Just over two years ago, Robert Malone was living a relatively quiet life on his Virginia farm, training and breeding Portuguese horses with his wife, Jill.
But once the novel coronavirus was discovered and sequenced in Wuhan, China, everything changed, nearly overnight. Within days, mRNA coronavirus vaccines were being widely acknowledged as one of our best bets against the virus. Scientists started using the technology to develop shots — on a breathtakingly rapid timeline.
Suddenly, it seemed, everyone wanted to know who was responsible for this promising technique.
Flattering high-profile features and deep dives were written about Katalin Karikó and her University of Pennsylvania colleague Drew Weissman, some of the first scientists who figured out how to properly modify mRNA to get it into human cells more than 15 years ago. Ugur Sahin and Özlem Türeci, the founders of the German biotech company BioNTech, also made the news for using that same technique to develop a coronavirus vaccine in partnership with the pharmaceutical giant Pfizer.
Malone felt slighted. He wasn’t getting any credit for his decades-old role in these new vaccines. What about all the initial work he did successfully injecting mRNA into mice for the very first time in the late 1980s? He began to attempt to set the record straight.
And people listened. Malone has become a regular on Fox News and spent three hours on Joe Rogan’s podcast in late December. He’s become a trusted source for people everywhere who aren’t quite sure about these mRNA vaccines or whether they are really safe. Rising to the crowd’s call for an indictment of the COVID-19 vaccines from Pfizer and Moderna, Malone has seemingly become more polarized by the day. Recently, Malone publicly vilified and threatened legal action against another physician who reported his vaccine misinformation campaign to the Maryland Board of Physicians, and accused the Centers for Disease Control and Prevention of scientific fraud.
After getting kicked off Twitter in December for sharing some misleading interpretations of Pfizer’s trial data, he’s now largely confined to the extremist margins of the internet and society, where, fired up by the applause he receives, he’s become a valuable resource to anyone who may want a reasonable person to tell them why, exactly, to be skeptical of the COVID-19 vaccines.
There are reasons people are listening to Malone — he’s an expert source, and he’s asking interesting questions about the vaccines
Malone isn’t the raving propagandist that some might like to dismiss him as — one who’s wrong about everything that comes out of his mouth. As easy as it can feel for a vaccinated person to say he’s full of it and lying about everything related to mRNA technology, the real story is far from that simple.
The mRNA vaccines we have are working to keep people from dying and staving off severe disease in many, many hundreds of millions of people around the world, but they’re not perfect. They don’t stop all infections, and it does seem like the immune protection they offer may fade more quickly than many would’ve hoped, especially now that new variants are at play.
They don’t promise to stop all transmission (but it’s worth mentioning that vaccinated people recover more quickly and easily from COVID-19, avoiding more severe disease themselves, lowering their viral loads, and making them less of a threat to their neighbors more quickly too). What’s more, some people do have severe, painful, and rare vaccine side effects. While those are largely temporary, we don’t totally understand why they are triggered in some people and not others.
Malone has thrived in this space of the sometimes unanswerable and often complicated, frustrating lingering questions of the pandemic. He’s become an icon and a friend to people who feel not only left out and dismissed by the scientific community but also ignored and shamed by their exhausted vaccinated friends, colleagues, and family with the dismissive attitude of, “Get vaccinated already, morons, and stop questioning any of this.” He’s created a comfortable home base for those who feel just as disenfranchised as he does, and there’s a reason they’re listening to him.
Left out of the Nobel buzz
Malone is known in his field, and his work is often cited by the many, many others who’ve followed him to work further on mRNA vaccines and therapeutics. However, Malone is but one of a great many scientists who’ve made today’s mRNA vaccines possible.
What he did, in a nutshell, was show that messenger RNA — a notoriously unstable and hard-to-work-with single-stranded molecule — could be injected into mammals by using a lipid nanoparticle (a glob of fat, basically) as its package. He worked on that ground-laying research in the late ’80s with scientists such as Philip Felgner, who is considered a contender for the Nobel Prize and who won Spain’s equivalent last year (The Princess of Asturias Award).
