Biden’s Covid recall plan pits White House against science advisers

WASHINGTON – The chaotic and contradictory messages from the White House on the booster injections of the Covid-19 vaccine have given Americans a boost. But what is more concerning, experts say, is that it risks undermining President Biden’s campaign commitment to listen to scientists and adhere to official approval processes.

The administration’s latest move – a midnight Friday decision to expand recall eligibility – highlights Rochelle Walensky, the director of the Centers for Disease Control and Prevention, who canceled her own scientific advisory group for make the call. Now she finds herself trapped between the White House, which has been pushing for expanded eligibility for months, and an expert advisory body that recommended booster shots only to a smaller portion of the adult population – and what the CDC does. almost never canceled.

The communications debacle comes as millions of Americans grapple with whether it is safe to get a third injection and whether it will help protect them from Covid. He highlighted tensions between the White House, its scientific agencies and their outside advisers. For many, the move was also a reminder of the Trump administration’s chaotic communications during a pandemic and the frequent hostility towards its own public health officials.

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“It’s been confusing, mixed, contradictions galore,” said Eric Topol, a physician-researcher who founded the Scripps Research Translational Institute. “It has been thwarted by political issues, rogue FDA scientists, infighting between the leadership groups of the various agencies and the White House. It is truly disturbing.

Despite the communications meltdown, Topol defended the administration’s eventual decision to give most Americans access to booster shots, delivered at 1 a.m. Friday by Walensky. The same goes for a range of public health leaders, like Brown University’s dean of public health Ashish Jha and former CDC director Tom Frieden.

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There is strong data allowing people over 60 to receive a booster, Topol said, although he criticized the White House for leaving people who received Moderna or Johnson & Johnson vaccines in the dark – the the only recall currently authorized is that of Pfizer.

Others, however, questioned the caliber of data used to support recalls at this point. And many wonder if the chaotic deployment will do more harm than good. The poll presented to the CDC advisory committee on Thursday found that a third of people who are still unvaccinated say the need for a third injection would make them less likely to agree to receive doses of the Covid vaccine.

One concern about rapid deployment is that there is little data available to support the safety of booster injections in younger populations – particularly for men under the age of 30, a tiny fraction of whom have developed myocarditis, or inflammation of the heart, after receiving the first or second dose of Covid-19.

“It is worrying to me that anyone under the age of 30 receives a third dose without any clear evidence that it is beneficial to them and with more than theoretical evidence that it could be harmful to them,” said Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Offit also expressed concern that by rescinding the CDC’s advisory committee on vaccination practices, Walensky may have undermined efforts to persuade more unvaccinated adults to get vaccinated against Covid. It is likely, he said, that people in highly vaccinated areas of states, such as New England, will receive a third dose while those in relatively unvaccinated areas, such as the South, will remain skeptical.

“It’s not hard to scare people who have already received two doses to get another one,” he said. “I’m sure you can get them 10 more doses.”

Whether or not the chaotic process elicits further hesitation about the vaccine, it has highlighted tensions and confusion between the White House, federal science agencies, and the advisory committees that exist to guide their decision-making.

The process began with a shifting schedule from President Biden himself: On August 18, he declared Americans would be eligible for boosters eight months after their second dose. On August 26, the Wall Street Journal reported that the White House was considering extending the deadline to six months. The CDC called the story “misleading” – but a day later, Biden announced that the timeline could actually drop to five months.

Then the science advisory groups of the FDA and CDC stepped in.

Last week, the Advisory Committee on Vaccines and Related Biologics, a group of scientists who advise the FDA on vaccine approvals, recommended approving the recalls for a population significantly smaller than that first described. by Biden: only those over 65 and at high risk of Covid-19.

The move was seen as a major rebuke from the Biden administration. And that closely followed the resignations of Marion Gruber and Phil Krause, the two main FDA vaccine regulators that Topol called “thugs,” who announced their departure days after the initial announcement of Biden’s recall.

However, when the FDA cleared the recall, it ruled out the recommendation of its advisers, adding any Americans at additional risk of exposure to Covid-19, such as teachers, doctors or grocery store workers.

Days later, ACIP, the CDC’s advisory committee, also recommended scaling back the Biden administration’s plans, recommending injections only for the population over 65. But on Thursday, Walensky also ignored his own advisers, ruling that the younger and at-risk population could also receive the injections.

More generally, the administration’s contempt for advisory councils can call into question whether the administration “follows the science”, as promised during the election campaign.

It is extremely rare for the CDC to oppose ACIP’s recommendations on vaccination guidelines. It is believed that a CDC director has deviated from the committee’s guidelines only once before, during a controversy in 2003 over the extent to which the George W. Bush administration should deploy to agents of the government. health and first responders a controversial smallpox vaccine which was also linked to a risk of myocarditis and pericarditis.

In a statement, Walensky defended the decision, saying she believed the decision “would do the greatest good” despite the lack of clear data and lingering uncertainty.

Although it clearly rejected the advice of the CDC’s vaccine advisory committee, the agency attempted to portray Walensky’s decision in a different light.

“The CDC director did not go beyond or ignore ACIP. She agreed with the committee and added the fourth recommendation. It was her decision and she was not influenced by outsiders, ”a CDC spokeswoman told STAT shortly after the release of Walensky’s statement.

And while there is more recent precedent for FDA regulators defying their scientific advisers, as happened this year with the controversial approval of an Alzheimer’s disease drug, the actions of the administration also represent a contradiction to Biden’s long-standing campaign pledge: that he would defer to the “experts.” “

In a 2020 interview with STAT, Vivek Murthy, one of Biden’s top pandemic advisers and now the surgeon general, identified two key groups whose advice should help guide vaccine approval decisions.

“The scientists we need to hear from are the scientists on the FDA staff who have been doing this for decades,” he said. He later added: “The other group we need to hear from is the external advisory committee, VRBPAC. It’s a group of scientists who understand how to evaluate vaccines. “

Instead, however, recent actions by the administration have pitted it against the recommendations of VRBPAC and ACIP, a tension that has not gone unnoticed by former government officials.

“I think staff are scratching their heads … in both agencies,” Norman Baylor, president and CEO of Biologics Consulting and former head of the Food and Drug Agency’s Office of Vaccines, told STAT.