Dr. Paul Offit MD, Vaccine Propagandist

Another window into how the "Mighty Wurlitzer" of propaganda works. When confronting an inconvenient truth, lie, obfuscate, or just bully those who disagree.

In case you were not aware, MedPage is a Pharmaceutical industry-funded marketing (synonym: Propaganda) operation posting as an objective source of medical truth.

On January 05, 2024, this Pharma Propaganda outlet published a video interview with Dr. Paul Offit, professional academic pediatrician and Vaccine shill, in which he states a series of falsehoods in continuation of the gaslighting and falsehoods which both he and Dr. Peter Marks (FDA/CBER) are becoming known for.

Paul Offit Debunks Florida Surgeon General's Anti-Vax Warning

— "It is hard to believe that Dr. Ladapo actually issued that statement," said vaccine expert

Lets take a look at the transcript of this series of falsehoods.

First off, starting with the title, is Paul Offit actually a vaccine expert? What have his contributions actually been? Well, he self-identifies as the co-inventor of a licensed rotavirus vaccine (one of many, and not the first), and has received significant royalties from that. I should say currently licensed rotavirus vaccine, because there was a prior rotavirus vaccine (RotaShield - Wyeth) which was associated with an intolerable level of a clinical syndrome called “intussusception”. If you know horses, you can think of intussusception as sort of like colic, but most often happening in children. More precisely, intussusception is a condition in which one segment of intestine "telescopes" inside of another, causing an intestinal obstruction (blockage). For some reason, rotavirus vaccines are associated with intussusception. It can be life threatening. The previously licensed rotavirus vaccine had a slightly higher rate of intussusception than the current one associated with Dr. Paul Offit (and Dr. H. Fred Clark, the senior of the two researchers). This essay details the events surrounding the RotaShield withdrawal, including the role of Paul Offit when participating in the Advisory Committee on Immunization Practices at the CDC. Basically, all US children are required to take either Paul Offit’s vaccine or a competing similar live attenuated virus product. According to the CDC:

There is also a small risk of intussusception from rotavirus vaccination, usually within a week after the first or second dose. This additional risk is estimated to range from about 1 in 20,000 to 1 in 100,000 US infants who get rotavirus vaccine.

About 3.66 million births per year in USA, so that means between 36 to 180 cases of life threatening intussusception in the USA per year due to mandated administration of this product.

Dr. Offit co-invented the Merck rotavirus vaccine product “RotaTeq”. RotaTeq is a live, oral pentavalent vaccine that contains five rotavirus strains produced by reassortment. The rotavirus A parent strains of the reassortants were isolated from human and bovine hosts. This process involves classical virology, and has nothing to do with the technology used for the modified-mRNA vaccines. Based on his comments below, much as seems to be the case with Dr. Peter Marks of FDA/CBER, it appears that Dr. Offit has neither experience with nor understanding of modern molecular and cell biology, and specifically with either DNA or mRNA transfection and in-vivo delivery - via self-assembling cationic nanoparticles or any other method such as electroporation.

Basically, Dr. Offit is an old school vaccinologist, who is apparently neither trained nor experienced in modern molecular virology, gene therapy technology, or genetic vaccines. Which makes sense of his insistence that these products are akin to old school vaccines like his live attenuated product. Unfortunately for both Dr. Offit and all of the rest of us, the technology is quite different, and has more to do with pharmacology than old school vaccinology.

Following is an annotated transcript of Dr. Offit’s comments regarding Dr. Joe Ladapo’s statement as transcribed by MedPage Today. Lets dive in to learn what Dr. Offit does or does not understand about this controversy.

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Paul Offit Debunks Florida Surgeon General's Anti-Vax Warning

— "It is hard to believe that Dr. Ladapo actually issued that statement," said vaccine expert

by Emily Hutto, Associate Video Producer January 5, 2024

<Emily Hutto joined the MedPage Today team in 2021 as an Associate Video Producer & Editor. After graduating with a B.A. in International Relations from Colgate University, she began working at the University of Notre Dame (Go Irish!) before returning to New York. Emily has been an event planner, a bench researcher, a science educator, and a documentarian.>

Florida Surgeon General Joseph Ladapo, MD, PhD, recently issued a statement that COVID-19 mRNA vaccines should not be used. In this video interview, Paul Offit, MD, of Children's Hospital of Philadelphia, discusses Ladapo's statement and how the vaccines are made.

The following is a transcript of his <Paul Offit, MD’s> remarks:

“On January 3 of 2024, the surgeon general of Florida, Dr. Joseph Ladapo, put out a warning that physicians and healthcare providers in this state, Florida, should not use mRNA vaccines. The reason is that supposedly they were contaminated with DNA fragments <RWM- they are so contaminated, not supposedly. This fact has been verified by multiple laboratories and confirmed by FDA, Health Canada, and EMA> that would then insert themselves into human DNA and could cause cancers like leukemia or lymphoma or autoimmune diseases or other problems.”

