(TNS) – It was up to Centers for Disease Control and Prevention director Rochelle Walensky to sort out a crucial question: which Americans should be the first to get COVID-19 booster shots.
And there was little consensus.
The CDC’s Advisory Committee on Immunization Practice on Thursday voted narrowly to restrict eligibility for boosters of the Pfizer Inc.-BioNTech SE shot authorized by the Food and Drug Administration. Walensky had a choice: side with the advisers, citing the paucity of data on whether younger, vaccinated adults are truly at risk of severe breakthrough cases of COVID-19. Or overrule them, and err on the side of boosters for front-line health workers and others.
Shortly after the panel’s vote, Walensky called Health and Human Services Secretary Xavier Becerra to lay out the options in front of them, and then met privately for hours with CDC officials to come to a decision, according to people familiar with the process.
Several factors weighed on Walensky, who revealed some of her thinking in a news briefing Friday afternoon. Nurses, teachers and others on the front line had put themselves at risk for the past year and a half, and intensive care units are full across parts of the country. Equity, too, was a factor: frontline workers disproportionately come from minority communities that have already paid a disproportionately high price in the fight against COVID-19.
“Withholding access for boosters from these people and communities would only worsen the inequities that I have committed to fight against,” she said Friday.
Late Thursday, she made a decision. The CDC ACIP panel was overruled, with Walensky expanding eligibility for boosters broadly to include those 18 to 64 at risk of workplace exposure, including health-care workers.
Walensky, who headed a division at a Boston hospital before Biden picked her to lead the CDC, was particularly motivated by her belief that nurses and other health officials on the front lines, working in COVID-19 units, should be eligible for third shots, according to one of the people familiar with the matter. Under the CDC advisory committee’s recommendation, they wouldn’t have been booster-eligible unless they had an underlying health condition, and many are already eight months past their second shot.
Walensky and other CDC officials discussed the issue deep into the evening on Thursday before settling on a decision. She called Becerra and told him, and HHS informed the White House shortly after 11 p.m., the people said. She announced her recommendations publicly just before midnight.
Though she is a political appointee, there’s no indication the White House directly influenced her decision. President Joe Biden didn’t speak to her as she considered her statement, nor did two of his top aides, Chief of Staff Ron Klain and COVID-19 Coordinator Jeff Zients, one of the people said.
Walensky noted that ACIP was divided on the issue. The panel’s vote was 9 to 6 against boosters based on high-risk workplaces. “Had I been in the room and on the committee, I would have voted yes,” she said Friday. “It was a decision about providing rather than withholding access.”
In the end, Walensky staked out something of a middle ground. She expanded eligibility for booster shots, but set up a two-tier recommendation. People 65 and up and people age 50-64 with underlying health conditions “should” get a booster, she said. Americans age 18-49 with health conditions, and those 16-64 with workplace exposure, “may” get one, she said.
The final decision and the machinations that preceded it resulted in a complicated — and potentially confusing — public message about who should get boosters and who should not.
Walensky said that officials would stick with a system of “self-attestation,” meaning that people who claim to be eligible are essentially taken at their word. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, warned people against getting a shot sooner than six months after their second, saying that going early could undercut the benefit of the booster.
Walensky on Friday defended her approach to the booster shots, saying she didn’t overrule the advisory panel because the decision was hers to make, not the advisory committee’s.
“This was a scientific close call,” she said. “In that situation, it was my call to make.”
Kathy Poehling, an ACIP member who voted against the measure ultimately restored by Walensky, said she supported Walensky’s move. The word “may” in Walensky’s recommendation for younger people was a crucial addition, she said.
“‘May’ is a wonderful way to allow people who would like to get the booster dose and highlight that the primary series is highly effective,” said Poehling, a professor of pediatrics and epidemiology and prevention at the Wake Forest School of Medicine. “As you could see from the meeting, we struggled and reviewed a lot of data. And this decision is really difficult. And ultimately you have to decide what is the best decision for the greatest good.”
It’s unusual for the CDC director not to follow the recommendations of their advisory panel, said Dorit Rubinstein Reiss, a professor at the University of California Hastings College of the Law legal and policy issues on vaccines. The only other time she could recall that happening was in 2003 around a smallpox vaccine.
“It’s not unprecedented but it’s very rare,” she said. “There was clearly different views in the committee and different views outside the committee. So this is not an area where the director is rejecting a united committee. This is an area where we had controversy within the committee with experts on both sides.”
Ashish Jha, dean of the Brown School of Public health, applauded Walensky for the reversal, which brought the CDC’s booster position closer to the FDA’s.
“Dr. Walensky fixed it,” he tweeted. “This is why it’s good to have a strong CDC director.”
Still, there is sparse data showing a need for broad booster shots. It’s dependent on predictions that vaccine efficacy will eventually wane even for younger adults. At the ACIP meeting, the CDC’s own presenter noted that much of the data supporting boosters was short-term and of “very low” certainty.
“For the most part, if you’ve been vaccinated with two shots, you can relax,” Pauline Rosenau, a University of Texas Health Science Center professor emeritus, said in an interview on Bloomberg Television’s “Balance of Power With David Westin”. “If you’re older, you should do what your doctor says. In most cases, that will be get a booster.”
While there is a hope among experts that a third shot given months later will lead to much longer-lasting immunity than the first two doses alone, that remains to be proven.
In the meantime, despite all the angst, breakthrough hospitalizations and deaths among vaccinated people under 65 are rare among the more than 2,000 daily deaths in the U.S. from COVID-19. Almost all of those are unvaccinated people — and the ACIP panel expressed fear that a round of boosters would reinforce doubts among the unvaccinated about whether the shots work at all.
Overall, there have been less than 4,000 U.S. hospitalizations for fully vaccinated people who contract COVID-19 and fewer than 400 deaths, according to CDC data through Sept. 13.
Walensky acknowledged the data are incomplete, but that they “reflect the potential increase for severe outcomes” among vaccinated people who get breakthrough cases, particularly if they have underlying conditions.
Fauci said officials want to prevent symptomatic cases, not just hospitalization and death. “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,’” he said. “It may not be the case.”
Measuring whether booster shots avert milder breakthrough cases is going to be difficult. The CDC stopped tracking such cases earlier this year.
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