This week the Florida Surgeon General said he is “very uncomfortable recommending the new Covid-19 vaccine to anyone” as it’s “anti-human.” Many of you have sent me this Fox News article that outlines his justifications.
In a state with an incredibly old population, his advice really is public health malpractice. Fortunately, lots of folks here in Florida are moving ahead with vaccines, when they can find them.
I actually had this discussion yesterday with a colleague. It would be interesting to see if, and to what extent, his comments are changing people's minds. Our guess was about 10% of people who would have gotten the shot in FL won't after his comments, but that's a guess.
My elderly in-laws are hesitant to get the new shot based on things this man has said recently. Plus they hate the side effects of the mRNA vaccines. If there is any signal at all about when Novavax is coming, we may be able to persuade them to get that, versus what they’re leaning towards (not vaccinating).
Exactly! At least when you get an mrna vaccine you can plan when you're going to feel crummy, it's short-lived, doesn't run a (decent sized) risk of hospitalizing them and doesn't come with possible long covid 🤦🏼♀️. Sigh. Human's risk assessment is terrible.
I absolutely agree with you re Covid being worse than the jab. The problem is getting them to agree. Now that Novavax is approved, my spouse can work on finding doses for them. They get a flu shot every year so I think they’ll do it. Fingers crossed.
Agreed. Benefits outweigh risks. Long term effects of illness are much scarier than a few spike proteins floating around. I fear coronary artery invasion, central and autonomic nervous system invasion, and post Covid conditions. I’m “pro-human” and therefore I’m getting my XBB booster today, and so is my daughter. I expect it will reduce my chances of getting infected for a while, and every time I don’t contract Covid is a pair of dice left uncast. I expect it will help reduce long Covid and collateral damage like previous vaccinations when I do get infected.
I’m not worried about hospitalization and death for my age group. But there is a lot of badness along a continuum that ends in death, and bolstering my defenses like an annual flu shot is what I’m talking about.
Well said. We had 3 generations receive ours together last week - my mom, myself (and husband) and our 14 year old. We are looking forward to our 9 year old duo getting it as soon as possible, and my dad getting his in the next month or so (he's still riding his immunity from having covid this summer and mentally preparing for the side effects that have always been a little rough for him). Unfortunately my mom tested positive (for the 1st time) 4 days after receiving her booster, so she was likely exposed prior to ornaroins the time she got her vaccine. Thankfully, with paxlovid (and her preexisting vaccine immunity) the course of illness has been not fun, but has been uneventful so far. We are so thankful for that in so many ways. We tried to get metformin for her (due to the decreased risk of long covid when taken during the infection) but unfortunately other health conditions made it contradicted for her.
I just tested positive 19 days after receiving the booster - just as a little reminder that these aren't sterilizing vaccines. But then again, most vaccines aren't. I trust the science that vaccination reduces the severity of the disease. Along with getting Paxlovid, this bout I'm having is looking a lot more like a live attenuated vaccine than an infection. That's sort of the whole point.
"1) We do have clinical data". You cite in vitro data that indicates an antibody response. This is not "clinical data". Clinical data should prove efficacy with regard to outcomes, not an antibody response. Furthermore the FDA has been on record for over 18 months saying that antibody responses are not a surrogate for protection. This was their justification in recommending the jabs for people who had already been exposed to the virus and had antibodies.
I spoke directly with Offer Levy, who is on the FDAs VRBPAC. He is conducting research to find markers for immunity because he firmly believes that antibodies do not serve that purpose. So, the present opinion of "the experts" is in alignment with the idea that we really do not have clinical data.
NO NEED FOR RCTs
"It's not feasible to run RCTs for everything". Okay, but the only RCTs we have looked at outcomes for only a mean time of six weeks (Pfizer). In that brief period the mRNA products demonstrated a remarkable efficacy in reducing symptomatic disease. Now you admit that it "real world studies" the vaccinated are more likely to become infected after six months (i.e. negative efficacy). This is the alarm bell that should be going off everywhere. How and why would a vaccine that initially had 95% efficacy then have negative efficacy a few months later? We can understand waning efficacy, but NEGATIVE efficacy? This points to something very concerning with regard to other aspects of immunological protection beyond an antibody response. The CDC and you are casually racking this up to timing and bias. These are, by your own admission, hypotheses only. There is no way to dismiss the possibility that the vaccines are harming immunity by merely hypothesizing. Furthermore, the CDC's own seroprevalence data demonstrates that antibodies to non-spike antigens is significantly less in the vaccinated population. Once exposed to the vaccine, a person cannot mount a response as broad as someone who is naturally infected. This is quite telling and could be an explanation as to why there is negative efficacy and why reinfection could be more frequent once jabbed. We should all be asking ourselves why the CDC is recommending these products when we know that in a few months you are more likely to contract the disease they target based on what data we have. Merely assuming that there are confounders that could explain the data is not rigorous, and the public deserves far better from an institution whose mission is disease control and prevention.
It is quite astonishing that you are using the "it would be unethical to run a RCT with a placebo control" argument. Just because vaccine giants like Paul Offit and the medical establishment use this line of reasoning doesn't mean it is sensical. Vaccine trial participants are a tiny portion of a population. If it is unethical to give a placebo to a trial participant then what about all the people who are not in the trial? They aren't getting the vaccine either. What do you mean by "if we know the vaccine helps..."? If we know the vaccine helps, why are we doing a trial??
