Are the mRNA vaccines really safe? Evaluating claims by Steven Kirsch on danger of spike proteins

There are a number of individuals on social media confidently claiming the mRNA vaccines are dangerous and killing people, and implying the vaccine distribution should be halted. Many are quasi-experts who are intelligent and articulate people, sometimes with impressive credentials, sometimes with some scientific background, and they often spin a compelling narrative that is understandable to the general public. These experts' videos and reports are heavily circulated on social media and strongly believed by many people who are distrustful of the vaccines, and some of these individuals become heroes, obtaining almost cult-like status, to people passionately against the vaccines.

I see a pattern: an individual makes strong statements that the vaccines are unsafe, essentially proposing hypotheses that fly in the face of the current scientific understanding. They post articles and videos on social media, and often do interviews on sympathetic websites, with cooperative interviewers who do not challenge their assumptions or evidence, but go right along with their case. In general, they do not provide strong empirical evidence (or sometimes don't provide any empirical evidence at all) to back up their claims, or in attempting to provide some empirical evidence misinterpret some of the public data in scientifically naive ways or ignore other established scientific principles that go against their hypothesis. Rather than providing detailed scientific evidence that could prove their hypotheses, they instead challenge other scientists in the establishment to prove them wrong, as though the burden of proof is on the scientific establishment to disprove their hypothesis rather than on them to prove why their hypothesis that flies in the face of the scientific establishment is true.

Their tone often comes across as condescending, like they understand the "real truth" and everyone in the scientific establishment is a deluded sheep, even in some interviews citing the movie The Matrix and saying they are "taking the red pill", while the rest of the scientific community "takes the blue pill", suggesting they are in the special class of people who are facing the real true state of nature while most of the world blissfully chooses to live in a delusion. They spend much of the time during their interviews decrying how the scientific establishment won't believe them, astonished at how they cannot see the obvious, and complaining that social media censors them, presenting themselves as martyrs of truth. These interviews lack the scientific rigor that one would need to provide to support a new hypothesis or dispute the status quo.

When it comes to vaccine safety, I am not saying their hypotheses are automatically wrong. I am concerned about the potential of minority harm, of serious adverse events that might have been missed by the clinical trials, either because they were too rare or in subgroups not well represented in the trial. However, given the fact that the double blind randomized trials found serious adverse events were just as high in placebo arm, and that all cause hospitalizations and deaths are way down in heavily vaccinated areas, if someone wants to make a case that the vaccines are inherently dangerous, they have a high bar of proof. In addition to scientifically supporting their claims, they need to explain how the clinical trial results and population hospitalization and death results could be what they are if their hypothesis of extreme danger were true.

I will consider any hypothesis, especially in a setting like this pandemic with fast accruing knowledge and a high degree of uncertainty, so I will not outright dismiss these claims. I will evaluate their claims, comparing with what I know in the rigorous data and studies I have already considered. So far, I have found their arguments unconvincing, based on speculation, unproven assertions, ignoring known scientific principles and established data and studies. One such expert is Steven Kirsch, an engineer and entrepreneur who has recently been making the rounds claiming that the the spike protein is cytotoxic, the mRNA vaccines distribute it all over the body at dangerous levels and cause all kinds of dangerous side effects, including the ovaries where it threatens women's reproductive health, and that vaccination should stop. His thoughts have become prominent through a viral YouTube video interview with Bret Weinstein, Robert Malone (who is described as the "true" inventor of mRNA vaccines) and him that very quickly reached >2 million views. Steven has written a google doc laying out his argument why he thinks the vaccines are dangerous that was the basis of this interview. I will evaluate the executive summary of this document and comment on his claims and evidence. I'll put their text in blue and my comments in red

Vaccine safety evidence

Assembled by Steve Kirsch (Twitter: @stkirsch) with help from Dr. Robert Malone

Executive Summary

It is now well established in the peer reviewed literature that the spike protein is toxic.

(do they have a reference for this?)

