To be representative, vaccine trials should recruit minorities in percentages similar to their representation in the population. Moderna’s 24% is well below that mark, as about 18% of the American population is Latino, 13% is black, and just over 1% is Native American or Alaskan, according to US census data.
Fauci recently told CNN he wanted to see minorities enrolled in coronavirus vaccine trials at levels at least doubling their percentages in the population, as Covid-19 has hit those groups particularly hard. This would mean that at least 66.4% of the volunteers would belong to these four groups.
Fauci said that number was a goal and not a requirement, but added that if the right percentages of minorities are not met by the time Moderna reaches 30,000 study subjects, the trials should continue to recruit.
Pfizer, the only other U.S. company in Phase 3 trials for a coronavirus vaccine, declined to disclose what percentage of its participants so far are minorities.
In a call with reporters on Friday, Paul Mango, deputy director of policy at the US Department of Health and Human Services, said the two ongoing Phase 3 vaccine trials in the United States are “over- above half “of their recruitment.
Mango said HHS feels very good about the entries in terms of overall diversity.
“We have a huge number of people over the age of 65. We have a lot of people with multiple chronic illnesses. We have a Hispanic stake. We have an African-American participation. We are trying to advance minority participation a little more. But we are very satisfied with these clinical trials, ”he said.
Operation Warp Speed, the government’s effort to develop a vaccine against the coronavirus, says it aims to deliver 300 million doses by January – a speed unprecedented in the history of clinical vaccine trials.
If an insufficient number of minorities enroll, the expert panel overseeing the trials may require the trials to recruit more than 30,000 people.
“The Data Security Oversight Committee could slow down the trial,” said Dr Nelson Michael, an official for Operation Warp Speed. “If the demographics aren’t correct, they might tell the sponsor to slow down sign-ups until you hit different numbers. They might say, “We don’t want you to develop a vaccine that is tested for safety and efficacy primarily on one ethnic group. “”
The recruitment of minorities into vaccine trials is important for two reasons.
First, drugs and vaccines can have a different effect on different ethnic groups.
Second, researchers need a certain percentage of their volunteers to come into contact with the virus, otherwise they have no way of knowing if the vaccine is working. They intentionally seek out people at high risk of infection, including minorities, who are more likely to have essential jobs requiring in-person work, and more likely to live in multi-generational and multi-family households, among other factors.
Recruiting minorities has proven difficult, due to the legacy of minority abuses in medical education, as well as current injustices in the medical system against minorities.
Overall, Moderna’s recruiting increased significantly over the past week, from 13,194 to 17,458 participants. If the company continues to recruit at the same rate as last week, it could fully register for the trial by mid-September.
Enrollment means recruiting participants and giving them their first vaccines, with half getting the vaccine and the other half getting a placebo – an injection that does nothing. Four weeks later, everyone gets a second injection.