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FDA’s New Drug Approval Process Too Slow and Complex. Usually.
A friend of mine used to do research for a pharma company. He told me of the day they sent the official application for a new drug patent to the FDA for review. At this point, they’d been working on this new drug for nearly 15 years, doing multiple long-term studies involving tens of thousands of patients in research centers worldwide. The application was enormous — five semi-trucks filled with paper. When the semis pulled out of the parking lot to drive the application to DC, everyone lifted their champagne glasses and cheered. That was 20 years ago. The process is much more complex and time-intensive now. Usually.
A new COVID vaccine was released recently. The Moderna version is supported by a research study that involved 50 patients. The Pfizer version has no human data at all — their study involved 10 mice. Neither has any efficacy data or safety data. The FDA has approved both, the CDC recommends that everyone over six months old should get these new vaccines, and the US government has already paid billions of dollars to Moderna and Pfizer for millions of doses.
While COVID remains common, it has predictably become less deadly over time. We’ve been averaging less than 100 COVID deaths per day all summer. In a country of 350 million people.
Suppose the new vaccine reduces the risk of death by half (which, of course, we don’t know, because there is no data). So we hope to reduce those deaths from 100 to 50. But to do so, we’d have to administer vaccines to nearly 350 million people.
Well, ok. But if any of the 349.999 million people who don’t benefit from the vaccine have an adverse reaction, we could be creating more disease than we are preventing. Even if the vaccines are very effective, which they might be. But we don’t know, because there is no data.
Again, I have no idea if those numbers are even close to correct.
But neither does anybody else. So how did the FDA approve these vaccines so quickly? And why?
The CDC is publicly stating that these new COVID vaccines reduce the risk of hospitalizations, prevent long COVID, and reduce the risk of spreading the disease to others. There is no evidence to support any of these claims. If Moderna or Pfizer had made such claims, the FDA would fine them hundreds of millions of dollars — it is illegal for Pharma companies to make claims that are not supported by data.
It’s ok for the CDC to do that, apparently.
I don’t understand what’s going on here. Why are the FDA and CDC doing this? It makes no sense. They’ve never done anything like this before. Approving untested drugs, which the government then buys in bulk whether anyone wants them or not. What on earth? I’ve been in this business a long time, and I’ve never seen anything like this.
I miss the days when our government tried to hide corruption. That was better.
This is unbelievable.
At least, I wish it was unbelievable. Crap.
Published in General
Sure, but, if you don’t get the shot AND DON’T GET THE FLU, that seems like a pretty good sign that your immune system is already doing well. If you GET the shot and DO GET THE FLU, how is that “better?” Seems to me like a signal that either the shot does nothing at all, or the shot did worse to your immune system than the actual flu does. Maybe distracted it from doing its job, or something.
Ke, the phenomenon you are discussing as far as an individual getting the shot and then getting the flu relates to antibody dependent enhancement.
This is not specific to COVID but can occur with any flu vaccine.
The individual gets jabbed, then their body is primed to have its immune system look for the particular viral strain of the flu on which that flu vaccine is based.
So if in that particular year, the flu vax actually is able to deal with the flu circulating right after the individual is jabbed, then the individual is spared getting sick that year.
Of course, since any given flu strain will mutate, some years the flu vaccine that is used has a pathetically low efficacy rate, like 16 to 22 percent. The vax developers went and bet on the wrong strain of the flu being dominant. (A placebo would give you 23% likelihood of beating the flu.)
However the next year, the individual who has gotten the effective vaccine is now going to be exposed to a new strain or strains of the flu. Their immune system is only primed to look for the virus strain relating to the vax they took the prior year is based on, so the individual ends up in the situation that the new viral strain slips right in, and they most likely will be sick as a dog..
People who “support” flu shots would presumably get the shot each year, not just once. But it still becomes a game of immunological whack-a-mole.
It could be a sign of that, or a sign that you never took in enough copies of the virus to seriously challenge your immune system, or a sign that you’re young enough that your immune system is in top condition. People do get flu, though, and it gets to be more risky as you get older.
My age is a moving target, and it keeps moving toward older rather than younger. Conditions aren’t static.
The data show that it reduces the risk of getting flu, and also that it reduces the risk of getting serious flu. I’ll go with that rather than the possibility that my immune system is a rare one that already protects me spectacularly well, and will continue to do so as I age. (I haven’t gone through life without the flu, as far as I know.)
Some do. I’m more of an every-other-year person at this point.
Maybe, maybe not. It’s an interesting topic, but AFAIK the data are far too scanty to make a blanket statement that it’s a game of whack-a-mole.
But it pretty much is by definition, isn’t it? Since they never really know in advance which strains they should prepare for.
I thought that by whack-a-mole you meant that you knock back one virus with the result that another one pops up elsewhere for which you are unprepared.
As for which strains might appear, they make their best, educated guess. As far as I know they do better than drawing virus variants out of a hat. Even if they did, I wouldn’t have thought of that as whack-a-mole.
I always found that part of whack-a-mole was getting you to hit at a place where nothing was actually coming up, and meanwhile something did appear elsewhere.
In a five year period, there will be two years where the efficacy of the flu shots happen to be less than 22%.
A sugar pill placebo ranks in at 23% effective, and it won’t help push you into early Alzheimer’s, or any of the following:
Common adverse reactions to the flu shot begin within 12 hours of vaccination and usually last several days. These common symptoms include: fever, fatigue, painful joints, and headache. Serious reported complications to the flu shot include brain inflammation, convulsions, Bell’s palsy, paralysis of limbs, neuropathy, shock, asthma, wheezing and other problems breathing, brain and nerve disorders including encephalopathy, optic neuritis, partial facial paralysis, brachial plexus neuropathy and vasculitis.
Another serious reaction to the influenza vaccine is Guillain-Barre Syndrome or GBS, which can occur 2-4 weeks following vaccination.
Until the COV vax series of jabs was released, the annual flu vax program was responsible for more adv effects than other vaccines. (It is of course the most commonly given jab, so I don’t know what its ranking would be if I had the numbers on the injuries of other vaccines.)
Yes, strains that are returning, not strains arriving for the first time.
They see new strains appearing prior to flu season, and have a chance to judge how dangerous they are before they go wide.