The question of the summer raging through Black American communities is whether it is wiser to use social distancing and other measures and wait it out or jump into clinical trials seeking a fast-tracked vaccine and remedy for the dreaded Covid-19 virus?
It is quite the paradox for a community whose history is replete with instances of medical experimentation, all manner of medical bias and Black health care disparities.
According to pharmacogenetics, a vaccine might not work for Blacks if they do not participate in clinical trials to create the drug.
Dr. Anthony Fauci, speaking at a July 31 congressional hearing in Washington, D.C., remains confident that a coronavirus vaccine will be ready by early next year, telling lawmakers that a quarter-million Americans already have volunteered to take part in clinical trials, reported the Associated Press.
As the government’s top infectious disease expert, Dr. Fauci heads the National Institute of Allergy and Infectious Diseases.
Under White House orders, federal health agencies and the Defense Department are carrying out a plan dubbed Operation Warp Speed to deliver 300 million vaccine doses on a compressed timeline. That will happen only after the Food and Drug Administration determines that one or more vaccines are safe and effective. Several candidates are being tested, said AP.
Don’t look for a mass nationwide vaccination right away, Dr. Fauci told lawmakers. There will be a priority list based on recommendations from scientific advisers. Topping the list could be critical workers, such as medical personnel, or vulnerable groups of people such as older adults with other underlying health problems, AP reported.
“But ultimately, within a reasonable period of time, the plans now allow for any American who needs a vaccine to get it within the year 2021,” Dr. Fauci said.
Nearly 4.5 million Americans have been infected with Covid-19, and more than 150,000 have died. In recent weeks the virus has rebounded in the South and West, and now upticks are being seen in the Midwest, AP noted.
Pharma giants GlaxoSmithKline and Sanofi Pasteur have announced they will supply 100 million doses of an experimental COVID-19 vaccine to the United States as governments buy up supplies in hopes of securing a candidate that works, said AP.
“The United States will pay up to $2.1 billion ‘for development including clinical trials, manufacturing, scale-up and delivery’ of the vaccine, the two companies based in Europe said in a statement,” according to the wire service.
The U.S. government has a further option for the supply of an additional 500 million doses longer term as part of its Operation Warp Speed program, said AP.
The world’s biggest Covid-19 vaccine study got underway July 27 with the first of 30,000 planned volunteers helping to test shots created by the U.S. government—one of several candidates in the final stretch of the global vaccine race, said AP.
“Volunteers won’t know if they’re getting the real shot or a dummy version. After two doses, scientists will closely track which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked,” the wire service explained.
“Moderna said the vaccination was done in Savannah, Georgia, the first site to get underway among more than seven dozen trial sites scattered around the country.”
“The massive studies aren’t just to test if the shots work—they’re needed to check each potential vaccine’s safety. And following the same study rules will let scientists eventually compare all the shots.
“Next up in August, the final U.S. study of the Oxford shot begins, followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October—if all goes according to schedule. Pfizer Inc. plans its own 30,000-person study this summer,” AP reported.
According to the news service, Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee study sites, said, “These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population.” He stressed that it’s especially important to ensure enough Black and Hispanic participants as those populations are hard-hit by Covid-19, said AP.
Dawn Baker, a Black woman and news anchor, was the first person dosed with an experimental Covid-19 in the U.S. She is with CNN affiliate WTOC in Savannah, Georgia. On July 27, she became the first volunteer to receive an injection in the first Phase 3 clinical trial of a coronavirus vaccine in the United States.
She said the deaths of so many people and the pandemic’s impact led her to get involved.
Nation of Islam Minister Louis Farrakhan, in his thought-provoking July 4 message, “The Criterion,” cautioned Blacks in America and abroad not to simply rush into and accept a vaccine cure without scrutiny and safeguards.
“I say to my brothers and sisters in Africa, if they come up with a vaccine, be careful. Don’t let them vaccinate you with their history of treachery through vaccines, through medication. Are you listening? I say to the African presidents, do not take their medications! I say to those of us in America, we need to call a meeting of our skilled virologists, epidemiologists, students of biology and chemistry, and we need to look at not only what they give us. We need to give ourselves something better,” he said.
“So my teacher told me, ‘Don’t speak for some. Speak for the whole.’ And now I’m speaking for Black America, for Hispanic America, for the Native American, and for those desirous of life. They are making money now, plotting to give seven billion five hundred million people a vaccination.”
He also called for ending an embargo on Cuba and allowing the socialist nation to lend its doctors, medical expertise and medical technology and treatments to the battle against Covid-19 in America.
Chicago epidemiologist Yaa Simpson, during an interview with The Final Call, agreed with the Minister’s assessment. “I wish more Black health professionals would provide good information on what vaccines have done for us in the past and the present and not take the vaccine until they get those answers for us first,” she said.
“The trials are something that we should be well educated about before participating. I want the manufacturers to be transparent about all of the ingredients in the vaccine, the meaning of safety and tolerability, to define what other evidence they have, what is the efficacy of phase II trials? These are the type of questions you want to know before participating. I would ask about the company, the cost of the vaccine, who is giving the money to pay for the vaccine, and their track record in the Black community?”
