Is There a Credible Large US-based Post-marketing Study Showing that Any US Vaccine is Safe? I couldn’t Find One. Whoops!
By STEVE KIRSCH
Did you know that the safety of every vaccine administered in America today has never been established? The whole “vaccines are safe” assumption is built on belief or very flawed studies. Whoops!!
Nobody could locate a single credible objective US study showing that ANY vaccine in America is safe to use. In short, the “vaccines are safe” narrative is built on faith in seriously flawed studies. It’s turtles all the way down.
Executive summary
There is a huge flaw in the narrative that nobody really realized existed:
The whole “vaccines are safe” narrative for the past 200 years is actually based on an assumption that all the vaccines are safe. There is actually no credible large-scale post-marketing study for any vaccine used in the US today that actually backs up this claim. It’s all based on faith in seriously flawed studies.
There isn’t a credible post-marketing objective epidemiological study for any vaccine in the US. That’s right. Not a single one.
Why isn’t there a study?
It’s not because it isn’t possible. In fact, every state in the US has the ability to do such a study.
It is because the states have never done the necessary studies nor will they expose data needed to allow the public to do the studies.
Will keeping public health data private improve clinical outcomes? No, of course not! It’s all kept hidden from view because there is no upside for them in doing the study. It can only end badly, very badly.
As Dr. Ryan Cole has often said, “You will never find what you don’t look for.”
In short, it’s time to call a spade a spade: “the Emperor has no Clothes.” It’s turtles… turtles all the way down.
The whole “vaccines are safe” narrative is built on belief and seriously flawed studies, and not on proper objective epidemiological studies which could have been easily done but were not.
If we cannot prove safety at the level of <1 death per 10M doses in children, we should not be vaccinating more kids until we have done the proper post-marketing safety study on the kids we’ve already vaccinated. The fact that no state is willing to do the study but is at the same time still recommending that kids get vaccinated should be deeply troubling to everyone. It is a symptom of a seriously out-of-control medical community that cares more about following directives from the CDC than patient safety. The rationale for vaccinating kids is nonsensical.
The most important points in this article are:
- It’s all built on a house of cards. There isn’t evidence that even a single vaccine in the US is safe.
- The required studies haven’t been done because data is under lock-and-key. Any state epidemiologist could surface the data. None want to.
- A single honest state epidemiologist who is willing to do the right thing could change the world by setting the data free. The others who do nothing should be ashamed of themselves for allowing the truth to remain locked behind closed doors.
- Hundreds of thousands of lives are lost because the FDA takes a lax approach and trusts the drug companies when they assure the FDA that the investigators didn’t believe that the drug caused any of the deaths in the treatment group.
- The DTP vaccine is a perfect example of why the public health data should be exposed. Had that been done, we could have eliminated nearly 50 years of excess deaths of females who took this vaccine.
This is a long but very important article. It took me a long time to research and write. I hope you will find it valuable.
Note: I split out the part about Dorit Reis into a separate article.
My $10,000 challenge aka “The Kirsch Safety Study Challenge”
Here are the terms of the offer which expires at the end of May 2023 (so I don’t have to keep monitoring this article):
- Show me the URL of any credible objective epidemiological post-marketing study done prior to May 10, 2023 (the contest launch date) that was done on people in the US which demonstrates that any of the vaccines currently in use in the US are “safe.” You can submit a single study, or if you need multiple studies in combination, that is acceptable as well.
- “Safe” is defined by Paul Offit back in 2002 as causing fewer than 1 excess death per million doses across an age-standardized US population over a one year observation period post-vaccine. The population consists of those people who would normally consume that vaccine. So a vaccine which is normally given to kids would measure the excess mortality of the kids who got the vaccine over a 1 year period. A vaccine given to all ages would be a standardized distribution for the US population measured over a year. For the purposes of this challenge, the failure to detect any statistically significant safety signal in any of the analysis buckets (which must not be unreasonably broad so as to miss safety signals) shall be deemed adequate proof of safety. As an example, the Swine flu was revoked for 1 serious adverse event per 100,000 doses; it wasn’t even a death!
