Booster confusion takes hold as Biden announces expanded eligibility

In addition to the elderly and those with workplace exposure to Covid-19, the Pfizer-BioNTech booster will now be available to nursing home residents and people 18 and older with underlying health conditions that increase their chances of severe illness. But the policy does not allow for boosters to be given to people initially vaccinated with the Moderna or Johnson & Johnson shots.

Despite the announcement, there are lingering questions about the data used to inform the administration’s policy on boosters, including whether there is enough to show the extent to which and the length that boosters can protect against hospitalization and whether the U.S. should worry about any breakthrough infection in the coming months. It is also unclear when exactly individuals working in high risk settings or with underlying health conditions will be able to receive their third shot.

CDC Director Rochelle Walensky told reporters Friday that the U.S. has “very little” data on whether a booster shot will increase transmissibility, especially in the context of the Delta variant. She said the CDC is already working on studies to determine what other portions of the population will be eligible to receive the booster shot next. But, she said: “I want to be clear, we are not going to boost our way out of this pandemic.”

Anthony Fauci, the president’s chief medical adviser, pushed back against the idea that the U.S. should look only at the data as it pertains to preventing severe disease — a talking point many health officials in the Biden administration have emphasized in recent weeks.

“The indication for the vaccine is you don’t really want people to get sick, you certainly don’t want them to go to the hospital. But I think that there is some misunderstanding, that if you don’t get hospitalized, everything is okay. That’s really not the case,” Fauci told reporters Friday.

“There are many people who don’t get sick enough to go to the hospital who have a waning immunity against symptomatic or moderately symptomatic disease,” he added. “So we’ve got to be careful that we don’t so neatly break it up into if you don’t get into the hospital, all as well.”

Biden’s announcement marks a turning point for his administration — and the country — as it takes its next step in fighting Covid-19 in the U.S. Federal health experts, including Fauci, have warned of the potential for a surge in cases and hospitalizations this fall as Americans begin to gather indoors for the holidays. Fauci and other officials believe vaccine efficacy will continue to wane over the next several months and more booster shots will be needed to help curb another surge.

The president’s remarks came hours after Walensky overruled an agency advisory committee to allow health care workers and other people with significant on-the-job Covid-19 exposure to get the Pfizer-BioNtech booster. That decision ended weeks of speculation about whether the Food and Drug Administration and CDC would move to authorize the shots before the president’s end of September deadline.

“As CDC director, it’s my job to recognize where actions can have the greatest impact,” Walensky said during a White House Covid-19 briefing on Friday. “In a pandemic, we most often take steps with the intention to do the greatest good even in an uncertain environment. And that is what I’m doing with these recommendations.”

She also rejected the notion that she overruled the advisory panel. “This was a scientific close call,” Walensky said.

Biden said the CDC’s decision would immediately make 20 million people eligible for boosters, with up to 60 million becoming eligible in the coming months. But even as the White House moves to expand booster availability, the president emphasized that a quarter of the country have not yet had even one dose of Covid-19 vaccine.

“We still have over 70 million Americans who have failed to get a single shot,” Biden said. “There are elected officials actively working to undermine with false information the fight against Covid-19. This is totally unacceptable.”

Top health officials inside the administration have for weeks debated whether there was enough domestic data to support administering boosters to most adults — a plan that White House officials pushed for this summer. In the end, the FDA and the CDC decided that the additional shots should be given to a narrower population.

Walensky’s decision early Friday means the federal government will once again need to kick-start a delivery and shipment operation to get booster shots to retail pharmacies and other health care facilities for distribution. The administration will draw on an existing infrastructure first concocted by former President Donald Trump’s Operation Warp Speed which allowed for the delivery of doses to a wide range of settings, including public health departments across the country.

Multiple state health officials told POLITICO they are on standby awaiting instructions from the federal government about ordering and allocating booster shots. Jeff Zients, the White House Covid-19 response coordinator, said states such as Colorado, New York and Ohio are set to open “large vaccination centers to get shots in arms as quickly as possible.”

Biden’s remarks followed several days of tense deliberations among members of the FDA and CDC’s independent vaccine advisory committees.

The FDA panel weighed in first, voting on Friday in favor of a rollout to the elderly, younger people at high risk of severe Covid-19 because of underlying health problems and people in high-risk jobs, such as frontline health care workers. The agency formally accepted that decision on Wednesday, authorizing the shot for those groups.

