Happy 2024! The first public health rumor of the year came in hot: the Florida Surgeon General sent an email airing his concerns about mRNA Covid-19 vaccines: billions of DNA fragments per dose of Covid-19 mRNA vaccines. This isn’t the first time he questioned the safety of mRNA Covid-19 vaccines, but it is a new angle. As always, each claim should be evaluated individually based on merit.
I do not agree with your dismissal of Dr. Ladapo's concerns around the potential dangers of the mRNA products. This is a complex issue which requires a much more thorough analysis than you have presented.
1) The quantity of DNA fragments deemed acceptable is based on traditional vaccines which are not encapsulated in LNPs which are specifically designed to protect the encapsulated mRNA (and the trace DNA contaminants) until they can enter a host cell's cytosol. In other words the risk of these DNA contaminants are greater when they are encapsulated inside the lipid delivery mechanism. Yet the FDA has not modified their assessment of risk accordingly. It is illogical to compare mRNA inside of LNPs with traditional vaccines.
2) Ladapo is NOT claiming that these products WILL result in the integration of said fragments into our genome. He is merely asking for evidence that they WON'T. Citing genotoxicy studies isn't, as he says, adequate to ensure this is may not be happening on a small scale.
3) Your statement "It is biologically impossible for random DNA fragments to integrate into our genes" is not substantiated by the arguments given. In fact it contradicts Dr. Marks' assurance that it is "implausible". There is a world of difference between impossible and implausible, especially given the fact that billions of people have been vaccinated. The reason why Dr. Marks has a tempered position is that he knows that FDA's own guidance around DNA vaccines acknowledges that integration is a possibility even though DNA vaccines do not have DNA integrase in them either. The fact that contaminant DNA "lacks stability" does not mean that none will survive long enough to be integrated.
4) This leads to your position about "billions" being relatively tiny compared to "trillions". No argument there. But a billion is a big number on its own, especially with regard to "implausibility". If only one in a million DNA contaminant strands get integrated that would result in thousands of cells with altered DNA.
5) We all agree that LNPs go places outside of the deltoid muscle. The bio distribution study you cite indicates that 0.1% get to the ovaries and testes. Is that really trivial? At what level would it be non-trivial in your opinion? Two points about this. The levels in the ovaries attained that concentration after 48 hours. Levels were still rising when the observational period ended. We don't know how much eventually ends up there. Moreover, this study was only made public after a FOIA request to the Japanese medical authorities in the Spring of 2021. Why didn't the FDA know about it? Isn't it their job to demand these studies from the vaccine manufacturers? How many people would have had second thoughts about getting jabbed if they knew that a small portion of the inoculate would migrate to the spleen, the liver, the heart, the ovaries and the brain? Would their concerns have been reasonable?
6) The lipid nanoparticles aren't just little bubbles of fat. The design of these particles is one of the major breakthroughs in bringing these products to market. They are designed differently depending on the payload being delivered. Medicine in the form of cancer therapy will be encapsulated in a different kind of "bubble" than an mRNA vaccine. The LNPs for these vaccines are designed to be pro inflammatory to incite an immunologic response. It should be of some embarrassment to the FDA that the bio distribution studies show that these things go all over the place, albeit in limited quantities. That being the case, one cannot dismiss the possibility that these particles could be responsible for organ inflammation in the form of irregular menses, myo/pericarditis, bells palsy, transverse myelitis, etc. etc. in a small subset of vaccine recipients. Given the fact that a quarter of a billion people in this country have gotten the vaccine that the three hundred thousand serious adverse events reported in VAERS may be due to the vaccine? Shouldn't we expect the CDC to do a serious investigation into these reports on behalf of the public?
7) 8,288 Floridians have lost their life to Covid-19? Your citation does not indicate the vaccination status of those fatalities. Are you suggesting that they were all unvaccinated? What exactly are you insinuating here? That Ladapo is somehow responsible for their deaths? He didn't prohibit people from getting the jab. 70% of Floridians are fully vaccinated.
There's a lot more we don't know about this technology. Posts like this do not aid in discovering more. mRNA technology could eventually be a transformative weapon against disease and infection but right now the public doesn't trust it, and for good reason. By dismissing reasonable requests for more information in this fashion you are unwittingly doing far more damage than you realize.
Thank you very much for an excellent analysis and response to more misinformation from Florida. Unfortunately, Ladapo's statement already hit the national press and was widely reported. This article needs to be sent to the news media so they can report the truth.
