Joanna Moon / Sun Graphic Designer

November 2, 2020

Concerns Over Safety Challenge Presidential Candidates’ Vaccine Plans

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As COVID-19 continues to dominate the political backdrop of the 2020 presidential election, the candidates’ plans for promoting public health and eventually distributing a vaccine have taken on outsized importance as voters head to the polls. 

For former Vice President Joe Biden, determinations of vaccine safety and efficacy should be left exclusively in the hands of scientists. His platform states that clinical trial data will be made public for any vaccine approved by the Food and Drug Administration, and he plans to invest $25 billion into manufacturing and distributing a vaccine. 

Biden said that Americans will be able to receive the vaccine at no cost, but does not explicitly target a date by which a vaccine should be approved. 

President Donald Trump has also planned to make a future vaccine cost-free but, in contrast to Biden, promises to produce and distribute 300 million doses of a vaccine by January 2021. 

To accelerate the process, government agencies, such as the Department of Health and Human Services, have supported the manufacturing of vaccine candidates prior to their receiving final approval. This proactive step will allow for faster distribution once a vaccine is finally deemed effective and approved for use. 

Dr. Anthony Fauci M.D. ’66 said he is “cautiously optimistic” that “we will get a positive answer in at least one and maybe two or more of the vaccines” by the end of December or January. Such a timeline — just about a year after the coronavirus was first identified — makes the development of a COVID-19 vaccine one of the fastest ever in medical history. 

However, the race for rolling out a vaccine has elicited concerns among the general public over whether a fast-tracked timeline will come at the cost of safety or efficacy. 

Prof. Sarah Kreps, government, told The Sun that vaccine hesitancy — people’s willingness to accept an approved vaccine — will be a critical factor in determining the extent of COVID-19’s spread after a vaccine’s eventual approval, especially in the face of a growing anti-vaccine movement

Kreps and her research team, which includes public health and medical experts, conducted a survey that asked American adults how a vaccine’s effectiveness, risk of side effects and the duration of protection shaped their inclination to take one. The study also examined the influence of factors such as the endorsement of a vaccine by agencies or political leaders, the level of FDA approval and the vaccine’s origin nation. 

“Timeliness of vaccine development and availability are not the only obstacles from a public health standpoint,” the study wrote. “Once a vaccine is developed, a sufficient share of the population must be vaccinated to reach herd immunity and prevent wider spread in the community.” 

The survey results revealed that one factor above all else lied at the heart of vaccine hesitancy — the efficacy of the vaccine.

“This finding is not so surprising, because…it’s one of these sort of intuitive things, that the efficacy of the vaccine is really important,” Kreps said. “And that’s true for other vaccine research as well — people don’t want to take a vaccine that doesn’t work.”

According to Kreps, an increase in vaccine efficacy from 50 percent to 90 percent was associated with an approximate 16 percent increase in the number of people willing to take a vaccine. 

Besides the efficacy of a potential vaccine, Kreps and her colleagues said that politics can play an important role in influencing public acceptance of a vaccine. For example, an FDA Emergency Use Authorization was associated with a decreased willingness to vaccinate when compared to full FDA approval. 

One point of public contention in Trump’s vaccine plan is the employment of Emergency Use Authorization, in which the FDA would be permitted to release a medical product without complete evidence of its effectiveness and safety given that certain conditions are met.

While EUAs have been deployed in many previous outbreaks, such as the 2009 H1N1 influenza pandemic, their use has been met with heightened controversy after the FDA initially authorized — and then later revoked — emergency approval for the use of drugs chloroquine and hydroxychloroquine in treating COVID-19.  

According to Kreps, although there is “nothing inherently wrong” with employing an EUA, the retraction of drugs previously championed by Trump has led to a growing sense of distrust of the process.

“One of the challenges, I think, with how the Trump administration has handled that is, he says that no one has pushed the FDA harder than he has,” Kreps said. “This really has kind of politicized the vaccine process.” 

Kreps explained that a key finding from the survey was that politicization of the vaccine development process has elicited skepticism from the American public, which is associated with reduced trust in a potential vaccine. 

“Even if it takes longer, going through full FDA approval process is actually going to generate more longer-term support, and, frankly, uncover some of these potential Phase 3 [clinical trial] challenges that, if those end up being real problems, could really backfire in terms of trust in the vaccine,” Kreps said. 

According to Kreps, Americans are most likely to trust a vaccine when partisan influence is minimal. Respondents were least likely to choose a vaccine endorsed by Trump, although this result was not significantly higher for a vaccine recommended by Biden.

By contrast, endorsement of the vaccine by the Centers for Disease Control and Prevention and World Health Organization was associated with a much higher probability of accepting the vaccine, according to Kreps.

“Our main conclusion is that the political leaders should stay out of this discussion and leave it to the public health authorities,” Kreps said. “[These organizations are] seen as above the political fray, and therefore much more likely to elicit the kind of credibility and trust that is necessary to generate widespread vaccination.”