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. He doesn’t have the greatest track record
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.
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.
"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.
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?
"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.
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 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.
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.
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.
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?
"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.
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.
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 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.