. . . . to ensure that clinical trials to establish vaccine safety and effectiveness actually include representative numbers of African Americans, Latinos and other racial minorities, as well as older people and those with underlying medical conditions, such as kidney disease.
Black and Latino people have been three times as likely as white people to become infected with COVID-19 and twice as likely to die, according to federal data obtained via a lawsuit by The New York Times. Asian Americans appear to account for fewer cases but have higher rates of death. Eight out of 10 COVID deaths reported in the U.S. have been of people ages 65 and older. And the Centers for Disease Control and Prevention warns that chronic kidney disease is among the top risk factors for serious infection.
Historically, however, those groups have been less likely to be included in clinical trials for disease treatment, despite federal rules requiring minority and elder participation and the ongoing efforts of patient advocates to diversify these crucial medical studies.
In a summer dominated by COVID-19 and protests against racial injustice, there are growing demands that drugmakers and investigators ensure that vaccine trials reflect the entire community.
Blacks make up about 13% of the U.S. population but on average 5% of clinical trial participants, research shows. For Hispanics, trial participation is about 1% on average, though they account for about 18% of the population.
When it comes to trials for drug treatments and vaccines, diversity matters. For reasons not always fully understood, people of different races and ethnicities can respond differently to drugs or therapies, research shows. Immune response wanes with age, so there’s a high-dose flu shot for people 65 and older.
Still, the pressure to produce an effective vaccine quickly during a pandemic could sideline efforts to ensure diversity, said Dr. Kathryn Stephenson, director of the clinical trials unit in the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.
“One of the questions that has come up is, What do you do if you’re a site investigator and you have 250 people banging on your door — and they’re all white?” she said.
Do you enroll those people, reasoning that the faster the trial progresses, the faster a vaccine will be available for everyone? Or do you turn away people and slow down the study?
New guidance from the federal Food and Drug Administration, which regulates vaccines, “strongly encourages” the inclusion of diverse populations in clinical vaccine development. That includes racial and ethnic minorities, elderly people and those with underlying medical problems, as well as pregnant women.
Moderna, which plans to launch its phase 3 trial Monday, said the company is working to ensure participants “are representative of the communities at highest risk for COVID-19 and of our diverse society.”
However, results of the company’s phase 1 trial, released in mid-July, showed that of 45 people included in that safety test, six were Hispanic, two were Black, one was Asian and one was Native American. Forty were white.
Phase 1 and phase 2 clinical trials aim to test the best dose and safety of vaccines in small groups of people. Phase 3 trials assess the efficacy of the drug in tens of thousands of people.
The guienea pigs should all be Republicans as it is their votes that are the proximate cause of the disastrous spread of the disease in America. Problem would be finding people of color who will admit voting for tRump.
@GailL1 I told you Gail you go first.I will not put myself in danger to please anyone. When I am assured that this vaccine is ok. I will do so. but not before. so please, this is not for the team. and remember yo can always go first.
Health care entities won’t get very far with this is they are ignorant about the pervasive fear and distrust many African Americans hold of the medical system. PARTICULARLY surrounding vaccines. White kids might not be taught about the Tuskegee Syphilis Experiment, decades forced sterilization of black women, and stories like Henrietta Lacks, but black kids certainly are. I’m glad the article at least mentions that, but it’s close to the bottom, like an afterthought. And medical entities need to understand that it’s a very real barrier.
Medical and research entities need to take a culturally competent approach to proactively recruiting patients of color. To do so, they need to educate themselves first.