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This week’s news that the UK could authorize a vaccine on December 7 – several days before the FDA likely gives the green light – has further angered White House officials who consider the first vaccine authorized. by the West is a key part of Trump’s legacy.
“It’s crazy to imagine that the European Union or the United Kingdom could approve a vaccine developed in the United States before us, right?” said a senior official involved in the process.
The vaccine development effort in the United States is still advancing at an historic rate, with the first shot due to be cleared within a year of the first sharing of the coronavirus genetic sequence. The fastest vaccine to date, against mumps, took four years to reach market, and FDA reviews like the one underway would normally take up to 10 months.
“While we certainly work around the clock, we feel this responsibility to act quickly, but we know we have to do our job … to make sure that any vaccine meets our high standards for safety and efficacy.” Hahn told state governors. an appeal summoned by the White House on Monday, according to the appeal notes obtained by POLITICO.
Some officials acknowledge the political overtones: Trump continues to argue privately that drugmakers withheld their promising vaccine findings until election day, and other senior officials channel their frustrations over the loss of the election and have chosen the FDA as their scapegoat. Many of the factors fueling the worsening pandemic – with nearly 200,000 new cases reported across the United States per day, as Americans continue to flout mask guidelines and meddle in person – are also unrelated of the will of the FDA and will not be affected if the agency rushes the vaccine a few more days, experts note. Only a fraction of Americans will receive the initial 40 million doses of vaccine covering 20 million people which should be available this month.
HHS Secretary Alex Azar on Monday called a meeting with Hahn and more than half a dozen senior health officials, including FDA senior vaccine regulator Peter Marks and acting chief of the agency’s pharmaceutical division, Patrizia Cavazzoni, where the group went through the state of the process and what needs to be done, according to three people with knowledge of the meeting. Azar has held a series of similar meetings since October.
“Azar has now sort of bypassed the commissioner,” said a senior HHS official. “He’s trying to get his house in order – the deadlines, ‘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 himself, but he is not.”
Meanwhile, Hahn was called to a meeting on Tuesday with White House Chief of Staff Mark Meadows, where he briefed officials on vaccine development, as the principals appointed by Trump continue to pressure the commissioner for his decisions.
Axios first reported on Monday evening that officials were unhappy that Hahn spent a week last month in the Outer Banks of North Carolina, which the FDA defended as the commissioner’s decision to quarantine after a exposure to the coronavirus at the agency’s headquarters. The revelation caused widespread confusion within the administration, with some FDA officials wondering why they had not been alerted to Hahn’s exposure. Still, officials who have interacted with Hahn in recent weeks said there was no indication that it had slowed down his work.
An HHS spokesperson and an FDA spokesperson declined to comment on the internal meetings. “Commissioner Hahn remains focused on the important scientific public health work of the FDA on behalf of the American public and supports the agency’s career staff of more than 17,000 people,” the FDA spokesperson said in a press release.
“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 performed according to standards, and the FDA will have the final, independent approval authority to determine safety and efficacy, using its rigorous scientific criteria.”
The White House did not 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 have also called hastily as the pandemic worsens.
“Every passing day kills 2,000 people. I don’t know of any other circumstance where waiting for drug approval has such an impact on mortality,” Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing, told the University of Pittsburgh. . “The implications of this are enormous medically, if you put politics aside.
Gellad argued that the FDA was pressured by its October decision to require drugmakers to provide two months of safety data before seeking emergency clearance for a vaccine. “Sometimes in a crisis you may have to cut costs,” he added.
Some Trump appointees have argued that Hahn should have found ways to cut government red tape, rather than creating what were seen as additional hurdles, like the decision to require additional data before granting an emergency use authorization.
“The rumble is that the bar has been shifted closer and closer to what a full license to practice would look like, thereby delaying access to the vaccine,” added a senior HHS official. “If you really follow the legal definitions of an EUA, the vaccine could have been licensed weeks ago, and what we do now would be closer to the licensing reviews.”
FDA officials have insisted they are following the science while moving forward as quickly as possible, stressing the need to review vaccine safety and efficacy data before making it available to hundreds of millions. of people. Hahn and other senior agency officials have also taken steps to make the vaccine review process as transparent as possible, even as polls show around 40% of Americans are reluctant to take a Covid vaccine. 19 – partly because of development and examination fears. process has been politicized.
These FDA officials are also aware of the growing anger of the White House, which has spent months fighting with Hahn for his determination to get potential Covid-19 vaccines to pass the high bar in terms of safety and health. efficiency.
Hahn has handed over much of the management of the vaccination process over the past few weeks to career officials led by Marks – an approach which the Commissioner’s allies say is aimed at boosting public confidence in a vaccine and protecting scientists from the political pressure agency.
Yet the move decimated Hahn’s own reputation in the White House, with officials complaining that it only made it more difficult for them to assess the FDA’s progress toward clearing a vaccine.
Hahn has repeatedly justified protecting information about the FDA’s work from HHS and White House officials by citing restrictions on the agency’s sharing of confidential business information, a senior official said. ‘administration.
And although Hahn, in conversations with public health expert Eric Topol, has indicated that he plans to stay throughout the transition, he also admitted that he has few allies in the White House and that he could be fired at any time.
“He knows the support is not strong,” Topol told POLITICO. “He’s been on thin ice since October.”
On such a call Monday night, Topol said Hahn had expressed concern that his Tuesday meeting with Meadows would end with his dismissal – but also vowed not to distort himself if he was in a hurry to speed up the process. authorization.
Senior HHS officials acknowledge that pressure from the White House earlier this year – including Trump-backed efforts to authorize hydroxychloroquine and accelerate convalescent plasma as treatments for coronaviruses, despite a lack of evidence – have left deep scars on federal health agencies. Marks, who helped design the government’s Operation Warp Speed project, has repeatedly raised concerns about the politicization of science, bristling in recent meetings at questions that he says are inappropriate, two officials said.
Meanwhile, Hahn has publicly pledged to “fight for science,” a pledge he has privately repeated to all the officials who are his main deputies.
“Commissioner Hahn is right to defer to the agency’s career scientists,” said Rachel Sachs, professor of health law at Washington University in St. Louis. “They are going much faster than usual to evaluate this product.”
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