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Saskatoon, Saskatchewan (CTV News) – Scientists from the United States and Puerto Rico are calling for more diversity in vaccine clinical trials after their new 2011-2020 study exposed a decade of inequality and could have affected minority vaccination rates.
The study, published Friday in the medical journal JAMA Network Open, found that demographic information was not reported in many US-based clinical trials – and those in which blacks, indigenous peoples, Latinx, and people over 65 were often underrepresented.
“This collaboration highlights a problem that has plagued the scientific community for too long,” said Dr. Steve Pergam, one of the study’s authors, in a press release.
The team went through 230 July-based vaccine trials of all phases with nearly 220,000 participants from July 2011 to June 2020.
Although Asian and Pacific islanders were equally represented in vaccination trials compared to the US population, whites and adult women tended to be over-represented.
In the article, the authors wrote, “If people from different backgrounds are not adequately represented, treatments that studies have shown to be effective may not be generalizable or effective for all populations.”
“Due to past experiences of exclusion and abuse, minority groups may be more likely to have hesitations to vaccinate and lack of trust in the medical facility, making inclusion even more important.”
Dr. Julie Silver, one of the study’s lead authors and Associate Professor at Harvard Medical School, called for immediate action.
“Going forward, we need to ensure that all vaccine studies include demographic information,” she said in the press release.
The researchers said that many studies did not meet guidelines and guidelines for reporting demographics, despite recommendations from the National Institutes of Health and the Food and Drug Administration.
“And missing data can be important in understanding health differences, such as social determinants of health (e.g. socio-economic barriers), implicit bias, and increased exposure to comorbidities,” the authors say.
COVID-19 A ‘PAIN REMINDER’ BIPOCS ARE VULNERABLE The Kaiser Family Foundation, a nonprofit organization that did not participate in the study but provided detailed information on key health policies, outlined why people of color may not be represented in trials.
Last month, their analysis found that it was a combination of inadequate contact efforts, lack of awareness or information, and structural access problems. The persistent feelings of colored people about historical abuse by the medical community also played a large role, as did the persistent bias against them in the health care sector.
The team behind the latest study found that those who are more exposed to infectious diseases should be given equitable inclusion in vaccine trials.
Pergam, associate professor in the Department of Vaccines and Infectious Diseases at the Fred Hutchinson Cancer Research Center in Seattle, Washington, said the COVID-19 pandemic is a “painful reminder” of how the virus blacks indigenous people and people of skin color and older Disproportionately devastated people in long-term care facilities.
In the study’s press release, he cited the efforts of vaccine developers as examples of how it is possible to further diversify study participants.
“The variety of COVID-19 vaccine studies shows that we can do this, but we need to make sure that future studies focus not only on quick registration but also on inclusion,” Pergam said.
Although some effort has been made to diversify vaccine trials, experts say there is still a long way to go. Throughout the development of COVID-19 vaccines, researchers have consistently had problems underrepresenting certain racial groups in vaccine trials.
“Hesitation about vaccines and a lack of understanding of safety is a huge challenge for COVID-19,” said Dr. Michele Andrasik, lead scientist at Fred Hutch and co-author of the study.
“By improving enrollment diversity, we can better engage these under-represented groups early in the testing phase and address the education and trust issues,” she added.
Engaging with racial groups is vital as vaccines are introduced around the world. Last year, research from the UK found that ethnic minority or lower income people were less likely to take the coronavirus vaccine.
To address the problem of enrolling more minorities in vaccine studies, the US-based National Academies of Science, Engineering and Medicine recently established a committee dedicated to improving the representation of women and underrepresented minorities in clinical trials and research.
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