Novavax may be the best COVID-10 Vaccine to date
Once upon a time, Dr. Marty Makary was a big fan of the Novavax vaccine. “It uses a tried & true mechanism of action,” he said. It just needed a “better PR firm,” he added, linking to an article titled The mRNA Vaccines Are Extraordinary, but Novavax Is Even Better.
Under this administration, we are prioritizing the Gold-Standard of Science
Things are very different today. Dr. Makary no longer cares about tried-and-true mechanisms of action when it comes to vaccines. With the assistance of Dr. Tracy Beth Hoeg, a COVID-fabulist, sports medicine doctor, and political appointee, Dr. Makary recently put the brakes on full approval for the Novavax vaccine. As the article FDA Asks Vaccine Maker to Complete New Clinical Trial for Delayed Covid-19 Shot reported, they are demanding a new randomized-controlled trial (RCT).
On social media, Dr. Makary, who authored We’ll Have Herd Immunity by April 4 years ago, depicted himself as a champion of science and evidence-based medicine. Although previous RCTs showed the Novavax vaccine was 90% effective against preventing COVID, including 80% in adolescents, Dr. Makary now claims that every tweak to it requires a fresh RCT. He also depicted himself as heroically standing up against Big Pharma. They were too greedy to run a new trial.
They did not honestly study the issue
However, there is no reason why the NIH should not fund such vaccine RCTs. Dr. Jay Bhattacharya agrees that RCTs are the only valid method for learning about vaccines. Although he massively overhyped them in April 2021, promising they blocked transmission and eliminated severe disease, in his article The Covid Vaccine Trials: Failures in Design and Interpretation he blasted previous public health officials for saying what he said. He wrote about “a mismatch between the clinical trial endpoints and the public health needs” as well as a “failure in the interpretation of the trials, with a mismatch between what public health officials claimed and recommended and what the trials actually showed.”
Moreover, Dr. Bhattacharya clearly feels that running such trials is the responsibility of the agency he now leads. In the video below, he excoriated his predecessors for not running such studies of drugs like ivermectin. They controlled “billions of dollars of funding,” Dr. Bhattacharya pointed out. “They did not honestly study the issue in 2020,” he said. Dr. Bhattacharya feels Dr. Fauci and the NIH should have “definitively” studied these medications and done “high-quality trials.” He implied they refused to study them to hide that they worked, and he also defended people’s right to take them. “Why would you not permit people to take it,” he asked? In reality, Dr. Fauci and the NIH tried to study hydroxychloroquine and azithromycin in 2020 but couldn’t get anyone to enroll.
There isn’t enough time between identification of strains included & release of vaccine
Unlike myself, Drs. Makary, Hoeg, and Bhattacharya did nothing to advance a COVID-RCT before they were sworn into office. They merely called for others to do RCTs and treated this as a genuine accomplishment. They made such trials sound really easy and blasted their predecessors for their supposed failures, the same way they are blasting Novavax today. There’s always a villain and it can no longer be the Medical Establishment. Now, these doctors are the Medical Establishment, with enormous power and resources at their disposal. Despite this, they still feel it’s someone else’s job to run RCTs. They still feel their role is to give TV interviews and send Tweets calling for other people to do the Gold-Standard of Science. RCTs were for Francis Collins and Toni Fauci only apparently.
However, by refusing to fund and perform vaccine-RCTs, they are advocating for Big Pharma to do the research that determines whether or not vaccines are safe and effective. Our Medical Establishment doesn’t want independent agencies to generate Gold-Standard of Science for the American public. They bash Big Pharma as greedy, but they expect people to trust the results of their studies.
Of course, we don’t have to play dumb about what’s actually happening here. Drs. Hoeg and Makary are not demanding a new RCT to advance medical knowledge or protect the America public, but rather to please their boss by sabotaging the Novavax vaccine. As they surely know, a new trial might be “prohibitively expensive“, and there is virtually no chance it could have actionable results before the next variant emerged. As Dr. Tara Smith said:
Dr. Michael Osterholm, who recently launched the Vaccine Integrity Project to safeguard vaccines the U.S. similarly said:
Since the season is only X number of weeks long, by the time they could get vaccine approved with early season studies, it would be too late… to get vaccine out. It makes no sense at all. Unfortunately, we’ve got a combination of government scientists and public relations people who don’t understand what they don’t understand. And this is potentially a very dangerous concern.
