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Trump to FDA: Why is Europe beating us on vaccine?


DECEMBER 1, 2020

President Donald Trump listens as FDA Commissioner Dr. Stephen Hahn, left, speaks during a media briefing at the White House on Aug. 23, 2020. – Alex Brandon/AP Photo

A president who preached “America First” is demanding to know why the United States could end up third, or worse, in the global vaccine race.

President Donald Trump and his deputies are privately admonishing Food and Drug Administration officials for not moving faster to authorize promising coronavirus vaccines — a push partially motivated by Trump’s desire to claim credit for record-fast vaccine development, four officials said.

HHS Secretary Alex Azar and White House Chief of Staff Mark Meadows grilled Commissioner Stephen Hahn and other top FDA officials in meetings this week on their decisions to require more rigorous review of initial data from the first vaccine candidates. In particular, they questioned why the agency won’t authorize a vaccine until after Dec. 10 at the earliest — about a month after Pfizer first reported that its shot was more than 90 percent effective, and roughly three weeks after Moderna announced similarly impressive findings. Multiple Trump appointees and even some career civil servants have argued that every day of delay could make a difference for the most vulnerable populations in a life-threatening pandemic.

This week’s news that the U.K. could authorize a vaccine on Dec. 7 — several days before the FDA is likely to greenlight one — further angered White House officials who view having the West’s first authorized vaccine as a key element of Trump’s legacy.

“It’s crazy to imagine the European Union or U.K. may approve a vaccine developed in the United States before us though, right?” said a senior official involved in the process.

The U.S. vaccine development effort still is moving at a historic clip, with the first shot due to be authorized less than a year after the coronavirus’ genetic sequence was first shared. The fastest vaccine developed up to this point, for mumps, took four years to reach the market, and FDA reviews like the one underway would normally take up to 10 months.

“While we are certainly working around the clock, we do feel that responsibility to move quickly, but we know we need to do our job…to make sure that any vaccine meets our high standard of safety and efficacy,” Hahn told state governors on a call convened by the White House on Monday, according to notes from the call obtained by POLITICO.

Some officials acknowledge the political overtones: Trump continues to privately argue that drugmakers held back on their promising vaccine findings until after Election Day, and other senior officials are channeling frustrations about losing the election and have settled on the FDA as a scapegoat. Many of the factors fueling the worsening pandemic — with nearly 200,000 new cases being reported across the United States per day, as Americans continue to flout mask guidelines and mingle in person — are also beyond the control of the FDA and won’t be affected if the agency rushes the vaccine by a few extra days, experts note. Only a fraction of Americans will get the initial 40 million vaccine doses covering 20 million people that are expected to be made available this month.

HHS Secretary Alex Azar convened a meeting on Monday with Hahn and more than a half-dozen senior health officials, including FDA’s chief vaccine regulator, Peter Marks, and the acting head of the agency’s drug division, Patrizia Cavazzoni, where the group ran through the state of the process and what needs to be done, according to three people with knowledge of the meeting. Azar has been holding a series of similar meetings since October.

“Azar has now kind of bypassed the commissioner,” a senior HHS official said. “He’s trying to get his house in order — timelines, ‘what do you need,’ ‘what can we do to help.'”

“He’s asking questions that a CEO should ask,” the senior official added. “In turn, these are questions that Commissioner Hahn — as CEO of the FDA — should be asking, but he’s not.”

Meanwhile, Hahn was summoned to a meeting with White House Chief of Staff Mark Meadows on Tuesday, where he briefed officials on vaccine development, as top Trump appointees continue to press the commissioner on his decisions.

Axios first reported on Monday night that officials were unhappy that Hahn spent a week last month in the Outer Banks of North Carolina, which FDA defended as the commissioner’s decision to quarantine after a coronavirus exposure at the agency’s headquarters. The revelation prompted widespread confusion within the administration, with some FDA officials wondering why they weren’t alerted about Hahn’s exposure. Still, officials who have interacted with Hahn in recent weeks said there was no indication it had slowed his work.

