Over the past month, the United States public has received a booster dose of confusion.
Follow this whiplash-inducing chain of events. On Aug. 16, the White House telegraphed through leaks and interviews that starting Sept. 20, most Americans could expect Covid-19 boosters eight months after their second shot, pending decisions from regulators. Then came the correction that the boosters would only be available at that time for those who received the vaccine developed by Pfizer and its partner BioNTech, not the Moderna or Johnson & Johnson shot.
On Sept. 17, however, a panel of advisers to the Food and Drug Administration recommended booster shots (six, not eight months after their second shot) only for those over 65, at high risk of Covid complications, or those who have jobs that put them at risk of severe Covid, like health care workers and teachers. Then, on Sept. 23, a different panel, advising the Centers for Disease Control and Prevention, said the people with risky jobs shouldn’t be among those getting boosters. In the wee hours of Sept. 24, Rochelle Walensky, the CDC director, overruled that second panel. It was only the second time in the 57-year history of that panel, the Advisory Committee on Immunization Practices (ACIP), that the federal government has overruled it.
If you’re lost, you’re not alone.
You could also miss what’s not controversial. All the experts agreed that older people should get booster shots. All agreed that, generally speaking, there may be more risk and fewer benefits for younger people, especially young men. That should be the clear message.
In part the confusion is the result of officials having to figure out how to battle the SARS-CoV-2 virus in real time. But it also reflects something worse, and more pervasive: The federal government seems to be forgetting how to solicit and follow scientific advice.
It was only three months ago that the FDA overruled a near-unanimous vote from one of its advisory committees and approved the Alzheimer’s drug Aduhelm. The FDA overrules its panels more often than CDC overrules ACIP, but the last time the agency went against such a lopsided vote it was to approve an opioid pill in 2013.
That the FDA is using outside experts at all is a testament to the agency’s knowledge that it needs their advice and political cover. In truth, the agency did not need to follow normal standards in order to authorize vaccines during an emergency. The FDA’s power to grant emergency use authorizations requires only that it is “reasonable to believe” that a treatment, vaccine, or diagnostic is effective.
A lot can go wrong with authority that broad. Without using its advisory committees, for instance, the FDA authorized hydroxychloroquine for use in treating hospitalized patients with Covid-19. Carefully done studies show it does those patients no good, and might do harm.
When it comes to the booster decision, the federal government has committed three cardinal sins. The White House disrupted the process by making boosters seem a fait accompli when they were not. The White House, the FDA, and the CDC focused the discussion on the question of a broad approval of boosters for everyone over the age of 16, when that was unlikely to begin with. And the CDC’s Walensky chose not only to overrule an expert panel, but to insist that she was doing no such thing. By not recognizing the gravity of the action, she likely made it easier for future CDC directors to erode ACIP’s authority. Following these steps wouldn’t just result in better decision-making, it would have made the process more transparent.
Certainly, federal advisory panels are just that, advisory. The CDC director was within her rights to insist on the vaccination of health care workers. The FDA was allowed to approve Aduhelm. The question isn’t whether the agencies have to follow outside advice, but whether ignoring it is a good idea.
One of the difficulties of the pandemic is that the panels are acting in ways they have never been meant to. To put it simply, the FDA’s advisory panel on vaccines, known as the Vaccines and Related Biological Products Advisory Committee, recommends whether a vaccine should be available. The ACIP gives advice on whether it should be recommended for broad use. During the pandemic, these roles have been blurred somewhat — for instance, when potential side effects to the vaccines have emerged, something that would traditionally fall under FDA’s remit, the deliberations have been done by ACIP.
In this case, the FDA did follow VRBPAC’s recommendation. But it does appear the agency pushed that recommendation to be as broad as possible. The panel’s initial reaction was that it did not want to approve a booster for everyone over the age of 16 because it wasn’t clear younger patients need it, and because, for younger men in particular, a booster’s risks might outweigh its benefits.
The main reason was the risk of a condition called myocarditis, an inflammation of the heart, which seems to occur with the Pfizer and Moderna vaccines. Overall, it seems very rare, occurring only once in tens of thousands of vaccinations. But the FDA has estimated that for younger men, it may occur as frequently as 1 in 5,000 vaccinations. There are no data to show how that risk might change with a third dose.
After a long day during which the panel recommended restricting use to those over 65 and those at high risk, some panelists brought up vaccinating health care workers. Vaccination prevents the health care workers from getting sick, but also could help prevent shortages of hospital workers, who need to quarantine if infected.
After this suggestion was made, Peter Marks, a top FDA official, jumped in and put a finger on the scales. He asked that the panel be polled as to whether health care workers and others at high risk should be offered the booster. Then, a CDC representative suggested the language be changed to include people with other at-risk jobs, too.
“I just want to make sure that the committee understands when we are saying people at high risk for occupational exposure what we will be taking that to mean at FDA is health care workers, frontline workers such as teachers, and potentially essential infrastructure workers as well,” Marks said.
For the panel, this was a last-minute decision, with the expectation that ACIP would be able to delve in deeper. Overturning ACIP’s deliberations is overturning the vote — it’s as simple as that.
Officials should publicly acknowledge, clearly, what the advice of experts is, even when they disagree. They should also refrain from publicly disparaging that advice, as the FDA’s Patrizia Cavazzoni did in June when she said that committees can be “swayed by emotion.” It seems fair enough for experts to become emotional when discussing public health.
It’s easy to say that this is an emergency, and that normal processes can’t always be followed. But it’s during emergencies, when everyone is under intense pressure, that processes can be most valuable. And officials should remember that, historically speaking, decisions made based on the wisdom of groups of independent experts have been better than those made without such advice.
https://www.statnews.com/2021/09/27/the-biden-administration-wants-scientific-advisers-it-just-doesnt-like-what-they-have-to-say/
