Trump to FDA: Why beat Europe for vaccination?

This week’s news that the UK could allow the vaccine to be allowed on Dec. 7 – a few days before the FDA is likely to turn green – further angered White House officials that the West’s first approved vaccine was a key part of Trump’s legacy.

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

U.S. vaccine development efforts are still progressing at a historic clip, with the first recording allowed less than a year after the coronavirus genetic sequence was first shared. The fastest vaccine developed to date for mumps lasted four years market, and FDA reviews, as ongoing, typically take 10 months.

“While we certainly work around the clock, we feel this responsibility for fast movement, but we know we need to do our job … to ensure that any vaccine meets our high level of safety and effectiveness,” Hahn told state governors in a call. convened by the White House on Monday, according to notes from a POLITICO call.

Some officials note the political overtones: Trump continues to privately claim that drug manufacturers withheld their promising vaccination results until election day, while other senior officials spread disappointments over the loss of the election and settled as scapegoats in the FDA. Many of the factors that are contributing to the worsening epidemic — nearly 200,000 new cases are reported daily in the United States as Americans continue to take mask guidelines and personally mix — are also beyond FDA scrutiny and will not be affected if the agency does a few extra days hastened the vaccination – experts note. Only a fraction of Americans receive the initial 40 million doses of the vaccine It covers 20 million people which are expected to be available this month.

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

“Azar has now bypassed the commissioner somewhat,” a senior HHS official said. “He’s trying to put his house in order – schedules, ‘what you need,’ ‘what we can do to help.’

“It raises questions that the CEO should ask,” the senior official added. “But these questions should be asked by Commissioner Hahn, as the CEO of the FDA, but not.”

Meanwhile, Hahn was invited to a meeting with Mark Meadows, the chief of staff of the White House, on Tuesday, where he briefed officials on the development of vaccines, whereas Trump’s top appointees continue to put pressure on the commissioner over his decisions.

Axios first reported Monday night that officials were unhappy that Hahn spent a week last month in North Carolina’s external banks, defended by the FDA as a decision to quarantine the commissioner after being exposed to a coronavirus at the agency’s headquarters. The revelation caused widespread confusion in the administration, with some FDA officials wondering why they had not been warned of Hahn’s exposure. Nevertheless, officials who have been in contact with Hahn in recent weeks say there is no indication that this has slowed his work.

An HHS and FDA spokesman declined to comment on the internal meetings. “Commissioner Hahn will continue to focus on the FDA’s important, science-based public health work on behalf of the U.S. public and support the agency’s career of more than 17,000 people,” an FDA spokesman said in a statement.

“Science and data drive the development of vaccines and therapies, from research and development to large-scale clinical trials.” an HHS spokesman said. “All medical protocols will be implemented to a standard and the FDA will have a final, independent approval authority to determine safety and efficacy based on strict scientific criteria.”

The White House did not answer the question in the article.

Some of the issues circulating in the White House also echo the concerns raised by external public health experts, who also urged the rush to worsen the epidemic.

“Every day, 2,000 people die. I don’t know of another circumstance where waiting for a drug to be approved would have such an effect on mortality,” said Walid Gellad, director of the Center for Pharmaceutical Policy and Prescription at the University of Pittsburgh. . “It has medically huge consequences if you put politics aside.”

Gellad argued that the FDA was constrained by its October decision to require drug manufacturers to submit two months of safety data before applying for an emergency license for a vaccine. “Sometimes in a crisis, you may have to cut corners,” he added.

Some Trump nominees argued that Hahn should have found ways to cut government bureaucracy instead of creating additional hurdles, such as the decision to need more data before granting permission for emergency use.

“The growl is that the bar has gotten closer and closer to what a full license might look like, thus delaying access to vaccines,” one senior HHS official added. “If you really follow the legal definitions in the EUA, the vaccination could have been authorized weeks ago, and what we’re doing now would be closer to reviewing the authorization.”

FDA officials have insisted on following science as quickly as possible, pointing to the need to review data on the safety and effectiveness of vaccines before making them available to hundreds of millions of people. Hahn and other agency leaders have also taken steps to make the vaccine review as transparent as possible, even though polls show that roughly 40 percent of Americans are hesitant to make a Covid-19 shot – partly fears of development and review due to. process is politicized.

FDA officials are also aware of the deep anger of the White House that has spent months saving Hahn over its determination that potential Covid-19 vaccines are a high standard for both safety and efficacy.

In recent weeks, Hahn has handed over much of the control of the vaccination process to Marks-led career civil servants – an approach the commissioner’s allies have said is designed to build public confidence and protect the agency’s scientists from political pressure.

Yet this decision destroyed Hahn’s own reputation in the White House, with officials complaining that it only made it difficult for them to assess the FDA’s progress towards vaccination approval.

Hahn has repeatedly argued for 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 administration official said.

And while Hahn, in conversations with public health expert Eric Topol, indicated that he still wanted to sustain the transition in its entirety, he also acknowledged that he had few allies in the White House and could be fired at any time.

“You know the support is not strong,” Topol told POLITICO. – It’s been on thin ice since October.

During such a Monday night call, Topol said Hahn expressed concern that his meeting with Meadows on Tuesday would end with his dismissal – but he also vowed not to join if pressure was put on him to speed up the permitting process.

Senior HHS officials acknowledge that White House pressure earlier this year, including Trump-backed efforts to authorize the malaria drug hydroxychloroquine and rapid-healing plasma as a coronavirus treatment, has left deep scars in the federal government, despite a lack of evidence. health agencies. Marks, who helped plan the government’s Warp Speed ​​operation, has repeatedly raised concerns about the politicization of science and has slipped on recent meetings on issues he thinks are inappropriate, two officials said.

Meanwhile, Hahn has publicly promised to “fight for science”. He reiterated this commitment in private to the civil servants who served as his chief deputies.

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