Japan-Large US COVID-19 Vaccine Trial Registered Prematurely, but Lags for Diversity of Participants

Modelna and Pfizer, US competition leaders in coronavirus vaccines, have revealed this week that they have registered more than half of the people needed for the final stage of the trial, 30,000. However, only about one-fifth of the participants are from the Black and Hispanic communities who were hit hardest by the virus.

According to the Federal Bureau of Investigation James Kublin, online registries (a list of about 350,000 volunteers) that people can use to voice their interest in vaccine trials have seen black and Hispanic people as of last weekend. Only about 10-11%. An HIV vaccine trial network based at Fred Hutchinson Cancer Research Center in Seattle. The HIV trial network has been diverted to testing coronavirus vaccines.

“We are doing a bit of a daunting task at the Sicilian Tasks in order to realize a study that represents (US) diversity. It is not just discrimination in the minority community, but complete unethical It also becomes a historical legacy of medical practice,” Kubrin said. ..

The main focus was to create a vaccine trial that minimally reflects the racial and ethnic breakdown of Americans, about one-third of the total for blacks, Hispanics, and Native Americans—all vaccines The need to make sure that is valid for everyone is widely accepted. The current number of registrations is behind even that target.

And in the last few weeks, discussions in the scientific community have focused on the need for coronavirus vaccine trials to do more than simply reflect the composition of the country’s population. Instead, as many scientists argue, enrollment efforts should reflect the disproportionate burden of illness, hospitalization, and death burdened by the Black, Hispanic, and Native American communities.

Nelson Michael said, “The intent is to make the vaccine safe and effective for all Americans. Because the burden of illness is unbalanced, people are enrolled based on census figures. This is the minimum goal.Director of the Center for Infectious Diseases Research at the Walter Reed Army Institute of Research.Michael is investigating vaccines at Operation Warp Speed, a federal program that speeds vaccine and treatment development. Is working on a community initiative for.

“What I can say is that a lot of people are spending a lot of time, and now I’m trying to make sure I can move the needle from its minimum goal to something better,” Michael said. It was.

According to the Centers for Disease Control and Prevention, the incidence of coronaviruses is more than 2.5 times higher in blacks, Hispanics and Native Americans than in whites, and hospitalization rates are 4-5 times higher. Mortality from COVID-19, a disease caused by the coronavirus, is twice as high in the black community and 1.4 times higher in the Native American community than in the white community.

Biotechnology company Moderna partnered with the federal government to develop the coronavirus vaccine. This was revealed by a telephone call Wednesday that revealed to investors that 15,239 people had registered for the trial. According to the company, blacks, Hispanics and Native Americans accounted for 19% of these participants.

Pharmaceutical giant Pfizer is in the process of registering, with 19% of participants being black or Hispanic and 4% Asian, said Nikolaschitin, senior director of vaccine clinical research and development, on the CDC Advisory Committee. Told.

Leaders at both companies said they are working on a trial that reflects those at highest risk. Scientists say diversity is crucial to understanding how vaccines work in the real world.

“How common are the questions that we always ask ourselves when conducting clinical trials?” Onyema Ogbuagu, head of the Pfizer vaccine study at Yale New Haven Hospital. He said. “When you do a study in the majority of the white population, where there are few blacks, it’s always questionable when you get results from that study. The same goes for blacks (people) compared to others. Does it work, and even more so with COVID?”

These numbers show that the trials, which started with the first dose of vaccine or placebo at the end of July, progressed rapidly. However, they also present an urgent task to improve the diversity of ongoing trials and make it a priority for future research. Such support is usually time consuming, and the legacy of racism and the abuse of research into ethnic minorities requires building trust with communities that may be distrustful of the healthcare system.

HIV doctors and scientists, who have provided much of the federal infrastructure for clinical trial efforts, have been building relationships with the surrounding community for decades, but more than the population and the elderly. A wide range is at risk for COVID-19.

Hala Borno, an oncologist at the University of California, San Francisco, studied a few clinical trials of coronavirus that disclose racial data and found Blacks to be underestimated. She said the trial needs to reflect the diversity of the population and should strive for more.

“That’s the bare minimum,” said Borno. “The reality is that the way scientific research works is to determine if there are enough samples to strengthen the analysis and if there are real differences in the populations. There is.”

Peter Hotes, director of tropical medicine at Baylor College of Medicine, said he believes that at least 35 percent of the minority group should participate in the US coronavirus vaccine trial.

“Given that COVID-19 caused excessive illness and death in American Hispanic, African-American, and Native American people, it is very likely that vaccine trials adequately reflect this reality. It’s important,” Hotez said in an email.

Recruitment at clinical trial sites that primarily register whites for greater diversity may be delayed while others are intensifying their efforts. The clinical trial site is also planning to use a mobile van to reach the community, instead of forcing volunteers to travel to the site, and is working on other forms of outreach.

“We are working with the community, and in a weird way we are doing all the community work and material development for TV ads, radio, etc. These are some of these (scientific) steps of the vaccine. It took longer than going through,” Kublin said. “It’s very frustrating for me.”