The president’s vow to make final decision on more stringent safety requirements for Covid-19 vaccine increases fears a harmful product could be rushed to market
by Naba’a Muhammad and Charlene Muhammad Final Call Staffers
The president dropped a powerful, but perhaps unsurprising bombshell when he declared he could veto a Food and Drug Administration decision to employ more stringent safety standards for approval of a controversial Covid-19 vaccine.
He deepened fears that politics and his almost obsessive drive for reelection, helped by a “cure” for the coronavirus as voters take to the polls Nov. 3, would compromise the safety of the American people.
“Mr. President, the FDA is reportedly considering stricter guidelines for the emergency authorization of a Covid vaccine. Are you okay with that?” asked a reporter during a Sept. 23 press briefing at the White House.
“We’re looking at that. That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” replied President Trump.
The president has pushed a nine-month almost unprecedented creation of a vaccine for a new virus, which the White House says would usually take at least four years. The White House insists no shortcuts will be taken with safety, but a majority of Americans are worried about politics and pressure corrupting the already rushed process.
Some questioned whether the president would have final approval, but ultimately high level officials at the FDA would have to approve the vaccine. The highest level FDA official is the commissioner, who is a presidential political appointee.
“What’s really the driver? The driver is you got a political system, a person who’s running for president, who is saying whatever they want to say, but there’s no facts to support it,” said Yaa Simpson, an epidemiologist in Chicago.
“Then you have another system like the FDA, who actually has to be very careful, because they know historically and presently if they make wrong moves now it can have an impact later. So they’re trying to adhere to what the president wants, but factually they know you can’t have a vaccine like that quick,” Ms. Simpson told The Final Call.
According to CNN, two “former FDA commissioners previously told CNN that while they think it’s very unlikely that Trump could pressure scientists into authorizing or approving a Covid-19 vaccine, it’s possible. The Department of Health and Human Services has in the past overruled the FDA’s recommendations on medications.”
“The confusion is heightening the mistrust, and some of it’s intentional,” said Dr. Rueben Warren, director of the Tuskegee University National Center for Bioethics in Research and Health Care.
“What I see is the building tension between the efficacy of science and development of a safe and effective vaccine, and the other influences, political and otherwise. And so we’ve got to be sure and stay steadfast to the science, and not only to the science, but the interpretation of the science has to be done by credible scientists,” Dr. Warren told The Final Call.
Polls find rejection, distrust of tainted vaccine process
Most Americans told pollsters again that they would not take any Covid-19 vaccine right away. Six in ten respondents to an Ipsos/Axios survey said they would wait to see how others fared after taking a vaccine.
“That number is up from 53 per cent in August and now only 9 per cent say they will get it immediately, down from 17 per cent. And 33 per cent of Americans told pollsters that they are ‘not at all likely’ to take the vaccine,” reported The Independent, a UK-based newspaper. Eighteen percent would wait at least a year and 23 percent would not get the vaccine at all, The Independent reported Sept. 23.
Polls consistently show a majority of Americans disapprove of the president’s handling of the coronavirus crisis as deaths exceeded 200,000 people with more than six million Americans infected with the virus.
Polls show Blacks most skeptical about a Covid-19 vaccine and least likely to take it, or take it early.
The National Medical Association, the Black physicians’ organization, announced Sept. 21 that it was forming a task force to examine Covid-19 clinical trials and vaccines. The group said questions about political influence in the process and FDA’s approval of emergency use authorization for hydroxychloroquine and convalescent plasma prompted the decision.
“In both cases the established safety protocols involving completion of Phase 3 clinical trials for treatment of SARS-CoV-2 were bypassed,” said the National Medical Association. “These questions of political influence on scientific process because of Operation Warp Speed (OWS), have threatened the public trust in the FDA that will adversely affect participation in clinical trials, especially in the African-American community,” said the group.
“The taskforce includes NMA physicians who belong to the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices, Infectious Disease Society of America, Pediatric Infectious Disease Society, and the CDC Health Equity Workgroup. The NMA Covid-19 taskforce will be positioned to provide timely recommendations to physicians and the community about future emergency use authorizations by the FDA for Covid-19 vaccines and therapeutics currently undergoing evaluation in clinical trials. The taskforce findings will be especially critical if such an authorization occurs immediately before the Nov. 3 U.S. election.”
“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.
“Right now, too many people don’t trust the process, because they fear that the Trump administration is putting political pressure on the FDA to approve a vaccine prematurely. It’s no secret that the White House believes the approval of a vaccine or treatment for Covid-19 would be a boon for the president’s reelection campaign,” said Marc Morial, president of the National Urban League. He still supports Black participation in clinical trials for a vaccine
The racial disparity of the pandemic is affecting the development of a safe, effective vaccine, argued Mr. Morial. According to a recent study, Blacks in America and Latinos are underrepresented in vaccine trials, despite being disproportionately affected by the virus, he said. Blacks are 4.7 times as likely to be hospitalized with Covid-19 than White Americans and Latinos are 4.6 times as likely.
