FDA moves on vaccines spark political worries

Public health officials are taking aim at the Food and Drug Administration (FDA), warning it should not bow to political pressure and clear a COVID-19 vaccine before one is ready. 

The officials say they are unnerved over the pressure cranked up by the president, and worry it will contribute to distrust in the public health system that could actually lead people to not feel confident about a vaccine.

They also worry the FDA will be rushed in its work to boost President Trump’s reelection chances. 

“I think Trump is setting up a no-win scenario on vaccines. The rush to distribute before completing trials means that even if the vaccine is effective, we won’t have proof, people will be reluctant to take it, and its perception will be tainted,” said Jeremy Konyndyk, former head of USAID’s Office of Foreign Disaster Assistance under President Obama and current senior fellow at the Center for Global Development.

“Rushing it to the public before it is proven is a remarkably damaging move. But the motive here is clearly politics, not public health,” said Konyndyk.

FDA Commissioner Stephen Hahn recently mentioned the possibility of ending clinical trials early if the benefits outweigh the risks.

“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said in an interview with the Financial Times. “If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

Trump administration officials have said they hope the FDA will approve a safe and effective vaccine by the end of the year.

Administration health officials have taken pains to reassure the public that health agencies are independent from political persuasion, especially when it comes to a potential coronavirus vaccine.

“The FDA has been very explicit that they are going to make a decision based on the data as it comes in. These trials have these independent data and safety monitoring boards that intermittently look at the data,” Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, said in a CNN interview. 

“Data has always been the thing that has driven me and my colleagues here at the NIH [National Institutes of Health] as well as the FDA. The FDA and the CDC [Centers for Disease Control and Prevention] they’re data-driven organizations. So I think that people can feel confident that when these data come in they’ll be examined appropriately and a decision made,” Fauci said. 

But critics say they’re worried about various signals.

This week, the CDC told states to start preparing for distribution of a vaccine as early as Nov. 1, part of an unusual planning process happening while clinical trials are still underway.

Some outside experts said the memo was innocuous, and was meant to ensure states are preparing for the massive infrastructure challenge of vaccine distribution.   

Besides the memo, the botched rollout on the authorization of convalescent plasma and the changes made to the CDC testing guidelines have further fueled concerns that the FDA is rushing to approve a vaccine before Election Day.

States have also expressed their concerns over the messages coming from the administration, especially about possibly authorizing a vaccine before clinical trials are completed. 

“The safety and efficacy of vaccines is paramount to protecting the health of the American public and to building confidence in our state and territorial immunization programs,” said Rachel Levine, president of the Association of State and Territorial Health Officials and Pennsylvania’s health secretary. 

“In these unprecedented times, the federal government must uphold a key principle of medical practice to ‘do no harm,’ ” she said.

The Washington State Department of Health on Wednesday issued a rare statement emphasizing that it would not distribute a vaccine until phase three trials were complete, unless an independent board of scientists says otherwise.

“At this crucial juncture, it is incumbent upon the federal government to critically evaluate these new vaccines for their safety and efficacy in an unbiased way” the state said.

Stephanie Zaza, a former CDC scientist and president of the American College of Preventive Medicine, said she wasn’t surprised by the statement from Washington, because states are finding themselves in an unprecedented situation.

“I think that what you’re hearing from the state health department is saying, well, we won’t be responsible for distributing a vaccine that hasn’t been proven to be safe and effective,” Zaza said. 

“And they shouldn’t have to say that, but this political rhetoric has pushed them into a situation where now they have to make these kinds of statements in order to gain the confidence of their constituents,” Zaza said.

Zaza said she wishes Trump had let experts like Fauci have the freedom to speak from the start of the pandemic, instead of trying to put his own stamp on the messaging.

She said it’s up to the heads of the agencies to start speaking out now, before public trust is completely eroded.

“I have absolute confidence in my [former] colleagues within the executive branch of government that they are … doing absolutely the best thing that they can do, so now it’s really about the leadership in those agencies to speak the truth, to be transparent and to push back when things are being said that are not true, and that are not scientifically correct,” Zaza said.

Reid Wilson contributed.