- “Objective” means that “experts” aren’t doing causality assessments on the cause of death. The numbers should do the talking. For example, the UK ONS data were used to prove the vaccines were safe and effective. The only problem was the data was flawed so the results were unusable.
- Epidemiological means in this case that the analysis is based on analyzing the death-vax records (the join between the death table and the vaccination table) as well as vaccination statistics by age range, gender, week, and vaccine type (and possibly more but that’s the minimum). However, if you know of a more accurate way than this, you are well more than welcome to use it.
- “Credible post-marketing study” means, for the purpose of this offer, the study was done after the vaccine was approved by the FDA by at least one of (a) -(c) and the “obvious flaws” condition is true (i.e., no obvious flaws)
- Done by a state government and published in paper or electronically,
- Done by the CDC and published in paper or electronically, or
- Published in a peer-reviewed medical journal anywhere in the world.
AND
The study does not contain obvious flaws that would discredit its conclusions.
- The study must study a minimum of at least 10M person-years over the standardized population of the vaccine.
- To win, your entry in the comments must clearly identify the specific section(s) showing that the people who get the shots aren’t dying at a statistically significantly higher rate than those that don’t. This should be an easy bar since the “healthy-vaccine bias” works in your favor and you don’t have to adjust for that.
- The first one to post a qualifying entry will win $10,000. There will only be one award.
- Entry order is determined by timestamps of the comment. If you modify your entry, your timestamp will be the latest timestamp.
- If you think this is not a legit offer, you have my permission to ignore it. You should see what happened to Mike Lindell on his $5M offer: Lindell lost in court. So maybe you should take it seriously since it costs nothing to enter and takes seconds if you know the material.
- My paid subscribers as of the 5pm on May 10, 2023 will vote to judge the contest and will select the first entry to meet the conditions.
- Anyone can enter in the comments in this article.
- If you make a legit entry and I fail to recognize it, my readers and the general public will hold me accountable.
- My readers will also help identify if an entry satisfies the challenge by upvoting it which will make it much easier for me to find it.
This is not a “trick contest” that is impossible to do
In fact, the UK ONS analysis satisfies every single one of these conditions except 1) it is in the UK and 2) the underlying data is deeply flawed (and they admitted it). I’m not thrilled with the bucket choice either, but I’ll take it.
An honest society would be able to produce these studies in every state in the US easily that meets all the conditions.
The sad fact is that, as far as I know, this doesn’t exist for any state in the US, for any vaccine, ever.
Here’s another challenge… this one is for $5K and has been out for 4 years with NO takers
He just gets personal attacks. The challenge has been out for 4 years. I’ll match his $5K so if there is a winner, I will double it for the first winner if you win before the end of June 2023.
The $5K Vaccine Safety Challenge
The video is short. Take 6 minutes and watch it.
The offer is on the next slide and the details on the last slide.
Here’s my tweet about the $5K vaccine safety challenge.
COVID Vaccines are unethical for children… This is VERY important!
For kids, COVID kills on the order of 1 child per million.
So you need a vaccine which kills fewer than 1 child per 10M doses for this to make sense (since you want to give something super safe relative to the risk).
So the fact that there is no safety data at this level for kids means that it is INSANE for the FDA and CDC to approve these vaccines without that safety data.
What are these people thinking?! I don’t know because I offered a million dollars to speak with them for four hours (no strings attached on that one), but nobody wanted to accept my offer. I totally get that… for $250,000/hr, it’s hard to justify the time. So I changed it to “name your price” and there were no takers either.
In short, without the studies I requested in hand, the CDC and FDA should have never in a million years approved these vaccines for kids.
Should we “trust” their judgment on balancing the unknown risk vs. benefit?
Absolutely not.