ADVERSE EVENTS
The gold standard is the RCTs as you acknowledge. Pfizer demonstrated in their only RCT 6 per 1000 recipients had a serious AE. 2,500 people needed the primary series to avoid a single case of serious Covid. The risk/benefit profile from the RCTs themselves showed that the risk outweighed the benefit from the very beginning. The study that you cited here did not prove statistical significance around the increased risk in the vaccinated. True, but it was BARELY NOT SIGNIFICANT. "Significance" is an arbitrary term, in this case we are talking about 95% confidence intervals. Drop it to 75% and there would be significance. In other words, we can accurately say that there is a three in four chance that the vaccines increase the risk of having an adverse event. In a rational world the CDC and epidemiologists around the country should be demanding larger studies to prove significance, not shrugging your shoulders about the lack of confirmatory data.
Meanwhile, hundreds of thousands of Serious Adverse Events have been logged to event reporting systems. The CDC continues to not investigate them, and the public is being told that they haven't been "verified" while they remain unaware of the fact that these systems were put into place specifically to warn the CDC (and the public) of any danger signal so that they could be openly investigated, not swept under the rug. Implementation of these systems was a concession made to the public when our Congress issued liability protection to vaccine manufacturers over thirty years ago.
MYOCARDITIS
The earliest admission of myocarditis by the FDA was in June of 2021 when our country was alerted to the problem by Israel. At that time, the FDA admitted that in this young and healthy cohort was about 50-70 per million, or about 1 in 20,000. Now you are citing newer data of 2 in 650 thousand cases of "verified" myocarditis. Did the problem go away? If so, why? You are have admitted that "The changes from the last vaccine are small, literally the difference of a few amino acids—like a few letter edits on a Word document." So, if the changes are small, why is the risk now a ten times less than before?? Isn't the CDC interested in knowing why things have changed, and how?
"We think this is because the increased time interval between doses reduces risk. However, there is limited data, so this estimate has some uncertainty." You think? This estimate has some uncertainty? There is limited data? Sorry, that is not good enough to recommend a preventative measure to healthy young people.
Obviously, the key here is "verification" of the myocarditis cases. How did they verify the two out of 650,000? Have standards changed? What about the risk of sub-clinical myocarditis which is much, much higher?
Framing public health in a "nothing to see here" manner is dangerous too.
I love Dr Jetelina's ability to explain and summarize new or complex issues, AND unless we as a society or scientific/ clinical communitycan have open, collegial, curiosity-based discussions of the kinds of concerns @Madhava Setty raises - it will be hard for people to trust proponents of any viewpoint on vaccines or other public health measures. That a spectrum of perspectives can be raised in this Substack is why I eagerly read and support it by subscribing. If only we could have a moderated real-time discussion. As I was taught in high school science class, well-informed and -expressed alternative opinions need to be shared--and addressed. I'm enthusiastic about *me* being vaccinated, but the many anecdotal reports of long covid-like sequelae to vaccination (such as those presented and quickly brushed off at the Jan FDA meeting) should be taken seriously enough to reassure the public.
A recent study at Yale showed that the myocarditis affecting a small subgroup of young males was not being driven by antibodies stimulated by the mRNA shots, nor was it autoimmune response. Rather, it was a response to cytokines, an inflammation response. My understanding is that COVID can generate a cytokine response too. Why a small fraction of young males show a special sensitivity to the shot is not clear. Subsequent exposures to the shots seem to generate less of an inflammatory response in that small group. Maybe the young male body just doesn't over-react after it's no longer naive. In my own experience (five covid shots and counting), I had a mild adverse reaction to the second shot, but none at all to the next three. Might as well have been a saline shot. Peer experience is much the same. But you are taking this tiny and vanishing effect and using it tar the efficacy of a vaccine that has saved literally millions and is now likely to prevent thousands if not hundreds of thousands if not millions of needless illnesses. As to the "real world" observational studies showing negative efficacy, they were so prone to confounding factors that the very best you do with them is say, "There is some reason to believe we need more research before making any sort of recommendation-- for or against--based on them."
There is no doubt multiple potential mechanisms for myocarditis in the vaccinated. There is the cytokine response. The lipid nanoparticles are designed to be pro inflammatory and we know they migrate all over the body within hours to days. The spike protein itself is physiologically active and there are ACE 2 receptors in the heart. I agree that it is unclear why young males have a special sensitivity to the shot. I personally know two young males who were crippled for weeks after getting jabbed. I also know of many people who suffered no untoward effects.
As you point out, we are talking about a minority of recipients who are suffering devastating repercussions for unknown reasons. These are generally the people who have the least benefit from the short term protection these products offer. For that reason alone it would be more sensible to have targeted recommendations, much like FL has been recommending for a year.
I also agree that we need more research before making recommendations based on observational studies, but that is not what we are doing, is it? Three years later the CDC has not changed their recommendations. In any case, I am not citing any third party opinions. The gold standard, RCTs, showed that mortality was increased in the vaccinated cohort, that should have been a hard stop, yet the vaccine was authorized anyway. Now we have a possible signal in the observational data and yet we feel justified in shrugging our shoulders and attributing that to confounders alone? Yes, there are confounders, but there could also be a signal there too. How would we know if we don't do another trial?
The "clinical data" that YLE cites is not substantiated by the FDA's own position on antibody responses. We have no reason to believe that the new round of vaccines actually will have a benefit based on these Moderna studies. Given what is known people have a reasonable argument for eschewing another round.
YLE alludes to clotting as a potential adverse event but only points to the J&J vaccine. Yes, that is what the CDC tells us. Yet there are tens of thousands of reports of clotting events like strokes and pulmonary emboli in VAERS. None get acknowledged. By not investigating we make more enormous assumptions. At what point would it be reasonable for the public to demand that the CDC look into the quarter million Serious Adverse Events and the thirty thousand deaths that have been reported in VAERS? Never? Or when those numbers top a million? What are our standards exactly?
