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Getting Ready for More mRNA Vaccine Fear-Mongering: A Compendium

Hilda Bastian Covid-19 Science Communication
Woman with furrowed brow thinking, "Hmmm..." (Cartoon by Hilda Bastian.)

Recently, I wrote about a depressingly successful campaign against the introduction of a next generation Covid vaccine in Japan. It is a self-amplifying mRNA vaccine, which uses less mRNA, but can make more after vaccination. The Japanese campaign was primarily based on claims about current Covid mRNA vaccines. We can expect more of this fear-mongering, especially with the influence anti-Covid-vax activists have on the incoming US administration. Misinformation about mRNA may even come from official channels.

I wanted to be ready with analysis of the sources currently used in mRNA-specific anti-vax discourse. In some of it, an explicit goal is to project doubt onto all future mRNA vaccines. So I went down several rabbit-holes looking for enduring anti-vax canon on the fundamental safety of mRNA vaccines: I wanted to have fact-checking for those sources at my (and others’) fingertips. That’s the goal of this compendium. Before I dig into this, though, I have some side-notes.

Note 1 – Terminology: By “anti-vaccine,” I mean the anti-vaccine activist movement, not simply critical discussion of vaccine. And in this post, I use the term “misinformation” – the possibly accidental spreading of inaccurate or misleading information – even where it appears to be deliberate disinformation, or typical methods of disinformation such as cherry-picking and misrepresentation.

Note 2 – References: I wanted to minimize directing traffic to sources of misinformation. There is a list of sources at the foot of this post that support my unreferenced statements about anti-vaccine discourse, without linking to them. Where I had to link to anti-vax literature within the post, I link to archived versions, not the direct sites.

Note 3 – I’ll add important issues/sources I’ve missed, if you let me know or I come across them. I moderate comments to this blog, and won’t let anti-vax links through. (And of course, moderation means I don’t release high-misinformation or abusive comments.)

Note 4 – Along the way, I was delighted to find an excellent fact-checking project I hadn’t dug into before: Science Feedback. It’s a non-profit group based in France, drawing on scientists internationally, covering climate, health, and energy. They are posting in English and French. Unlike much fact-checking, their posts identify and critique the sources being used to underpin viral claims, and they tend to support their own statements with references. Their current website is here, and there’s an archived earlier version of the website with older reviews here. (You can sign up for their newsletter here, and they’re on Mastodon, Bluesky and Facebook, as well as LinkedIn and WhatsApp.)

Back to mRNA claims: I’ve organized this post into 7 sections on themes and specific claims, each with its own direct link for navigation and sharing. I dug into some issues right down to the major sources typically relied on for the arguments. I’ve addressed some themes in the first 2 sections more generally, and I explain why. Some of the topics I don’t unpack in detail are covered in a recent discussion article on mRNA vaccine safety by Rani Sellers and Philip Dormitzer (2024). You can also search at Science Feedback current and archived sites, as they reviewed a lot of claims about mRNA vaccines as they emerged.

Contents:

  • Claims of risks found in adverse event reporting systems and exploratory analyses.

Claims of risks found in adverse event reporting systems and exploratory analyses

Adverse event reporting databases, like the US VAERS, support systems for vaccine safety surveillance. Doctors (and others) are encouraged to report health incidents that occur after vaccination – whether or not they could possibly be related to vaccination. This enables investigation and analysis for trends to see if any of these adverse events – things that happened – could actually be an effect of vaccination. You can read more about what adverse event reporting systems can and cannot do at Johns Hopkins University. Similar exploratory analyses for possible trends can be undertaken in hospital records and other data.

Working out whether or not events are definitely happening more often than usual is complicated. Every day, vast numbers of people have minor or awful health incidents, including dying unexpectedly. When there was mass vaccination in a short period of time, unrelated misfortune continued. That generated a massive amount of data that coincided with recent vaccination – and a lot of analyses, setting off chains of investigation. It led, for example, to establishing that myocarditis was a rare adverse effect of some Covid vaccines.

Event reports from these databases and studies, as well as individual case reports and small case series, are also used to spread misinformation and scare stories where no association with vaccination is established. There’s far too much of it for me to try and tackle it comprehensively, so I sifted out these claims and sources.

Overall, scientific and drug regulatory communities have seriously investigated signs of potential harm of mRNA vaccines. The vaccines have been used in many countries with well-resourced drug regulatory agencies. That means we don’t have to rely on the biases, idiosyncrasies, and weaknesses of any one agency: Many high-caliber groups are investigating independently, and often doing so very transparently. In addition, scientists who aren’t affiliated with regulators also study potential vaccine adverse effects.

If you’re interested in how this works, I followed the first identification of a major adverse effect in a Covid vaccine after rollout, and wrote about it as it unfolded – including at The Atlantic. It was the Oxford/AstraZeneca vaccine, not an mRNA vaccine, but the processes are the same. I was documenting the episode in real time here at Absolutely Maybe, as agencies in countries with differing attitudes to rare risks grappled with the events as they were reported.

It can be a turbulent process for a time, but the multiple layers of investigation from authorities and independent scientists and medical experts involved in the global community provide safety nets for catching actual harmful effects – especially when a vaccine is widely used in the US and Europe.

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Purely speculative hypotheses

I also left to the side speculative hypotheses that weren’t supported by anything suggesting harm of the actual vaccines. Of course, hypothesis and speculation are normal parts of science, and I’m not referring to that. Indeed, these discussions often look similar to regular scientific discourse, except that they are a pile-on of negative speculation only, often inaccurate, and generally disregarding or discrediting the body of clinical and laboratory research about what mRNA vaccines actually do. Typically, too, a lot of the references aren’t to studies, but to blog posts, websites, and YouTube videos elaborating on opinions, speculation, and conspiracy theories.

