Why COVID-19 Vaccine Clinical Trials Need People of All Heritages

COVID-19 Booster
Clinical Contributors to this story:
David Kountz, M.D.
Ihor Sawczuk, M.D.

Clinical trials are underway in many parts of the world, including right here at Hackensack Meridian Health, in hopes of finding a successful vaccine against COVID-19.

As diversity continues to be an important topic of public discussion, so too should be the topic of diversity in COVID-19 vaccine clinical trials. We’ve connected with experts across our network to help answer some of the top questions we’re seeing:

Why is it important for people of diverse backgrounds to volunteer for COVID-19 vaccine trials?

“For a vaccine to be effective, it needs to be tested on a population like the one in which it will be used in,” says David Kountz, M.D., co-chief academic officer at Hackensack Meridian Health. “In fact, there are several federal regulations that demand clinical trials be representative of a diverse test group.”

If a vaccine is only tested on a small group of people that’s not representative of the larger population, it could mean that the vaccine can act differently when distributed broadly.

That’s why it’s so critical that people of all heritages and all ages participate so that their communities are represented in the vaccine development.

How can people of color be sure trials won’t be like historical abuses of the past?

There have been many prominent examples of violations of several medical and ethical standards in clinical trials within communities of color. Following a few landmark cases, major changes and reforms were made in U.S. laws and regulations to ensure the protection of people that volunteer for clinical trials. Now, every clinical investigator is required by federal law to ensure that every participant is safe. Additional measures include:

  • An Institutional Review Board (IRB) must approve every study in the U.S. The board is made up of doctors, researchers and other clinical members who ensure that the study is conducted safely.
  • An informed consent process will ensure that you are informed of all the risks and what to expect during the particular trial. You will also have a chance to ask any questions you may have about the trial.

“Federal regulators and the private sector have really come together to make some meaningful changes to the way we conduct clinical trials,” says Ihor Sawczuk, M.D., chief research officer at Hackensack Meridian Health. “All of these steps are designed to ensure all participants are safe from any unnecessary risk during clinical trials.”

COVID-19 has exposed disparities in health care, but these disparities have existed for a great while. What can we do about these disparities of health care in general?

The Centers for Disease Control & Prevention (CDC) says there is increasing evidence that some racial and ethnic minority groups are being disproportionately affected by COVID-19. Several news organizations across the world have also reported on how communities of color have been hit especially hard by the virus.

The pandemic has brought to light major disparities in our nation’s health care system for communities of color. COVID-19 has also exposed the social and economic factors that have put these communities at higher risk from getting sick or dying from the illness.

To move forward, we need to work together to continue to identify areas of improvement and have ways to communicate those ideas with the people who can make the changes happen.

Next Steps & Resources:


The material provided through HealthU is intended to be used as general information only and should not replace the advice of your physician. Always consult your physician for individual care.



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