Lisa, I haven’t made a lot of claims. I am only citing the FDA and the original trial data that has been in print for three years. What are you looking for with regard to sources and evidence exactly?
We shouldn't be arguing about details. We shouldn't have to decide which studies are more reliable or which researchers are more honest.
In the original Pfizer clinical trial, MORE PEOPLE DIED IN THE VACCINATED GROUP THAN IN THE CONTROL GROUP.
That should be the end of the trial. Go back to the drawing board and design a different vaccine.
Historically, the second year of a pandemic has always been an echo of the first year with a much smaller toll of disease and death. This is because (1) in the first year, many of the most vulnerable people have already died, and (2) pathogens evolve toward being more transmissible and less lethal.
In the case of COVID, twice as many people died in 2021 compared to 2020, worldwide. Do we need any more evidence that the vaccines did more harm than good?
All-cause mortality is up significantly in most vaccinated countries. Live births are down 10-20%. Rates of disability are at all-time highs.
Meanwhile, a dozen governments are sitting on separate databases of (A) who was vaccinated and (B) who died in 2021-22. They have refused to correlate these databases, or to release de-identified data so that others can do the statistics. Do you think they wouldn't be broadcasting these correlations from the rooftops if they were favorable to the vaccines?
That's just what Pfizer said, and it got past the FDA. "These people died of something else besides COVID so it must have nothing to do with the vaccine." We know as a matter of theory that if rates of myocarditis are up, it can't be because of the vaccines. If people are dropping dead on the soccer field, it can't be because of the vaccine. If the rates of heart disease are up overall, it can't be because of the vaccine. If people are dying of turbo cancers, it can't be because of the vaccines.
You can't be serious. People die. It's what we do. Vaccines don't make you immortal. They reduce the risk of severe outcomes from particular diseases. Do you expect your dishwasher to make coffee?
People die all the time. .That's sufficient explanation for the increase in ACM from 2020 to 2021. No need to look any further. Let's move on already. It would be a waste of any epidemiologist's time to investigate whether vaccinated people had higher mortality risk than a demographically matched group of unvaccinated.
You’re right. It’s not a metric for effectiveness; it’s a metric for safety, which is the issue at hand. Identifying a situation where more people die if treated is exactly what a Phase III trial is for. There is no way Pfizer can claim that the increased deaths were not due to their product while claiming that it also prevented symptomatic Covid-19. The trials are based in correlations only. They proved their product, when given to 20 thousand people, is associated with fewer Covid infections and more fatalities. That is all.
Can someone point me to the Pfizer trial data that indicated increased risk of death in the vaccinated group? I'm looking at the original trial, https://www.nejm.org/doi/full/10.1056/nejmoa2034577, where it says " Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the vaccine or placebo. No Covid-19–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of vaccine." Or were you referring to the 2-year followup safety monitoring? (I realise this question might not be relevant to today's situation). Thanks.
15 deaths in the vaccinated, 14 in the placebo. This should have been a hard-stop. It doesn't matter that investigators "considered" that the fatalities were unrelated to the vaccine. They cannot claim a Covid-19 mortality benefit from their product from this data while simultaneously denying that the increased deaths were unrelated.
Beyond that, there is an enormous conflict of interest at play. That is why it is important to only consider the data and nothing else.
This table is why Pfizer was able to conclude that Covid-19 mortality is halved in the vaccinated in less than a six month period of observation. The same table shows that it quadruples mortality from cardiac arrest.
To my knowledge there has never been a product or therapy where Phase III trials demonstrated more all cause mortality in the therapy cohort and the the therapy was given to people outside the trial.
Furthermore, there is no safety monitoring for two years. The entire control group was given the vaccine only a few months into the trial. This was justified by superiority, in other words, the used the efficacy numbers from the initial results, which by the way were accrued after only an average of six weeks of observation. The end result is that we no longer have any long term data on safety or efficacy from an RCT despite the fact the public was promised this at the start of the vaccine campaign.
"He combines legitimate points with profoundly foolish ones, which muddles the picture, creates a sense of false equivalency, and makes it difficult for the general public to discern the truth."
This is quite literally the playbook of QAnon. Mix truth and fantasy just enough and thousands, if not millions, will buy the garbage. And this is what is being promulgated by the government of Florida. Astounding and depressing at the same time.
Thank you very much for these comments-This should be publicized throughout our state. What has really frustrated me though, is the lack of response to these draconian policies from Florida's surgeon general and governor. Why don't our local medical leaders speak up and inform our communities of the correct science?
I am pro-vaccine and have all my allowable boosters for COVID (plus 2 infections).
BUT: I had no idea there is a correlation between vaccination and negative efficacy. This actually seems huge. The idea that vaccinated people are more likely to be out and about and exposed to COVID seems unlikely--anti-vaxxers were tossing caution to the wind from Day 1. Perhaps vaccinated folks are indeed more likely to test... but we really should want to find out, no? Glossing over this seems like a very bad idea.
Yes. Excellent point. The UKHSA (UK Health Security Agency) was publishing data as early as September 2021 showing us that infection rates in the vaccinated were higher. They cautioned the public to not draw any conclusions because, they said, unvaccinated people were more likely to stay at home and not get exposed, which is, obviously absurd as you point out. Moreover, the differences in infection rates got larger and larger. Then, in March 2022, they stopped reporting on this metric.
Agencies of public health knew about negative efficacy for over two years. It is shocking that it has taken this long for the orthodoxy to acknowledge this. Perhaps this phenomenon is due to something other than a weakening of the immune system of those who were vaccinated, but the onus is on those who are recommending this product to prove that it isn't, not on those who are raising question to prove that it is.
