Reports that members of a secret safety panel, the Data Monitoring Safety Board, will essentially pick Covid-19 vaccines didn’t necessarily increase trust, despite Food and Drug Administration and Centers for Disease Control promises of transparency and vows to make findings public before any vaccine is approved.
The reports came on the eve of news that President Donald Trump, who is pushing to create a vaccine within months, and his wife, Melania, joined the over 7 million people infected with coronavirus in the U.S.
The Data Monitoring Safety Board is an “independent” group of experts who oversee and monitor Phase 3 clinical trials and determine whether a study should continue without change, be modified, or be terminated. The National Institutes of Health sets its guidelines and policies.
“Such a board, as the name implies, looks at data and protocol. Regardless of who is on the board, they are not the point of origin of the vaccine, they are relying on the truth of the information they are given from the pharmaceutical companies who manufacture the vaccine and conduct the clinical trials,” stated Nation of Islam Student Minister Ava Muhammad, National Spokesperson to the Honorable Minister Louis Farrakhan.
“The Nation of Islam has created a task force on the coronavirus. We will rely on our researchers and scientists in cellular biology, molecular biology, microbiology and other fields relevant to vaccine development. The only way to know what is in a vaccine is to look at it under a microscope. Anything less leaves us relying on hearsay,” said Min. Muhammad.
Typically, according to Kaiser Health News, “there’s one board for each product. This time, a joint DSMB with 10 to 15 experts will review unblinded data across trials for multiple coronavirus vaccines whose development the U.S. government has helped fund, according to five people involved in the Trump administration’s Operation Warp Speed or other coronavirus vaccine work.”
“It is run through the National Institute of Allergy and Infectious Diseases at the National Institutes of Health and consists of outside scientists and statistical experts, not federal employees, NIH Director Francis Collins said on a call with reporters,” continued Kaiser Health News.
But experts and even one former Data Monitoring Safety Board member told the media it was not clear the entity would be able to withstand political pressure. No president has ever exerted the type of pressure President Trump has for a desired outcome, they said. We’re in unchartered waters, they said.
Four vaccine candidates are in Phase 3 trials, which maximizes chances of a vaccine or multiple vaccines by January 2021, according to Alex Azar, secretary of the U.S. Department of Health and Human Services.
Moderna CEO Stéphane Bancel has said its vaccine won’t be ready until mid-spring. And Pfizer CEO Albert Bourla told employees the company, which is involved in vaccine trials, won’t bend to political pressure.
STAT News reported the studies being run by Moderna, AstraZeneca, and Johnson & Johnson with the National Institutes of Health share a common DSMB, while Pfizer and BioNTech have their own.
Approval of a vaccine based on the data rests with heads of the FDA, under the helm of Dr. David Hahn, a political appointee. Typically the process takes weeks, sometimes months, from the time the FDA receives the data until they make an authorization, depending on the complexity of the data, he stated, during a recent Senate Health, Education, Labor, and Pensions Committee hearing. He testified that there would no delay or shortcuts.
“I must admit my bias that I do not trust these people at all. They have lied to us for over a century about the safety of vaccines and about the transparency. They are transparent, but they are deceptive in their transparency,” stated Michelle Ford, president and founder of Vaccine Injury Awareness Week.
“What I mean by that is everybody knows because of mainstream news, that safety trials are happening right now with the Covid-19 vaccine. … What’s going to happen is they’re going to report their success. We’ve done our 60 trials, and we are ready to roll out this vaccine,” said Ms. Ford. “What they’re not going to report on or highlight are the severe outcomes, the severe adverse events. They’re going to downplay the adverse events, and they’re going to roll out a vaccine as the savior of the world and then they’ll be able to report the whole time that the safety studies were done,” Ms. Ford told The Final Call.
Concerns have also been raised about the military’s vast involvement and have added to the public’s concerns about a rushed vaccine under political pressure from the president, who wants a vaccine prior to November elections.
STAT News released an organizational chart of the $10 billion Operation Warp Speed initiative, which it says “reveals the fullest picture yet of Operation Warp Speed: a highly structured organization in which military personnel vastly outnumber civilian.”
“The labyrinthine chart, dated July 30, shows that roughly 60 military officials—including at least four generals—are involved in the leadership of Operation Warp Speed, many of whom have never worked in health care or vaccine development. Just 29 of the roughly 90 leaders on the chart aren’t employed by the Department of Defense; most of them work for the Department of Health and Human Services and its subagencies,” wrote STAT News.
Virginia-based news company Politico reported in a recent exclusive that Trump officials interfered with CDC reports on Covid-19, saying, “The politically appointed HHS spokesperson and his team demanded and received the right to review CDC’s scientific reports to health professionals” and “the health department’s politically appointed communications aides have demanded the right to review and seek changes to the Centers for Disease Control and Prevention’s weekly scientific reports charting the progress of the coronavirus pandemic, in what officials characterized as an attempt to intimidate the reports’ authors and water down their communications to health professionals.”
“In some cases, emails from communications aides to CDC Director Robert Redfield and other senior officials openly complained that the agency’s reports would undermine President Donald Trump’s optimistic messages about the outbreak, according to emails reviewed by Politico and three people familiar with the situation,” it continued.