But the FDA does not have final word over how vaccines are used; the CDC is charged with refining which people should get a shot and when. That agency’s advisory panel — the Advisory Committee on Immunization Practices — ruled Thursday to limit the distribution of the booster shots to people aged 65 and older and nursing home residents, along with people 18 to 64 with health conditions that increase their risk of severe Covid-19. The committee did not endorse booster shots for individuals working in high-risk settings.

“I think [the committee’s] decision on health care workers was less about the fact that there isn’t enough data. I think they started worrying that there were too many people that were going to become eligible at once,” said Ashish Jha, dean of Brown University’s School of Public Health. “They were worried about sending the wrong signal. But ACIP shouldn’t be worrying about signals. If you are an ICU nurse who is 8 months out from getting your second shot … I think you absolutely should get a booster.”

Walensky overruled her advisory board just before 1 a.m. Friday, endorsing the use of Pfizer and BioNTech’s Covid-19 booster shot for workers at high risk as well as the groups covered in the advisory panel’s recommendations. Walensky framed the action as bringing CDC’s recommendation in line with FDA’s booster authorization.

Hours later, during the White House briefing, the CDC chief noted that the ACIP vote on whether to offer boosters to groups such as health care workers, teachers and prisoners had been close. “In an effort protect those at greatest risk, our initial vaccine rollout prioritized these individuals,” she said. “I must do what I can to preserve health across our nation.”

Walensky also said that concerns about the disproportionate harm Covid-19 has had on communities of color and the poor also factored into her actions.

“Many of our frontline workers, essential workers and those in congregate settings come from communities that have already been hardest hit,” she said. “Withholding access for boosters from these people and communities would only worsen the inequities that I have committed to fight against.”

Her decision to contradict her advisory committee and expand the eligible population for boosters was closely held within the administration, with some senior health officials only finding out after it went public. But it prompted a series of late-night calls between White House aides and Biden’s top health officials, according to three people with knowledge of the matter.

The officials strategized through the evening over how to best message the CDC’s highly unusual split with its outside advisers. They also discussed how to manage the inevitable blowback, including the possibility that advisory committee members would be angry at being overruled and take their frustrations public, said one person with knowledge of the matter.

“Dr. Walensky made a good judgment and showed good leadership in making that decision,” Fauci told POLITICO. “I totally agree and support that decision she made.”

Camille Kotton, an ACIP member who voted in favor of allowing frontline workers to access boosters, said Walensky adapted the panel’s comments and concerns about the occupational booster question into her ultimate recommendation.

“I believed that additional flexibility was useful for people in occupations at high risk of exposure, but definitely did not think that it should be recommended for all of them,” said Kotton, an infectious disease clinician at Massachusetts General Hospital. “And that’s definitely not indicated.”

While Walensky made the right call on the prescribing guidance, the confusion over the CDC’s advisory panel’s advice is a larger problem that should have been dealt with earlier in the pandemic, said Scott Gottlieb, the former commissioner of the FDA who currently sits on Pfizer’s board.

“We’ve superimposed a process that was built to be very slow, very deliberative [and] works very well for making decisions around pediatric immunization schedule. And we’ve assumed that this process would be fit for purpose in the setting of a fast-moving global crisis,” he said.

The broad categories of adults now eligible for boosters — and their ability to self-attest to their need, without providing any further proof — mean millions more Americans anxious to protect themselves amid rampant community transmission may be able to access the shots even if they don’t technically qualify.

Fauci warned against that Friday, saying that “you get more bang from the shot” by waiting at least six months after initial vaccination is completed.

Already, 2.37 million Americans had received additional vaccine doses as of Thursday, according to CDC data, nearly six weeks after the administration allowed some immunocompromised people to seek out additional doses of either Pfizer’s or Moderna’s vaccines. Those individuals don’t need a doctor’s note to get the extra shots.

Some governors began urging their residents to seek out boosters before the FDA and CDC officially endorsed them. The Maryland Department of Health updated its Covid vaccine bulletin Friday to encourage health care providers to contact immunized individuals to get them “to consider their eligibility for a [Pfizer] booster or additional doses” of either messenger RNA vaccine if they’re immunocompromised.

“Providers shall not turn away any individual who self-attests to eligibility for a booster or additional dose if immunocompromised,” the department said.

Asked about whether any individual who wants a booster should ask their providers or pharmacies for a shot now, Biden urged individuals to wait.

“Wait your turn,” he said.

David Lim contributed to this report.