A pivotal meeting in early March between vaccine developers and Donald Trump, “almost felt like an episode of ‘Shark Tank’” reported CNN in a May 1 investigation.
While various company heads told Trump development was way off, he perked up when Moderna CEO Stéphane Bancel announced he needed just “a few months” to start phase two of a three-part clinical trial of vaccine development, which typically can take more than a decade.
The next day, the FDA gave Moderna the green light to begin trials. Never mind that the biotech company had never actually made an approved vaccine, or had any of its various vaccine candidates approved for use by the FDA.
Since 2010, Moderna has been developing experimental gene-edited mRNA vaccines. “Unlike traditional vaccines, which require the laborious production of actual viruses or viral proteins, gene-based vaccines are made from DNA or mRNA,” explained a Chemical & Engineering article in April.
Currently, there are no RNA vaccines approved for human use.
In a 2016 report on Moderna, health website STAT explained: “In nature, mRNA molecules function like recipe books, directing cellular machinery to make specific proteins. Moderna believes it can play that system to its advantage by using synthetic mRNA to compel cells to produce whichever proteins it chooses. In effect, the mRNA would turn cells into tiny drug factories. It’s highly risky. Big pharma companies had tried similar work and abandoned it because it’s exceedingly hard to get RNA into cells without triggering nasty side effects.”
This hasn’t stopped our government, with approval by Dr. Anthony Fauci, from pouring close to half a billion dollars into funding the company’s Covid vaccine research.
“I don’t know what their thinking was,” Moderna’s former R&D Chief, Dr. Joseph Bolen told CNN about the $483 million federal funding, “When I read that, I was pretty amazed.”
And Biopharma Drive noted: “No mRNA vaccine is approved for any kind of infectious disease and Moderna, as a biotech with no approved products, has little experience manufacturing at the kind of scale which would be needed if its vaccine succeeds.”
Others were surprised that the FDA was fast tracking development an untested vaccine on humans before the usual animal trials. “I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,” said Tal Zaks, Moderna’s chief medical officer.
Federal regulators typically require that manufacturers show their product are safe before it can be given to people – usually in lab animals before human volunteers.
In the background, as he seems to be in a lot of vaccine development, is Bill Gates. In 2017, the Gates Foundation pledged to give Moderna up to $100 million to develop mRNA-based vaccines for infectious diseases.
Gates is an especially big fan of RNA vaccines. “An RNA vaccine is significantly different from a conventional vaccine,” he posted. “A flu shot, for example, contains bits of the flu virus that your body’s immune system learns to attack. This is what gives you immunity. With an RNA vaccine, rather than injecting fragments of the virus, you give the body the genetic code needed to produce lots of copies of these fragments. When the immune system sees the viral fragments, it learns how to attack them. An RNA vaccine essentially turns your body into its own vaccine manufacturing unit.”
On May 18, to major press coverage, Moderna announced the success of the first COVID vaccine tested on 8 humans. They said it appears to be safe and generated antibodies which stopped the virus replicating.
However STAT was skeptical. “While Moderna blitzed the media, it revealed very little information — and most of what it did disclose were words, not data.” Moderna “doesn’t publish its work in scientific journals. What is known has been disclosed through press releases.”
“My guess is that their numbers are marginal or they would say more,” Yale University vaccine researcher Jack Rose reported.
The report of neutralizing antibodies in subjects who were vaccinated comes from blood drawn two weeks after they received their second dose of vaccine. “That’s very early, we don’t know if those antibodies are durable,” said Anna Durbin, a vaccine researcher at Johns Hopkins University, about the two week measure.
Who cares about scientific journals when you can make huge profits on press releases. After last Monday’s announcement, CBS News reported Moderna CEO Stéphane Bancel and other top executives of the firm have made millions selling stock. Four of Moderna’s top executives netted a total of $30 million in stock transactions.
Bencel is now a billionaire. Based on Friday’s closing price his remaining 24 million shares are worth around $1.7 billion.
And also aboard the gravy train, our new vaccine czar, former GlaxoSmithKline executive Dr. Moncef Slaoui, who kept his more than 155,000 shares after Trump appointed him, and landed a windfall of $3.4 million. A Moderna board member, at least Slaoui resigned that position
So besides the jubilant shareholders should we be happy that Moderna is zipping along with a new vaccine?
