Several polls have suggested that as much as half of the U.S. population is unlikely to get the vaccine for a variety of reasons, including not feeling it is safe.
As company after company presents promising clinical data for their COVID-19 vaccines, the public, for the most part, appears optimistic about the likelihood of a viable vaccine hitting the market by the end of this year or early 2021. However, several polls have suggested that as much as half of the U.S. population is unlikely to get the vaccine for a variety of reasons, including not feeling it is safe.
Another problem is that minority groups, such as blacks and Latinos, are typically less likely to participate in clinical trials, even though they are more likely to be most severely affected by COVID-19. Polls show this is consistent in COVID-19 trials as well. They have found that Americans expressing interest in participating in the COVID-19 trials tend to be young, white and healthy. But in order for it to be proven that the vaccine is safe and effective most broadly, clinical trials need to be conducted that include a range of ethnicities, races and age groups, especially in populations most at risk of catching the disease.
“You have to be able to get into some of these communities where there may not be as much experience or trust for science, and just be very convincing in helping people understand why this is important for their health,” Angela Branche at the University of Rochester Medical Center in New York, told the Wall Street Journal.
The push for including more varied ethnicities and races in clinical trials has been an increasing concern, now heightened by the COVID-19 pandemic. Some degree of uniformity is necessary when looking for a narrow patient group to study that falls into a specific age or a disease without other comorbidities that would add unmanageable complexity to data analysis. Other issues include access to trial sites.
For example, in January, Stand Up To Cancer (SU2C), a division of the Entertainment Industry Foundation that raises funds for cancer research, launched an initiative to increase minority representation in cancer clinical trials.
A 2019 study published in JAMA Oncology found that a third of cancer clinical trials that led to approved drugs didn’t report on the race of patients in the trials between 2008 and 2018. And the ones that did had far fewer black and Hispanic cancer patients than expected.
Native Americans also present logistical issues, with most clinical trial sites associated with metropolitan areas and academic research healthcare institutions—typically where populations of Native Americans are low and often distant from where they live. However, Linda Burhansstipanov, founder of the Native American Cancer Research Corporation, estimated that 85% of Native Americans wish to take part in clinical trials when they know about them.
Because COVID-19 vaccine development is moving so fast, many scientists have expressed skepticism that drug companies will emphasize broader recruitment strategies. “Everybody’s against the gun in terms of enrolling as quickly as possible,” Kathryn Stephenson, director of the clinical trials unit in the Center for Virology and Vaccine Research at Beth Israel Deaconness Medical Center in Boston, told The Wall Street Journal. “Nobody’s really going to want to wait around for those efforts to mature.”
One potential advantage in this regard to COVID-19 vaccine trials is the international nature of the trials. Most of the companies who are developing the vaccines have simultaneously entered into manufacturing partnerships with companies around the world. For example, Moderna, based in Cambridge, Massachusetts, has a partnership for vaccine manufacturing with Switzerland-based Lonza and with Madrid-based Laboratorios Farmacéuticos Rovi; New York-based Pfizer is working with Germany-based BioNTech on their vaccine, and have signed a deal with the UK government to manufacture 30 million doses of the vaccine, as well as others.
Many of these trials are also being conducted in other countries. For example, the Pfizer-BioNTech is being conducted in Germany, the U.S., Brazil and other countries. Some of the rationale behind this is to run the tests where outbreaks of the disease are most common, but it also has the added benefit of broader ethnic and racial diversity.
They are also looking not just for racial differences, but to test people who are at high risk, including people with comorbidities such as diabetes, high blood pressure, and older adults.
Still, it’s not entirely an issue of access, but also of culture and trust. A survey conducted by the Pew Research Center found that black Americans are more hesitant to trust medical scientists, leading them to be less likely to sign up for clinical trials. However, as of June 2, although black Americans made up about 13% of the U.S. population, they accounted for about 24% of COVID-19 deaths. This was particularly broad in some states, such as in Kansas and Wisconsin, where blacks account for 6% of each state’s populations, but make up 29% and 26% of COVID-19 deaths, respectively.
Some of this is skepticism about the scientific and health care industries and some of it is undoubtedly related to higher rates of preexisting health conditions that complicate COVID-19, such as high blood pressure, diabetes and obesity. There are also likely inequities related to health care access, and social and economic factors.
When it comes to providing access to clinical trials as well as health care in general to minorities in the U.S., we could and should do better.