The vaccines cause the spike protein to be manufactured for up to 48 hours in all parts of the body including the brain thanks to the efficient delivery mechanism of the lipid nanoparticles and PEG.

(Reference please? What is the concentration? Where is the documentation that it is dangerous at those concentrations?)

The spike proteins produced in these cells do not remain anchored as designed; they also break off the cell and become “free spike” which is even more dangerous since it can circulate in the blood. The net result is inflammation and micro-clotting inside all organs (including the brain) throughout the body as well as temporary opening of the blood brain barrier (which explains the severe migraine headaches)

(Where is this verified? Reference please) .

BTW, the evidence provided supporting the "free spike" argument is a Japanese

biodistribution report on the Pfizer vaccine

Here is the plot they present showing the alarming amounts of "free spike" and emphasizing

ovaries:

This is an accurate representation of the data, except they leave off the injection site (my plot):

When you include that, you can see the vast majority remains at the injection site, as intended.

Omitting this and not mentioning it is blatantly misleading. Also, they fail to mention these concentrations are of lipid nanoparticles in rats-- it is not clear:

1. How much spike protein is generated at each site? Can the particles enter cell and produce spike like at the injection site?

2. If so, then it is also not clear whether these much lower levels have any clinical value.

3. How relevant this is to humans since the rats were given 30-50x higher doses than the equivalent dose that is used to vaccinate humans.

They assume this is all over the body and causing all kinds of problems, but without any proof

or even plausible scientific explanation -- all they have is anecdotal reports of unexplained bad effects after vaccination, and when it comes to potential reproductive damage, they don't even have that.

This explains the wide range of neurological systems after injection.

(Where is the data showing this? Also, if so dangerous, how does he explain the fact that the double blind randomized clinical trial found no higher rates of deaths and serious adverse events at 2 months post vaccination than a saline placebo?)

The mechanism of action is confirmed in the data.

(Which data in particular? Please elaborate. He never does) VAERS database shows that over 6,000 people have possible vaccine-related deaths as well as over 300,000 SARs that are consistent with the mechanism of action. If we remove 500 “background deaths” in the VAERS system each year, we are left with over 5,500 “excess deaths” that are coincident with the vaccine rollout.

Where does he get the “500 background deaths” to suggest the 5500 are “excess deaths”? All he does is plot reported deaths in VAERs from past years, showing ~500 per year in past years, and suggesting that therefore if there are 6000 this year then 5500 must be excess deaths. This is exceptionally shoddy methodology. He is ignoring the fact that there is much greater awareness of VAERs given (1) we are in the midst of a worldwide pandemic that has made this virus the center of all of our lives, (2) we have quickly vaccinated 1/2 the population, including nearly all senior adults and long term care residents and (3) there is great attention paid all over society to the mRNA vaccines, their newness, the fast development. (4) there is much more discussion about VAERs in society -- it is likely >>90% of the people talking about VAERs now had no idea it existed before this year. All of these factors inflate the numbers in VAERs. First, in past years we were not vaccinating all senior citizens and nursing home residents who have a high risk of death as it is, and second, the increased awareness given the pandemic, the mRNA vaccines, and societal discussion of VAERS makes it much more likely for deaths to be reported to VAERs.

This is especially true since doctors are REQUIRED to report to VAERs any adverse event or death after vaccination, regardless of causation, thus requiring consideration of baseline rates and follow up studies to figure out which might be caused by vaccines.

He is ignoring the baseline death rate, and the fact that when you vaccinate half the population there is bound to be thousands of deaths in the days following vaccination, even if the vaccine is perfectly safe, based on the daily death rates in the country. 7500-9000 people die every day in the USA, about 50-60k per week. Thus, if a random half of the country is vaccinated, we would expect 25-30k to die the week after vaccination even if it were perfectly safe. Even if they were given a saline injection. Not all of these would be reported to VAERs, but they are all SUPPOSED to be, and likely are in this hypersensitive environment driven by the factors above, many of these would be reported to VAERs -- far more than in previous years with other vaccines during normal times.)