“There are many, many contributors to the field, and it’s really hard to distinguish and determine who brought more,” Ingmar Hoerr, the founder of the German biotechnology company CureVac, told Insider.
Pierre Meulien, a molecular biologist who runs the European Union’s Innovative Medicines Initiative, said that in 1993 he and his team “were the first to group to demonstrate that you could induce an immune response with mRNA.” But, like Malone’s experiments before, that research was in mice only.
“I don’t think there is one inventor of mRNA vaccines,” Meulien said. “It’s how science works. I mean, you add up the number of people who’ve published in this area over the last 30 years — it is hundreds and hundreds of people.”
It wasn’t until more than 10 years after Meulien that Hoerr injected “the first human beings ever worldwide with RNA” in 2005, he said. At the time, many scientists hoped mRNA would be a great help for cancer treatment, and Hoerr was just one of them.
Matthew Winkler, a geneticist and biotech entrepreneur, was also hoping to develop mRNA therapeutics to kill tumors when he started Mirna Therapeutics in 2007. “We were delivering micro RNAs into humans for therapeutic purposes,” Winkler said. “These are the clear antecedents to delivering mRNAs as a vaccine.”
By that point, Malone had long moved away from the field of mRNA vaccine development. More recently, he authored papers on how to combat Zika and accelerate DNA-vaccine development.
At the outset of the pandemic, he offered some initial ideas about what doctors might take off the shelf to help treat COVID-19. He was part of a research group that won a $21 million emergency contract from the Trump administration to study famotidine (brand name, Pepcid AC) as a coronavirus therapeutic. It’s still unclear whether famotidine does much for COVID-19 patients. Some very small, low-powered studies suggest it could help decrease inflammation and marginally speed recovery.
According to Science Magazine, he was also part of a classified US government project called DOMANE, which used artificial intelligence and computer simulations to identify existing drugs that might be successfully repurposed “against threats such as new viruses.”
An attempt to set the record straight began morphing into an anti-vaccine crusade
Malone is fully vaccinated — he got both shots of Moderna’s COVID-19 vaccine in spring last year after it was authorized by the FDA in December 2020.
He was hoping getting jabbed might help with some of the long-COVID-19 symptoms he was having at the time, but it didn’t. Scattered anecdotal media reports were suggesting that promise at the time, but the idea has largely faded as more people have gotten vaccinated and more time has elapsed since their jabs.
Dr. Bruce Patterson, who runs a long-COVID-19 treatment center, said at a conference this month that many of his long-COVID-19 patients “who got better, after a week or two, reverted back to where they were.”
Malone said the side effects from his first shot were nothing remarkable, but after his second, he started complaining of
unfounded concerns that the usual protocols weren’t being followed at the FDA — the federal agency that’s meant to view new drugs, treatments, and vaccines as “guilty until proven innocent,” as he often says., saying he’d been given a “bad batch,” and raising
It’s true that vaccination isn’t one-size-fits-all. Different immune systems will react differently to vaccines and likely benefit from different COVID-19-vaccine regimens in the future, an immunological truth that everyone from Dr. Anthony Fauci to Malone agrees on. It’s also possible that Malone didn’t need a second shot since he’d already had COVID-19.
But to imply the FDA hasn’t taken all the appropriate safety measures for these vaccines — simply because people may react differently to getting immunized or experience other issues around the time of their vaccination that may or may not have anything to do with the shot itself — is misleading fearmongering. The CDC and FDA both keep an eye out for discrepancies in vaccine-batch quality, and no recalls have been issued for any of the COVID-19 vaccines.
“Following vaccination, after an immune response is triggered, the body breaks down the components of the vaccine and eliminates them in approximately 36 hours after vaccination,” an FDA spokesperson told Insider.
