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Why the COVID-19 Vaccine Approval Course of Ought to Be Pushed by Science, Not Politics

Before a measles vaccine was developed, I nearly died of the disease as a teenager. With this personal experience and over 30 years of experience in women’s health, I believe that vaccines are generally safe, effective, and save millions of lives worldwide every year.

According to a recent survey conducted by STAT and the Harris poll, 78% of Americans fear that the COVID-19 vaccine approval process is driven more by politics than science.

I have spent over 30 years advancing scientific research and women’s health. During my decades of research, I’ve worked closely with Democratic and Republican members of Congress, five commissioners from the U.S. Food and Drug Administration (FDA), the director of the National Institutes of Health (NIH), and the heads of Health and Human Services (HHS)) from both major political parties. Through an impartial lens, I can discuss the scientific realities of the COVID-19 vaccine regulatory process and explain why I believe we need to build public confidence in vaccines.

How vaccines are developed

COVID-19 is a serious disease. Although older adults and people with existing chronic conditions are at a higher risk of developing seriously the disease, no person is exempt from potentially developing a serious case or experiencing long-term health complications. A vaccine to protect against COVID-19 may be our best chance to keep millions of Americans healthy and safe.

Vaccines typically take many years – and sometimes decades – of research before they are subjected to clinical trials. The severity of the current coronavirus pandemic has led researchers around the world to work towards developing a safe vaccine. To date, 44 vaccines have been tested in human clinical trials.

There are many misconceptions about clinical trials, which are research studies done on people evaluating whether new treatments are safe. Clinical trials consist of four phases. The earliest stages assess whether a new treatment is safe for people, while the final stages determine whether a drug, vaccine, or other therapy is better than any other treatment that may already be used. Although researchers are racing to develop a COVID-19 vaccine, there is no chance of getting approved and distributed to the public until it has gone through all the stages and is FDA approved.

Will a COVID-19 vaccine be safe?

While vaccines are safe, none of them are 100% effective. For example, the measles vaccine is about 98% effective.

The COVID-19 vaccine will not be a “magic wand”, but it will ease the burden of disease. The FDA does not offer approval of a COVID-19 vaccine unless it is at least 50% effective.

I am encouraged to see that nine of the top drug companies working on COVID-19 vaccines are committed to “standing with science” and working together to ensure that any vaccine that is first approved by the FDA is safe and effective.

However, I acknowledge that vaccine approval is only the beginning of an ascent to eradicate COVID-19. Distributing vaccines to people in the United States will be difficult. Not only must a large enough volume of vaccines be produced, but supply chains must also be able to properly store, refrigerate, transport and distribute large numbers of vials.

Public trust and vaccine reluctance

Even before the current pandemic broke out, public perceptions about the safety and effectiveness of vaccines ranged from people who thought they were very safe and necessary to people who were skeptical of science. This skepticism led the World Health Organization to identify vaccine reluctance as one of the top ten threats to global health in 2019.

I think there is a COVID-19 vaccine on the horizon. As a researcher who trusts science, I hope that if most people are able to do it, they will get the vaccine. To do this, we need to build public confidence in vaccines.

In September, HealthyWomen signed a letter with the Alliance for Aging Research and 77 other national organizations calling on those in charge of federal health authorities to rise above policies to address public concerns and skepticism about COVID-19 vaccines to clear out. If we focus on science and demanding government leaders make impartial decisions based on evidence, all we can do is build public confidence in vaccines and end the current pandemic.

What now

While we don’t yet have a cure or vaccination for COVID-19, we can take care of our own health by making sure we have the most up-to-date research and scientific information. The Alliance for Aging Research has published a short, helpful video about how vaccines work. It debunks common myths and misconceptions about vaccines.

We also have to listen to the experts. I have known and worked with Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases and a member of the Coronavirus Task Force at the White House. I also spoke to NIH Commissioner Dr. Francis Collins worked together. These are people who have advised many presidents and government agencies on both sides of the aisle. You can count on them to provide us with accurate, scientifically sound information.

Right now the most important advice is to follow proper social distancing guidelines and wear your mask in public. That way, researchers can work towards developing a vaccine that will keep as few people sick as possible – including you, your loved ones, and those in your community.

Phyllis E. Greenberger is Senior Vice President Science and Health Policy at HealthyWomen. She has more than 30 years of experience in promoting scientific research and women’s health, including as CEO and President of the Society for Women’s Health Research. Greenberger has received numerous awards, including the Department of Health and Human Services pioneer for women’s health.

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