The safety signals have been flashing “red” since January in VAERS, but nobody was paying attention (except for a few users on Twitter who were being ignored).

Really? No one paying attention? I have seen repeated analyses of VAERs presented by scientists, and discussed in the media. These analyses have detected and presented data on the anaphylactic reaction to mRNA vaccines, the VITT syndrome form viral vector vaccines, and now the myocarditis in young men after vaccination. There has been more attention given to VAERs in the past 6 months than perhaps the cumulative attention shown since its inception.

This is a HUGE number of excess deaths and SARs. So the question for the CDC is “OK, if the vaccine did not kill these people, then what did?”

Note their implication that we should assume the vaccine caused these deaths unless proven otherwise -- according to him, the burden of proof is on proving "not causation", not on proving causation. They explicitly state this in the next section.

This is not caused by excess reporting since doctors are less likely to make VAERS reports for the “safe” vaccine because nobody wants to create vaccine hesitancy. Doctors (such as Dr. Hoffe) have been fired for filing adverse event reports and speaking out. Anyone who speculates this is simply excess reporting of “normal deaths” has the burden of proof since excess deaths that are proximate to the injection date are assumed by default to be vaccine related. Nobody has met the burden.

It is not just doctors but individuals uploading to VAERs. Do you really think that someone whose family member died within a week of vaccination who knew about VAERs wouldn’t file a report? I sure would. And doctors are told they are REQUIRED to report all deaths after vaccination to VAERs independent of causation so by intent it SHOULD contain the many background deaths not caused by vaccine.

The Yellow Card system in the UK showed a similar safety signal. Independent analysis of that data by an expert in medical evidence concluded that the vaccines are unsafe for use in humans. It wasn’t a close call.

If you look at the details, he links to this report from Tess Lawrie, an active proponent of Ivermectin who wrote the meta-analysis that proponents of Ivermectin quote as scientific evidence. She goes through the Yellow Card system, similar to VAERs in the USA, and documents all reported side effects and deaths, again assuming all were CAUSED by vaccines, ignoring the fact that deaths, strokes, pulmonary embolisms, heart attacks etc. occur at a certain baseline rate each day even without vaccination, and there is no accounting for this factor in her analysis at all.

Even the WHO called for the vaccines not to be used in children, but political pressure forced them to recant just 48 hours later.

Where is their evidence the recanting was political pressure? The cost/benefit of vaccination in children may be an open question, but that is a far cry from claiming the vaccines are inherently unsafe and shouldn't be used at all as this document implies.

The cost-benefit analysis for anyone is a wash according to the scientific literature (new paper published June 24, 2021. This peer-reviewed paper looked at the real cost-benefit analysis and concluded that “This lack of clear benefit should cause governments to rethink their vaccination policy.”

Good that they cited a peer-reviewed article, but this is a single brief article by 3 authors in an obscure journal, and if you look at the paper, it is hardly a comprehensive assessment of the cost-benefit of vaccination. There are numerous unstated assumptions underlying their analysis that many would dispute.

1. Like others cited in this report, they assume 100% of all reported suspected vaccine related serious adverse events were in fact caused by the vaccine, not adjusting for background death rates, not even in nursing home residents.

2. By using absolute risk of infection and death during the trial, they disregard the indirect benefit of vaccines that reduce the probability of exposure once higher proportions of the population are vaccinated. The use of absolute risk and number needed to treat (NNT) in prevention settings like vaccine can be extremely misleading and flawed, as highlighted and explained here. In short, any potential deleterious effects of vaccine are immediate, while the benefits are spread over a long period of time -- at least the next 1-2 years in which it can confer protection vs. infection, hospitalization and death from COVID-19, so using only a 15 day time frame to compute the vaccine benefit for a cost-benefit analysis is fraudulently misleading.

3. Among more than a dozen countries with adverse events ranging from 15 to 700 per 100,000, with a median of 124 per 100,000, they choose to assume the worst case of 700 for their calculations.

