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Biden team’s booster divide deepens as risk of winter virus surge looms - POLITICO

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President Joe Biden’s top health advisers are split over the role booster shots should play in the next phase of the pandemic, setting up key fault lines to close in the coming weeks as they try to ward off further surges this fall and winter.

Their disagreement centers on whether the U.S. should eventually offer an additional shot to every vaccinated adult in hopes of preventing even mild and moderate symptomatic breakthrough infections, according to three senior health officials and two people familiar with the government’s internal discussions.

The Biden team’s deliberations have intensified in recent days, as officials scrutinize the incomplete and sometimes conflicting data on vaccines’ performance. One group, including some scientists at the Centers for Disease Control and Prevention and the Food and Drug Administration, argues that boosters aren’t capable of blocking all infection, the sources said. They think additional vaccine doses should be given only as needed to reduce cases of severe illness and death. Another group — including Biden’s chief medical adviser, Anthony Fauci — says the government should not rule out using boosters to help stave off even mild Covid-19 infections that can keep people out of work for weeks.

Whatever decisions health officials make will have major implications for the course of the pandemic in the coming months, when the combination of colder weather and holiday gatherings is poised to fuel the virus’ spread. The growing tension among the president’s top Covid-19 advisers raises questions about whether the goals of the nation’s vaccination campaign are changing, and the degree to which breakthrough infections may be inevitable. It comes as many scientists warn that while the pandemic will eventually end, the virus itself will remain a significant presence for years to come.

“We are in a vulnerable position,” said Eric Topol, a professor of molecular medicine at Scripps Research. “We’re very much under-vaccinated. We're also one of the countries that whatever vaccination rate we achieve, we got most of it early, so a lot of those people are now becoming vulnerable. That doesn't portend a nice descent ramp from Delta.”

The White House, CDC and the Department of Health and Human Services declined to comment. A senior administration official pointed to recent comments by Fauci and CDC Director Rochelle Walensky endorsing the idea that even mild breakthrough infections are of concern.

For months, administration officials have grappled with how to interpret and respond to domestic and international data that suggest available vaccines’ effectiveness against infection, and in some cases hospitalization, is beginning to wane.

Biden’s team originally aimed to offer boosters to all adults starting the week of Sept. 20. But the administration scaled back its vision amid pushback from scientists at the FDA and CDC and on the agencies’ outside advisory committees. They objected because of the limited CDC studies on vaccine performance did not prove definitively that large portions of the country were in immediate need of a booster — or how long the benefit from a booster would last.

For now, the FDA and the CDC recommend boosters only for certain people who originally received the Pfizer-BioNTech vaccine — including those 65 and older, and people over 18 with underlying health conditions or jobs that increase their risk of severe Covid-19. But federal officials are already weighing which groups might be next in line for boosters this fall and winter as cold weather drives people to spend more time indoors.

The current conversations about how to prepare for the potential rise in cases come at a tenuous time for the administration and its pandemic response.

The highly contagious Delta variant continues to spread across the country. Health experts are warning that the country could see another surge, especially if vaccine efficacy falls off dramatically over the next several months as it did in Israel. But federal officials do not have solid data, particularly domestic data, that spells out exactly how long boosters last and which populations would benefit. That muddies any risk-benefit calculations.

But waiting for definitive findings before making the shots widely available could have its own cost, said Leana Wen, an emergency physician and public health professor at George Washington University.

“I don't think that the federal government should be in the business of telling people what is valuable to them. I don't need the federal government telling me that I shouldn't care about infecting my young, vulnerable family members,” she said. “That's why the CDC meeting last week was so frustrating because they were basically saying, ‘We know better than you do about preventing or about what's important to you.’”

And the difficulty of forecasting how the U.S. outbreak will behave over the next several months increases the policy challenge facing the Biden administration. Senior federal officials are essentially trying to predict the unknowable. The big question for many members of Biden’s Covid team is whether the U.S. should give boosters to otherwise healthy Americans to help reduce transmission and infection, limit boosters until most of the world receives its first dose or try to do both at once. The answers vary widely.