He noted Blacks represent 13 percent of the population but are only 8 recent of Pfizer’s U.S. trial and 10 of Moderna’s. He feels the only way to bring the virus under control is through a safe, effective vaccine that works for everyone.
“But Americans have to trust the process if we expect widespread participation,” he added. Mr. Morial didn’t say what safeguards should be in place and who should guarantee the safety of the vaccine development process and its products in this highly charged political environment.
“The National Urban League is closely monitoring the vaccine trials to make sure they are both racially diverse, transparent, driven by science and unaffected by politics,” he said when asked if the National Institutes of Health or the non-profit research group RTI International, which is paid to promote outreach for clinical trials, had reached out to the Urban League to help increase the numbers of Blacks in clinical trials. He did not say whether the Urban League was working with RTI International.
“Clearly, the Black community, in light of the record of the terrible treatment of our people, medical experimentation, genocidal plans carried out against us, we need Divine Guidance. And the man that God has given us as that guide is the Honorable Minister Louis Farrakhan,” said National of Islam Student Minister Ava Muhammad, who is Min. Farrakhan’s national spokesperson.
“What he has given us is the straight path to health, which involves studying the use of successful therapies and treatments for Covid-19 by other nations. We must address our overall health, ” she said.
She cited recent Centers for Disease Control statistics showing Covid-19 was the sole cause of death in only six percent of the total deaths. Ninety-four percent of people who died with Covid-19 had an average 2.6 additional conditions or causes contributing to those deaths, she said.
“It is important at this time that we do not become fixated on taking vaccines because vaccines are, as a matter of record, a very high risk solution to a disease,” warned Min. Muhammad. “The universal view in the medical and health professions is that vaccines should only be utilized when the lethality (fatality rate) from a particular infection is so high that it requires dramatic, high risk intervention.”
The American people’s reluctance to take the vaccine stems from doubt about its necessity along with concerns about efficacy and safety, Min. Muhammad commented.
“As attorney Robert F. Kennedy, Jr., said, to vaccinate is to stage a medical intervention on a person who’s not suffering from the disease. You’re injecting it directly into the person’s bloodstream, bypassing the body’s defense mechanisms,” she said.
Coronavirus, whether it’s Covid-19 or the common cold, is contracted through the nose or mouth, which is why CDC Guidelines place hand washing and social distancing as the foremost effective means of preventing spread, she continued.
Corporate cartels and political power
“We must not be fixated on the president because he’s not the ultimate power. He’s politicizing the virus to stay in office. But conversely, the Democrats are politicizing it to get in office,” said Min. Muhammad.
“If you remember, from the outset it has been the liberal Democratic media that has been telling us we need a vaccination. They have parroted Bill Gates and the pharmaceutical cartel. The Jewish- controlled media has promoted the words of Bill Gates and Ezekiel Emanuel, Alan Dershowitz and others, including Anthony Fauci. They all have said the final solution to this problem is a vaccination.
“This is the age of the multinational corporation. That’s where the power is now. Minister Farrakhan taught us on that back in the ’90s,” said Min. Muhammad.
“He said the U.S. government has been hijacked by multinational corporations. So this is not a government in the sense that we understand government for the people and by the people. The people we elect to office have minimal power. They have power. I don’t dismiss that. The president of the United States absolutely has power, but his power pales in comparison to the multinational corporations, in this case, the pharmaceutical cartel.”
And, she added, when Min. Farrakhan spoke on July 4, they knew they were going to have to abandon intimidation as the means to get people to take a vaccine.
When Minister Farrakhan pushed back, and the world heard him say don’t take their vaccine, the number of people saying they would not take a Covid vaccine grew exponentially, she said.
Questions from members of the U.S. Senate during a Capitol Hill hearing added to the chorus raising questions about the safety of a Covid-19 vaccine and integrity of the vaccine development process.
“I am concerned that Americans are losing confidence in the federal government’s Covid-19 vaccine review process,” said Sen. Lisa Murkowski, a Republican from Arkansas, to hearing witnesses that included Food and Drug Administration Commissioner Dr. Stephen Hahn, White House Coronavirus Task Force members Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases; Dr. Robert Redfield, CDC director, and Admiral Brett Giroir, M.D., an assistant secretary with the Department of Health and Human Services.
They testified Sept. 23 before the Senate Health, Education, Labor, and Pensions Committee about their latest pandemic responses.