4. They cite an Israeli report for 9 covid-related deaths after vaccination -- but fail to account for the fact all of these were before full vaccination was completed -- there were 0 deaths after full vaccination.

It looks like people have caught on to just how flawed this paper is. A group of associate editors of the journal have resigned over the fact they published such a misleading and flawed paper and the journal has posted a "notice of concern" over the paper as they investigate (no doubt it will be retracted once they see how substantially flawed it is). Update 7/2 -- it was retracted today.

Evaluation of individual VAERS records show the cause of death is consistent with the mechanism of action of the vaccine and have no other rexplanation, e.g., a healthy 20 year old who dies in his sleep less than 24 hours after vaccination.

That is one example -- is there a more thorough or scientific analysis they have done to demonstrate there are a substantial number of deaths with "no other explanation" like this one? Plus, every serious adverse event has a background rate as you can see in historical data that young people die suddenly for various reasons and sometimes without explanation. Certainly it should be considered that the vaccines might have played a role in any death that occurs a certain amount of time after vaccination, especially in a young person, but again it should not be assumed all were caused with vaccine unless proven otherwise -- this approach is guaranteed to cause one to attribute all of these background events that would have occurred anyway to the vaccine. Individual anecdotes are not scientific evidence -- more is needed to make their case.

Half of the deaths reported are within 72 hours of vaccination. This can’t be explained by reporting bias since the CMS data backs up the claim that the vaccines are killing people.

If you vaccinate a randomly selected 150 million people, a little under half the country, then you would expect by random chance that 7500 x 3 x 150/330 = 10,000 or so to die within 3 days of vaccination by random chance alone, even if the “vaccine” was a perfectly safe saline placebo. So is 2500-3000 deaths so unusual, especially when the vaccinated group includes the people in society at higher risk of death -- with nearly all people at long term care or very elderly have been vaccinated, and most of the unvaccinated being the young with very low risk of death?

Through multiple methods (including comparing with a CMS query of the same data), we show that the 5,500 deaths are under-reported by at least a factor of 5X, giving approximately 30,000 deaths so far.

I won't even get into the questions about his methodology in coming up with the 5x number, but even so 30,000 is right in line with the background deaths we would expect to see by random chance within a week if ½ the country is given a perfectly safe substance. Again, he is ignoring the background death rate and assuming all reported deaths are caused by vaccine.

Historically, the stopping condition for a vaccine is 25-50 deaths .

Would be nice for him to reference this threshold and give it context if he is going to repeat it over and over again as some absolute. It would be nonsense to have such a fixed threshold without accounting for number vaccinated. Maybe if causation was established, this type of criteria might make sense to some, but when vaccinating half the population including entire nursing home population that have substantial risk of death in any given week, it is inevitable that there would be >50 reported deaths, even if you gave a saline shot instead of vaccine.. They still haven’t provided evidence that these deaths had anything to do with vaccines other than their hypothetical (or anecdotal) 20 year old dying in their sleep.

But there is no stopping condition for this vaccine in the US or UK.

How do they know that the US or UK officials do not have a stopping criterion for toxicity? They have no idea what criteria the FDA/CDC are using to stop vaccination, although the fact that they were paused for weeks over a side effect VITT with incidence <1/250k suggests they have some criteria. I am sure they don't have a stopping criteria based on raw counts of deaths in VAERs, as they should not given the known and transparently communicated limitations of VAERs.

The CDC claims nobody has died from the vaccine, but has produced no analysis showing this to be the case.

He argues the CDC owes it to him to “prove” the deaths are NOT due to vaccine. So he assuming that all reported deaths after vaccination should be assumed to be caused by vaccination unless "proven" to have some other cause? Notice again the switching of the status quo -- if you use that criteria and give a saline placebo to half the country and tell them it is an mRNA vaccine, you will have numerous deaths within a week of vaccination by chance and for many of them it won't be possible to "prove" the shot had nothing to do with it, so then we could conclude that the saline placebo is deadly and killing people. Sorry it doesn't work like that and no scientist would use that thinking to evaluate causation -- to "assume causation unless it can be disproven"

They don’t even have the staff to investigate 6,000 death reports. They never even tried to hire the needed staff.

