States are bracing for confusion as the Biden administration begins rolling out booster doses of Pfizer's COVID-19 vaccine.
Chaotic and at times disparate messaging from administration health officials over the past month has culminated in a complicated set of recommendations about who should be getting booster shots, and why.
A Centers for Disease Control and Prevention (CDC) advisory panel on Thursday recommended an additional dose of Pfizer's vaccine for people aged 65 and older and nursing home residents, along with people between 18 and 64 with underlying health conditions.
The panel grappled with the question of whether people in potentially high-exposure risk occupations should get a booster, but ultimately decided against recommending it.
Panel members indicated they wanted to avoid giving a recommendation that was too broad, since there was not enough evidence that vaccinated people under the age of 50 were losing protection against severe disease and hospitalization.
But in a decision announced after midnight on Friday morning, CDC Director Rochelle Walensky broke with the advisory committee and signed off on a broader policy.
Starting immediately, anyone between the ages of 18 and 64 who is at increased risk of COVID-19 "exposure and transmission because of occupational or institutional setting" can get a third dose.
Experts said Walensky's decision will make boosters available for health care workers, teachers, grocery store workers and other frontline workers. President Biden on Friday said there could be 60 million Americans who fit the bill.
But essentially, anyone who wants a third dose can get one, even though they may not technically qualify.
"There's going to be confusion. If we are going to create guidelines that are essentially making the vaccine available to almost everyone, the simplest solution is, make it available to everyone," said Celine Gounder, an infectious disease specialist and epidemiologist at NYU and Bellevue Hospital. "The best public health programs are the ones that are simple and easy to understand and clear, and the more complexity you build into it, the more difficult it is to roll out."
Gounder, who advised the Biden transition team on COVID-19, has been critical of the administration's fervent push for boosters, and said the evidence for a third dose based on occupation was mixed at best.
"You have to step back and ask the question, why is it that we're vaccinating people in high risk settings? Is it because they as individuals are at high risk, or is it because it would be disruptive to the workplace," Gounder said.
Breakthrough infections can be disruptive, especially for health workers. But if the goal of a booster shot is mainly to allay fears and anxieties among frontline workers, Gounder said, "there just isn't data to back that a young healthy health care worker is actually at risk."
Expanding the use of the Pfizer-BioNTech booster to frontline workers is still narrower than what the administration envisioned.
Last month, Biden and top health officials, including Acting Food and Drug Administration (FDA) Commissioner Janet Woodcock, Walensky and Surgeon General Vivek Murthy announced that a booster shot program for all adults would begin the week of Sept. 20, well before the FDA and CDC had examined the evidence.
The administration initially wanted people to receive boosters beginning eight months after their second shot, in an effort to reduce transmission amid the spread of the delta variant. But the scientific advisory panels decided on six months.
While officials were careful to say the booster program was contingent on the FDA and CDC giving the green light, the move was criticized by scientists inside and outside the government. They argued there wasn't enough evidence that showed protection against severe illness and hospitalization dropped to levels that warranted a booster.
During a White House briefing on Friday, Walensky acknowledged there isn’t any way for states or the federal government to ensure that people are adhering to the eligibility criteria.
"What we are doing now is self-attestation," she said.
In deciding to give boosters based on occupation, Walensky aligned CDC policy with the FDA’s authorization. But neither agency specifically defined who qualifies as a high risk worker.
Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials, said states are not expecting additional clarity from the federal government.
"That's going to be complicating, because it's not clear. I think everybody knows that health care workers are in that mix ... but there's all kinds of other occupations or institutional settings" that could meet the definition, Plescia said.
Adding further confusion, a third dose of both the Moderna and Pfizer vaccines was authorized in mid-August for people with severely weakened immune systems.
The administration's initial plan called for boosters of all three vaccines to begin at the same time, but it wasn't clear until recent weeks that only Pfizer would be able to submit clinical evidence in time.
States have been preparing for the green light from the federal government, but Plescia said it would have been easier if all three shots were authorized at the same time, or if states had flexibility to mix shots from different drug makers.
While there's no evidence about mixing a third Pfizer dose with two doses of the Moderna vaccine or a single dose of the Johnson & Johnson shot, Plescia said state health officials will have a difficult time conveying that to members of the public clamoring for boosters.
Those overpromises now create a messaging challenge, as state and federal officials need to manage expectations.
"It's much easier to make a political announcement than it is to do the hard work of analyzing science and making evidence based recommendations," said Richard Besser, a former acting CDC director.
"The fact that we won't have recommendations for people who received a Moderna and J&J because the companies haven't gotten the data in ... that's gonna cause heartburn all over the place," said Besser, who is now president and CEO of the Robert Wood Johnson Foundation.
"People didn't have a choice of what vaccine they got. They're all effective, but only one of them can get boosted right now."
https://thehill.com/policy/healthcare/573899-confusion-reigns-over-vaccine-booster-rollout
