Playing God (badly)

As I write this, I’m finishing A Shot to Save the World, the new book about the hunt for a Covid vaccine.

Which - surprisingly - I don’t hate. Written by Gregory Zuckerman of the Wall Street Journal, the book is a serious look at the decades of scientific work that helped produce the mRNA and DNA/AAV Covid vaccines.

Even better, it contains this line about Stephane Bancel, Moderna’s chief executive, from Derrick Rossi: “He was asking me to steal from a hospital that treats children. Stephane is someone without a moral compass.”

Who’s Derrick Rossi? Some crazy ivermectin-loving anti-vaxxer, no doubt!

Cofounder of Moderna? Oh, that was my second guess. Meantime, Stephane has $10 billion in Moderna stock to buy a new moral compass.

But to read this book is to see that these new biotechnologies are to ordinary small-molecule drug development as a manned mission to Mars is to a cross-country road trip. They are so complicated that even explaining them coherently is hard.

Old-school small-molecule drugs like aspirin are usually relatively simple chemicals with atomic structures that can be sketched out on a napkin.

Aspirin:

In general, these drugs work in straightforward ways, by attaching to receptors on the surface of our cells and either activating them or blocking them from being activated.

The body then breaks them down, usually quite fast, and their cellular effects wear off. They must be dosed again after a few hours or a day. At this point, after generations of developing them, scientists and physicians understand how they work quite well. Even so they need to be carefully tested because they can have off-target effects or be toxic in unexpected ways.

But we’re pretty good at making them. In fact even 20 years ago we were so good at making them that we had hit most of the obvious targets for them, like cholesterol and blood pressure and diabetes.

Unfortunately, fiddling with cell receptors can only do so much. Most cancers, brain diseases, autoimmune diseases, and genetic disorders are simply not amenable to small-molecule treatments. Treating them requires larger and more complicated proteins and enzymes that mimic the body’s existing proteins, attach to specific parts of deranged cells (cancer or other), or have other effects.

For decades, those proteins were generally grown outside the body and then injected into it.

Artificially produced erythropoietin, or EPO - a molecule our own kidneys make to help stimulate the production of red blood cells - is a relatively simple example of such a treatment.

But mRNA/LNP and DNA/AAV vaccines go still further.

They involve not using a simple chemical to interfere with a single receptor or injecting a protein we have grown in specifically purified cells but hijacking the body’s own fundamental processes of biological creation.

AND OUR BODIES DO NOT LIKE HAVING THEIR FUNDAMENTAL PROCESSES OF BIOLOGICAL CREATION HIJACKED. NOT BY VIRUSES, AND NOT BY SCIENTISTS. They fight the process at every step. This is why we have immune systems.

Thus using mRNA or DNA to make our cells produce proteins carries risk at every stage. At the moment of injection, the mRNA must be both disguised AND hidden inside a tiny ball of fat (and the DNA attached to a cold virus), or our bodies will likely destroy it before it can even reach our cells.

As Zuckerman explains in his book, “The [Moderna] scientists ran into a huge new problem… subsequent administrations saw the protein production plummet. It was as if the body’s defenses had learned to fend off the injected molecule and its genetic payload.”

Moderna wound up turning away from making mRNA drugs for repeated dosing and focusing on vaccines for just this reason; a successful vaccine should need only one or two doses to produce a sustained if not permanent immune response, thus eliminating the need for regular dosing.

But the problems don’t end there. If the injected particles drop their genetic payload into the wrong cells, they can also do damage.

Scientists have also now repeatedly demonstrated that the spike proteins the mRNA Covid vaccines create can be toxic - especially to blood vessel cells - all by themselves, without the rest of Sars-Cov-2 attached. (See, for example: https://www.frontiersin.org/articles/10.3389/fcvm.2021.687783/full)

Which doesn’t matter, the Covid vaccine fanatics told us, because the spike protein the vaccines generate doesn’t circulate.

Except it does.

But wait, there’s more.

We know that in the short run, mRNA vaccines lead to a drop in crucial white blood cells called lymphocytes - Pfizer and BioNTech themselves acknowledged this problem.

(SOURCE: https://www.nature.com/articles/s41586-020-2814-7)

Now the British government is warning that people who receive the vaccines appear to have a less complete immune response to Sars-Cov-2 after infection.

Maybe even more concerning, scientists now have found evidence the vaccines may produce worrisome longer-term changes in the immune system:

The BNT162b2 mRNA vaccine against SARS-CoV-2 reprograms both adaptive and innate immune responses

(SOURCE: https://www.medrxiv.org/content/10.1101/2021.05.03.21256520v1)

To be clear, evidence is not proof. These changes may not matter to our overall immune response. Even the severity of the risk is an immensely complex question that I am not qualified to discuss in depth.

But neither is almost anyone else.

And many of the people who understand these issues best have an enormous financial stake in the success of the Sars-Cov-2 vaccines. Zuckerman’s book makes clear that Moderna was facing real problems in 2019, before Covid hit. Bancel had spent too many years making promises that hadn’t come true, and Moderna was burning through money at a stunning rate without any marketable drugs to show for the spending.

Now, of course, both Bancel and Moderna have no such worries.

As for the regulators, they had a hard enough time back in the small molecule days. In 1999, they were unable to figure out that Vioxx caused heart attacks even when Merck presented them with clear data showing that Vioxx caused heart attacks.

This is not to say that the mRNA (and DNA/AAV) Covid vaccines are necessarily dangerous, or that their risks outweigh their benefits. But we should all understand just how radical these therapies are, and how many unknowns they carry.

The only solution to these unknowns is very large trials conducted for long periods.

A 40,000-person clinical trial may sound large, it is not, not in the context of a drug that governments are going to give (or more accurately force) on BILLIONS of healthy people. In 1954, the Salk polio vaccine trial covered almost two million children - yes, 2,000,000 - including 400,000 who received the vaccine. And polio was far more dangerous to children than Sars-Cov-2.

But an equally large sin against science was the fact that regulators allowed Pfizer/BioNTech and Moderna to unblind and thus destroy their pivotal trials within weeks after they presented early data.

Now we are stumbling in the dark.

And that might not matter much if the Covid vaccines had ended the Covid epidemic. But they have not. Not even in places where nearly every adult has received them - like Waterford, Ireland, where 99.7 percent of all adults are fully vaccinated.

Now the public health authorities and the rest of the media are pushing “boosters” - again, for a biotechnology that was repurposed as a vaccine BECAUSE IT FAILED UPON REPEATED DOSING.

Meanwhile, they are simply ignoring the odd increase in all-cause non-Covid mortality that many countries are now seeing.

Where this journey ends I do not know.

But I know this: we invented about the most complex product imaginable, tested it in a relative handful of people for a few months, a far shorter timetable than is typical for drug development. Now we are shoving it on every human we can reach - to prevent (or more accurately fail to prevent) an illness that is not particularly dangerous to most of them.

Not aspirin:

What could go wrong?