Some called the latest coronavirus vaccine announcements by big pharmaceutical companies Moderna and Pfizer encouraging. Others pointed out serious unanswered questions and unknowns, despite talk of FDA approvals and company declarations of success.
Moderna, which claimed a 94.1 percent success rate in its Covid-19 vaccine in preventing infection or transmission of the virus, applied for emergency use authorization with the Food and Drug Administration on Nov. 30. The FDA’s Vaccines and Related Biological Products Advisory Committee is scheduled to review Moderna’s data during a Dec. 7 public hearing at Final Call presstime.
Pfizer applied for federal approval Nov. 20, claiming a 95 percent success rate. It’s review by the FDA’s oversight committee is planned for Dec. 10, but the United Kingdom approved the Pfizer product Dec. 2.
Therein lies a big part of the problem, according to critics of pharmaceutical giants. They want safe vaccines and are concerned about vaccine injuries. Such critics, who include scientists, epidemiologists, and medical doctors, argue there are viable alternatives to rushed Covid-19 vaccines.
The reported results from vaccine manufacturers is based on little data but even a safe, working vaccine would not magically end the pandemic. Mask wearing and social distancing would still be necessary as a safe vaccine worked its way through the population, which has been hesitant to accept vaccines pushed by federal officials.
Even the investor publication, Motley Fool, conceded vaccines include things to worry about.
In an article titled “Pfizer’s Vaccine Candidate Is Effective—But It Has Issues,” writer Jason Hawthorne admitted it was much less than a slam dunk. “Beyond regulatory approval, there are manufacturing, logistical, and efficacy questions to deal with. With the world waiting, there is no question human ingenuity will prevail. But getting this vaccine out to billions of people may not be the walk in the park the markets seem to assume,” said the writer.
The Pfizer vaccine’s reported effective rate “is only an interim analysis—an early look. While there were more than 40,000 participants in the overall trial, this reported efficacy is based on 170 individuals. I’ll be curious to see whether the efficacy rate holds up when more data is revealed,” wrote Mr. Hawthorne.
Approval means that during a public health emergency, the FDA can invoke its Emergency Use Authorization authority to allow unapproved medical products, or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases, according to the FDA. Certain criteria must be met first, including the absence of adequate, approved, and available alternatives per the FDA.
“We also don’t know how long this vaccine will remain effective. While vaccines are normally not approved unless they protect people for at least a year, these aren’t normal times,” he noted.
“Messenger RNA—the method used by Pfizer’s vaccine candidate—is very unstable, and no mRNA vaccines have yet been approved for human use. Creating mRNA in specially designed stainless steel bioreactors requires sterile conditions with a precise temperature and humidity. This instability is one of the reasons the vaccine must be kept so cold,” the Motley Fool article continued.
“As you might imagine, it’s a lot easier to make a small batch of mRNA for a clinical trial than it is to make hundreds of millions of doses for full-scale distribution.”
Experts at Johns Hopkins in Baltimore also admitted “vital questions remain unanswered.”
There is “much about the vaccines—such as the duration of immunity they offer, possible long-term side effects and variance across different ages, races and ethnicities—will likely take another year or so to understand,” Johns Hopkins’ experts said, according to the Baltimore Sun Dec. 4.
“The promise of a vaccine comes as COVID-19 wreaks new havoc across the country. More people are being hospitalized and dying of the disease caused by the virus than at any other point during the pandemic, and hospitals are reporting troubling signs of strain.
“But even if vaccines become widely available before the end of the year, many more months of study, clinical trial testing and research will be required before vaccines can be deemed effective,” said Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, during a virtual media briefing.
While crediting vaccine makers with “astonishing” progress in a little more than 12 months, Dr. Moss told the Sun, “not enough time has elapsed to determine whether the vaccines have any long-term side effects … or whether vaccines can prevent transmission.”
And another Hopkins professional noted, “vaccines won’t save lives if the majority of the public has doubts or refuses to get one.”
And, while federal officials, vaccine proponents and even some Black medical professionals cheerlead for vaccines and having Blacks and other non-Whites hit hard by the coronavirus get vaccines first, skepticism and distrust remain.
Dr. Anthony Fauci and others have said “trusted messengers,” like athletes and celebrities, will be recruited to promote the vaccine and likely take it themselves. Former President Barack Obama has already said he would publicly take the vaccine. He is to be joined by former Presidents Bill Clinton and G.W. Bush.
Yet Black people still don’t trust the Covid-19 vaccines nor claims by vaccine makers and the U.S. government that they are safe.A recent poll indicated “fewer than half of Black adults, 48 percent, say they probably or definitely would get a coronavirus vaccine if it were available for free—including just 18 percent who definitely would get vaccinated.”Against that backdrop, there is talk of paying Americans to take the vaccine. One proposal would offer a federal $1,500 payment per person and another suggests paying at least $1,000 per person. A medical ethicist called such proposals “a very bad idea.”
“If you pay people to get vaccinated, the strong implication is it’s not safe, there’s something wrong, you have to use money to persuade them,” he said in a media interview. During the Tuskegee Experiment which lasted 40 years, treatment for Black men with the disease was withheld by the U.S. government. That kind of medical malpractice, other abuses and failures have made Blacks leery of medical experiments and trials.
