The Trump administration wants states to be ready to distribute a coronavirus vaccine two days before the presidential election.
The Centers for Disease Control and Prevention (CDC) has asked state and local health officials to prepare to distribute a potential coronavirus vaccine as soon as late October, amplifying concerns about the federal government rushing a vaccine in order to boost President Donald Trump’s re-election campaign.
Public health experts are concerned that Trump may try to pressure the Food and Drug Administration (FDA) into using its emergency powers to bypass its formal approval process and authorize an unproven coronavirus vaccine before Election Day, Nov. 3. Supporters of such an emergency authorization say it could save thousands of lives, but opponents warn that it could be dangerous and worsen the already -powerful anti-vaccination sentiment in the US.
Those who are worried about the Trump administration rushing a vaccine point to the recent controversy surrounding the FDA’s emergency authorization of blood plasma as a treatment for patients hospitalized with COVID-19. During a press conference announcing that approval, Trump, Health and Human Services Secretary Azar and FDA Commissioner Stephen Hahn cited a faulty statistic that the plasma treatment had reduced deaths by 35%. Experts accused the FDA of grossly misrepresenting data and worried the agency was being co-opted by Trump, and the a National Institutes of Health panel also contradicted the FDA’s decision, saying the therapy “should not be considered the standard of care for the treatment of patients with COVID-19.” Dozens of hospitals around the country have also considered ignoring the FDA’s emergency use authorization for the time being.
Now, experts fear he may be rushing a vaccine. Three coronavirus vaccines are undergoing Phase 3 clinical trials, the final step before seeking approval from the FDA. Data on the efficacy of one or more of these trials is likely to come in November, according to a recent report from Morgan Stanley. But pharmaceutical giant Pfizer, which is behind one of the trials, has also said they believe they’ll have data to present to regulators in October.
Public health experts have said that robust data is critical if the FDA is considering invoking an “emergency use authorization.” That is when the agency issues a temporary approval to speed along public availability of medical products during public health emergencies.
To receive emergency authorization, a product only needs to show that it “may be effective” and that its “known and potential benefits” outweigh the risks. The agency has already invoked the power during the pandemic to authorize hundreds of coronavirus tests and a few treatments, though never a vaccine at this scale.
Dr. Tom Frieden, former head of the CDC, emphasized the difference between the two processes in a tweet on Wednesday.
“Licensing a vaccine requires that it be proven safe and effective. That’s a reasonable standard. If reached, I also would feel comfortable getting a vaccine and recommending to my family,” he wrote. “An Emergency Use Authorization, in contrast, is a much lower standard.”
Supporters of a potential emergency use authorization argue that it could save thousands of lives if used correctly. Former FDA commissioner Scott Gottlieb told the Post that he believes “it is highly likely” the first vaccine or vaccines will be cleared through an emergency use authorization for certain populations, such as health-care workers. He said this would be an appropriate decision “as long as the data shows that the vaccine is safe and that it works.”
The Trump administration pushed back on the idea that it would politicize a vaccine. Health and Human Services Secretary Azar said the Nov. 1 deadline for states had nothing to do with the presidential election just two days later. He said “career people at CDC” came up with the deadline, implying that political appointees such as himself weren’t involved.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccine approval, told the Washington Post their “intention … is not to give the American public anything less than a gold standard.”
Dr. Anthony Fauci, a career government official and the nation’s top infectious disease official, told Kaiser Health News (KHN) that he was “not concerned about political pressure.”
Fauci said a vaccine could be available earlier than expected if the clinical trials produced overwhelmingly positive results. While those trials are not expected to end until the end of the year, Fauci said an independent board of non-governmental vaccine experts could end the trials weeks early if interim results are overwhelmingly positive or negative.
Rachel Levine, MD, president of the Association of State and Territorial Health Officials (ASTHO) and Secretary of Health at the Pennsylvania Department of Health, said Thursday that her organization opposes authorizing the use of a vaccine prior to the end of phase 3 clinical trials.
“The nation’s health officials strongly encourage FDA to require the completion of phase 3 trials—or an equally rigorous evaluation—prior to approving a COVID-19 vaccine,” Levine said in a statement.
The consequences of this controversy and of fears over vaccine politicization could be profound for a country that is already skeptical of vaccinations. Only 49% of Americans said they would definitely get a vaccine, according to a May poll from AP-NORC Center for Public Affairs Research. One in five said they would refuse to get a vaccine and another 31% said they weren’t sure.
Rushing a vaccine that is already being developed at an unprecedented pace could accelerate vaccine skepticism. “If the public doesn’t trust the authorization process and sees it as politically influenced, what is vaccine uptake going to be?” John Moore, a virologist at Weill Cornell Medicine, told the Post.
This could make it more difficult for the US to reach herd immunity, which most experts say requires the nation to vaccinate about 70% of its population—or 200 million people.
The debate is likely to heat up in the coming weeks, but it may ultimately prove moot. Moncef Slaoui, who is leading the federal government’s ‘Operation Warp Speed’ vaccine effort, said on Thursday that a vaccine by late October was “extremely unlikely.”
“There is a very, very low chance that the trials that are running as we speak could read before the end of Oct.,” Slaoui told NPR. “And therefore, there could be—if all other conditions required for an [emergency use authorization] are met—an approval. I think it’s extremely unlikely but not impossible.”
Slaoui said he expected a vaccine to be approved this year and to have enough doses produced to immunize “between 20 and 25 million people,” by the end of 2020, and the rest of the American population by mid-2021.