“I don’t think anything is an open-and-shut case right now. I think things are suggestive,” said Craig Spencer, an emergency medicine doctor at New York University, of vaccine efficacy data. “Will [boosters] be justified? I think that depends on what you think we should be doing with our vaccines. We're sitting on hundreds of millions of doses that could immediately be used in places to stop the spread and stop people from dying from a largely vaccine-preventable illness.”

The Biden administration faced immediate backlash in August when it announced that it would begin offering booster shots in September. Health experts and international officials said the U.S. should do more to help vaccinate the rest of the world before it moved forward with an additional dose for Americans. Medical and public-health experts with connections to the White House, including former Biden transition team members, also argued that available data showed vaccines still did a good job preventing severe disease and death, even if their power to prevent mild infection was waning.

That criticism kicked off a series of conversations within the White House and among Biden Covid-19 officials about how best to get ahead of a potential surge as the pandemic nears the end of its second year.

Scientists at the CDC and the FDA, and the agencies’ external advisers, made clear in recent presentations that boosters would not necessarily prevent mild infection. They argued that the shots should be used to protect the elderly and other groups for whom vaccination was becoming less effective at warding off hospitalization and death.

Through it all, Fauci has been vocal about his thinking on boosters, saying Israeli data is clear: Vaccine efficacy against mild and moderate illness is decreasing, and boosters are the solution. He argues that the U.S. should not reserve third shots as protection against severe disease, bucking the FDA and CDC’s latest recommendations.

“It seems like [the advisory groups] were saying it is okay as long as you don’t wind up in the hospital and die,” Fauci said in a recent interview with conservative radio talk-show host Hugh Hewitt. “I don’t feel that way. I feel we need to protect not only from getting people in the hospital ... but we don’t want people to get sick. You can also get pretty sick and not necessarily have to go to the hospital.”

Fauci added that his approach was not in conflict with Biden’s goal of helping to vaccinate the world, noting that the administration “is committed to be doing even more” on that front.

Walensky has also noted the importance of finding a way to deal with mild breakthrough infections, even though her agency decided in May to track only cases that resulted in hospitalization. If a health care worker calls in sick with a breakthrough infection “that could be an ICU bed that can’t be filled because they don’t have workforce,” she said recently at the Atlantic Ideas Festival.

But Walensky also said last week at a press conference that getting booster shots is a “walk, don’t run, situation,” stressing that driving up the overall vaccination rate is also a powerful method to protect the vulnerable.

The administration’s internal struggle over boosters continues to spill out into public view as experts search for ways to prevent a repeat of last winter’s devastating surge.

“There's a reluctance to use the third jabs in this country, even though they could help a lot to basically get all those people who are early vaccinated to get them back to fully protected,” Topol said. “We're starting to negate the importance of infections. And that's not good. The other thing that I think is discounted is the long-Covid story. The only prevention of long Covid is to prevent the infection.”

For others like Spencer, the emergency room doctor from New York City, any move to dole out boosters broadly now would gloss over the fact that the U.S. still does not have good data on the shot's benefits — and potential risks.

“Are we ever going to be able to boost people enough so that they have sterilizing immunity, meaning they can't get infected?” Spencer said. “For someone like myself or someone younger ... we don't know what the risk is of a third dose of a vaccine. What is the impact on myocarditis? We don't know. I prefer we know that before we may roll broad policy recommendations, which could ultimately undermine our push to expand vaccines.”

The administration has begun to discuss what other strategies it can recommend or encourage to prevent a spike in infections during the coming holiday season. Possible approaches include revising guidelines for mask wearing and increasing access to rapid Covid-19 testing.

“If we all were doing rapid antigen tests every day or every other day, we would know that but here we have a blind guide to getting those out there to help navigate through this,” Topol said.

Rapid tests are still relatively expensive in the U.S. and are not widely available. Without wide use of strict public health measures like frequent testing, and in light of the country’s relatively low vaccination rate, officials said they are still struggling to develop a long-term pandemic strategy.

“The question for society is what is the level of death we are willing to accept? And what's the price that we're willing to pay?” Wen said. “I think there are some people who might say, 'Hey, it's a win if we can make Covid to be like a flu.' But even then, we're talking about double the flu. Then the question becomes, what is the price we're willing to pay to reduce the level of Covid? Do we actually want to reduce the burden of suffering even more if that requires wearing masks every winter? Are people willing to take on that price?”

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