Can he document these very confidently asserted facts? Again just because he hasn't seen who the staff are doesn't mean that they don't have the staff or didn't try. How does he know anything about who the staff are? Because he asked and didn't get an answer he assumes they are making it up? Really?

The required toxicology studies were never done.

He does not elaborate on which toxicity studies were not done but just asserts this as fact. We have no idea on the reproductive tox. A LTE (letter to the editor) submitted to the NEJM pointed out that based on the data to date there is >82% spontaneous abortion rate at <20 weeks.

The link to this letter is here. They are commenting on a paper published with preliminary results from Vsafe suggesting 12.6% of pregnancies in vaccinated women ended in miscarriage, which is close to the background rate without vaccination. They claim the methodology was flawed and suggested the true miscarriage rate was >82%. The letter was rejected by NEJM on the basis that it was determined to be incorrect.

Looking at the paper, I can see her error and it is a naive one. The table she cites presents proportion of completed pregnancies ending in miscarriage which includes (1) miscarriages, many in first trimestwe as usual and in women vaccinated during first trimester and (2) live births, almost all from women vaccinated in second or third trimester since for a woman to be vaccinated in the first trimester to have a live births already she would have had to been vaccinated December or before or her baby would have to be very premature.

her analysis ignores the >900 women vaccinated during first trimester who did not have miscarriages so are still pregnant. When those are included, we see about a 10% miscarriage rate in vaccinated women, which is the expected background rate of miscarriages in the first trimester.

it should have been clear 82% couldn’t have been right. If the miscarriage rate after vaccination was close to 82%, after half the population in many countries has been vaccinated, don't you think someone would have noted the extreme rate of miscarriages? I can tell you that at the University of Pennsylvania Health System we have many vaccinated and have not seen any increase in miscarriage rate that would be clearly evident if their claim were correct.

We don’t know what the true number is because the data isn’t available to anyone.

The "true number" of almost any toxicity or efficacy for a drug or vaccine is never "available to anyone" since typically we don't have complete data. That is why we need qualified scientists to analyze these data. Again, what is their argument? Because we don't know the number it must be large unless proven otherwise? Is that the right way to think about uncertainty? If something "might" be true we assume it is unless we have "the true number" to show it is not? No, the burden of proof is on HIM to prove his hypothesis! Not on the world to disprove it!

Thus, we are telling pregnant women to get vaccinated even before we have any of the safety data. This is appalling. It is backwards. We are injecting first, doing safety studies later. What is this doing to the reproductive system of our kids? We don’t know.

It is typical that pregnant women and children are not included in clinical trials, but post approval doctors use judgment on whether it is safe, and the post approval safety monitoring is a crucial tool to follow up. Again, where is the strong evidence that it is dangerous to the fetus or to children's reproductive organs? Where is the scientific hypothesis and laboratory studies to back up the proposed mechanism of action? Are they saying because they have a hypothesis that it is, that we should all assume it is true? What is the scientific rationale, and where are the basic science end epidemiological studies to even provide one iota of support for this worry? It is important to carefully check these things, but again they are assuming their worry is right until it is disproven.

The cost-benefit analysis for children is non-existent; it is 1 to 2 lives per 1,000,000 assuming the vaccine is safe. But the vaccine isn’t safe. It has already killed at least one child who died after getting myocarditis already and that story was censored by social media. More importantly, the chance of permanent disability is quite high.

Really? The "chance of permanent disability is quite high?" How high? Based on what data and study? What qualifies as "permanent disability"?

Consider the case of 12-year old Maddie de Garay who is now permanently paralyzed, cannot walk and must eat via a feeding tube. She was part of the Pfizer clinical trial for 12-15 year olds which reported her result as “abdominal pain.” This trial had only 2,200 participants. This suggests that the rate of disability even for kids is on the order of 1 in 2,000. So that means the vaccine has the potential to disable 500 previously healthy kids for every life saved.

