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POLITICO spoke to 11 current and former health officials and people familiar with the matter who described growing exasperation over the administration’s rambling process to implement its stimulus plan. These sources said there was little coordination among federal health agencies, even though two senior FDA officials are trying to guide the deployment.

“We understand the importance of additional vaccine doses in controlling this pandemic and will act as quickly as possible to assess all submissions. Responding to this pandemic requires a whole-of-government approach, ”an FDA spokesperson told POLITICO. “The FDA has made and will continue to make regulatory decisions. And the [Centers for Disease Control and Prevention’s vaccine advisory committee] will continue to make clinical recommendations.

Acting FDA Commissioner Janet Woodcock sent a memo Tuesday night to vaccine regulators, reiterating her support as frustration over the process spreads through their ranks. “The issues are complex and the days are long, but know that the work you have all done so far and will continue to do in the days, weeks and months to come will hopefully one day to completely put Covid-19 behind us. and better prepare for future challenges, ”Woodcock wrote.

President Joe Biden’s Covid-19 Tsar Jeff Zients backed the FDA as the regulatory “gold standard” during a press briefing on Tuesday shortly after the departure was announced. “[The booster] The decision was taken and announced by the country’s main public health officials … and as our medical experts explained after reviewing all the available data, it is in their clinical judgment that it is time to prepare the Americans have a recall, ”he said. “We have announced our approach to stay ahead of the virus and be transparent about the latest data.”

Tensions between FDA regulators and senior officials in the Biden administration – including Woodcock, who publicly approved the recall plan – come as the agency begins to make its most difficult decisions yet on the Covid-19 shots. Many focus on making them available to children under 12, whose bodies respond differently to the virus and to vaccines to prevent it. The FDA will need to decide whether the growing number of cases in children warrants urgent vaccine availability before the longer approval process, which is more likely to detect rare side effects.

But for now, much of the contention within the agency centers on the administration’s decision to go ahead with the boosters before the top FDA scientists had the chance. chance to speak out.

It was “The administration’s recovery plan; it wasn’t the FDA’s recall 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 kind of leaned against the wall here. “

Woodcock and Marks were instrumental in shaping an Aug. 18 HHS officials statement on the September 20 recall timeline, a senior official said. This person said the timeline was partly informed by Woodcock and Marks’ estimate of when they would get key data from vaccine manufacturers, but could also change based on new data, echoing the joint statement.

Another senior health official with first-hand knowledge of the situation said those nominated by politicians in the White House largely spearheaded the mid-August recall announcement.

Tension within the administration and open skepticism of outside experts fueled accusations and divisions among health agencies. Career scientists in particular were confused and surprised by the process, several people involved in the talks said.

Biden added to the confusion and controversy last weekend by suggesting that the boosters could be given just five months after the initial regimen, rather than the eight his administration had just proposed. The remarks, coming after a meeting with Israeli Prime Minister Naftali Bennett, fueled concerns that an administration that was committed to “following the science” was letting politics dictate results.

But others familiar with the thinking of the administration said Biden and his senior health aides, including Zients and Chief Medical Advisor Anthony Fauci, needed to set the stage for booster shots so the public could be ready for what they saw as the inevitable reality of additional vaccinations. .

“If the White House didn’t lead, what would happen? said a person familiar with the behind-the-scenes discussions.

Yet confusion over the plan continues to mount. While Pfizer completed its initial recall request on August 27, it is unclear when Moderna and Johnson & Johnson could join its ranks, or when the FDA will approve Pfizer’s submission. Pfizer also has data coming in mid-October for tracking booster doses given 4.8 to eight months after the initial regimen.

Biden’s five-month remark was “an innocent question” from the president after hearing from Bennett that Israel had moved forward on a large dose of booster, a person familiar with the discussion said. In reality, the timeframe for additional doses depends on the FDA and the companies submitting the data – and will likely turn out to be a range of several months to get 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 this call, the familiar person said. Several pointed to Israel’s recall data and a “clear” benefit from the extra doses, as one health official said.

But the abrupt departure of two senior officials from the FDA’s vaccine department, the Center for Biologics Evaluation and Research, has rocked many current and former officials who say it resonates at a critical time in vaccine regulation. “Supporting the career staff of CBER is extremely important at this time, they have tremendous experience,” Bush-era FDA commissioner Mark McClellan told POLITICO.

While third doses are still only allowed for people who are immunocompromised, including organ transplant patients, others that don’t fit into this category have started additional vaccinations under the mistaken belief that the FDA has already given its green light. Almost a million booster doses have already been given in the United States according to the latest data from the CDC.

“Lots, Lots, Lots” of Suppliers in Southern States with Outbreaks of Coronavirus Cases Are Dosing Healthcare Workers and Patients with Recalls Without FDA Approval Due to Confusion by Biden’s recall remarks, said Helen Talbot, an infectious disease specialist at Vanderbilt University and a member of the CDC’s Advisory Committee on Immunization Practices, the panel of experts that recommends how vaccines are used.

“This critically highlights the need for any vaccine recommendation to follow normal channels and not come outside,” she said at an expert group meeting on Monday. . “It is very scary to me that health care providers, trying to do the best they can, are taking the advice of the HHS and the White House, and are now putting themselves in danger.”

Former Trump administration officials are also privately enraged at Biden’s approach to recalls after being pilloried for pressuring the agency over drug and vaccine decisions. In the pandemic’s first year, then-President Donald Trump repeatedly accused the FDA of slowing down key vaccine decisions to politically injure him and sought FDA clearance for the unproven treatment, hydroxychloroquine.

“It’s unprecedented,” for the Biden administration to announce a specific date for the booster’s deployment before regulators weighed in, a Trump official said. This person argued that although the former president criticized the FDA, he did not say that a regulatory decision would occur on or before a particular date. Trump said the vaccines were likely before election day, and while aides played down his promises, the effect was frightening for confidence in vaccines.

In contrast, Biden took office promising that scientists would lead those decisions and messages, not the White House – a commitment driven in large part by the politicization of vaccines and other public health measures leading up to the election.

But the president may regret this commitment after witnessing the slow processing of data by the CDC, the public health agency gathering vast amounts of information on vaccine performance, including the likelihood of infections. revolutionaries, said another former Trump official.

While the agency has released five studies in the past few weeks – some showing waning immunity among healthcare workers and more breakthroughs than previously recorded – other Biden officials say they are eagerly awaiting a blood drive. state data that many believe will provide more definitive evidence of this breakthrough. infections are much higher than previously thought.

The CDC has worked with a small group of state health departments over the past two months to collect data on groundbreaking cases, including mild infections. Several health departments in participating states said they submitted their data weeks ago, but two senior CDC officials told POLITICO they are still collecting and analyzing the information.

Concerns about the pace of the CDC could color future decisions about vaccinating young children against Covid-19. As the agency that collects data on infections and hospitalizations in children, the CDC is well positioned to give the FDA the clearest picture of how quickly it should act to make vaccines available. children under 12 years old.

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

Erin Banco and David Lim contributed to this report.

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