Biden’s Top-Down Booster Plan Causes FDA Anger

POLITICO spoke to 11 current and former health officials and those familiar with the matter, explaining the growing frustration of the government’s disparate process of implementing the booster program. These sources said there was little coordination between federal health agencies when the two top FDA executives tried to guide the deployment.

“We understand the importance of additional vaccine doses to control this pandemic and will act as quickly as possible to evaluate all submissions. To respond to this pandemic. Needs every approach by the government, “a FDA spokeswoman told POLITICO. “The FDA has made regulatory decisions and will continue to do so. [Centers for Disease Control and Prevention’s vaccine advisory committee] We will continue to make clinical recommendations. “

Janet Woodcock, FDA’s deputy commissioner, sent a note to vaccine regulators Tuesday night, reiterating her support as frustration with the process spread within their ranks. “The problem is complicated and the days are long, but please be aware that the work you’ve done so far will continue for the next few days, weeks, and months. One day, Covid-19 I hope we can put it off completely. We will be ready for future challenges. “

President Joe Biden’s Covid-19 Emperor Jeff Seiens endorsed the FDA as a regulatory “gold standard” at a press conference on Tuesday shortly after departure news. “”[The booster] The decision was made and announced by the major public health authorities in the United States … and showed that our medical professionals reviewed all available data, so Americans for booster shots. It’s their clinical judgment that it’s time to prepare for, “he said. “We have announced an approach to make the latest data transparent ahead of viruses.”

Tensions between FDA regulators and top executives of the Biden administration, including Woodcock, who publicly approved the booster program, arose when the FDA began working on the most difficult decision to date on the Covid-19 shot. increase. Many people focus on helping children under the age of 12 react differently to viruses and vaccines to prevent them. The FDA needs to decide whether an increase in the number of cases in children justifies the availability of shots in an emergency before a longer approval process that is likely to detect rare side effects. I have.

But so far, much of the discord within the FDA has focused on the government’s decision to promote boosters before the top FDA scientists have the opportunity to participate.

It was “The administration’s booster program. It wasn’t the FDA’s booster program,” said Paul Ofit, an infectious disease expert at the University of Pennsylvania, a member of the FDA’s Vaccine Advisory Board. “The administration is a bit like turning its back on the wall here.”

Woodcock and Marks contributed to the production on August 18th A senior official issued a statement by HHS officials regarding the booster timeline on September 20th. He said the timeline was partially informed by Woodcock and Marks’ estimates of when to get important data from vaccine manufacturers, but could shift based on new data. rice field. Echo the joint statement..

Another senior health official, who knows the situation directly, said political appointees in the White House had largely piloted the booster announcement in mid-August.

Tensions within the administration and open skepticism from outside experts have fueled pointing and division between health organizations. Career scientists, in particular, were confused and surprised by the process, said several people attending the meeting.

Biden joined the turmoil and controversy last weekend when he offered to administer boosters just five months after the first regimen, rather than the eight that his administration had just proposed. These statements after the meeting with Israeli Prime Minister Naftali Bennett fueled concerns that the administration, which promised to “follow science,” had politics direct its consequences.

But others familiar with the administration’s ideas, Biden and his best health assistants (including Zyents and Chief Medical Advisor Anthony Fouch), said they were the inevitable reality of additional vaccinations. Said he had to lay the foundation for booster shots so that the public could prepare for what he saw.

“What if the White House didn’t take the lead?” Said someone familiar with the behind-the-scenes debate.

Still, the confusion over the plan continues. Pfizer completed its first booster application on August 27, but it is unclear when Moderna and Johnson & Johnson will join the ranks, or when the FDA will approve Pfizer’s submission. Pfizer also has mid-October data to track booster doses administered between 4.8 and 8 months from the first regimen.

Biden’s five-month statement was an “innocent question” by the president after hearing from Bennett that Israel was promoting widespread booster administration, a controversial person said. In reality, the time frame for additional doses depends on the FDA and the companies submitting the data, and they are likely to be in the range of months to get a third dose rather than a specific time period. Added.

Biden’s health officials are still confident that they “have enough information and enough data” to make the call by September 20, a familiar person said. As one health official said, some have pointed out the “clear” benefits of Israeli booster data and additional doses.

However, the sudden withdrawal of two senior officials from the FDA’s Vaccine Division, Biopharmaceutical Evaluation Research Center, has upset many current and former officials who say they resonate at the crucial moment of vaccine regulation. “Supporting CBER’s career staff is very important now. They have so much experience,” Bush-era FDA Commissioner Mark McClellan told POLITICO.

A third dose is only allowed for immunocompromised people, including organ transplant patients, but others who do not fall into that category add under the false belief that the FDA has already given approval. We are in a hurry to get vaccinated. According to the latest CDC data, nearly one million boosters have already been given in the United States.

Helen Talbot, an infectious disease specialist and member at Vanderbilt University, said that “many, many, many” healthcare providers in the southern states, where cases of coronavirus are on the rise, administer to health care workers. A patient with a booster said he had no FDA approval due to confusion over Vanderbilt’s remarks. It is a committee of the Advisory Board on Immunization Practice of the CDC and recommends the use of vaccines.

“This critically highlights the need for vaccine recommendations to go through the normal path and not come out,” she said. During the panel’s Monday meeting.. “It’s very scary to me that healthcare providers trying to do their best work, under the guidance of HHS and the White House, are now at risk.”

Former Trump administration officials have also personally yelled at Biden’s approach to boosters after being looted for putting pressure on authorities on drug and vaccine decisions. During the first year of the pandemic, then-President Donald Trump repeatedly accused the FDA of delaying important vaccine decisions to politically hurt him and sought FDA approval for the unproven treatment hydroxychloroquine. rice field.

“It’s unprecedented,” said one Trump official, saying the Biden administration would announce a specific booster rollout date before regulators consider it. He claimed that while the former president criticized the FDA, he did not say that regulatory movements would occur on a particular date or by a particular date.Mr. Trump said the vaccine is likely before the election day and during aides. Disregard his promise The effect is Cool for vaccine confidence..

In contrast, Biden took office with the promise that scientists, not the White House, will lead these decisions and messages. This is a pledge largely driven by the politicization of vaccines and other public health measures leading up to the election.

However, according to another former Trump official, the president may have regretted his pledge after witnessing the slow pace of data processing by the CDC.

The agency Published 5 studies in the last few weeks — Some have weakened immunity among health care workers, showing more breakthroughs than previously recorded — other Biden officials say breakthrough infections are much higher than previously thought Rather, he says he is worried about collecting state data, which many expect to provide clear evidence.

For the past two months, the CDC has worked with a small group of state health departments to collect data on breakthrough cases, including mild infections. Health departments in several participating states said they submitted the data a few weeks ago, but two senior CDC officials told POLITICO that they were still collecting and analyzing the information. ..

Concerns about the CDC’s pace could color future decisions regarding immunization of infants against Covid-19. As an agency that collects data on infectious diseases and hospitalizations in children, the CDC is in a position to clearly indicate to the FDA how quickly children under the age of 12 should make the transition to access the vaccine.

Biden officials are familiar with the looming dilemma, and those familiar with the debate said they are “trying to pressure them to get the data quickly.”

Erin Banco and David Lim contributed to this report.