You probably haven’t heard. The only reason I know about it is because I am still getting dozens of emails every week from research groups and institutions that were actively reporting on COVID from 2020 to 2022, when I was actively interested in and reporting on it. I don’t have time to read all of them – but when I see something that confirms one of the arguments that I was making way back then, I can’t resist a little I-told-you-so report.
So here it is…
The FDA is preparing to approve Moderna’s new mRNA flu vaccine, and some scientists have concerns about it that sound awfully familiar. Like: Where does it go in the body? How long does it stay there? What happens when millions of people take it every year for the next decade?
The interesting thing is that the concerns aren’t coming only from the usual skeptics. Two of the articles I’m linking to below come from the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP) – about as mainstream and pro-vaccine a source as you’re likely to find. Another comes from BioPharma Dive, an industry publication that covers pharmaceutical companies for a living. Another comes from Nature Biotechnology, one of the world’s leading scientific journals.
None of them are anti-vaccine. Yet all three reported on a vaccine approval process that raises some uncomfortable questions:
* Why did the FDA initially reject Moderna’s application and then reverse itself days later?
* Why are some researchers concerned that key studies normally used to understand where a drug goes in the body and how long it remains there were never conducted for this specific vaccine?
* Why are regulators relying on just six months of follow-up data for a product intended to be injected repeatedly into tens of millions of people?
* Why did the trial, which demonstrated only a modest reduction in flu infections, not establish a statistically significant reduction in hospitalization or death?
Supporters of the vaccine will make what has become a familiar argument: None of the risks have been proven. Fair enough. But history is littered with products that worried some scientists long before definitive proof arrived.
A few examples:
* Cigarettes. By the 1930s and 1940s, a growing number of physicians suspected a connection between smoking and lung disease. The tobacco companies responded by pointing out that the evidence was incomplete. They were technically correct. They were also disastrously wrong.
* Asbestos. Workers were developing serious lung problems years before regulators acted. The standard response was that no one had conclusively proven causation. By the time causation was conclusively proven, countless workers had already paid the price.
* Thalidomide. Doctors began noticing troubling patterns before they could prove what was happening. Definitive proof came later. The birth defects came first.
I’m not saying that this new vaccine belongs in the same category. I’m saying there is reason to believe that it does. Saying that “the danger hasn’t been proven” is not a particularly reassuring argument. It’s not even logical – and it’s doubly illogical when the product is new and long-term data does not yet exist.
If you think I’m being unnecessarily mistrusting of Big Government and Big Pharma… if you think this latest move is nothing to worry about, then you must answer this: If the benefits remain uncertain and the risks remain uncertain, why is the burden of uncertainty once again being placed on the public?
After everything we learned during COVID, you might think regulators would be demanding more evidence before approval, not less.
Whatever your beliefs are at the moment, you should check out the following articles. They won’t answer every question. More likely, they will leave you with more questions than answers. I’m hoping they will suggest to you, as they did to me, that in this case, skepticism is an entirely reasonable response.
From: Focal Points
This is the first article I found on the subject. These guys are not at all trusting of Big Pharma, Big Health, Big Health Insurance, and Big Media.
From: University of Minnesota’s CIDRAP
CIDRAP is generally viewed as a mainstream infectious-disease organization. Yet it devoted significant coverage to the FDA’s highly unusual sequence of decisions: first refusing to review Moderna’s application and then reversing itself days later.
From: BioPharma Dive
Again, not an anti-vaccine publication. It covers the biotech and pharmaceutical industry professionally and generally from an industry perspective – yet its June 16 coverage emphasized that FDA scientists themselves identified shortcomings and uncertainties in the evidence package supporting approval.
From: Nature Biotechnology
This is perhaps the most establishment publication of the bunch. It described the FDA’s reversal as a “backpedal” and highlighted the unusual regulatory sequence. Again, not evidence that the vaccine is unsafe – but evidence that the process itself was controversial.
There is surely a chance that this latest vaccine will prove safe and effective. I certainly hope so. But when you consider the evidence that there is at the moment – and the FDA’s, CDC’s, and mainstream media’s track records for telling the truth on the COVID story from Day One – I can’t see an argument you could put forward that would make any sense at all.
If you have one, please let me see it. I’ll respond to it next week.
