Problems mount for billion-dollar vaccine push promoted by politically motivated, relentless President Donald Trump
Questions about presidential pressure for results, a growing lack of confidence that the federal Food and Drug Administration and Centers for Disease Control will issue unbiased scientific rulings and outright lies have increased distrust and skepticism about the safety and efficacy of a Covid-19 vaccine and vaccine trials.
Millions of Americans, with Blacks leading the way, are vowing not to take a vaccine or to wait to see how it impacts those who do.
“Human beings are not guinea pigs, and certainly the ways in which this virus has disproportionately impacted Black and Brown people, if anyone is going to need to be able to have some trustworthy treatments, it will be our communities. But we can’t have maximum confidence in a treatment that continues to be determined by the kind of maniacal whims of Donald Trump and his sycophants,” said Pastor Michael McBride, co-founder of the Black Church PAC. The coalition of faith leaders is working to end mass incarceration, protect voter rights, curb gun violence, and obtain equitable treatment for Black and Brown communities.
Troubles have plagued Covid-19 vaccine trials. And a pledge by big pharmaceuticals in the vaccine race has done little to squash concerns or entice Blacks and other non-Whites to markedly increase participation in clinical trials.
A woman in AstraZeneca’s Phase 3 trials experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder, which causes muscle weakness, paralysis, pain and bladder problems, according to STAT News.
AstraZeneca has resumed its trials, but Phase 3 studies were put on hold in the U.S. on Sept. 8 and remained on hold at Final Call press time.
Dr. Avindra Nath, senior investigator at the National Institutes of Health’s Intramural Research Program, told media, “the highest levels of NIH are very concerned” and cited a lack of information as a major worry. AstraZeneca’s problems were revealed first to shareholders, not to federal authorities.
AstraZeneca has also come under fire for raising drug prices, though it received over a billion dollars in federal funding to create a vaccine.
President Trump claims to foresee an immediate roll out of a Covid-19 vaccine as early as October or November amid growing concerns he is rushing a “miracle cure” to market to help win reelections. Criticisms have also arisen over reports that his administration steered Centers for Disease Control Covid-19 guidelines to align with his political messages.
Moderna, one of the leading pharmaceuticals in the race to get a Covid-19 vaccine to market, has also had trouble with its clinical trials.
Even Microsoft co-founder Bill Gates, perhaps the largest non-government source of funding for vaccine development, came out in a major way against the FDA and CDC. He told STAT News and major news outlets, in a series of interviews, that he struggles to trust the CDC and FDA because officials with “crackpot theories” have sidelined top-notch experts.
He and others have said any vaccine will likely take multiple doses to be effective, casting doubt on the president’s claims to have a safe, workable vaccine by Nov. 3 elections.
Is vaccine push necessary and correct?
Student Minister Ava Muhammad, National Spokesperson for the Honorable Minister Louis Farrakhan and the Nation of Islam, pointed to problems with Moderna vaccine trials and systemic side effects.
Min. Muhammad, who is also an attorney, said, 80 percent of those who received a low dose during Moderna’s Phase 1 vaccine trials experienced fatigue, chills, headaches, and muscle pains, while 100 percent of those in a second group who got a higher dose suffered negative side effects.
This virus is demonstrating a need for a very high dosage and multiple injections over a period of time to be effective, she said. And that is one reason Blacks should resist involvement in clinical trials, Min. Muhammad argued.
“You have some who say, Black people, Brown people need to participate so that we can know whether it’s effective for us, but in subjecting oneself to clinical trials, one is subjecting themselves to both short term and long term side effects that may turn out to be worse than things would have been if you contracted the virus itself,” she said.
Pfizer and its Germany-based partner BioNTech have expanded enrollment of their Phase 3 study from 30,000to approximately 44,000 participants, and lowered the age of participants to 16 to get more racial diversity.
Blacks comprise seven percent of its overall study, and eight percent of its U.S. study, according to Pfizer.
On Sept. 16, the National Institutes of Health announced a $12 million award to the non-profit research group RTI International for outreach and engagement in primarily Black, Latino, and Indigenous populations.
“I think it’s outrageous and it’s a display of arrogance and wickedness to think you can commercialize this. You can act like you’re selling cars, and sell us on what a great, wonderful thing it is that you’re being asked to take part in yet another instrument of death, because that’s what it is,” said Min. Muhammad.