<RWM- Well stated. That happens to be precisely what FDA regulatory guidance and Moderna patents warn about with DNA contamination of vaccines or DNA/gene therapy-based vaccines.>

“So is that possible? Is it possible that Dr. Ladapo is correct and that for that reason we should avoid mRNA-containing vaccines? In order to understand the answer to that question, you need to understand how mRNA vaccines are made. So, we'll start at the beginning.

What you start with when you make an mRNA vaccine is a small circular plasmid of DNA, double-stranded DNA, into which is inserted the gene that codes for the SARS-CoV-2 spike protein. You then amplify that plasmid in bacteria -- you cut the bacteria, you've released the plasmid, then you cut out that small piece of DNA.”

<RWM- Stop right there. This is wrong. You do not “cut out that small piece of DNA”. You purify the fairly large circular bacterial plasmid DNA from a bacterial lysate, which happens to also include quite a bit of endotoxin. The purification process uses centrifugation. Right away we have established that Dr. Offit does not know what he is talking about here. Offit has not taken even a minimal amount of time to understand the manufacturing process employed in this case.>

“Then you use an enzyme, RNA polymerase, to transform that DNA into messenger RNA.”

<RWM: Bacteriophage T7 RNA polymerase, to be precise. As I originally pioneered in the first paper demonstrating large scale manufacturing, purification, and cationic lipid transfection of mRNA. But instead of including A, U, G, C bases like I did, you use A, modified Pseudo-U, G, C.>

“There are a variety of purification steps, there are filtration steps, there's treatment with DNA ACE1, which is an enzyme that cuts DNA.”

<RWM: Wrong again. The treatment is with DNAse. Probably a transcription error, which shows that Ms. Hutto’s time as a “bench researcher” also did not involve molecular biology or molecular virology experience.>

“So is it possible that despite purification and filtration that you are left with small amounts of fragmented DNA? Yes, you are. You have roughly a billionth of a gram, nanograms, of this fragmented DNA.”

<RWM: this is not a possibility, it is a fact. More gaslighting. Or denialism. Or just plain ignorance. This step is a major problem in the purification process, which is why Moderna has filed a patent on their own special way of doing this. Which still does not work that well. The quantity is not the issue here. The issue is whether there is a safe threshold for DNA fragment contamination when co-delivered via self-assembling cationic lipid nanoplexes together with modified-mRNA. If so, show us the data which proves that this is a safe level of adulteration. Joe asked the FDA to show those data, and FDA’s director of CBER Peter Marks responded with lies, falsehoods, gaslighting and a complete failure to disclose such data - which apparently do not exist. Much like the approach used here by Offit. >

“So could that DNA then affect your DNA? In order for that to happen, three things would have to occur, all of which are for the most part impossible.”

<RWM: Here is where this just interview veers into the childish and absurd. The process here is called DNA transfection. DNA transfection is a routine practice in virtually every molecular and cellular biology (and molecular virology) laboratory in the world. Here is a paper, which Offit purports to be familiar with, which shows that you can get DNA into the nuclei of post-mitotic cells - ergo not dividing - and it will make mRNA and protein. Muscle cells. Even without cationic lipid nanoplexes. It has tens of thousands of citations. It was published in Science in 1990. I was the second author. I am flabbergasted. Is Paul Offit really this ignorant? It is hard to imagine that this person has been trusted to provide FDA or CDC advice on these mod-mRNA products.>

“The first is that the DNA would have to enter your cytoplasm. Now, our cytoplasm hates foreign DNA and it has a variety of mechanisms, including innate immunological mechanisms and enzymes, to destroy foreign DNA.”

<RWM: This condescending explanation is partially true but substantially false. Transfected DNA gets into the nucleus of both mitotic and post-mitotic cells. Once again, every first year graduate student working in cell and molecular biology or virology knows this.>

“Then that DNA, which would never survive the cytoplasm, would have to then cross the nuclear membrane into the nucleus, which would require a nuclear access signal that these DNA fragments don't have.”

<RWM: Getting hard to tell what are intentional lies and what is just profound ignorance. The SV40 sequences include a nuclear localization signal (NLS), but a NLS is not necessary for DNA transfection. Any first year molecular and cell biology graduate student knows this. DNA gets into the nucleus quite efficiently. Especially with electroporation. But that is an advanced topic.>

“Even if they entered the nucleus, which they can't, they would have to insert themselves into your DNA, which means they would have to cut your DNA, which would require enzymes like integrases, which they also don't have.”

<RWM: I just do not know where to begin here. Offit appears to be completely ignorant, child like, in his lack of understanding of the basics of integration, DNA replication, and mammalian cell biology.>

“So the chance that DNA could affect your DNA is zero.”

