On the Medical Watch: One of the largest COVID-19 vaccine trials hits a road block.
The Moderna vaccine is in phase 3 which means it’s in the final stage of testing. But after doctors raised a red flag — warning more minority participants were needed to determine if the vaccine is effective — the manufacturer agreed.
Dr. Richard Novak has been testing vaccines for more than 25 years and now the University of Illinois at Chicago infectious disease physician is on the frontline again managing the Chicago arm of the <oderna COVID-19 vaccine trial. But early on he expressed concerns particularly about recruitment of study participants and targeting populations most at risk.
“We recognize it was very important to make sure we know the vaccine is working in people who are most at risk for getting the disease,” he said.
Here’s how a clinical trial works:
A pharmaceutical company partners with academic centers like UIC to recruit patients and administer either placebo or the experimental vaccine. At the same time, the company contracts with commercial sites around the country – facilities paid by the drug maker to run the same study protocols.
“The more they enroll the more they are paid and so there’s motivation to just enroll quickly,” Novak said. “Ideally it should reflect the population of the country.”
In Moderna’s case, instead of enrolling a diverse group of study participants, the commercial facilities quickly filled spots in the 30,000-person trial with mostly Caucasian volunteers. Now the company has slowed the study to focus on more minority recruitment. At UIC, 75% of study participants are minorities. But there are long-standing challenges with recruitment, particularly within the African American community.
“Part the challenge is there is a great deal of mistrust particularly in the African American community in participating in research b/c of the history of clinical research among African Americans,” Novak said.
Like the Tuskegee syphilis study. African American participants were not informed when an effective treatment — penicillin — became available.
“By today’s standards that’s disgraceful and we have much more safeguards to protect the rights and safety of our participants than existed then but that is fresh in the minds when we talk to groups of African Americans about research that often comes up,” Novak said.
Community advocates are joining the effort to help address the sense of mistrust.
“I think we should be part of the tests but it’s going to take some convincing to make it happen,” the Rev. Jesse Jackson, with the Rainbow PUSH Coalition, said.
“When we don’t have input from diverse populations then these interventions down the line may not be able to be adequately adopted by the populations that need them most,” Dr. Inger Burnett-Zeigler, Northwestern Medicine, said.
“Our input is valuable our input is critically important in making sure that novel medical treatments meet us, are right for us and can help heal our communities as a whole and that is the role we can play as citizen scientists by making sure our voices are heard in research studies,” Burnett-Zeigler said.
“I encourage people to participate this is so important for us all so we can get out of this pandemic we need these vaccines,” Novak said.
UIC is getting ready to launch another clinical trial for a COVID-19 vaccine made by Janssen. That study will have satellite sites in Latinx and African American communities.