Consider the DTP vaccine: Four studies show that it increased all-cause mortality for females by more than 2X.That’s stunning. A 2X mortality increase is a train wreck. That should have been spotted in the trials. But it took them nearly 50 years before that vaccine was pulled from the US market. That’s how bad the safety testing is for these vaccines. It’s a %$#$# shit show.
You may ask:
How can a vaccine which doubles the risk of death not have been detected for 50 years?
The answer is simple. It’s because they used the exact same trick for the DTP vaccine in the clinical trials as they already used for the COVID vaccines:
“Sure, there were excess deaths but none of them were judged by our investigators (who are paid by us) to be caused by the vaccine.”
In the case of the COVID vaccines, the data from Pfizer Phase 3 “gold standard” clinical trial showed that people in the vaccine group were 31% more likely to die than people in the placebo group. But Pfizer said that none of the deaths were judged by their investigators to be caused by the vaccine. Here it is from their paper:
These people NEVER did the histopathology to investigate ANY of these deaths so it was IMPOSSIBLE for them to have made that statement with any amount of medical certainty. None of the doctors I know would make such a determination without these specialized stains. The FDA should have demanded this but looked the other way.
Allowing the drug companies to make these no-causality assessments without serious external review is extremely problematic. Had this one policy been changed, we could have saved hundreds of thousands of American lives. So a huge problem is:
THE FDA never held them ACCOUNTABLE to show PROOF that the drug didn’t cause any of the deaths. They are simply TRUSTING them.
Or more recently consider Vioxx. It killed an estimated 50,000 Americans. The FDA never pulled it. Merck voluntarily withdrew it 5 years later due to all the lawsuits, not because of the FDA. The FDA was asleep at the wheel. That’s how safety conscious they are.
How can I be so confident that the safety study doesn’t exist?
None of my colleagues I asked knew of such a study.
A big clue for me was the analysis done in the US for the COVID vaccines. It’s terrible.
It basically sucks because the CDC doesn’t have the vaccination data of each person.
So the CDC has never been able to do a proper analysis to prove safety using their own data. They could use VSD, but that would be seriously flawed as I’ll show below.
The states, who do have the information needed for a proper analysis, may be:
- not sophisticated enough to do the epidemiological studies required.
- not motivated enough to do the work because there is not enough public pressure on them to do this the right way and this is hard work to get it right.
What you need is analysis like that described in my “Is it safe?” article which goes into detail about how I think the data should be made public and analyzed (and I confirmed it with professional epidemiologists I work with). Nobody in the US has ever done it this way AFAIK. That’s pretty sad. The records are not available anywhere and the states won’t do the required analyses for reasons I just noted.
They do it in the UK to some extent. The UK ONS bucket analysis is decent, much better than anything in the US I’ve seen. At least in the UK they have the right methodology; this is exactly the style of report all countries and US states should be adopting. But they are deficient in the choice of buckets and the quality of the underlying data; they undercount the unvaccinated so that the vaccines look like they work. If you know what you are doing, you can take one look at their tables and realize the data makes no sense (e.g., all cause non-COVID age-standardized mortality suddenly instantly changes dramatically when people start to get vaccinated).
Martin Neil, Norman Fenton, and others caught them red-handed and they were honest enough to admit their data was crap and should not be used to determine whether the vaccines are safe. This was a major embarrassment, but there’s a lot to be said for such honesty especially during these times. I applaud the UK ONS people for their honesty.
Even though their data is flawed, I have enormous respect for what the UK did. They made a very credible attempt to do a proper epidemiological study and they made the full data summary public. So kudos to the UK. Still deficient (data quality and bucket choice), but scores highly (7 out of 10) for their approach which was very good. Bravo. To get a 10 out of 10, they need to release the underlying data. That is critical. That mistake caused lives. They are still not doing that. I told them how to do that and comply with the regulations and they stopped responding to me. That’s not commendable.
