groups.
Expanding target groups “will go a long way in using these vaccines properly and putting them in the arms of individuals,” said Hahn.
Biden’s advisers did not discuss the rest of his plan to review the vaccine’s distribution; they say more details will be released next week. Biden has always promised a federal response much more vigorous than the approach of leaving for Trump states, and he has outlined his vision in public appearances and interviews on local radio stations during the campaign earlier this week for Democratic Senate Candidates. .
“Our plan will focus on firing guns, including launching a fundamentally new approach, establishing thousands of community vaccination centers administered or supported by the federal government of various sizes located in places such as school gyms and NFL stadiums,” said Biden. said during an interview with WFXE-FM in Columbus, Ga.
“And,” he continued, “they can be managed by federal employees, contractors, volunteers, including FEMA, you know, the emergency management group, the Centers for Disease Control, the US military, the National Guard” .
A person familiar with Biden’s vaccination plan said it would take time to establish mass vaccination sites. Biden himself said on Friday that the vaccine effort would be the “biggest operational challenge we will ever face as a nation” – which would cost “billions of dollars”.
Joshua M. Sharfstein, a former senior FDA official who is now a professor at the Johns Hopkins School of Public Health, said that mobile units would be especially important for reaching people in rural areas, as well as underserved populations, where there is transportation or a lack of interest was a barrier to vaccination.
“We need to make the vaccine readily available to people who are eager to get it now, and we need to go out and reach people who are at special risk, but who still have doubts or cannot reach vaccination sites,” he said. “If we only vaccinate people who are anxious to be vaccinated, we will miss people who really need to be vaccinated and deserve special access.”
The dosing schedule, however, is a major complication. Booster vaccines for the Modern vaccine should be administered four weeks after administration; for the Pfizer-BioNTech vaccine, the interval is three weeks. On Friday, World Health Organization officials issued recommendations saying the interval between giving two doses of the Pfizer vaccine could be doubled to six weeks. But the FDA did not approve of that change.
Biden, who received the vaccine almost three weeks ago, will receive his second dose on Monday, his spokeswoman, Jennifer Psaki, told reporters on Friday.
With the virus spreading across the country, and more than 367,000 Americans already killed by Covid-19, some experts expressed hope that speeding up the vaccine’s release would help control the pandemic.
But there is still not enough data to know what effect the vaccine has on the transmission of the virus. And without knowing the effect that the vaccine has on transmission, it is impossible to predict whether vaccinating more people will decrease the number of cases.
The models that describe the impact of the first doses of frontal loading are intriguing, said Olivia Prosper, a mathematical modeler at the University of Tennessee.
But while “they bring a lot to think about and some hypotheses to test,” it is still premature to use them to inform public policy, she said. Models also have their limits, she noted, because most do not take into account the country’s layered vaccination strategy, which prioritizes high exposure and high-risk people for early vaccination.
Sheryl Gay Stolberg reported from Washington and Katherine J. Wu from New York.