Trump attacks FDA plan for tougher standards on emergency vaccine approval as a ‘political move’



“I don’t see why it should be delayed further,” he said. “That is a lot of lives you’re talking about.”

His comments raised questions about the integrity of the vaccine approval process on the same day that four top administration health officials, including FDA Commissioner Stephen Hahn, in a Senate hearing, tried to reassure the public that any vaccine decision would be free of political interference and based strictly on data reviewed by FDA career scientists.

Trump suggested that the vaccine makers were getting good results in their late-stage trials. In fact, the trials have not produced any results — it’s too early. The White House, the FDA and the companies do not know yet whether the vaccines work.

Trump has been predicting for months that a vaccine could be available before Election Day. The proposed FDA standards, if implemented, would make that highly unlikely, according to two people familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public. More likely, vaccines would be cleared in mid- to late November or December, or even later.

The FDA’s plan is part of an effort by the agency to increase transparency and build public trust in the vaccine — something that has been difficult given the White House’s repeated interfering with government health agencies. But Trump said late Wednesday that the plan “has to be approved by the White House. We may or may not approve it.”

During the hearing before the Senate Committee on Health, Education, Labor and Pensions, top health officials sought to dispel accusations that the federal response to the coronavirus pandemic is being driven by politics, with each official saying he would trust a vaccine enough to take it himself.

Hahn said the decision on whether a vaccine is safe and effective will be made by the agency’s career scientists, following “the science and data and our rigorous standards.”

“FDA will not permit any pressure from anyone to change that,” he said.

Hahn said he could not predict when the companies developing the vaccine candidates that are furthest along in clinical trials would be ready to apply for federal clearance — or how long that FDA assessment might take.

“What I can tell you is, we do feel the urgency of the moment,” he said. “We will not delay, but we will not cut corners.”

FDA officials have indicated they might permit a vaccine under an emergency authorization — a simpler and far quicker path than a full-fledged approval process. But they have said that they would use most of the standards that are required for a full approval.

The proposed FDA guidance, for instance, would request two months’ safety follow-up data after the second vaccine shot.

Hahn’s emphasis on the scientific judgment of the agency’s nonpolitical staff was part of an attempt by all four officials to counter concerns that Trump has politicized the nation’s worst public health crisis in more than a century. Critics say the president has downplayed the pandemic’s gravity as he repeatedly claims it is nearing an end, marginalized some government scientists responsible for managing the government’s response, and pushed others to alter their recommendations.

Four companies have begun late-stage clinical trials in the United States. AstraZeneca’s is now on hold in this country as regulators investigate whether its vaccine candidate caused a serious neurological problem in a participant in Britain. The pace of the vaccine trials will depend on how quickly participants become infected with the novel coronavirus.

Hahn also reiterated his agency’s commitment to asking its outside panel of vaccine experts for advice on every vaccine application.

He said he would be willing to get any vaccine his agency deems safe and effective — and to encourage his family to do so. That sentiment was echoed by Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases; Brett Giroir, an assistant secretary of the Department of Health and Human Services who coordinates federal coronavirus testing efforts, and CDC Director Robert Redfield.

Democrats on the panel grilled Redfield about instances in which his agency altered or even reversed published guidance about the pandemic.

Sen. Patty Murray (Wash.), the committee’s senior Democrat, focused on testing guidelines, noting that late last month, the agency revised its advice, saying that people who show no symptoms but have been exposed to an infected person “do not necessarily need a test.”

“I’m concerned about why CDC put out guidance that contradicted the widespread views of the medical and public health community, was not drafted by CDC scientists and did not undergo CDC’s strict scientific review process,” Murray said.

Redfield reiterated a previous explanation that the late-August guidelines had not meant to suggest that no one without symptoms should get a test. But he said the CDC revised its testing advice again last week because people were finding it confusing.

He also adhered to a prediction he gave at another Senate hearing this month that it might take until June or July for the public to be fully vaccinated — a comment that prompted a public rebuke from Trump. Redfield elaborated on his previous remarks, saying that 700 million doses probably will be manufactured by March but that it will take a few more months for everyone to get two shots, as most of the prospective vaccines would require.



First Published at www.washingtonpost.com on 2020-09-24 05:50:50

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