Fact vs. Fiction: Following the Science for a COVID-19 Vaccine

While conversation and questions around COVID-19 have been all-encompassing since March, I’m hearing one question more and more frequently in recent days:

“If a COVID-19 vaccine becomes available, will you get it?”

According to a recent poll, nearly two-thirds of Americans say they will not get a coronavirus vaccine as soon as it becomes available—and 1 in 4 say they would never get one.

While the pandemic is bringing mistrust in a vaccine to the forefront, these concerns are unfortunately nothing new. Over 20 years ago, a physician by the name of Andrew Wakefield released a fraudulent research study that demonstrated a link between autism and the MMR vaccine. Although his data was falsified, and the study later redacted, there’s no turning back time—people still believe the false claims that gave rise to the anti-vaccine movement and continue to stoke fears around vaccination today.

While pharma companies and government regulatory bodies have responded with public health campaigns around vaccine efficacy and increased transparency around their protocols and rigorous safety standards, the anti-vaccination movement continues to garner attention with important consequences still playing out. We’ve seen resurgences in measles, an extremely contagious but entirely preventable disease, as well as polio, a disease previously on the threshold of eradication. And in this current season, where coronavirus cases continue to rise in multiple areas, we’re seeing it play into fears regarding a potential COVID-19 vaccine—with potentially dire consequences.

I understand why people are fearful—these are unprecedented times and, though we’re desperate for solutions, we are also unaccustomed to the speed with which the current efforts have brought progress, with several vaccine candidates already in Phase III trials. But it’s the combination of science and technology building on prior success that have enabled this journey, alongside comprehensive, global collaboration—not the cutting of corners.

In fact, the consequences of cutting any corners in pursuit of a COVID-19 vaccine would be catastrophic not only for public trust in vaccines, but for science overall. Just a few weeks ago, nine pharma companies came together and signed a pledge committing to stand with science and not put forward a vaccine without thorough testing for safety and efficacy. A COVID-19 vaccine approved by the US Food and Drug Administration will be subject to the same rigorous protocols and safety standards as any other approved treatment or preventative drug.

From the start, companies working to introduce any drug, therapy or preventative to the market must follow a rigorous process that includes pre-clinical testing followed by clinical trials, first in a small population and then gradually moving to a larger, more diverse set of people, before regulatory approval—with consistent monitoring throughout and following. Each trial is overseen by an independent monitoring board also required to report and evaluate any adverse events, with each trial participant monitored through each and every step of the process to ensure the highest ethical and safety standards. This is precisely why the AstraZeneca trial was halted, making breaking news. Although voluntary pauses and clinical holds are not uncommon, particularly during large Phase III trials, the company was transparent in reporting the news to the public and conducting a thorough investigation. The trial has resumed in the UK—though with less robust coverage—and is still under consideration by the FDA in the U.S.

If you work in this field, then it’s imperative you trust the science and the scientific process. As the CEO of an agency hyper-focused on health and science, it’s my duty to help educate around not only the science and the purpose behind vaccines but reinforce that, even during the toughest of times, the FDA will not approve a drug that does not undergo the necessary stages or is deemed harmful to the human body. In fact, FDA may heighten Emergency Use Authorization standards for a COVID-19 vaccine to include an additional two-month observation period after Phase III trial participants receive the second vaccine dose and require at least five severe cases of COVID-19 in the placebo group.

The many false narratives around vaccines and politicizing science are swaying public opinion, undermining the science behind the systems we’ve created in service to society. But the reality is there were only ever two ways we were going to establish the needed herd immunity to end this pandemic: with a safe and effective vaccine or after the majority of the population has contracted the virus. The latter will lead to an unimaginable number of deaths, while the former will have minimal, if any, risk.

An FDA-approved vaccine is undoubtedly our best bet to recovering from COVID-19. Sure, the transition will take more than just the development of a vaccine. Most likely the need for masks in public places and maintaining a safe distance from those around you will still be necessary for a while to come. But this is a global effort, and it’s on us to trust the science, to protect our loved ones and communities and to restore this concept of living again.

If we all wait it out and delay receiving the vaccine, we’ll be waiting forever—and COVID-19 will persist.

I’m all in—are you?

This article was originally published on LinkedIn by Jonathan Wilson, Owner and CEO.

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