Communities targeted by the National Institutes of Health’s Community Engagement Alliance (CEAL) Against Covid-19 Disparities include counties in Alabama, Arizona, California, Florida, Georgia, Louisiana, Michigan, Mississippi, North Carolina, Tennessee and Texas, according to a press release.
Many of those states are in what’s considered the “Diabetes Belt,” said Min. Muhammad.
According to the CDC, the area includes 644 counties in 15 southern and southeastern states, where nearly 12 percent of the population was diagnosed with diabetes, compared with only 8.5 percent of the population outside of the belt. Diabetes is a major underlying condition that contributes to death from Covid-19.
“The same corporate-run government that’s financing this is the reason we have all the preconditions that we have, that make us more susceptible to covid than anyone else,” said Min. Muhammad. “We’re not looking for diversity in clinical trials, where you use my body to see whether this thing kills me, or makes me permanently damaged in some way. For what?” she asked.
“What have you done about kidney failure, high blood pressure, obesity, cancer, diabetes? What have you done to address this, about us living in food deserts, about us being denied competent medical care, about Black women, when they say they’re in pain, they’re told no you’re not?” Min. Muhammad asked.
Americans not buying vaccine promises
According to a Pew Research national survey, released Sept. 17, intent to get a vaccine has declined across all major political and demographic groups.
Just 32 percent of Black adults would definitely or probably get a Covid-19 vaccine, compared with Whites (52 percent) Hispanics (56 percent) and nearly three-quarters (72 percent) of Asian Americans.
Seventy-seven percent of those surveyed think it’s very or somewhat likely a Covid-19 vaccine will be approved in the U.S. before its safety and effectiveness are fully understood.
Seventy-eight percent of respondents said their greater concern was the vaccine approval process will move too fast, without fully establishing safety and effectiveness, compared with just 20 percent who are more concerned approval will move too slowly, creating unnecessary delays.
Those surveyed cited concerns about side effects and uncertainty around the effectiveness of a vaccine if one were available today.
Dr. Rueben Warren, director of the Tuskegee University National Center for Bioethics in Research and Health Care, said vaccines are effective, useful, and at the foundation of public health, but the question is when and how?
“The question says under what conditions do we participate, do we take the vaccine?” asked Dr. Warren.
He is also part of a Bioethics Commission formed by the Samuel DeWitt Proctor Conference and its convening partners, the National Center of Bioethics at Tuskegee University, the William Monroe Trotter Justice Collaborative, Harvard University, and the Democracy Collaborative.
“As we know, historically, from before the U.S. Public Health Study of Syphilis at Tuskegee, we didn’t get equitable health or health care, so if it’s there, that don’t mean we’re gon’ get it,” Dr. Warren told The Final Call.
The vaccine issue requires a discussion on efficacy and on ethics, he said.
He’s concerned about reports that a Trump appointee from the Department of Health and Human Services, demanded to review all scientific data coming from the CDC, including the weekly publication on morbidity and mortality.
Dr. Warren linked Blacks’ skepticism and concern around a Covid-19 vaccine and clinical trials to what he calls historical memory. “You heard something that happened back in the day. You don’t know what happened, but they told you it wasn’t good, so you’re hesitant, wisely so, to participate in something that seems similar,” he said.
“So you don’t have to know the details about the U.S. Public Health Study of Syphilis at Tuskegee. You know something was wrong. You know something happened to Black folk. So when somebody ask you about something similar to that, like getting involved in vaccine clinical trials, then you pause and say, ‘Wait a minute! Hold on! Give me more information from trusted sources, not just more information,’ ” Dr. Warren continued.
According to the CDC, vaccines contain some form of the same germs that cause the disease. The CDC said, for example, measles vaccine contains measles virus. But the germs have been either killed or weakened to the point that they don’t make people sick, the agency said. Some vaccines contain only a partof the disease germ, said the CDC.
Holding up a basic pale blue surgical face mask, Dr. Robert Redfield, CDC director, said masks are the most powerful public health tools America has against Covid-19.
“If we did it for 6, 8, 10, 12 weeks, we’d bring this pandemic under control. … There’s scientific evidence that they work,” he told the U.S. Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies.