As a Floridian, emergency manager AND advocate for persons with disabilities, thank you so much for posting this. This "doctor" is a serious danger to public health and my fellow Floridians. His efforts and actions have seriously impacted me and my team at work's ability to increase vaccine access to those with disabilities.
And another reason I am so glad to have left that agency before he got arrived. Again, thank you for posting this. You are appreciated.
"Regardless, we have been tracking the safety of Covid-19 vaccines at unprecedented levels across the globe for more than three years. Scientific evidence from the lab, clinical trials, and epidemiological real-world data continue to verify a highly favorable profile of benefit to risk of Covid-19 vaccines."
Which clinical trial demonstrated a mortality benefit? a hospitalization benefit? It most certainly was not the Phase III Pfizer trial that led to the approval of the mRNA vaccine. There is no evidence of a "highly favorable profile of benefit to risk" for a healthy 30 year-old, for example. None. Yet these shots continue to get pushed on everyone.
Floridian here. Ladapo is a danger to public health and safety. He's already lied multiple times and should not be Surgeon General much less be allowed to have a medical license. He's violated his oath both as SG and as a physician. He does nothing but harm. He's part of the reason Florida still has one of the the highest Covid death rates in the country. They stopped tracking everything years ago so we have no accurate data about Covid. And they continue to lie to people who put the rest of us in danger on a daily basis. DeathSantis would make the vaccines illegal if he could and there was at least one petition to do so already. I still cannot safely participate in public life because of people like Ladapo and constant lies and bad messaging.
Now I have a question about DNA. We know that DNA from every pregnancy stays inside the mother forever after birth. And that the DNA can cause cancer later in life (not always). Why doesn't the female body break down those DNA fragments? Is it because the DNA isn't technically foreign because the body recognizes it from gestation?
Thank you for your excellent response. I am a medical provider in Florida and got his email and was about to forward that to you. You beat me to it. Thanks
Thank you so so much for this perspective. Without your expertise, it would be very hard for people to understand how dangerous it can be to safety-test these vaccines. We KNOW as a matter of theory that they are safe. If we keep demanding tests, sooner or later a red flag will appear and then where are we? The companies would probably be required to add some expensive procedure for removing DNA from their products, and profits would suffer. They would suffer. And avoiding suffering is the noble purpose of medical science.
We know for sure that DNA cannot integrate into the genome, so it is uber-important that we don't run the lab tests that might cast doubt on this scientific certainty. The very profits of Moderna and Pfizer are at stake here -- the profits that they use so efficiently to reward their investors for keeping us safe.
Yes, adding safety tests for mRNA is certain to cause a great deal of death and destruction in the long run. I'm so so grateful to you for having the wisdom to point this out to the stupid public, people like me who don't have the education to understand that safety testing can be really, really bad for public health.
Sadly, these claims cause those already on the side of misinformation to dig in further, and those on the side of evidence based science to invest more time on distractions.
Question ms are important and anyone should feel like they should ask for more data and more information.
But this, this, is simply political dog whistling and these self serving individuals are leading to the loss of loved ones and increased medical costs... that we all pay for.
Wonderful analysis. I can't help but wonder why the AMA or some similar certifying agency doesn't publish a rebuttal to the continuous stream of dis-information coming from the Florida Surgeon Generals office
Thank you for this article. I saw an article yesterday about the Florida Surgeon General and my first thought was, how does this doc still have a license? I'm guessing that in any other state, the regulatory board would be questioning him. Hopefully, the general public can see past his misguidance and will decide to ignore him.
Thank you for such a clear and concise explanation (and happy New Year)! Naive question: why aren't we seeing very public genuine, curiosity-driven discussion among those who hold these widely differing perspectives (moderated by someone who knows how to keep the discussion from turning into debate or worse)? Distant 2nd choice: Dr. Ladapo responds to your points in the way that a scientist ought to. 3rd alternative (which is what we have now): News/opinion bubbles whose members are increasingly convinced they're right.
Thank you so much for your analysis. As a psychiatrist, the science of this had been outside my expertise to evaluate. I do make recommendations to my patients regarding vaccination and they often have questions for me about Covid safety. I have an additional question about a contemporary issue regarding mRNA vaccines. What are your thoughts regarding the observations that repeated mRNA vaccinations can increase IgG4 levels and, therefore, have unintended negative consequences?
Thank you for your prompt and clear analysis of the science regarding these vaccines. I am glad I subscribe to YLE. I worked for 31 years in 2 Florida county health departments, and salute the dedicated workers remaining, despite politicized leadership. I have ¨Unsubscribed ¨ from further Florida DOH announcements. Steven A. Hale M.D. (retired)
I do not agree with your dismissal of Dr. Ladapo's concerns around the potential dangers of the mRNA products. This is a complex issue which requires a much more thorough analysis than you have presented.