Doctors Who Performatively Fetishized RCTs Aren’t Out to Advance Medical Research, But Rather to Sow Doubt & Mistrust
He’s, right, though this sort of methadolatry is an old anti-vaxx trick, which we’ve written discussed often here at SBM. While it would be great if RCTs could be whipped up in an instant, there’s a reason I titled one of my previous articles Doctors Who Performatively Fetishized RCTs Aren’t Out to Advance Medical Research, But Rather to Sow Doubt & Mistrust. Now, these merchants of doubt have power, and they are using the same tricks, wielding RCTs as a weapon.
This is all part of a broader assault on vaccines. Dr. Makary is currently downplaying measles, refusing to advise parents to get the MMR, and cheering for the pediatric COVID vaccine to be taken away. Meanwhile, the headlines read US Halts Funding for New COVID-19 Vaccines and, Dr. Bhattacharya wants to pull existing mRNA vaccines from the market. There is no reason to think that the mRNA boosters will be treated different than the Novavax vaccine.
None of this surprises those of us who paid attention. Drs. Makary, Hoeg, and Bhattacharya spread copious anti-vaccine misinformation over the past several years. Today, they are threatening to take away all COVID vaccines under the guise of protecting the American public from itself. They feel that they, the Medical Establishment, knows what’s best for your health, and they want to use government power to limit your choices.
Obviously, a study of the Novavax vaccine, specifically funded by Novavax the company, won’t convince anyone to get it. Moreover, absolutely no one who was going to get the Novavax vaccine asked for a new RCT of it. They were satisfied with the existing data. Recent data from the company showed it has fewer side effects than the mRNA vaccines, and its many fans are rightfully angry that our Medical Establishment is threatening their medical freedom. Apparently, the question “Why would you not permit people to take it?” applies only to quack treatments, not to vaccines with a proven track record.
This Is Not How We Do Science, Ever
Our current Medical Establishment doesn’t seem to grasp that they are no longer just Fox News and Twitter celebrities who can comment from the sidelines as if they were passive observers. They are in charge, and it’s their job generate high-quality data, exactly like they demanded from their predecessors. Similarly, the rest of us have the right to call for them to do RCTs and hold them accountable for their failures. They signed up for this. Since Drs. Makary, Hoeg, and Bhattacharya claim we need new RCTs of COVID vaccines, we should all call for them to do these trials themselves.
Yet, instead of providing the American public with the Gold-Standard of Science we deserve, our Medical Establishment is continuing the pattern they established during COVID. For vaccines, they required the Gold-Standard of Science. They felt it was necessary to protect the public from potential risks of the vaccine. We must be very careful!
However, such none of this was necessary when it came to the virus. Listen to what they said in summer 2021, when the virus was 1-year old, right before the Delta and Omicron waves arrived. These confident pronouncements were not made based on the the Gold-Standard of Science. There was no RCT that showed we had herd immunity in May 2021 or that natural immunity to COVID was likely lifelong. For the virus, vibes were just fine. There was no need for the Gold-Standard of Science, and there was no need to be careful. Nothing’s changed, except who has power and who is the Medical Establishment.
Today, these doctors are going to use our tax money to dredge private medical records to “discover” the cause of autism and attack transgender people, with the “results” known in advance. As Katherine Wu recently reported about this inversion of the scientific method:
NIH officials found the memo’s directives appalling. “This is not how we do science, ever,” one of them, who requested anonymity out of concern for professional retribution, told me. “This is politicized research, exactly what we were always told we would never do.”
For the past 5 years, the attitude of our Medical Establishment has been: RCTs for thee, fishing expeditions for me. This is the quality of “science” they are going to give us today. We all know the “conclusions” in advance and because it’s not the Gold-Standard of Science, we should reject the predetermined results.