Biden's top-down booster plan sparks anger at FDA

POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing anger over the government’s incoherent process of implementing their booster plan. These sources said there is little coordination between federal health authorities even with two leading FDA officials trying to lead the rollout.

“We understand the importance of additional doses of vaccine in controlling this pandemic and will evaluate all submissions as soon as possible. Responding to this pandemic requires a state-wide approach, “an FDA spokesman told POLITICO. “The FDA has and will continue to make regulatory decisions. And the [Centers for Disease Control and Prevention’s vaccine advisory committee] will continue to give clinical recommendations. “

Acting FDA Commissioner Janet Woodcock sent a memo to vaccine regulators Tuesday evening reiterating her support as frustration with the process spreads among her ranks. “The problems are complex and the days are long, but please know what work you have all done so far and will continue to do in the coming days, weeks and months. Hopefully this will one day allow us to have Covid-19 completely behind us allow.” and better prepare us for future challenges, “wrote Woodcock.

President Joe Biden’s Covid-19 Tsar Jeff Zients supported the FDA in a press conference on Tuesday shortly after the departure news as the regulatory “gold standard”. “[The booster] The decision was made and announced by the country’s top public health officials … and as our medical experts have pointed out after reviewing all available data, based on their clinical assessment, it is time to prepare Americans for a booster, “said he. “We announced our approach of staying one step ahead of the virus and being transparent about the latest data.”

Tension between FDA regulators and senior officials in the Biden administration – including Woodcock, who publicly endorsed the booster plan – comes as the agency begins to address its toughest decisions yet about Covid-19 shots. Many focus on making them available to children under the age of 12, whose bodies respond differently to the virus and vaccines to prevent it. The FDA will have to decide whether the rising number of cases in children warrants providing them with emergency shots before going into the lengthy regulatory process, which identifies rather rare side effects.

But right now, much of the disagreement within the agency has centered on the government’s decision to push boosters before the FDA’s top scientists had a chance to interfere.

It was “The government’s booster plan; it wasn’t the FDA’s booster plan, ”said Paul Offit, an infectious disease expert from the University of Pennsylvania who sits on the FDA’s vaccine advisory committee. “The administration has stood a bit against the wall here.”

Woodcock and Marks were instrumental in making an August 18th Statement by HHS officials regarding the booster schedule dated Sept. 20, a senior official said. That person said the schedule was influenced in part by Woodcock and Marks’ estimate of when they would receive key dates from vaccine manufacturers, but could also shift due to new data. repeat the joint statement.

Another senior health official with direct knowledge of the situation said political officials within the White House largely directed the announcement of the boosters for mid-August.

The tensions within the administration and the open skepticism of external experts have led to clues and divisions between the health authorities. Professional scientists in particular were confused and surprised by the process, said several people involved in the talks.

Biden added to the confusion and controversy last weekend when he suggested that boosters could be given just five months after the first regimen, instead of the eight months his administration had just suggested. These remarks, following a meeting with Israeli Prime Minister Naftali Bennett, fueled concerns that a government that had promised to “follow science” was letting politics dictate the results.

But others familiar with the government’s mindset said that Biden and his top health aides, including Zients and Chief Medical Officer Anthony Fauci, needed to lay the groundwork for booster vaccinations in order for the public to be ready for the inevitable reality of additional vaccinations.

“If the White House didn’t take the lead, what would happen?” Said one person familiar with the behind-the-scenes discussions.

But confusion about the plan continues to grow. While Pfizer completed its first booster application on August 27, it is unclear when Moderna and Johnson & Johnson could join its ranks or when the FDA will approve Pfizer’s filing. Pfizer also has data arriving in mid-October to track booster doses given between 4.8 and eight months after the initial treatment.

Biden’s five-month remark was “an innocent question” from the president after hearing from Bennett that Israel had made progress on the large booster, said a person familiar with the discussion. In reality, the timeframe for additional doses will depend on the FDA and the companies submitting data – and will likely be a period of several months to receive a third dose, rather than a specific window, they added.

Biden health officials are still confident they will have “enough information and data” by September 20 to make that call, the familiar said. Several pointed to Israel’s booster data and “clear” benefit from additional doses, a health official said.

But the abrupt departure of two top officials from the FDA’s vaccines division, the Center for Biologics Evaluation and Research, has rocked many current and former officials who say this arrives at a critical moment in vaccine regulation. “The support of the career workers at CBER is extremely important right now, they have a tremendous amount of experience,” Bush-era FDA commissioner Mark McClellan told POLITICO.

While third doses are still only approved for immunocompromised people, including organ transplant patients, others who don’t fit into this category have pushed for additional vaccinations on the mistaken assumption that the FDA has already given the go-ahead. According to the latest CDC data, nearly a million booster doses have already been administered in the United States.

“Many, many, many” providers in southern states with spikes in coronavirus cases are dosing health workers and patients with boosters who are banned from FDA approval due to confusion over comments on Biden boosters, said Helen Talbot, an infectious disease specialist at the Vanderbilt University and a member of the CDC Advisory Committee on Immunization Practices, the body that recommends the use of vaccines.

“This critically underscores the need for all vaccine recommendations to go through the normal channels and not come from outside,” she said during a panel meeting on Monday. “It is very scary to me that healthcare providers who are trying to do their best have been guided by HHS and the White House and have now put themselves at risk.”

Former Trump administration officials also privately resent Biden’s approach to boosters after being pilloried for pressuring the agency to make drug and vaccine decisions. During the first year of the pandemic, then-President Donald Trump repeatedly accused the FDA of slowing down key vaccine decisions in order to politically violate him, and called for FDA approval of the unproven treatment, hydroxychloroquine.

“It is unprecedented” that the Biden administration would announce a specific date for the introduction of boosters before regulators weighed in, a Trump official said. That person argued that while the former president criticized the FDA, he did not say any regulatory action would be taken on or by a specific date. Trump said vaccines were likely before election day, and while aides downplayed his promises, the effect on confidence in the vaccine was terrifying.

In contrast, Biden came into office promising that scientists would guide these decisions and news, not the White House – a promise driven in large part by the politicization of vaccines and other public health measures in the run-up to the elections .

But the president may regret that promise after witnessing the slow pace of data processing by the CDC.

While the agency has released five studies in the past few weeks – some of which show declining immunity among healthcare workers and more breakthroughs than previously recorded – other Biden officials are eagerly awaiting a collection of state data many of which are expecting Infections are much higher than previously thought to provide more definitive evidence for this breakthrough.

The CDC has been working with a small group of state health officials for the past two months to collect data on breakthrough cases, including mild infections. Several participating state health officials said they submitted their data weeks ago, but two senior CDC officials told POLITICO that they are still collecting and analyzing the information.

Concerns about the pace of the CDC could affect upcoming decisions about vaccinating young children against Covid-19. As the agency that collects data on infections and hospitalizations in children, the CDC is able to give the FDA a clear picture of how quickly to make vaccines available to children under the age of 12.

Biden officials are well aware of the looming dilemma, said a person familiar with discussions, and will “try to put pressure on them to get data quickly”.

Erin Banco and David Lim contributed to this report.

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