1) The quantity of DNA fragments deemed acceptable is based on traditional vaccines which are not encapsulated in LNPs which are specifically designed to protect the encapsulated mRNA (and the trace DNA contaminants) until they can enter a host cell's cytosol. In other words the risk of these DNA contaminants are greater when they are encapsulated inside the lipid delivery mechanism. Yet the FDA has not modified their assessment of risk accordingly. It is illogical to compare mRNA inside of LNPs with traditional vaccines.
2) Ladapo is NOT claiming that these products WILL result in the integration of said fragments into our genome. He is merely asking for evidence that they WON'T. Citing genotoxicy studies isn't, as he says, adequate to ensure this is may not be happening on a small scale.
3) Your statement "It is biologically impossible for random DNA fragments to integrate into our genes" is not substantiated by the arguments given. In fact it contradicts Dr. Marks' assurance that it is "implausible". There is a world of difference between impossible and implausible, especially given the fact that billions of people have been vaccinated. The reason why Dr. Marks has a tempered position is that he knows that FDA's own guidance around DNA vaccines acknowledges that integration is a possibility even though DNA vaccines do not have DNA integrase in them either. The fact that contaminant DNA "lacks stability" does not mean that none will survive long enough to be integrated.
4) This leads to your position about "billions" being relatively tiny compared to "trillions". No argument there. But a billion is a big number on its own, especially with regard to "implausibility". If only one in a million DNA contaminant strands get integrated that would result in thousands of cells with altered DNA.
5) We all agree that LNPs go places outside of the deltoid muscle. The bio distribution study you cite indicates that 0.1% get to the ovaries and testes. Is that really trivial? At what level would it be non-trivial in your opinion? Two points about this. The levels in the ovaries attained that concentration after 48 hours. Levels were still rising when the observational period ended. We don't know how much eventually ends up there. Moreover, this study was only made public after a FOIA request to the Japanese medical authorities in the Spring of 2021. Why didn't the FDA know about it? Isn't it their job to demand these studies from the vaccine manufacturers? How many people would have had second thoughts about getting jabbed if they knew that a small portion of the inoculate would migrate to the spleen, the liver, the heart, the ovaries and the brain? Would their concerns have been reasonable?
6) The lipid nanoparticles aren't just little bubbles of fat. The design of these particles is one of the major breakthroughs in bringing these products to market. They are designed differently depending on the payload being delivered. Medicine in the form of cancer therapy will be encapsulated in a different kind of "bubble" than an mRNA vaccine. The LNPs for these vaccines are designed to be pro inflammatory to incite an immunologic response. It should be of some embarrassment to the FDA that the bio distribution studies show that these things go all over the place, albeit in limited quantities. That being the case, one cannot dismiss the possibility that these particles could be responsible for organ inflammation in the form of irregular menses, myo/pericarditis, bells palsy, transverse myelitis, etc. etc. in a small subset of vaccine recipients. Given the fact that a quarter of a billion people in this country have gotten the vaccine that the three hundred thousand serious adverse events reported in VAERS may be due to the vaccine? Shouldn't we expect the CDC to do a serious investigation into these reports on behalf of the public?
7) 8,288 Floridians have lost their life to Covid-19? Your citation does not indicate the vaccination status of those fatalities. Are you suggesting that they were all unvaccinated? What exactly are you insinuating here? That Ladapo is somehow responsible for their deaths? He didn't prohibit people from getting the jab. 70% of Floridians are fully vaccinated.
There's a lot more we don't know about this technology. Posts like this do not aid in discovering more. mRNA technology could eventually be a transformative weapon against disease and infection but right now the public doesn't trust it, and for good reason. By dismissing reasonable requests for more information in this fashion you are unwittingly doing far more damage than you realize.
Thank you very much for an excellent analysis and response to more misinformation from Florida. Unfortunately, Ladapo's statement already hit the national press and was widely reported. This article needs to be sent to the news media so they can report the truth.
As a Floridian, emergency manager AND advocate for persons with disabilities, thank you so much for posting this. This "doctor" is a serious danger to public health and my fellow Floridians. His efforts and actions have seriously impacted me and my team at work's ability to increase vaccine access to those with disabilities.
And another reason I am so glad to have left that agency before he got arrived. Again, thank you for posting this. You are appreciated.
"Regardless, we have been tracking the safety of Covid-19 vaccines at unprecedented levels across the globe for more than three years. Scientific evidence from the lab, clinical trials, and epidemiological real-world data continue to verify a highly favorable profile of benefit to risk of Covid-19 vaccines."