The Reverend Anthony Evans, who heads the National Black Church Initiative, a coalition of 150,000 Black churches, said, “If we say we are not going to participate and we are the chief victims of the virus, we will never find out how to solve this problem, and it will continue to kill us off. We have to participate.”
“I think that there is a need for the trials. One of our best methods of preventing this virus is to find a safe and effective vaccine,” Dr. Marjorie Speers, of Clinical Research Pathways Leadership, told The Final Call in a wide-ranging interview.
“This disease disproportionately affects Blacks and Latinos when we look at the decease burden, severe cases hospitalizations, ICU admissions, and death. Blacks and Latinos carry that burden. I would argue they absolutely have to be included in the trials because it is essential that a vaccine works in the minority population most affected by Covid-19. We need, the pharmaceutical companies, National Institutes of Health, clinical investigators, we need to do all we can to encourage minority participation.”
In a country that has grossly mistreated people of color for centuries, Black antennas go up when pharmaceutical executives, philanthropist billionaires and government leaders talk morally about the need for Black people to take action as test subjects and get in line for shots. And, questions arise when efforts to counteract Covid-19’s impact has not been met with generous funding for testing and other services as the politicians groan about how the disease is hurting Black people.
According to a study conducted by the Pew Research Center Black adults expressed more wariness than Hispanic and White adults about some forms of medical care, including expanding access to experimental drugs before clinical trials are completed, as is occurring now with some coronavirus patients. A 57 percent majority of Black adults say the risks of expanding experimental treatments outweigh the benefits. In comparison, 41 percent say the benefits outweigh the risks. Hispanic (53 percent) and White adults (63 percent) are more likely than Black adults to say the benefits outweigh the risks.
Blacks aren’t the only skeptics, “polls say as few as 50 percent of people in the United States are committed to receiving a vaccine, with another quarter wavering. Some of the communities most at risk from the virus are also the most leery: Among Black people, who account for nearly one-quarter of U.S. Covid-19 deaths, 40 percent said they wouldn’t get a vaccine in a mid-May poll by the Associated Press and the University of Chicago,” observed Science magazine online.
“It’s one thing to say you need to include minorities in these trials. It is another thing to make that happen because of the dismal history—the Tuskegee studies, other studies that involved research abuses to people of color. So, we don’t start off at a neutral point. We need to start with that history,” Dr. Speers said.
“I understand there is an urgency to find a safe and effective vaccine. Still, we cannot rush the trial at the expense of African Americans and Latinos. If we do that because of urgency, all we are going to do is create a larger health disparity larger gap between minorities and Whites.”
Black experience with government medical malpractice has been devastating, with the infamous and unethical Tuskegee Syphilis Study, that allowed Black men with the disease to suffer for decades as the U.S. Public Health Service monitored and watched some die. Mistrust doubles when tied to unequal access to health care, information barriers, racial bias and unequal treatment for Blacks who have insurance and even unequal relief from pain.
Then you have draconian positions taken by people like Alan Dershowitz who Nation of Islam attorney Abdul Arif Muhammad noted argued, “if you refuse to be vaccinated, the state has the power to literally take you to a doctor’s office and plunge a needle into your arm.”
“I am not eager to consume any product that has such an accelerated course of development. I don’t feel confident that all of the steps can be condensed safely to warrant taking a vaccine at this time,” Philadelphia-based Dr. Safiyya Shabazz told The Final Call. The University of Pennsylvania trained physician added, “So far there is really no treatment that I have become convinced that will work consistently. For me, the best approach is prevention, distance yourself, and staying away from large groups of people.”
Throughout Final Call interviews, the need to include Black medical authorities in any vaccine trials and produce quality information about the virus and vaccines was stressed.
“If you want optimal safety in efficacy information in our population, you would need Black participation. If you want to be sure something is going to work in your group, you need to be a part,” Dr. Shabazz said.
“Those who are funding these trials need to put extra funds into the research sites to hire staff to go out and work with (minority) communities. They need to place these trials (research sites) with a clinical investigator who already has a relationship with the community, build on existing partnerships. There are universities and schools of medicine that work in minority communities like the Morehouse School of Medicine in Atlanta,” added Dr. Speers.
Dr. John Maupin, past president of Morehouse College School of Medicine in a July NBC news article, stated he believes HBCUs’ roles in testing would increase the number of Black participants.
“Specific clinical research,” he said. “How do you administer treatments? Do you present a cure at an early or later stage? Is a higher dosage needed? Those questions have to be answered because everybody’s different. Races have different genetic makeup and genetic impact. So it’s critically important that clinical trials are across the spectrum of individual differences that pick up their minute differences that may not be noticed from one racial makeup to another. That’s why we have to be there.”
The right information is what is needed said, Dr. Speers. “As far as trust-based information, I would recommend the CDC based on info on the website. I am aware that some Black churches are conduits of good information in the Black community. Seek local organizations, hospitals, and medical schools. The National Medical Association would be a good resource as well,” she pointed out.
Minister Farrakhan concluded in his July speech, “So, whether I’m present or absent, the Executive Council of the Nation of Islam must call our scientists. Come and let’s sit down—our virologists, our epidemiologists, those of us who know the science. We cannot let them bring anything to us that we don’t dissect. Don’t you take a vaccine unless you say to our people, ‘We’ve checked it out.’ And you’d better be of the truthful ones.”