September 9, 2020

Drugmakers and FDA are trying to calm Americans' fears about a coronavirus vaccine. Will it work?

Daily Briefing

    Recent polls suggest that a sizeable portion of Americans say they won't get a coronavirus vaccine once one becomes available, which could threaten the country's ability to control its epidemic. Here's why—and the steps FDA and leading drugmakers are taking steps to assuage Americans' concerns.

    A vaccine approval is coming. Get ready to ask these 8 questions.

    Why many Americans won't get a coronavirus vaccine

    A Gallup poll of 7,632 adults conducted between July 10 and August 2 found that one in three Americans said they wouldn't get a new coronavirus vaccine if it had been available at that time. Gallup asked respondents if they'd get a coronavirus vaccine if there had been a no-cost, FDA-approved vaccine available at the time of the survey, and 65% of respondents said they would, while 35% said they wouldn't.

    According to the Wall Street Journal, a separate Harris Poll survey published in late August had similar results, with around 30% of respondents saying they would be unlikely to get a new coronavirus vaccine. And a new poll from CBS News and YouGov published Sunday found that 21% of respondents said they'd get a no-cost coronavirus vaccine immediately if one becomes available this year, while 58% said they'd wait to see how the vaccine affects others before getting it themselves and 21% said they'd never get a coronavirus vaccine.

    Meanwhile, a survey by USA Today and Suffolk Poll published Friday found an even greater share of respondents who expressed hesitancy about a coronavirus vaccine, with 67% saying they either would never get the vaccine or that they'd would wait to see how others who got it fared. And a poll by Jarrard Phillips Cate & Hancock that surveyed 1,101 Americans in early August found two out of five health care workers participating in the poll said they were either on the fence about or unlikely to get a coronavirus vaccine.

    Kathryn Edwards, scientific director of the Vanderbilt Vaccine Research Program, said, when combined, the survey results show that more than just a small fraction of the American public are hesitant to get a coronavirus vaccine once one becomes available—and that people could be hesitant to get a coronavirus vaccine because of fear that the inoculation was rushed.

    Edwards' theory was backed up by findings from the recent CBS News/YouGov poll, which found that 65% of respondents said they believe a coronavirus vaccine produced before the end of 2020 would be the result of "rushed" production with insufficient testing, as opposed to a scientific breakthrough. Likewise, a recent poll conducted by STAT News and the Harris Poll found that 78% of respondents said they were worried the approval process for a coronavirus vaccine is being driven more by politics than science.

    Black Americans are especially unlikely to get a new coronavirus vaccine, according to modeling from Matt Motta, a political scientist at Oklahoma State University. Motta's research, which was published August 12, found that Black Americans are about 40% more likely to refuse a coronavirus vaccine than white Americans.

    According to Zinzi Bailey, a social epidemiologist at the University of Miami, Black Americans' reservations about a coronavirus vaccine stem from "historically rooted, long-standing issues" tied to past events in which Black communities were exploited and injured by medical research. "I think a lot of people feel like they're going to be experimented on," and "[w]ords like 'warp speed' are not reassuring in this case," she said, referring to the Trump administration's Operation Warp Speed initiative for a coronavirus vaccine.

    And NIH Director Francis Collins has acknowledged that the name "Operation Warp Speed" potentially "isn't helping here because it sounds as if that might include some cutting of corners that would increase the likelihood that this vaccine isn't really safe and isn't really effective."

    But assuring Americans that a coronavirus vaccine is safe and effective, and ensuring a large portion of Americans get the vaccine, is vital to controlling America's coronavirus epidemic, public health experts say.

    "If you have 330 million doses of vaccine and nobody wants it, it accomplishes nothing. You've got to use the vaccine. It's just as important as how effective the vaccine is," David Salmon, a professor at the Bloomberg School of Public Health at Johns Hopkins University, explained. "You probably need between 70% and 80% of the population to get immune in order to really control Covid[-19]. And when I say immune, I mean both get the vaccine and the vaccine worked for them."