Tragic case study, but do they have any medical explanation how the vaccine caused this, and do they really think this 1/2,000 means that 500 would occur out of a sample of 1 million? This ignores the incredible uncertainty in the 1/2000 estimate since it is based on just one case and completely ignores measures of uncertainty that are used in scientific research. It seems almost all of his inferences are based on this singular tragic case study.

Is it worth it, especially when safer alternatives are available?

What safer alternatives and where is the evidence they are effective? And how do we know they are safe? He is of course hinting at Ivermectin. He complains "efficacy and safety" for mRNA vaccines is not established in spite of large rigorous trials with clear results, yet seems to assume the "efficacy and safety" of Ivermectin is established and to be assumed in spite of the fact that there are no trials anywhere near the size and rigor, on the basis of a single meta-analysis published in a second-tier journal that has been strongly criticized by scientists, and little published safety data on its use for COVID-19.

Shouldn’t we do a larger trial to find out the true number before we do a mass rollout to kids?

This could be argued. But the "larger trial" has been done on adults, with tens of thousands of subjects in a double-blind randomized trial, and yet he completely ignores the positive results from these trials.

Of course we should. But we aren’t. We are doing everything backwards, experimenting first, and looking at the data after the experiment. This is the biggest unregulated unaccountable medical experiment in the history of mankind.

All of the typical clinical trial steps were followed before the EUA and the efficacy and safety data far surpassed the prespecified bar for approval. Given dozens of population and cohort studies from among the billions vaccinated around the world in the past 6 months, we now have more efficacy and safety information on these mRNA vaccines at the time of submission for full approval than literally any drug or vaccine in history. Sure there are still some uncertainties, but that is always the case.

The phase 3 studies simply do not match the reality. There are reports of “missing SAE data'' in other clinical trials as well (not just Maddie’s trial). This explains why the Phase 3 trials can make it appear as if the vaccines are safe when in fact they are not.

Where is the evidence the phase 3 studies left out SAEs? And given the trial was double blind, how could these left out SAEs only affect the vaccine and not placebo, thus making the vaccines appear safe? They don't discuss the inconvenient truth that the double blind randomized trial found the rate of SAE and deaths as high or higher in placebo than vaccine.

There is no transparency of the data like there would be in a normal trial.

He is ignoring the unprecedented transparency of releasing the full protocol and full FDA report for the EUA on the web. Full protocols are not typically publicly released when a trial starts, and the FDA does not publicly publish the report before an EUA or full approval meeting is done, but they did in this case. He is also ignoring the inherent transparency of the VAERs system itself (transparency that causes all kinds of trouble from those who misinterpret and misunderstand what it can and can't tell you).

The V-SAFE database is kept out of sight and the CDC only releases selected snippets that they determine are of interest. VAERS records, which are publicly accessible, are removed without reason.

(Evidence? How does he know the reason why records might have been removed?)

There is no informed consent. Nobody is notified of the potential large number of deaths. Kids in in the Pfizer Phase 3 trials were never informed that they could die or be disabled.

Nobody is informed of the alternative of natural infection and early treatment.

What natural infection or early treatment, and is the evidence for these as strong or stronger than for the vaccines? Is he suggesting the informed consent for the vaccine trials should disclose "you could just let yourself get infected and then you'll have immunity?" Is he assuming it should disclose "you could just let yourself get infected get early treatment with Ivermectin and you'll be just fine" without evidence that this is the case? If it were that easy, why are places using Ivermectin still experiencing infectious surges, hospitalizations, and deaths?.

The NIH stonewalls on recognizing ivermectin as a safe and effective treatment, even after publication of a peer-reviewed systematic review, the highest level of evidence in evidence-based medicine (EBM).

Scientists don't agree with their claim that this meta analysis is strong evidence given the well documented limitations in these studies, and no biomedical scientist would argue it is stronger evidence than the double blind randomized placebo controlled mRNA vaccine trials. If Ivermectin had a strong double blind randomized study like the mRNA vaccines it would be approved.