“I might even go so far as to say that this face mask is more guaranteed to protect me against covid than when I take a covid vaccine because the immunogenicity (or ability to provoke an immune response) may be 70 percent, and if I don’t get an immune response, the vaccine’s not going to protect me,” explained Dr. Redfield.
That is a profound statement, coming from the head of the CDC, observed Min. Muhammad.
Based upon his conclusion that wearing a mask is safer and 100 percent effective, any effort to manufacture a vaccine for Covid-19 should be abandoned completely, she said.
“Why administer something harmful, with questionable effectiveness, when the little blue surgical mask he was wearing offers better protection?” she continued.
The coronavirus vaccines all carry a risk of vaccine enhancement, meaning the vaccine can worsen the disease when a person is infected with the wild virus, said Min. Muhammad.
“The theory is that (a vaccine) will cause your immune system to rise up and spike what’s in the vaccine so that when the true virus that’s out in nature is contracted, you will already be prepared to defend yourself, when you already have a defense,” she said.
In recent lectures, “The Law of God,” she said it’s important to pay attention to the fact that despite trying for decades, researchers who produce vaccines have been unable to make one for the coronavirus. The effort to make one has such a record that it would indicate for all intents and purposes, this one is not going to work either, said Min. Muhammad.
The United States seems to be incapable of improving the situation, she added.
However, the protocol used by Cuban doctors is one of several successful therapies and treatments. And that’s why the Nation of Islam wants the 60-year embargo lifted off of Cuba and treatment by its doctors.
“It is a matter of record that Cuba has been overwhelmingly successful in dealing with Covid-19. Cuba is using a protocol that consists of four major components: alpha interferon, antibiotics, hydroxychloroquine, and, addressing the underlying condition of the patient,” stated Min. Muhammad.
“We’re not looking at the fact that the American people are being held hostage by the corporate controlled U.S. government, and we’re not being allowed to avail ourselves of proven treatment programs to manage this virus until the body gets rid of it. Vaccines are a last resort, not a first one, because there’s so notoriously harmful,” she said.
Billions have been sunk into a Covid-19 vaccine, with the president pushing for a reelection miracle.
The presidents at respected Black medical schools at Xavier University and Dillard University received a quick and hard clap back after sending out a letter calling for students and alumni to join Covid-19 vaccine trials.
The Black Church PAC demanded that the presidents of Dillard University and Xavier University of Louisiana “refrain from offering their students up as guinea pigs for controversial and untested coronavirus vaccine trials.”
Democratic presidential hopeful Joe Biden said he would not trust President Trump on vaccines during a Sept. 17 town hall meeting. The president came under fire for telling author Bob Woodward, who was writing a new book, “Rage,” that Covid-19 was deadly serious while downplaying its seriousness in the public. The president said he didn’t want to panic people but a former member of his Covid-19 task force who worked with Vice President Pence told a different story. She came forward saying the president was only concerned about how the pandemic would impact his chances for reelection.
“Don’t take the vaccines. There are 14 therapies that are in the world today that we can use to fight against the covid virus,” said Nation of Islam Minister Louis Farrakhan, in a July 4 address, “The Criterion,” from his Michigan home.
He warned Blacks in America and in Africa not to simply accept vaccines or treatments from those who have a history of medical malpractice and evil against Black people. He called for ending the Cuban embargo to allow Cuban treatments and doctors to get involved in saving U.S. lives and for convening Black experts to discuss and develop ways to protect Black people from harm.
Blacks have generally accounted for one-third of deaths from Covid-19, usually from pre-existing conditions like diabetes, obesity, asthma, heart disease, high blood pressure and other ailments that increase susceptibility to the coronavirus.
“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.
According to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, the hospitalization rate per 100,000 Blacks stands at 247, compared to 53 per 100,000 Whites.
“One thing I think that is actually encouraging is that there are more diverse voices raising concerns, not just ours,” said Safiyya Shabazz, M.D., owner of Fountain Medical Associates based in Philadelphia.
“Sometimes you have to stand on the soap box by yourself, but right now, we’re not just standing on the soap box by ourselves. Many people are raising concerns, because there’s been a pattern of misinformation and a pattern of outright lying coming from obviously the president, but then also people that have been placed in positions in departments and government organizations that we used to be able to at least have some level of confidence, some reasonable assurance that it’s credible information,” said Dr. Shabazz.