You have provided a brilliant, perspicuous, and necessary exegesis of the latest inflammatory stuff put out by this very strange dude whose CV indicates that he is presently a Professor of Medicine at the University of Florida. His modus operandi is becoming clearer as time passes -- viz. spew odd blarney repeatedly. I mean REALLY odd and definitely blarney. No thoughtful person can be criticized for pondering how in hell he received both the MD and PhD (Health Policy ) degrees at Harvard, of all places. Those are certainly not mediocre academic tickets. Something is just not right here. Jesus, please send us some kind of message today that the world has not wobbled off its rotation axis.
As someone working to increase vaccine update among persons with disabilities and older adults IN FLORIDA, this makes my job exponentially harder. He is a disgrace to physicians and public health practitioners everywhere.
How is there a “legitimate debate” to be had about limiting the COVID vaccine to only higher-risk people when we *know* for a *fact* that:
1) Per the CDC’s ACIP meeting, half of the kids who died of COVID had no underlying conditions
2) COVID can cause immune dysregulation in “healthy” people, thereby now making them high-risk
3) Americans are notoriously unhealthy as a lot, with a majority of us having at least one comorbidity?
4) Long COVID is, and will unfortunately continue to be, a huge strain on the economy and the healthcare system. The only way to prevent Long COVID is to not get infected at all.
Your position on this makes no sense to me, and doesn’t track with the data.
Politics should not be mixed with science. Calling the vaccine "anti-human" is clearly provocative, but it looks like the Surgeon General achieved his goal of grabbing headlines and that's gross!
This was excellent, and it will always dismay me when I see Dr. Ladapo standing in front of the logo for Florida Health, which struggles mightily in getting out health education to its local communities. (As a pro-human, I got both my COVID monovalent and flu shot a few weeks ago.)
I’m very happy FDA authorized Novavax’s monovalent covid booster 3 days ago. Does anyone know when it will be available at pharmacies and which ones? The www.vaccines.gov website allows one to locate nearby vaccines based on manufacturer (including Novavax), yet it doesn’t appear to be accurate.
Many pharmacies in my area are booked until early November with Pfizer and Moderna appointments, so even if a pharmacy had Novavax in stock today, they don’t have any available spots for administering it. CVS, Rite Aid and Walgreens all let you select by manufacturer, but none of them display Novavax yet. Very disappointing!
I’d be interested in information about this as well. I also found the website highly inaccurate, both as to types of vax available and locations, so I walked to my three nearest pharmacies (CVS, Duane Reade, and an independent) to find out what I could. This is what aI learned: CVS was not able to advise which vaccines it had; Duane Reade, while listing appointment availability on the website, had no vaccines of any type in stock; the independent pharmacy was not listed on the website, but does offer the mRNA vaccines, though was temporarily out of stock. (This feels very much like the experience every older person I knew had in early 2021: inaccurate and incomplete information and only sporadic availability.)
I took my elderly parents last week to Safeway to get the Moderna covid booster. We called beforehand and the pharmacist told us “we only have Moderna.” We showed up, and the pharmacist told us he’d be administering Pfizer. (Safeway’s website doesn’t let you pick manufacturer in advance).
We protested, mostly because we were hoping to mix and match, and both parents have received Pfizer in the past, plus I think Moderna is a slightly better mRNA vaccine. The pharmacist (supposedly) found a few vials of Moderna. Mom and Dad got jabbed, and their vaccine card says “Moderna.”On the way home, we wondered which vaccine they really got.
There doesn’t seem to be much media attention to Novavax, maybe because there aren’t any appointments yet. Even if it’s FDA authorized, if appointments aren’t available, you still can’t get it. 😠
I stopped googling it every morning on the day of our shot. :/ We have a situation (out of our control) that meant we had to find a shot this past week. But I have friends with more flexibility who were hoping for Novavax, so I’ve let them in on the good news. They’re excited.
I think the main issue is that anti-vax sentiments are impervious to facts and logic, and they seem to be a growing demographic in this country. I greatly appreciate knowing the facts, but I also know it's not going to change the minds of anyone I know who is already anti-vax to begin with, because they're "just asking questions" forever and ever
I am seeing a great deal of enthusiasm about Novavax posted on various sites but I am not sure how to interpret much of the information. I understand that it is a fabulous option for some people who were unable to utilize mRNA vaccines but the data on its efficacy is unclear to me in that some people are claiming it has broader immunity over a longer period of time. Some claim that this is the case after one shot, others claim that this is the case only after beginning a new series. Some point to homologous boosting and encourage it; others seem to discourage it. Some say Novavax’s power is really for people who have already had Omicron. Others say that it is particularly efficacious for “Novids” or those with no prior infection. Can someone help decipher this data? :) I may also post to Dr. McBride’s site, my other go to.
In a state with an incredibly old population, his advice really is public health malpractice. Fortunately, lots of folks here in Florida are moving ahead with vaccines, when they can find them.
I actually had this discussion yesterday with a colleague. It would be interesting to see if, and to what extent, his comments are changing people's minds. Our guess was about 10% of people who would have gotten the shot in FL won't after his comments, but that's a guess.
My elderly in-laws are hesitant to get the new shot based on things this man has said recently. Plus they hate the side effects of the mRNA vaccines. If there is any signal at all about when Novavax is coming, we may be able to persuade them to get that, versus what they’re leaning towards (not vaccinating).
Novavax is now FDA approved or EUA. Should be available in Pharmacy or clinic by now might want to check the local Health Department.
If they don't like the side effect of vaccine, likely they won't like the front, back and side effect of COVID-19. It's not mild...
