We desperately need clean long-term safety data on the mRNA shots

Here's how we get it

The red flags about mRNA shots are everywhere.

Cellular-level research shows the artificial mRNA in the jabs lingers in the body for months. Side effect data show they are linked to far more problems than other vaccines. Most importantly, deaths from all causes remain high in countries that used the shots.

But we do not have the most crucial evidence - long-term safety data from large, randomized, blinded, placebo-controlled clinical trials. Those trials compare two groups of evenly matched people who receive either a vaccine or a placebo shot. They are not perfect. But they are the cornerstone of modern medicine, the strongest evidence available for (or against) any therapeutic.

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(YOU ARE FEELING VERY WIDE AWAKE)

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Pfizer and Moderna, the mRNA vaccine companies, ran those trials in 2020, including about 70,000 people. Then the companies ruined them. With regulatory approval, in early 2021 Pfizer and Moderna gave people who had received placebo shots in the trial the option to take the vaccines instead. In doing so, they destroyed any chance for long-term safety data.

We need that data.

We need a do-over.

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And the companies have given us a chance for one, if only regulators will take it.

How?

After all, no one is running large clinical trials of mRNA Covid vaccines right now. Not when regulators will authorize boosters based on a handful of mice. And not with demand for Covid boosters falling faster than China’s commitment to human rights.

(Actual Centers for Disease Control report on current mRNA vaccine demand)

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But Pfizer and Moderna have not given up on the mRNA dream. (I’ll avoid calling it a grift; I am sick to death of that word.)

And so both companies have started large pivotal trials for mRNA vaccines for influenza. Pfizer’s includes 25,000 people, and Moderna’s 23,000.

At this point we have very little reason to believe the mRNA flu shots will work any better than the mRNA Covid shots. Flu is even more prone to mutate than coronaviruses (at least coronaviruses that don’t face massive evolutionary pressure from mRNA vaccines, as Sars-Cov-2 does, but that’s another story).

And immune imprinting - aka original antigenic sin - is at least as big a problem for flu vaccines as Covid vaccines. In fact Dr. Thomas Francis Jr., the epidemiologist who coined the term “original antigenic sin” in 1960, was writing about influenza outbreaks.

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But whether the mRNA flu shots work hardly matters at this point.

What matters is that the companies are now running more large placebo-controlled and randomized trials on mRNA vaccines. Regulators have a new chance to examine long-term safety data.

They must seize it. The Food and Drug Administration needs to insist that the companies provide at least two full years of safety data on every trialist before it will even consider their applications. It should also ask the companies to collect detailed pre- and post-shot heart data on all men in the trials under 40, and maybe 25 percent of the remaining trialists.

The FDA has every right to do so. Regulators demand changes in trial design all the time. The Covid shots were rushed to market in 2020 because Covid was supposedly an emergency requiring an immediate solution.

Influenza is not an emergency, and even if it were we already have several flu shots available. The fact they don’t work very well is irrelevant, as Pfizer and Moderna have provided no strong evidence that their jab will work any better.

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To say Pfizer and Moderna will hate being asked for this extra data is an understatement.

They will object to the delay it will cause. To which regulators can remind them that most drugs take a decade or more to develop. They will object to the cost. To which lawmakers can gently remind them of the tens of billions that American taxpayers have already given them for the Covid shots. The government can even offer to pay the extra cost to collect the data, which would likely be well under $100 million.

What if Pfizer and Moderna still object, or even threaten to withdraw from the trials and discontinue development of the mRNA influenza shots? Regulators could try to compel them to continue - though such a move would be legally problematic.

But imagine the anger and blowback if the companies insist they are unwilling to move forward with an mRNA vaccine trial merely because they are being told to collect meaningful long-term safety data.

At this point, having begun the trials, they have almost no choice but to move forward.

Of course, the long-term data might not reveal any meaningful safety concerns. Such a finding would not prove the mRNA Covid shots are safe. Maybe the problem with the Covid shots comes from something specific in the Sars-Cov-2 spike, as opposed to the hemagglutinin flu protein.

But a safety signal - especially a cardiac or auto-immune safety signal - in the influenza trial would be a huge red flag for the entire mRNA vaccine platform.

This is our chance - maybe our only chance - to find out.

Regulators and politicians need to stand up to Pfizer and Moderna and take it.