    How FDA, HHS are responding

    FDA is trying to address Americans' concerns by promising to share with the public as much data on potential coronavirus vaccines as possible and ensure the public that independent experts will review the data.

    For instance, in a blog post published in Health Affairs in mid-August, FDA Commissioner Stephen Hahn and two physicians at FDA—Anand Shah and Peter Marks—detailed the steps the agency will take to "offer reassurance that any potential vaccine will be safe and effective." They wrote, "First, the agency established clear recommendations for vaccine performance prior to the initiation of Phase 3 trials to provide assurance that any authorized vaccine will meet appropriate standards for safety and effectiveness." And, "[s]econd, FDA has committed to use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public," they continued.

    Further, Bloomberg reports that Hahn last week sent an email to all FDA staff that stated the agency will adhere to science in its reviews of coronavirus vaccine candidates and follow guidelines the agency issued in June, which state that any coronavirus vaccine candidates would need to be at least 50% effective to be considered for approval.

    According to officials who spoke with Bloomberg, FDA will apply that guidance to any applications for coronavirus vaccine candidates that the agency receives, whether those application seek the agency's traditional, full approval or an emergency use authorization. FDA also has said it will leave the decision of when to submit an experimental coronavirus vaccine for approval or authorization up to the drugmakers developing and testing the vaccine candidates, Bloomberg reports.

    In addition, HHS has announced that it plans to launch a public awareness campaign on television, radio, and social media that will focus on coronavirus vaccine safety and efficacy, as well as the hesitancy Americans are feeling about it. Collins said that campaign will most likely feature medical experts alongside celebrities.

    And Hahn in a series of tweets posted Tuesday said he will use Twitter "and other venues" to "highlight FDA's work, process, and important considerations of FDA's professional staff related to bringing a safe & effective [Covid-19] vaccine to the American public."

    How drugmakers are looking to alleviate vaccine concerns

    Drugmakers, too, are looking to address Americans' concerns about a coronavirus vaccine.

    In response to Americans' skepticism that FDA is facing political pressure to authorize a coronavirus vaccine before the upcoming presidential election, a group of nine drugmakers on Tuesday issued a statement pledging that they will not submit a coronavirus vaccine candidate for federal approval until they've gathered and analyzed enough data from large, late-stage clinical trials to ensure the vaccines' safety and efficacy.

    Officials from AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi signed the statement. It states the companies pledge to "only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA."

    During an interview on the Today show on Tuesday, Pfizer CEO Albert Bourla said the pledge is historic. "With increasing public concerns about the processes that we are using to develop these vaccines and even more importantly the processes that will be used to evaluate the vaccines, we thought it was critical to come out and reiterate our commitment," he said.

    Do those efforts go far enough to address Americans' concerns?

    However, despite these efforts, some public health experts are skeptical of whether the federal government's and drugmakers' efforts go far enough to adequately assuage Americans' concerns about a coronavirus vaccine.

    For instance, Eric Topol, founder and director of the Scripps Research Translational Institute, in a tweet noted that drugmakers' statements "doesn't say outright that they will wait until completion of Phase 3 [trials] and its analysis before seeking any approval" of their vaccine candidates—a fact he called "[d]isturbing."

    And when it comes to the federal government's response, some experts say the Trump administration needs to do more, faster, to address Americans' fears.

    "The response should be done at a massive scale," Saad Omer, director of the Yale Institute for Global Health, said. "Pandemics have large impacts on the overall population. So communication and intervention efforts should match that impact" (Hopkins, Wall Street Journal, 8/28; Elbeshbishi/King, USA Today, 9/7; De Pinto, CBS News, 9/6; Resnick, Vox, 9/4; O'Keefe, Gallup News, 8/7; Kacik, Modern Healthcare, 8/28; Edney et. al., Bloomberg, 9/8; Hahn tweets, 9/8; Chappell, NPR, 9/8; Smith-Schoenwalder, U.S. News & World Report, 9/8).

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