“Frankly, I’m not going to trust the federal government’s opinion and I wouldn’t recommend to New Yorkers based on the federal government’s opinion,” stated Governor Andrew Cuomo (D-New York) about vaccine safety in a recent press conference. New York, with over 465,000 cases of coronavirus, will put together its own review committee headed by the Department of Health that will advise him, he said.
Elon Musk, CEO of Tesla, declared in a recent interview that he would not take a Covid-19 vaccine and that anyone at risk should be quarantined until the storm passes.
Also, more doctors have indicated they’re wary of a vaccine, according to a poll released by Medscape, an online medical news organization. Only 17 percent of doctors said they would get a Covid-19 vaccine if authorized before all clinical trials have been completed, it found. Sixty-three percent said no and 20 percent were unsure. Eleven percent of the nurses polled said they would take a vaccine, while 69 percent said they would not and 20 percent were unsure, it continued.
“Don’t take their vaccines,” said the Nation of Islam’s Honorable Minister Louis Farrakhan in his July 4 “The Criterion” message delivered from his home in Michigan.
Minister Farrakhan stated there are 14 therapies worldwide to help combat the virus, and that Blacks are not justified in trusting those who have misused them in a history of medical malpractice and evil against them. 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.
“In terms of what Minister Farrakhan said, I think he’s spot on. I am fully aware that the Black community, by and large has been targeted by I think it’s really the global thinkers, the global elite that have targeted the Black community and brought not only oppression to neighborhoods with predominantly African American families, but they’ve also brought sickness,” said Ms. Ford.
“The problem is there’s this belief that the vaccine is going to save the world and it concerns me greatly that the Black community is being targeted. I mean, Melinda Gates said herself in an interview that she was doing alongside her husband, that health care workers, first responders and the Black community, were going to be getting the vaccine first, and I am outraged at that and I believe that the Black community needs to know that this is part of the agenda of those that have been pushing vaccines for decades and proceed with caution. Listen to the Minister and do not take that vaccine,” said Ms. Ford.
Another problem is that vaccine testing is being conducted in a utopian manner, on people with no known health conditions, adverse events may be exacerbated in people with underlying compromised immune systems and other underlying health conditions, such as diabetes and chronic heart disease, she added.
Authors of the paper “Warp Speed for COVID-19 Vaccines: Why are Children Stuck in Neutral?” published in September by Oxford University Press for the Infectious Diseases Society of America, advocated for immediate implementation of Phase II clinical trials for Covid-19 vaccines for children, saying there are potential direct and indirect benefits of pediatric vaccination.
“Dr. Patricia Whitley Williams, a pediatric infectious disease physician, has told us that children are not eligible for the vaccine. They are not being subjected to clinical trials here in the United States,” stated Min. Muhammad.
“Medical doctors in the National Medical Association have advised us that children should not receive the coronavirus vaccination. It is a fact that children rarely contract or become ill from the virus. A vaccine is unnecessary for children, thus, to inject a child with an untested vaccine would pose a reckless, dangerous and unnecessary risk of serious injury,” argued Min. Muhammad, who is also an attorney.
“Because vaccines have a history of injury and long-term side effects in many people and are effective less than 70 percent of the time, their use on the population requires a sufficiently high fatality rate from the disease to justify the risk,” she continued.
“The major media outlets give raw statistics but no statistical analysis. Their objective is for the public to believe that a vaccine is the only solution for the virus; therefore the people allow the government to deny them access to the ever-increasing number of therapies that are proving successful in control of and recovery from it.”
“Dr. Deborah Birx, White House Coronavirus Task Force Coordinator, stated last month, in speaking on the decreases in death rates, ‘When people start to realize that 99 percent of us are going to be fine, it becomes more and more difficult to get people to comply [with safety guidelines].’ Based on deaths per capita, the probability of surviving an encounter with Sars-CoV-2 [COVID-19], is 99.991 percent. Why are Black people nearly one-third of the 207,000-plus deaths in the United States? It is because in 94 percent of the deaths, we have an average of not one, but 2.6 pre-conditions.
“And one of those two conditions is most likely diabetes,” concluded Min. Muhammad, citing statistics issued by the federal Centers for Disease Control.
“I want to just continue to renew my and I think many others’ concerns around the attempt to politicize this issue as a way to prop up Donald Trump’s failed presidency and his hopefully to be failed candidacy in his re-election,” said Pastor Michael McBride, co-founder of the Black Church PAC.
The Black Church PAC will defer to a broad coalition of ethicists, scientists, virologists, epidemiologists respected in the Black health profession, and they will help inform justice minded clergy and lay leaders about next steps, he said.
“I don’t care if you’re young, old, rich, poor, I don’t care if you’re from the ’hood, any effort that seeks to accelerate the testing or the scaling up of vaccines, while Donald Trump is the president, without a necessary identification of the circumstances and protocols, you deserve to be harshly critiqued, deeply questioned and held in suspicion, until we can verify your intentions,” Pastor McBride told The Final Call.