Which clinical trial demonstrated a mortality benefit? a hospitalization benefit? It most certainly was not the Phase III Pfizer trial that led to the approval of the mRNA vaccine. There is no evidence of a "highly favorable profile of benefit to risk" for a healthy 30 year-old, for example. None. Yet these shots continue to get pushed on everyone.
Floridian here. Ladapo is a danger to public health and safety. He's already lied multiple times and should not be Surgeon General much less be allowed to have a medical license. He's violated his oath both as SG and as a physician. He does nothing but harm. He's part of the reason Florida still has one of the the highest Covid death rates in the country. They stopped tracking everything years ago so we have no accurate data about Covid. And they continue to lie to people who put the rest of us in danger on a daily basis. DeathSantis would make the vaccines illegal if he could and there was at least one petition to do so already. I still cannot safely participate in public life because of people like Ladapo and constant lies and bad messaging.
Now I have a question about DNA. We know that DNA from every pregnancy stays inside the mother forever after birth. And that the DNA can cause cancer later in life (not always). Why doesn't the female body break down those DNA fragments? Is it because the DNA isn't technically foreign because the body recognizes it from gestation?
Thank you for your excellent response. I am a medical provider in Florida and got his email and was about to forward that to you. You beat me to it. Thanks
Katelyn and Guests
Thank you so so much for this perspective. Without your expertise, it would be very hard for people to understand how dangerous it can be to safety-test these vaccines. We KNOW as a matter of theory that they are safe. If we keep demanding tests, sooner or later a red flag will appear and then where are we? The companies would probably be required to add some expensive procedure for removing DNA from their products, and profits would suffer. They would suffer. And avoiding suffering is the noble purpose of medical science.
We know for sure that DNA cannot integrate into the genome, so it is uber-important that we don't run the lab tests that might cast doubt on this scientific certainty. The very profits of Moderna and Pfizer are at stake here -- the profits that they use so efficiently to reward their investors for keeping us safe.
Yes, adding safety tests for mRNA is certain to cause a great deal of death and destruction in the long run. I'm so so grateful to you for having the wisdom to point this out to the stupid public, people like me who don't have the education to understand that safety testing can be really, really bad for public health.
A simple reply to vaccine critics:
What do you suppose would have if you injected yourself with a cc of sterilized steak? Would you turn into a cow?????
Erm...
No.
NOTHING would happen except you’d get a local very unpleasant tissue response.
Sadly, these claims cause those already on the side of misinformation to dig in further, and those on the side of evidence based science to invest more time on distractions.
Question ms are important and anyone should feel like they should ask for more data and more information.
But this, this, is simply political dog whistling and these self serving individuals are leading to the loss of loved ones and increased medical costs... that we all pay for.
Wonderful analysis. I can't help but wonder why the AMA or some similar certifying agency doesn't publish a rebuttal to the continuous stream of dis-information coming from the Florida Surgeon Generals office
Thank you for this article. I saw an article yesterday about the Florida Surgeon General and my first thought was, how does this doc still have a license? I'm guessing that in any other state, the regulatory board would be questioning him. Hopefully, the general public can see past his misguidance and will decide to ignore him.
Thank you for such a clear and concise explanation (and happy New Year)! Naive question: why aren't we seeing very public genuine, curiosity-driven discussion among those who hold these widely differing perspectives (moderated by someone who knows how to keep the discussion from turning into debate or worse)? Distant 2nd choice: Dr. Ladapo responds to your points in the way that a scientist ought to. 3rd alternative (which is what we have now): News/opinion bubbles whose members are increasingly convinced they're right.
Apparently Ladapo also said the vaccines are the Mark of the Beast, so you know he's reliable! /s
Thank you so much for your analysis. As a psychiatrist, the science of this had been outside my expertise to evaluate. I do make recommendations to my patients regarding vaccination and they often have questions for me about Covid safety. I have an additional question about a contemporary issue regarding mRNA vaccines. What are your thoughts regarding the observations that repeated mRNA vaccinations can increase IgG4 levels and, therefore, have unintended negative consequences?
Thanks again for your excellent newsletter!
Thank you for your prompt and clear analysis of the science regarding these vaccines. I am glad I subscribe to YLE. I worked for 31 years in 2 Florida county health departments, and salute the dedicated workers remaining, despite politicized leadership. I have ¨Unsubscribed ¨ from further Florida DOH announcements. Steven A. Hale M.D. (retired)
Did the Florida Surgeon General sleep during his biochemistry classes?