Dr. Hahn said the FDA would issue stricter protocols toward greater transparency and would not approve any vaccine unless it met requirements for safety and efficacy. The president later said the White House would decide whether stricter protocols would be approved.
Dr. Redfield told lawmakers that while a vaccine could be ready early, it would not be “generally available to the American public” until the late second quarter or third quarter of 2021.
Mr. Trump responded later, saying Dr. Redfield was “confused” about the vaccine’s timing.
Dr. Hahn and Dr. Redfield promised to make clinical data and findings for vaccines being developed public before the FDA approved or authorized vaccines. Dr. Fauci professed confidence in vaccine development monitoring by the Vaccines and Related Biological Products Advisory Committee.
Dr. Redfield, however, did not reply to Sen. Tina Smith’s (D-Minn.) questions regarding changes to CDC guidelines for coronavirus testing after President Trump’s directions to slow down such testing. He also failed to confirm or deny reports the president called him directly. He reiterated previous statements about the importance of wearing masks to combat the spread of Covid-19.
Sen. Murkowski blamed widespread concern about FDA independence and the Covid-19 vaccine review process in large part on Dr. Hahn’s actions and inaccurate statements.
Four Covid-19 vaccine candidates are in Phase 3 clinical testing in the U.S. in just under eight months, according to the National Institutes of Health. Normally, it takes between 10-15 years to develop a vaccine, according to one expert.
More than 90 physician groups, doctors and public health experts recently expressed concern about FDA transparency, said Sen. Murkowski. In a letter to Dr. Hahn, the coalition asked him to ensure vaccine approvals, or authorizations were based on facts and science, and free from political influence, she said.
Troubles plaguing Covid-19 vaccine trials include calls for Dr. Mocef Slaoui, co-leader of the federal government’s Operation Warp Speed vaccine initiative, to step down.
According to watchdog group Public Citizen, Dr. Slaoui was brought on as a private contractor. The move allowed him to maintain an extensive web of financial interests without the need to divest, recuse himself or disclose conflicts, said Public Citizen.
All of the witnesses responded “no” when Sen. Elizabeth Warren (D-Mass.) asked if they have stocks or financial investments in any companies developing Covid-19 vaccines.
“Dr. Moncef Slaoui, the man that President Trump selected as the government’s ‘vaccine czar,’ is a former drug company executive,” said Sen. Warren. The Trump administration used a loophole in federal ethics law to hire him to keep his conflicts from the public, she charged. Mr. Slaoui reportedly owns about $10 million in stock in GlaxoSmithKline, a drug company that’s working on a coronavirus vaccine, said Sen. Warren.
And, she continued, according to documents released on Sept. 22, he may own stock in Lonza Group, a company working with Moderna, another pharmaceutical company developing a Warp Speed vaccine.
“Why does this matter? Well, Operation Warp Speed, the federal vaccine project that Dr. Slaoui heads up has invested billions, that’s billions of dollars in the companies that Dr. Slaoui holds stock in. So, Dr. Hahn, you and other FDA officials involved in the Covid-19 vaccine must comply with conflict of interest laws. You just told me how seriously you take that. So can you explain to me why Dr. Slaoui should get to play by a different set of rules?” she asked.
She called for passage of her “Coronavirus Oversight and Recovery Ethics Act,” which prohibits conflicts of interest in the federal Covid-19 response. “The first person to be fired should be Dr. Slaoui. The American people deserve to know that Covid-19 vaccine decisions are based on science and not on personal greed,” said Sen. Warren.
“Granted, Dr. Slaoui has taken an initial step to ameliorate perhaps one of his most egregious conflict of interest—resigning from the corporate board and divesting of ownership in Moderna, a pharmaceutical company expected to receive large government contracts and assistance from the Warp Speed project. But many other conflicts of interest appear to persist, many of which may not be public,” wrote Public Citizen and Lower Drug Prices Now in a letter to the Department of Health and Human Services Inspector General and U.S. Office of Government Ethics.
They asked the offices to determine whether Dr. Slaoui is serving as a special government employee and should resolve his conflicts of interest and secrecy surrounding his financial interests.
Meanwhile, the U.K. government “is considering launching a clinical trial where it gives healthy volunteers ‘human challenge trials’ where healthy volunteers are purposefully infected with the coronavirus that causes Covid-19 in a bid to speed up development of a vaccine,” reported CBS Marketwatch.
Volunteers would receive a potential vaccine before getting a dose of the SARS-CoV-2, the coronavirus that causes Covid-19. The government-funded studies to be run by Open Orphan and Imperial College London could begin in January, and AstraZeneca’s coronavirus vaccine work in collaboration with Oxford University is not part of the program, according to CBS Market Watch.