I should add that if they don't like the side effects of the vaccine they're likely not to like the side effects of covid-19
Exactly! At least when you get an mrna vaccine you can plan when you're going to feel crummy, it's short-lived, doesn't run a (decent sized) risk of hospitalizing them and doesn't come with possible long covid 🤦🏼♀️. Sigh. Human's risk assessment is terrible.
"doesn't come with possible long covid". HUH?
I absolutely agree with you re Covid being worse than the jab. The problem is getting them to agree. Now that Novavax is approved, my spouse can work on finding doses for them. They get a flu shot every year so I think they’ll do it. Fingers crossed.
It’s so true. Watch out for alligators down there, too.
Agreed. Benefits outweigh risks. Long term effects of illness are much scarier than a few spike proteins floating around. I fear coronary artery invasion, central and autonomic nervous system invasion, and post Covid conditions. I’m “pro-human” and therefore I’m getting my XBB booster today, and so is my daughter. I expect it will reduce my chances of getting infected for a while, and every time I don’t contract Covid is a pair of dice left uncast. I expect it will help reduce long Covid and collateral damage like previous vaccinations when I do get infected.
I’m not worried about hospitalization and death for my age group. But there is a lot of badness along a continuum that ends in death, and bolstering my defenses like an annual flu shot is what I’m talking about.
I’m very grateful, really.
Well said. We had 3 generations receive ours together last week - my mom, myself (and husband) and our 14 year old. We are looking forward to our 9 year old duo getting it as soon as possible, and my dad getting his in the next month or so (he's still riding his immunity from having covid this summer and mentally preparing for the side effects that have always been a little rough for him). Unfortunately my mom tested positive (for the 1st time) 4 days after receiving her booster, so she was likely exposed prior to ornaroins the time she got her vaccine. Thankfully, with paxlovid (and her preexisting vaccine immunity) the course of illness has been not fun, but has been uneventful so far. We are so thankful for that in so many ways. We tried to get metformin for her (due to the decreased risk of long covid when taken during the infection) but unfortunately other health conditions made it contradicted for her.
I just tested positive 19 days after receiving the booster - just as a little reminder that these aren't sterilizing vaccines. But then again, most vaccines aren't. I trust the science that vaccination reduces the severity of the disease. Along with getting Paxlovid, this bout I'm having is looking a lot more like a live attenuated vaccine than an infection. That's sort of the whole point.
Yes, Let's dig in...
SURROGATES FOR EFFICACY
"1) We do have clinical data". You cite in vitro data that indicates an antibody response. This is not "clinical data". Clinical data should prove efficacy with regard to outcomes, not an antibody response. Furthermore the FDA has been on record for over 18 months saying that antibody responses are not a surrogate for protection. This was their justification in recommending the jabs for people who had already been exposed to the virus and had antibodies.
I spoke directly with Offer Levy, who is on the FDAs VRBPAC. He is conducting research to find markers for immunity because he firmly believes that antibodies do not serve that purpose. So, the present opinion of "the experts" is in alignment with the idea that we really do not have clinical data.
NO NEED FOR RCTs
"It's not feasible to run RCTs for everything". Okay, but the only RCTs we have looked at outcomes for only a mean time of six weeks (Pfizer). In that brief period the mRNA products demonstrated a remarkable efficacy in reducing symptomatic disease. Now you admit that it "real world studies" the vaccinated are more likely to become infected after six months (i.e. negative efficacy). This is the alarm bell that should be going off everywhere. How and why would a vaccine that initially had 95% efficacy then have negative efficacy a few months later? We can understand waning efficacy, but NEGATIVE efficacy? This points to something very concerning with regard to other aspects of immunological protection beyond an antibody response. The CDC and you are casually racking this up to timing and bias. These are, by your own admission, hypotheses only. There is no way to dismiss the possibility that the vaccines are harming immunity by merely hypothesizing. Furthermore, the CDC's own seroprevalence data demonstrates that antibodies to non-spike antigens is significantly less in the vaccinated population. Once exposed to the vaccine, a person cannot mount a response as broad as someone who is naturally infected. This is quite telling and could be an explanation as to why there is negative efficacy and why reinfection could be more frequent once jabbed. We should all be asking ourselves why the CDC is recommending these products when we know that in a few months you are more likely to contract the disease they target based on what data we have. Merely assuming that there are confounders that could explain the data is not rigorous, and the public deserves far better from an institution whose mission is disease control and prevention.
It is quite astonishing that you are using the "it would be unethical to run a RCT with a placebo control" argument. Just because vaccine giants like Paul Offit and the medical establishment use this line of reasoning doesn't mean it is sensical. Vaccine trial participants are a tiny portion of a population. If it is unethical to give a placebo to a trial participant then what about all the people who are not in the trial? They aren't getting the vaccine either. What do you mean by "if we know the vaccine helps..."? If we know the vaccine helps, why are we doing a trial??
ADVERSE EVENTS
The gold standard is the RCTs as you acknowledge. Pfizer demonstrated in their only RCT 6 per 1000 recipients had a serious AE. 2,500 people needed the primary series to avoid a single case of serious Covid. The risk/benefit profile from the RCTs themselves showed that the risk outweighed the benefit from the very beginning. The study that you cited here did not prove statistical significance around the increased risk in the vaccinated. True, but it was BARELY NOT SIGNIFICANT. "Significance" is an arbitrary term, in this case we are talking about 95% confidence intervals. Drop it to 75% and there would be significance. In other words, we can accurately say that there is a three in four chance that the vaccines increase the risk of having an adverse event. In a rational world the CDC and epidemiologists around the country should be demanding larger studies to prove significance, not shrugging your shoulders about the lack of confirmatory data.