Further, both the FDA and the CDC monitor the safety of all vaccines all the time, in two key ways. First, federal regulators keep tabs on the Vaccine Adverse Event Reporting System, which gathers reports from both citizens and healthcare workers nationwide of anything amiss after a vaccination — whether it is directly related to vaccination or not. Second, the FDA and CDC also review large, population-based healthcare datasets, to round out the picture of what happens after people get vaccinated with a more active form of surveillance. These are both strategies that Malone is well aware of, given his career trajectory.
Malone has a pretty good grasp on how the US regulatory systems for vaccines operate, having worked in California‘s biotech industry, as well as on government contracts and scientific review boards for many years. He calls out Peter Marks, the head of the Food and Drug Administration’s Center for Biologics Evaluation and Research, by name, saying they’ve spoken about COVID-19-vaccine safety before. (When asked whether Marks had indeed spoken with Malone, an FDA spokesperson told Insider: “We cannot comment on or confirm any non-public meetings.”)
The Rogan effect catapulted Malone further into fame and controversy
Malone’s celebrity as a vocal vaccine opponent, already many months in the making, skyrocketed to stratospheric proportions in December — thanks to Rogan, the former “Fear Factor” host who’s become one of the most popular podcasters.
Rogan’s podcasting strategy is unabashedly ill-informed.
“Oftentimes, I have no idea what I’m going to talk about until I sit down and talk to people,” he said recently.
This means people like Malone and Dr. Pierre Kory have come on his show and remained largely unchallenged as they touted unproven COVID-19 treatments and said the vaccines aren’t safe — without providing context or evidence. (Kory is one of the most prominent voices advocating for more ivermectin prescriptions.)
On December 29, Malone was suspended from Twitter after saying that people who got Pfizer’s vaccine were getting sicker than those who didn’t. (They weren’t. A small number of study participants in both the vaccine trial group and the placebo group — i.e. people in the trial who did not receive the vaccine — got sick, which happens when you’re studying more than 40,000 people over a period of several months. Importantly, disease and death rates were not markedly different among the vaccinated versus unvaccinated cohorts in the study.) On December 30, Malone recorded a podcast with Rogan, and on December 31, their three-hour interview aired on Spotify, where Malone railed against some kind of “mass formation psychosis” driving people to worry too much about COVID-19.
Malone has also become a regular on Fox News, even as he’s described the experience as “a little weird.”
“Right now, conservative media are the ones that are open,” he told TrialSiteNews, where he’s a member of the advisory committee, last year.
He’s moved to the social-media platform Gettr — an alternative to Twitter founded by a former Trump aide — and become more prolific and political on his lucrative Substack. He speaks to large crowds of cheering fans, as he did most notably this year at a January 23 “Defeat the Mandates: An American Homecoming” rally on the National Mall in Washington, DC.
“Regarding the genetic COVID vaccines, the science is settled: They’re not working,” he told the crowd. “Whether they made sense for protecting our elderly and frail from the original virus is irrelevant.”
With a new, more infectious variant on the scene, and the far-right embracing his guidance far more than the scientific community ever will, he’s turned from a vocal asker of vaccine questions to an outright vaccine-opposing evangelical, seemingly ignoring any and all evidence of vaccine safety.
Malone has found good company lately in the ivermectin-promoting the Front Line COVID-19 Critical Care Alliance (of which Kory is a leading member), whose off-kilter COVID-19 treatment guidance he touts in an autoreply to anyone who emails him.
“As a scientist and clinical trial specialist, I do not see patients and do not prescribe drugs,” Malone says in his autogenerated email response. “If you are searching for a physician, I suggest going to the FLCCC website to see if anyone from that organization can help you.”
Malone told Tucker Carlson in an interview last month that it was “unfortunate” US military personnel, among other employees, were being “forced to take these products, while they’re still experimental.” (Both Moderna’s and Pfizer’s vaccines are fully approved for adults by the FDA, and the military has a long history of requiring many vaccines to protect US forces from disease.)