<RWM: This is just pure propaganda. Contradicted by decades of FDA regulatory guidance, Moderna’s own patents, and what must be thousands of peer reviewed publications concerning DNA delivery (transfection) into cells. I can only conclude that Offit is a shameless liar and propagandist. Just for kicks and giggles, I ran a pubmed search on the key word string “Plasmid DNA transfection”, which resulted in over 26,000 references. See for yourself by clicking on the link provided.>

“It's interesting that the minute you bring up the notion of foreign DNA, people get scared, right? Because DNA is the blueprint of life, and we certainly don't want to affect our blueprints for life. But you're exposed to foreign DNA all the time.”

<RWM: But not injected DNA fragments wrapped and formulated with the most efficient in vivo non-viral gene delivery technology ever discovered. Duh. This has to be gaslighting. Offit can’t be this stupid and/or ignorant!>

“One, you have trillions of bacteria living on your body, which is foreign DNA too. Assuming you live on this planet and you eat animals or plants on this planet, you are ingesting foreign DNA, some of which enters your circulation -- which has been proven.”

<RWM: Completely irrelevant. Except that these bacteria could potentially take up the Kanamycin antibiotic resistance sequences present in the plasmid DNA fragments that are being injected.>

“Also, all vaccines that are made in cells, whether it's the measles vaccine, the mumps vaccine, the German measles rubella vaccine, the varicella vaccine, the rotavirus vaccines, yellow fever vaccines -- any viral vaccine that's made in cells will have residual quantities of DNA in the picogram (which is trillions of a gram) to nanogram (which is billions of a gram) category. There is no avoiding that.”

<RWM: but those DNA fragments are not coated with cationic lipid nanoplexes. Get real, Paul. Are you really dumb as a stump, or are you just playing that role?>

“I think that we should be reassured that when you fragment this DNA and you have it in quantities that are just trace quantities, knowing what you know about the inability of these trace fragmented DNAs to be able to enter your nucleus and cause harm, it is hard to believe that Dr. Ladapo actually issued that statement.”

<RWM: Actually, what you have proven with your statements above, Dr. Offit, is that you are the one that is hard to believe. When did you stop doing bench research or even supervising others? Are you really this ignorant? Almost every single argument you have offered in your criticism of Dr. Ladapo is readily demonstrated to be false. And could be demonstrated false by virtually anyone with any transfection experience, or even a rudimentary ability to do a PubMed search.>

“Ironically, he said that you should use other COVID vaccines. The other COVID vaccine that's licensed for people over 12 in this country is Novavax's vaccine. Novavax's vaccine is also made in cells. It's a so-called baculovirus expression vector.”

RWM: No, Paul, it is not a baculovirus expression vector. Once again, Dr. Offit has revealed his fundamental ignorance. It is a purified protein vaccine, formulated with a novel adjuvant. The protein component is produced in insect cells after infection with a recombinant insect (caterpillar) virus. Another system that I have deep knowledge and understanding of.

“The baculovirus has inserted into it the gene that codes for the SARS-CoV-2 spike protein. It is then infected into cells, the cells were so-called Spodoptera frugiperda cells or Sf9 cells, so you'd also have residual DNA there as well. There's just no avoiding it.”

<RWM: Yes, there is some residual insect cell DNA. But it is not wrapped in a self-assembling cationic lipid delivery nanoparticle. Paul just does not understand Joe’s point, despite the fact that Dr. Ladapo has spelled it out quite clearly in his statement.>

“The point is to have it at such little and in fragmented levels that it can't possibly do harm. So scaring people unnecessarily like this has been hard to watch. Hopefully, this has been reassuring.”

<RWM: And with this concluding statement, we learn that Dr. Paul Offit does not understand fundamentals of regulatory science and regulatory law. The rule is that if there is a potential risk involving a contaminant, studies must be done to demonstrate that the level of contamination is below the threshold of demonstrable clinical risk to patients. And submitting spurious and demonstrably false propaganda statements is not the same as actually performing studies to evaluate that risk, at what point the risk manifests (threshold of toxicity) and whether the allowed level of contamination is demonstrated to be sufficiently lower than that associated with toxicity. That is how things are supposed to be done. Anyone experienced in assessing drug toxicity knows this. Are we to imagine that “vaccine expert” Dr. Paul Offit does not? If not, he has no business advising the FDA or CDC on anything having to do with drug development or licensure.>

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By way of helpful suggestions, Dr. Offit should take some time to read the following before he embarrasses himself (and misleads the public) further :

Guidance for Industry Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications

Redbook 2000: IV.B.1. General Guidelines for Designing and Conducting Toxicity Studies

The determination and interpretation of the therapeutic index in drug development

That is just scratching the surface.

And while I am at it, here is a reference which is particularly relevant to the current situation in Dr. Offit’s vaccine industry:

Kesselheim, A. S. Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety. Clin. Pharmacol. Ther. 87, 645–647 (2010).

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