Censorship keeps these events from public view. Facebook has removed groups of over 200,000 people discussing vaccine side effects. If the vaccine was safe, that group would have nothing to talk about and there would be no reason to remove it.

I also am concerned with how censorship is being used -- I'd rather there be debate and presentation of facts. But the censoring itself does not prove anything about the veracity of their claims

It is time to call a halt to these dangerous vaccines immediately. Vaccination should not be mandatory for any students at any university worldwide. In fact, they cannot be justified even for the highest risk patients due to the safety profile compared with the better alternative of early treatment.

In spite of their passionate plea, the only evidence they have provided in their summary is two individual anecdotes, misrepresented biodistribution data omitting the injection site concentrations, misinterpreted VAERS death statistics, retracted papers and an unpublished letter to the editor that can be easily shown to be naively flawed. The so-called “evidence” in the full text is filled with cut and paste anecdotes from social media, links to YouTube videos and other non-peer reviewed claims by other individuals pushing similar hypotheses, but providing no rigorous scientific evidence. Before pulling a vaccine that data suggests is clearly preventing numerous cases, hospitalizations, and deaths, they should probably provide a little more evidence. And why do they assume Ivermectin is better when the only evidence is contained in a single meta-analysis of disparate studies, most small and low quality, published in a low impact factor journal? And where is the evidence that Ivermectin used for COVID-19 is safe?

Allowing people to be naturally infected and treated with early treatment protocols can reduce the relative risk by >100 (far better than any vaccine) with virtually no chance of death or disability.

Wow! better than vaccines, and "virtually no chance" -- where is the evidence for this?

The natural immunity is more robust against variants and is the better path to eliminating the virus than a non-sterilizing vaccine.

Declarative statement -- where is the evidence? What studies are there on natural immunity vs. variants, and what about people who have not been infected? There are studies showing high efficacy for vaccines against all of these variants. And is he saying that everyone should try to get infected to achieve this "natural immunity" so that they can ... be better protected against infection? Huh?

We are not anti-vax.

The Novavax vaccine appears to have a much better safety profile, comparable to other vaccines. The antigen for these vaccines is pre-manufactured and there are no LNPs that would transport the spike protein into unwanted areas.

Where is the evidence the Novavax is safer? There is very little data out, and while we have >1 billion individuals given mRNA vaccines in the population, there are very few for Novavax. If they complain that the phase 3 trials plus population data after billions of doses distributed are not enough data, how can they think they have sufficient knowledge Novavax is safe when all we have is the phase 3 trial, whose results have not even been made public yet, unlike the mRNA vaccines?

Conclusions:

His document is filled with unverified assertions, and much of his argument is based on misunderstandings and misrepresentations of VAERs data and discredited papers and letters. The "evidence" he provides primarily consists of screen shots of individual anecdotal reports, links to social media posts from other individuals making similar claims, selective citations of obscure articles and an unpublished letter to the editor. And the one peer reviewed study he cites has been debunked and is on its way to a humiliation retraction. Throughout, he speaks as thought his assertions should be assumed true unless proven otherwise, suggesting the burden is on the scientific community to disprove his hypothesis, when in fact the burden is on him to provide rigorous evidence for his hypotheses that fly in the face of existing scientific and medical understanding. Paradoxically, he blithely makes assumptions that other alternatives, including Ivermectin and Novavax vaccines, are more efficacious and safer without presenting any data (and in fact there is far less data for these than mRNA vaccines), and certainly not holding those to the same standards -- of assuming they are dangerous and asking if there is enough data to prove they are safe. He is certainly passionate about his hypotheses, but the scientific reasoning and evidence is sorely lacking, and it is easy to see why the scientific community does not believe his assertions. But no matter how unsupported these assertions are, in our modern world they gain traction on social media and alternative social media and contribute to the perception of many that the vaccines are inherently dangerous that is driving the level of vaccine hesitancy in the population.