Meanwhile, hundreds of thousands of Serious Adverse Events have been logged to event reporting systems. The CDC continues to not investigate them, and the public is being told that they haven't been "verified" while they remain unaware of the fact that these systems were put into place specifically to warn the CDC (and the public) of any danger signal so that they could be openly investigated, not swept under the rug. Implementation of these systems was a concession made to the public when our Congress issued liability protection to vaccine manufacturers over thirty years ago.
MYOCARDITIS
The earliest admission of myocarditis by the FDA was in June of 2021 when our country was alerted to the problem by Israel. At that time, the FDA admitted that in this young and healthy cohort was about 50-70 per million, or about 1 in 20,000. Now you are citing newer data of 2 in 650 thousand cases of "verified" myocarditis. Did the problem go away? If so, why? You are have admitted that "The changes from the last vaccine are small, literally the difference of a few amino acids—like a few letter edits on a Word document." So, if the changes are small, why is the risk now a ten times less than before?? Isn't the CDC interested in knowing why things have changed, and how?
"We think this is because the increased time interval between doses reduces risk. However, there is limited data, so this estimate has some uncertainty." You think? This estimate has some uncertainty? There is limited data? Sorry, that is not good enough to recommend a preventative measure to healthy young people.
Obviously, the key here is "verification" of the myocarditis cases. How did they verify the two out of 650,000? Have standards changed? What about the risk of sub-clinical myocarditis which is much, much higher?
Framing public health in a "nothing to see here" manner is dangerous too.
I love Dr Jetelina's ability to explain and summarize new or complex issues, AND unless we as a society or scientific/ clinical communitycan have open, collegial, curiosity-based discussions of the kinds of concerns @Madhava Setty raises - it will be hard for people to trust proponents of any viewpoint on vaccines or other public health measures. That a spectrum of perspectives can be raised in this Substack is why I eagerly read and support it by subscribing. If only we could have a moderated real-time discussion. As I was taught in high school science class, well-informed and -expressed alternative opinions need to be shared--and addressed. I'm enthusiastic about *me* being vaccinated, but the many anecdotal reports of long covid-like sequelae to vaccination (such as those presented and quickly brushed off at the Jan FDA meeting) should be taken seriously enough to reassure the public.
If I'd not come across your post on the events of 9/11, I might be willing to give your statements on COVID vaccines some consideration. But, no.
A recent study at Yale showed that the myocarditis affecting a small subgroup of young males was not being driven by antibodies stimulated by the mRNA shots, nor was it autoimmune response. Rather, it was a response to cytokines, an inflammation response. My understanding is that COVID can generate a cytokine response too. Why a small fraction of young males show a special sensitivity to the shot is not clear. Subsequent exposures to the shots seem to generate less of an inflammatory response in that small group. Maybe the young male body just doesn't over-react after it's no longer naive. In my own experience (five covid shots and counting), I had a mild adverse reaction to the second shot, but none at all to the next three. Might as well have been a saline shot. Peer experience is much the same. But you are taking this tiny and vanishing effect and using it tar the efficacy of a vaccine that has saved literally millions and is now likely to prevent thousands if not hundreds of thousands if not millions of needless illnesses. As to the "real world" observational studies showing negative efficacy, they were so prone to confounding factors that the very best you do with them is say, "There is some reason to believe we need more research before making any sort of recommendation-- for or against--based on them."
There is no doubt multiple potential mechanisms for myocarditis in the vaccinated. There is the cytokine response. The lipid nanoparticles are designed to be pro inflammatory and we know they migrate all over the body within hours to days. The spike protein itself is physiologically active and there are ACE 2 receptors in the heart. I agree that it is unclear why young males have a special sensitivity to the shot. I personally know two young males who were crippled for weeks after getting jabbed. I also know of many people who suffered no untoward effects.
As you point out, we are talking about a minority of recipients who are suffering devastating repercussions for unknown reasons. These are generally the people who have the least benefit from the short term protection these products offer. For that reason alone it would be more sensible to have targeted recommendations, much like FL has been recommending for a year.
I also agree that we need more research before making recommendations based on observational studies, but that is not what we are doing, is it? Three years later the CDC has not changed their recommendations. In any case, I am not citing any third party opinions. The gold standard, RCTs, showed that mortality was increased in the vaccinated cohort, that should have been a hard stop, yet the vaccine was authorized anyway. Now we have a possible signal in the observational data and yet we feel justified in shrugging our shoulders and attributing that to confounders alone? Yes, there are confounders, but there could also be a signal there too. How would we know if we don't do another trial?
The "clinical data" that YLE cites is not substantiated by the FDA's own position on antibody responses. We have no reason to believe that the new round of vaccines actually will have a benefit based on these Moderna studies. Given what is known people have a reasonable argument for eschewing another round.
YLE alludes to clotting as a potential adverse event but only points to the J&J vaccine. Yes, that is what the CDC tells us. Yet there are tens of thousands of reports of clotting events like strokes and pulmonary emboli in VAERS. None get acknowledged. By not investigating we make more enormous assumptions. At what point would it be reasonable for the public to demand that the CDC look into the quarter million Serious Adverse Events and the thirty thousand deaths that have been reported in VAERS? Never? Or when those numbers top a million? What are our standards exactly?
So...Tylenol should do the trick. As expected
Madahava you've made a lot of claims and provided no sources or evidence for them.
Lisa, I haven’t made a lot of claims. I am only citing the FDA and the original trial data that has been in print for three years. What are you looking for with regard to sources and evidence exactly?
"In other words, we can accurately say that there is a three in four chance that the vaccines increase the risk of having an adverse event". No.