Malone’s concerns, from unfounded to impossible to refute
Despite his qualifications and industry expertise, many of Malone’s loudest concerns about these vaccines are off base. When he says the vaccines can permeate the blood-brain barrier, or that the tiny fatty particles they’re packaged inside might hang around in women’s ovaries, those are gross misinterpretations of how these vaccines work. They sound scary but aren’t grounded in good evidence.
There will always be hypothetical “what ifs” for any new drug, vaccine, or treatment. But Malone’s concerns are not ones that have other mRNA scientists worried. Take Andrew Geall, who developed some of the first lipid nanoparticles for mRNA vaccines.
“There was a pandemic. You need to do something — there’s no doubt the right thing was done,” Geall said. That’s why his entire family is vaccinated.
Still, vaccine research and development doesn’t end with the first doses in arms. Scientists are still studying the vaccines to improve them. Already, Canadian researchers have learned that spacing out the first and second doses of mRNA vaccines, to more than one month apart, can help prevent more cases of myocarditis in teens and young adults and improve the body’s immune response at the same time, a win-win for vaccination safety and efficacy — one that the CDC adopted earlier this week, to the applause of many US experts.
However, the truth is there is a lot we already know about these vaccines, safetywise.
That data isn’t just being collected by American regulators at the FDA and CDC. There’s also mandatory pharmacovigilance in the European Union, Japan has its own regulatory agency, and there are many other vaccine-surveillance systems in place in nations and hospitals around the world. None have raised major issues about the mRNA vaccines for COVID-19.
“It’s not as if there hasn’t been a huge amount of safety data on millions and millions of people,” Meulien said. “In order to find those very, very, very rare events, you have to look at safety data on absolutely millions of people — and this has been done. So I don’t think we can turn around and say these vaccines aren’t safe. I think they are safe.”
The idea that a terrifying, mysterious safety signal we haven’t seen yet might surface years from now is not only highly unlikely — it has never happened with any vaccine, because that is not how vaccines work. Vaccine side effects, and human immune responses to vaccines, surface in minutes, hours, days, weeks, or, sometimes, months — not years.
Take messenger RNA. It does not hang around in the body for a long time. At most, it’s detectable for a few days. The injected mRNA tells your body to make a viral protein to teach the immune system how to fight the coronavirus. That protein, in turn, hangs around for about a week of viral boot camp.
“Nature made a messenger. It’s called messenger RNA,” Hoerr, CureVac’s founder, said, expressing the transient nature of this molecule, which only instructs the body in what to do to fight the coronavirus. “It’s an ideal molecule to work on in terms of therapies and drugs’ development.”
Scientists agree with Malone on one thing
Certainly, today’s COVID-19 vaccines can and will be improved. Vaccine makers will likely do more to refine the vaccines’ lipid nanoparticle (vaccine package) in coming years, with the goals of lessening side effects, improving the performance of the vaccines against future variants, and stepping up how long vaccine protection lasts (an especially critical issue for older people).
Geall calls getting infected the equivalent of “a booster against all 26 proteins in the virus,” instead of a single antigen. But, of course, the risks of infection are still far greater than the risks of vaccination, no matter who you are, how vulnerable, or how old. (And the hybrid immunity afforded by vaccination and infection may turn out to be the best kind of immunity you can get.)
If Malone is right about one thing pertaining to the mRNA vaccines, Geall said, it’s that it is still important to keep researching these products and answering any yet unanswered questions about them, in addition to improving how and when they’re used.
“Would I have preferred that there had been 15 years of research and safety generation through clinical trials? Absolutely,” Geall said. “But that wasn’t an option during the pandemic.”
So he, and all the other scientists interviewed for this article, got vaccinated with the mRNA vaccines that they, Malone, and many others helped create over a 30-year period.
Malone, when reached by phone, said he was extremely busy, and unsure about giving an interview.
“I’ve gotten kind of wary of journalists for some reason,” he said.
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