According to the “COVID Collaborative Survey: Coronavirus Vaccination Hesitancy in the Black and Latinx Communities,” released by Lang Research Associates on Nov. 23, two-thirds of Black adults believe the government can be rarely or never trusted to look out for the interests of the Black community. Just four in 10 in this majority would get the vaccine.
A national group of doctors and nurses with the Black Coalition Against Covid is pushing through Black organizations a “Love Letter” to start a national dialogue about Covid-19.
The letter pleads with Blacks to continue practicing safety protocols and guidelines until vaccines are widely available. The Black doctors and nurses ask Blacks to join them in participating in clinical trials and take a vaccine once it’s proven safe and effective.“This particular coalition of our Black medical and health professionals urging us to submit ourselves to the new vaccination tell us in the letter to hold them accountable. This is at best naive and at worst deceptive. How do we hold them accountable for that which they did not produce, that which they have no control over?” asked Student Minister Ava Muhammad, national spokesperson for the Honorable Minister Louis Farrakhan and the Nation of Islam.
“The mRNA Covid-19 vaccine will be the first of its kind. By definition it is experimental. It is designed to instruct our cells to manufacture a type of immune response that will shut down the virus,” she said. Both major U.S. firms, Pfizer and Moderna, are using mRNA in their vaccines.
Where is focus on the pre-conditions that are present in virtually everyone who dies from the virus? she asked.“I say to the coalition, get behind Minister Farrakhan and call for a lifting of the Cuban embargo. They have had overwhelming success in overcoming the virus. One of the components of their treatment protocol is to address the patient’s comorbidity,” said Min. Muhammad, referring to guidance and instructions Minister Farrakhan issued in his July 4 message, entitled “The Criterion.”
Minister Farrakhan warned Black people and others against blindly taking a vaccine for Covid-19. “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,” Min. Farrakhan said.
“I’m speaking for Black America, for Hispanic America, for the Native American and for those who are desirous of life. They’re making money now plotting to give seven billion, five hundred million people a vaccination,” he added. The Minister also spoke of therapies and treatments other countries are utilizing that need to be investigated, including therapies against Covid-19 used in Cuba. The Lang study found knowledge of the Tuskegee Syphilis Study, which allowed Blacks stricken with syphilis to suffer for decades under the supervision of the U.S. Public Health Service, made those surveyed less likely to trust the federal government.
The Lang survey revealed just 14 percent of Blacks said they trust a vaccine will be safe, while 18 percent would trust a vaccine to prevent virus infection.
And, KSHB TV in Kansas City noted in early December, “Two polls show confidence in a vaccine for COVID-19 is low among Black Americans. According to a STAT-Harris poll from October, only 43 percent of Black Americans said they would take a vaccine if it became available. In September, a Pew-Research poll reported only a third of Black Americans would get the vaccine.”
“It is understandable that developing vaccines during a pandemic is fraught with challenges and glitches. Many COVID-19 vaccine candidates are being developed using novel but unproven vaccine technologies,” read an article published online at Science: The Wire, https://science.thewire.in.
“Vaccine developers and health department authorities have continued to insist that safety and efficacy will not be compromised. But it is not clear how safe and efficacious the vaccines that are now on the verge of emergency approval will actually turn out to be,” admitted Science: The Wire.
The article covered a global range of different vaccines and their various challenges and stages of development. “All the leading COVID-19 vaccine candidates have revealed safety signals that can’t be ignored. The first was an instance of transient but serious adverse event (SAE) in four of the 45 participants in Moderna’s phase 1 trial,” reported Science: The Wire on Dec. 3. The website said “more than 70 vaccine candidates have entered clinical trials around the world, with a dozen in phase 3 trials” in a year since the Covid-19 onslaught.
Many question why so much emphasis on a hastily developed vaccine initially driven by President Trump’s desire for a pandemic win to save his presidency?The pharmaceutical industry, or Big Pharma, also stands to make billions as the vaccine is produced and distributed worldwide.
Dr. Judy Mikovits, an epidemiologist, believes vaccines with mRNA will be dangerous and perhaps deadly.She doesn’t believe the vaccine manufacturers’ efficacy claims and said mRNA could exacerbate underlying health conditions.
“It goes in every cell of the body, unlike the virus where the virus only goes in cells that have receptors for that spike protein,” she said.Normally a virus wouldn’t infect every cell in the body, she explained.
She fears bad outcomes manifested as inflammatory diseases like multiple sclerosis and neuro-inflammatory diseases, and chronic fatigue syndrome, citing research conducted in 2011.
The result could also be sterilization and even death for those who are already compromised in regard to their health, she argued.
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. President-Elect Joe Biden has said he will ask the public to wear masks for his first 100 days in office to curb Covid-19.
There are also questions about whether people will have to get a vaccine shot annually, or two doses of vaccines. So-called success rates are self-reported by the companies and cover between a month and three months of results. Critics and some Black health experts and analysts say its problematic that the announced results haven’t been peer-reviewed by independent experts. There were over 14.7 million cases of Covid-19 infections and nearly 285,000 deaths reported as of Dec. 7. According to Vox.com, one in every 1,000 Black Americans have died from Covid-19 since February, while death rates for Whites were one in every 2,150 people.
(Charlene Muhammad contributed to this report.)