Would you explain what a 75% confidence interval signifies to you?
We shouldn't be arguing about details. We shouldn't have to decide which studies are more reliable or which researchers are more honest.
In the original Pfizer clinical trial, MORE PEOPLE DIED IN THE VACCINATED GROUP THAN IN THE CONTROL GROUP.
That should be the end of the trial. Go back to the drawing board and design a different vaccine.
Historically, the second year of a pandemic has always been an echo of the first year with a much smaller toll of disease and death. This is because (1) in the first year, many of the most vulnerable people have already died, and (2) pathogens evolve toward being more transmissible and less lethal.
In the case of COVID, twice as many people died in 2021 compared to 2020, worldwide. Do we need any more evidence that the vaccines did more harm than good?
All-cause mortality is up significantly in most vaccinated countries. Live births are down 10-20%. Rates of disability are at all-time highs.
Meanwhile, a dozen governments are sitting on separate databases of (A) who was vaccinated and (B) who died in 2021-22. They have refused to correlate these databases, or to release de-identified data so that others can do the statistics. Do you think they wouldn't be broadcasting these correlations from the rooftops if they were favorable to the vaccines?
You're misusing all-cause mortality. It's not an appropriate metric for the effectiveness of a treatment for a specific condition. Why would it be?
That's just what Pfizer said, and it got past the FDA. "These people died of something else besides COVID so it must have nothing to do with the vaccine." We know as a matter of theory that if rates of myocarditis are up, it can't be because of the vaccines. If people are dropping dead on the soccer field, it can't be because of the vaccine. If the rates of heart disease are up overall, it can't be because of the vaccine. If people are dying of turbo cancers, it can't be because of the vaccines.
You can't be serious. People die. It's what we do. Vaccines don't make you immortal. They reduce the risk of severe outcomes from particular diseases. Do you expect your dishwasher to make coffee?
People die all the time. .That's sufficient explanation for the increase in ACM from 2020 to 2021. No need to look any further. Let's move on already. It would be a waste of any epidemiologist's time to investigate whether vaccinated people had higher mortality risk than a demographically matched group of unvaccinated.
You’re right. It’s not a metric for effectiveness; it’s a metric for safety, which is the issue at hand. Identifying a situation where more people die if treated is exactly what a Phase III trial is for. There is no way Pfizer can claim that the increased deaths were not due to their product while claiming that it also prevented symptomatic Covid-19. The trials are based in correlations only. They proved their product, when given to 20 thousand people, is associated with fewer Covid infections and more fatalities. That is all.
Can someone point me to the Pfizer trial data that indicated increased risk of death in the vaccinated group? I'm looking at the original trial, https://www.nejm.org/doi/full/10.1056/nejmoa2034577, where it says " Two BNT162b2 recipients died (one from arteriosclerosis, one from cardiac arrest), as did four placebo recipients (two from unknown causes, one from hemorrhagic stroke, and one from myocardial infarction). No deaths were considered by the investigators to be related to the vaccine or placebo. No Covid-19–associated deaths were observed. No stopping rules were met during the reporting period. Safety monitoring will continue for 2 years after administration of the second dose of vaccine." Or were you referring to the 2-year followup safety monitoring? (I realise this question might not be relevant to today's situation). Thanks.
Table S4 from the Pfizer six month interim results.
https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf
15 deaths in the vaccinated, 14 in the placebo. This should have been a hard-stop. It doesn't matter that investigators "considered" that the fatalities were unrelated to the vaccine. They cannot claim a Covid-19 mortality benefit from their product from this data while simultaneously denying that the increased deaths were unrelated.
Beyond that, there is an enormous conflict of interest at play. That is why it is important to only consider the data and nothing else.
This table is why Pfizer was able to conclude that Covid-19 mortality is halved in the vaccinated in less than a six month period of observation. The same table shows that it quadruples mortality from cardiac arrest.
To my knowledge there has never been a product or therapy where Phase III trials demonstrated more all cause mortality in the therapy cohort and the the therapy was given to people outside the trial.
Furthermore, there is no safety monitoring for two years. The entire control group was given the vaccine only a few months into the trial. This was justified by superiority, in other words, the used the efficacy numbers from the initial results, which by the way were accrued after only an average of six weeks of observation. The end result is that we no longer have any long term data on safety or efficacy from an RCT despite the fact the public was promised this at the start of the vaccine campaign.
"He combines legitimate points with profoundly foolish ones, which muddles the picture, creates a sense of false equivalency, and makes it difficult for the general public to discern the truth."
This is quite literally the playbook of QAnon. Mix truth and fantasy just enough and thousands, if not millions, will buy the garbage. And this is what is being promulgated by the government of Florida. Astounding and depressing at the same time.
Thank you very much for these comments-This should be publicized throughout our state. What has really frustrated me though, is the lack of response to these draconian policies from Florida's surgeon general and governor. Why don't our local medical leaders speak up and inform our communities of the correct science?
Because the governor is a petty tyrant who exacts revenge against those who speak out.
I am pro-vaccine and have all my allowable boosters for COVID (plus 2 infections).
BUT: I had no idea there is a correlation between vaccination and negative efficacy. This actually seems huge. The idea that vaccinated people are more likely to be out and about and exposed to COVID seems unlikely--anti-vaxxers were tossing caution to the wind from Day 1. Perhaps vaccinated folks are indeed more likely to test... but we really should want to find out, no? Glossing over this seems like a very bad idea.
Yes. Excellent point. The UKHSA (UK Health Security Agency) was publishing data as early as September 2021 showing us that infection rates in the vaccinated were higher. They cautioned the public to not draw any conclusions because, they said, unvaccinated people were more likely to stay at home and not get exposed, which is, obviously absurd as you point out. Moreover, the differences in infection rates got larger and larger. Then, in March 2022, they stopped reporting on this metric.