An HHS spokesperson and an FDA spokesperson declined to comment on internal meetings. “Commissioner Hahn remains focused on the FDA’s important, science-based public health work on behalf of the American public and supporting the agency’s career staff of more than 17,000 strong,” the FDA spokesperson said in a statement.

“Science and data are driving the development of vaccines and therapeutics, from research and development to large-scale clinical trials,” the HHS spokesperson said. “All medical protocols will be executed to standard, and the FDA will have final, independent approval authority to determine safety and efficacy, using its rigorous, scientific criteria.”

The White House didn’t respond to a series of questions for this article.

Some of the questions circulating in the White House echo concerns raised by outside public health experts, who also have urged haste as the pandemic worsens.

“Every day that goes by is 2,000 people dead. I don’t know another circumstance where waiting on drug approval has such an impact on mortality,” said Walid Gellad, the director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “The implications of this are huge medically, if you put aside politics.”

Gellad argued that FDA was constrained by its October decision to require drugmakers to provide two months of safety data before applying for emergency authorization for a vaccine. “Sometimes in a crisis, you might have to cut corners,” he added.

Some top Trump appointees have argued that Hahn should have found ways to cut government red tape, rather than create what have been perceived as additional barriers, like the decision to require additional data before granting an emergency-use authorization.

“The grumbling is that the bar has been moved closer and closer to what a full licensure would look like, thus delaying vaccine access,” added a senior HHS official. “If you truly follow the legal definitions of an EUA, the vaccine could’ve been authorized weeks ago, and what we’re doing now would be closer to reviews for licensure.”

FDA officials have insisted that they’re following the science while moving as fast as possible, pointing to the need to review safety and efficacy data on vaccines before making them available to hundreds of millions of people. Hahn and other top agency officials have also taken steps to make the vaccine review process as transparent as possible, even as polls show that roughly 40 percent of Americans are hesitant to take a Covid-19 shot — in part because of fears the development and review process has been politicized.

Those FDA officials are also aware of the deepening anger from the White House, which has spent months sparring with Hahn over his determination that potential Covid-19 vaccines clear a high bar for both safety and effectiveness.

Hahn in recent weeks has ceded much of the management of the vaccine process to career civil servants led by Marks — an approach that the commissioner’s allies said is meant to build public trust in a vaccine and shield the agency’s scientists from political pressure.

Yet that decision has decimated Hahn’s own reputation within the White House, with officials complaining he has only made it more difficult for them to evaluate the FDA’s progress toward authorizing a vaccine.

Hahn on several occasions has justified shielding information about the FDA’s work from HHS and White House officials by citing restrictions around the agency’s sharing of commercial confidential information, a senior administration official said.

And while Hahn in conversations with public health expert Eric Topol has indicated he plans to stay on through the entirety of the transition, he has also acknowledged he has few allies in the White House and could be dismissed at any time.

“He knows that the support is not strong,” Topol told POLITICO. “He’s been on thin ice ever since October.”

During one such call Monday night, Topol said Hahn voiced concerns his Tuesday meeting with Meadows would end with his firing — but also vowed not to buckle if pressured to speed the authorization process.

Senior HHS officials acknowledge that White House pressures earlier this year — including Trump-backed efforts to authorize malaria drug hydroxychloroquine and speed convalescent plasma as coronavirus treatments, despite a lack of evidence — have left deep scars inside the federal health agencies. Marks, who helped conceive the government’s Operation Warp Speed project, has repeatedly raised concerns about politicization of science, bristling in recent meetings at questions that he’s argued are inappropriate, said two officials.

Meanwhile, Hahn has publicly pledged to “fight for science,” a commitment he’s repeated privately to the array of civil servants who serve as his top deputies.

“Commissioner Hahn is right to defer to the agency’s career scientists,” said Rachel Sachs, a health law professor at Washington University in St. Louis. “They’re moving much faster than normal to review this product.”

Courtesy/Source: Politico