In the US, the best that researchers can do is use the VSD system but that is really flawed as well because it doesn’t capture all the events. It’s also hard to get access to… they keep it under lock and key. If you find anything bad, they yank your access to the system (Brian Hooker has stories he can tell you… once he got close, the CDC told him that the HMO’s didn’t like his results so they are cutting off his access).
The other problem with VSD is that there are reporting issues. For example, I remember sitting in on ACIP meetings where they showed event rates in VSD were sometimes lower than VAERS (they made the false assumption that VAERS is fully reported). There was the famous “fountain of youth” study that I’ve written about before that is unbelievably flawed (despite that it got accepted in a peer-reviewed journal). And there are only 9M people in the VSD system and not everyone gets vaccinated so it’s hard to get to the numbers you need. So I’m not impressed with VSD as a reliable source of data. Plus, because it is so controlled, only positive studies can emerge.
So basically, the US is set up for failure which means it is highly unlikely someone would get reliable data or the proper setup.
Then I checked with Harvard Professor Martin Kulldorff who I consider to be one of the world’s top epidemiologists, but also a super nice guy. Could Professor Kulldorff cite such a study which was sufficiently powered to be able to prove safety across a standardized age distribution in the US? Nope. He sure couldn’t.
So I made a calculated risk and put out my challenge knowing that I had a 99.9% chance of being right.
The post-market safety study for the COVID vaccine was deeply flawed as well
The CDC did a post-marketing safety study for the COVID vaccine using the secretive VSD database to prove that the vaccines are safe.
I wrote about this famous “fountain of youth” study 18 months ago. Similar to the study Dorit gave me, the CDC study was deeply flawed.
Then there was the Barda study done in an HMO in Israel. This was not a mortality study and wasn’t done in the US. The most striking thing is the pulmonary embolism claim in Fig. 3. It jumped off the page when I first saw the study used in a presentation by ACIP Chair Grace Lee. How do you explain that? PE was off the charts in VAERS (close to 1,000X normal), yet in this study, it shows that PE is reduced from baseline rates!?! (there is a small amount going over baseline within the 95% CI). Sorry, but that’s just not credible. There is too much data which is all aligned behind the “increased PE” post-vaccination; the Barda study is the only exception I’ve seen.
When I asked one of Dorit’s followers to explain the discrepancy in PE, he said it wasn’t statistically significant and that VAERS is unreliable. A nice hand-waving response, but not convincing at all.
Summary
Does the lack of proof of safety mean all vaccines are not safe?
No. It just means that nobody did the required studies to prove they are safe or not.
Without those studies, we should not assume they are safe. That is the precautionary principle of medicine.
The authorities have the data. They can provide the needed data at any time.
But they either (a) won’t make the data public or (b) they won’t do the proper objective large-scale epidemiological studies to determine whether the vaccines are safe. The lone exception I’m aware of is the UK where they did the correct type of study, but the underlying data is flawed and they refuse to make the underlying data public so that these flaws can be corrected or compensated for.
These large, post-marketing epidemiological studies on vaccine safety can easily be done by the public if the health authorities would make the necessary underlying data public (as described here). They all keep the underlying data under lock and key even though it is easy to make it public without any privacy issues.
It’s almost as if they don’t want anyone to know the truth, isn’t it?
This is a huge embarrassment to the medical community that nobody has ever pointed out that we have the data but it’s being kept secret so nobody really knows if the vaccines are safe or not.
The narrative that vaccines are safe is built on belief and/or flawed studies, not on data.
It’s an even greater embarrassment that it was an MIT engineer (who has been labeled as a liar, misinformation superspreader, creep, stupid, ignorant, etc), and not a member of the mainstream medical community, that is calling them out on it.
The bottom line is this: They have the data, but they won’t release it. It’s turtles… turtles all the way down…
What the world needs now is just one honest epidemiologist in the right position.
Original Source: https://stevekirsch.substack.com/p/is-there-a-credible-us-based-study