In a US Securities and Exchange Commission filing, Bancel indicated that Moderna may request special permission to give people like doctors and nurses access to its vaccine this fall, before a formal approval.
Let’s remember that we have no vaccine for SARS or MERS. There hasn’t yet been a vaccine, let alone an mRNA vaccine, for any of the seven types of coronavirus known to infect humans, reports Biopharma Drive. Thomas Russo, the chief of infectious disease at the University of Buffalo’s Jacobs School of Medicine and Biomedical Sciences said there is some concern among experts that a coronavirus vaccine might need to target other surface proteins, too, for the body to generate a durable immune attack.
“The jury is out on what problems might still arise or where we might find hang-ups,” said Jonathan Watts, an associate professor at the RNA Therapeutics Institute at University of Massachusetts Medical School.
Some scientists have warned that once inside the cell nucleus, mRNA vaccines have a risk of permanently changing a person’s DNA in unpredictable ways.
A scientific paper funded by several Chinese universities and republished by the NIH in 2019, reviewing the development of the new messenger RNA technique for vaccines sounded some warnings, noting that there were, “concerns with instability and low immunogenicity.”
A 2018 review, mRNA Vaccines – A New Era in Vaccinology noted: “Recent human trials have demonstrated moderate and in rare cases severe injection site or systemic reactions for different mRNA platforms. Potential safety concerns that are likely to be evaluated in future preclinical and clinical studies include local and systemic inflammation, the biodistribution and persistence of expressed immunogen, stimulation of auto-reactive antibodies and potential toxic effects of any non-native nucleotides and delivery system components.
“The mRNA strand in the vaccine may elicit an unintended immune reaction. Preclinical experience with vaccine candidates for SARS and the Middle East respiratory syndrome (MERS) have raised concerns about exacerbating lung disease, either directly or as a result of antibody-dependent enhancement. A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity. Another study showed that extracellular RNA promoted blood coagulation and pathological thrombus formation.”
Professor Isabelle Bekeredjian-Ding, head of the microbiology division of Germany’s Paul Ehrlich Institut, told Horizon Magazine: “What is really the current challenge is to understand whether these vaccines will really be able to mount a sufficiently protective immune response in the human and to understand, for example, which quantities of mRNA will be needed to do this.”
(The Ehrlich Institut is currently researching a therapeutic option (rather than a vaccine) for the treatment of COVID-19 disease, antibodies that prevent the transmission of viruses in the human body from cell to cell, so-called neutralizing antibodies, are currently being tested).
The 2016 profile on Moderna in STAT was scathing. Their investigation found that the company’s caustic work environment has for years driven away top talent. Bancel built a culture of recrimination at Moderna, former employees said. Failed experiments have been met with reprimands and even on-the-spot firings. They recalled abusive emails, dressings down at company meetings, exceedingly long hours, and unexplained terminations. “It’s a case of the emperor’s new clothes,” said a former Moderna scientist. “They’re running an investment firm, and then hopefully it also develops a drug that’s successful.”
Also back in 2016, an op-ed published in the science journal Nature criticized Moderna at the time for not having published a single peer-reviewed paper.
And Forbes in a new “Buyer Beware” article, urged caution: “Moderna has not sold any products to generate revenue. It has relied upon collaboration revenue from other companies and grants to fund its research. These are perfectly fine ways to generate revenue, but at some point in time the company needs to successfully develop products that can be sold.” It estimated bottom line losses by 2019 as $514 million.
So should we celebrate or be concerned?
In the May 1 CNN article, Dr Suhab Siddiqi, Moderna’s former director of chemistry, reported: “I would not let the (vaccine) be injected in my body. I would demand: where is the toxicity data?”
p.s. A Moderna vaccine phase 1 trial volunteer reported that 12 hours after receiving his second dose, he developed a fever of more than 103 degrees, sought medical attention, and, after being released from an urgent care facility, fainted in his home. He recovered within a day. “I hope that it doesn’t fuel any sort of general antagonism towards vaccines in general or towards even this vaccine,” he said.