Agencies of public health knew about negative efficacy for over two years. It is shocking that it has taken this long for the orthodoxy to acknowledge this. Perhaps this phenomenon is due to something other than a weakening of the immune system of those who were vaccinated, but the onus is on those who are recommending this product to prove that it isn't, not on those who are raising question to prove that it is.
You have provided a brilliant, perspicuous, and necessary exegesis of the latest inflammatory stuff put out by this very strange dude whose CV indicates that he is presently a Professor of Medicine at the University of Florida. His modus operandi is becoming clearer as time passes -- viz. spew odd blarney repeatedly. I mean REALLY odd and definitely blarney. No thoughtful person can be criticized for pondering how in hell he received both the MD and PhD (Health Policy ) degrees at Harvard, of all places. Those are certainly not mediocre academic tickets. Something is just not right here. Jesus, please send us some kind of message today that the world has not wobbled off its rotation axis.
As someone working to increase vaccine update among persons with disabilities and older adults IN FLORIDA, this makes my job exponentially harder. He is a disgrace to physicians and public health practitioners everywhere.
Thank you. This is a calm, generous, and rational response to an outrageous abuse of office.
How is there a “legitimate debate” to be had about limiting the COVID vaccine to only higher-risk people when we *know* for a *fact* that:
1) Per the CDC’s ACIP meeting, half of the kids who died of COVID had no underlying conditions
2) COVID can cause immune dysregulation in “healthy” people, thereby now making them high-risk
3) Americans are notoriously unhealthy as a lot, with a majority of us having at least one comorbidity?
4) Long COVID is, and will unfortunately continue to be, a huge strain on the economy and the healthcare system. The only way to prevent Long COVID is to not get infected at all.
Your position on this makes no sense to me, and doesn’t track with the data.
I completely agree. The known and unknown long term effects of repeated infection were not being taken into account by the author.
Politics should not be mixed with science. Calling the vaccine "anti-human" is clearly provocative, but it looks like the Surgeon General achieved his goal of grabbing headlines and that's gross!
This was excellent, and it will always dismay me when I see Dr. Ladapo standing in front of the logo for Florida Health, which struggles mightily in getting out health education to its local communities. (As a pro-human, I got both my COVID monovalent and flu shot a few weeks ago.)
I’m very happy FDA authorized Novavax’s monovalent covid booster 3 days ago. Does anyone know when it will be available at pharmacies and which ones? The www.vaccines.gov website allows one to locate nearby vaccines based on manufacturer (including Novavax), yet it doesn’t appear to be accurate.
Many pharmacies in my area are booked until early November with Pfizer and Moderna appointments, so even if a pharmacy had Novavax in stock today, they don’t have any available spots for administering it. CVS, Rite Aid and Walgreens all let you select by manufacturer, but none of them display Novavax yet. Very disappointing!
I’d be interested in information about this as well. I also found the website highly inaccurate, both as to types of vax available and locations, so I walked to my three nearest pharmacies (CVS, Duane Reade, and an independent) to find out what I could. This is what aI learned: CVS was not able to advise which vaccines it had; Duane Reade, while listing appointment availability on the website, had no vaccines of any type in stock; the independent pharmacy was not listed on the website, but does offer the mRNA vaccines, though was temporarily out of stock. (This feels very much like the experience every older person I knew had in early 2021: inaccurate and incomplete information and only sporadic availability.)
I took my elderly parents last week to Safeway to get the Moderna covid booster. We called beforehand and the pharmacist told us “we only have Moderna.” We showed up, and the pharmacist told us he’d be administering Pfizer. (Safeway’s website doesn’t let you pick manufacturer in advance).
We protested, mostly because we were hoping to mix and match, and both parents have received Pfizer in the past, plus I think Moderna is a slightly better mRNA vaccine. The pharmacist (supposedly) found a few vials of Moderna. Mom and Dad got jabbed, and their vaccine card says “Moderna.”On the way home, we wondered which vaccine they really got.
I cannot believe I missed this announcement. Where was it?? We got jabbed Tuesday. Ugh.
There doesn’t seem to be much media attention to Novavax, maybe because there aren’t any appointments yet. Even if it’s FDA authorized, if appointments aren’t available, you still can’t get it. 😠
https://www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-formulated-better-protect-against-currently#:~:text=The%20FDA%20has%20determined%20that,years%20of%20age%20and%20older.
I stopped googling it every morning on the day of our shot. :/ We have a situation (out of our control) that meant we had to find a shot this past week. But I have friends with more flexibility who were hoping for Novavax, so I’ve let them in on the good news. They’re excited.
I think the main issue is that anti-vax sentiments are impervious to facts and logic, and they seem to be a growing demographic in this country. I greatly appreciate knowing the facts, but I also know it's not going to change the minds of anyone I know who is already anti-vax to begin with, because they're "just asking questions" forever and ever
I am seeing a great deal of enthusiasm about Novavax posted on various sites but I am not sure how to interpret much of the information. I understand that it is a fabulous option for some people who were unable to utilize mRNA vaccines but the data on its efficacy is unclear to me in that some people are claiming it has broader immunity over a longer period of time. Some claim that this is the case after one shot, others claim that this is the case only after beginning a new series. Some point to homologous boosting and encourage it; others seem to discourage it. Some say Novavax’s power is really for people who have already had Omicron. Others say that it is particularly efficacious for “Novids” or those with no prior infection. Can someone help decipher this data? :) I may also post to Dr. McBride’s site, my other go to.