When I was parsing through articles and posts about the issues I dig into below – like the claim that mRNA vaccine changes DNA – most of the references to solid scientific literature in them were used to build speculations like this:“If x is true, then y might happen, and that might cause z, and that might cause [cancer etc] – and no one has proven that this isn’t possible.” This would be peppered with references from cell biology, immunology, and studies about the virus or the part of it used in vaccines.

These hypotheses spooled out, filling discussions with a lot of technical language and wrapping them in an aura of scientific evidence, even when they are not plausible enough to justify studies. I didn’t toss out articles that included this kind of speculation without going further, but I didn’t try to tackle all those hypotheses. They include hypothetical harms from modifications made to mRNA, or from the fatty protective shell surrounding the mRNA (lipid nanoparticles – LNPs), or from frequent boosting.

There is one exception, though, which I spent time unpacking. It was a claim based on speculative hypotheses that got me started on this post – that vaccinated people shed genetic material on unvaccinated people.

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Concerns about how quickly mRNA vaccines were introduced

You don’t need to be extreme about vaccines at all to wonder about this. However, people fanned the flames of this concern with misinformation. I didn’t try to tackle all the claims, with 2 exceptions. Firstly, in this section I address the claim that drug regulators cut major corners to enable emergency use authorization. Secondly, I address the debate about whether mRNA vaccines should have faced the additional requirements for gene therapy below.

One of the reasons I didn’t try to check every claim is that they are generally no longer relevant from a vaccine user point of view. Manufacturers were never exempt from doing the usual studies for full approval: Emergency use authorization was an interim step based on preliminary results. The vaccines have long since met the requirements for full approval by multiple major regulators. In addition, there has been so much independent study of the vaccines since they were rolled out, that we don’t have to rely solely on the manufacturers’ pre-approval studies on safety and clinical effectiveness any more.

These vaccines did indeed reach us very quickly. But the reasons it typically takes years relate more to logistics, financial risks, and the size of outbreaks than to the time it takes to get results on safety. Competing priorities and workload issues prolong processes all along the way. In the emergency, Covid vaccines jumped to the head of every queue, and governments poured resources into giving some manufacturers a lift by making sure they had access to everything they needed to develop and test some vaccines. The story of these vaccines is, in part, the story of what can be achieved when money is no object.

I wrote about some reasons the 2 major mRNA vaccines were so fast here. Their short-term effectiveness was extremely high: Effects like that are screamingly obvious. The smaller a difference a drug makes, the larger the number of trial participants you need to be sure something works, and that takes time. On top of that, major life-threatening harms of Covid happen very soon after people get infected: Impact on outcomes like that show quickly.

Luck had a hand, too. The big trials for those 2 vaccines were run in the US, and the US had a huge Covid outbreak soon after they started. That was utterly terrible for the people affected. However, it slashed the time it would otherwise have taken to see if the vaccines worked, because the high rate of Covid in the control groups showed the dramatic difference very quickly.

Other factors key to the speed of vaccine development related to investment risks for developers and trial participants. Major studies requiring escalating resources are done consecutively to minimize investing in a drug that might not go the distance. Here, some were done in parallel. On top of that, manufacturers took the financial risk of developing manufacturing capacity early in development instead of waiting till the vaccine was approved.

In addition, although no mRNA vaccine had gotten across the finish line before Covid, that didn’t mean there was no scientific track record of the effects of mRNA vaccines in the human body. There had been several mRNA vaccines for other infectious diseases in small clinical trials – the first in 2013.

With Covid damaging health and socioeconomic conditions so dramatically in countries like the US, emergency use authorizations made sense. I was following these developments closely in real time, and it was mind-boggling to see the resources the US FDA and the European equivalent, the EMA, brought to this. They didn’t just wave the vaccines through. It was an all-hands-on-deck situation, with dozens of statisticians and other experts re-analyzing data as soon as it landed, for example.

It’s easy to give a frightening impression of the conditional processes in emergency use authorization. But the regulators weren’t actually taking big risks, especially in the context of countries where so many people were dying from Covid. Let’s walk through this.

Ordinarily there is at least 6 months of follow-up for people from a phase 2 trial to see if common adverse effects occurred later than the short time-frame required for results from phase 3 efficacy trials. The first-in-human trials for the BNT/Pfizer vaccine, for example, began late in April 2020, and multiple regulators were monitoring safety reports as the trials progressed. The FDA’s emergency use guidelines required manufacturers to provide the safety data that had been gathered from those early trials when they applied for authorization/conditional approval.

Picking through regulatory documents now, you can see how much of that data was available at the interim and full approval stages for the first mRNA vaccine (BNT/Pfizer):

  • At emergency use authorization, the cut-off date for data was mid-November 2020, and included:
    – longer term data for 24 people from the phase 1 trial who had the same dose of vax applied for;
    – at least 2 months of follow-up after dose 2 for 9,531 people in the vax group, including 3 months of follow-up after dose 2 for 780 people (382 in the vax group). [Source: Europe’s regulator, page 98]

Full approvals of the vaccine for adults were coming through from July 2021, along with public data. The argument that there was less than usual safety data for mRNA vaccines was therefore only valid for a few months. And since then, the amount of data that has become available on these vaccines from many different groups of scientists independent of the manufacturers and regulators is enormous.

Globally, I’m very critical of the way some drug regulators went about this business for some vaccines at least, overly shepherding instead of gate-keeping. However, the mRNA vaccines cleared high bars.

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Claims that mRNA vaccines enter or otherwise modify DNA

Drugs that aim to change DNA are treated as gene therapy by the US FDA and by the EMA (Europe’s equivalent authority). The mRNA Covid vaccines aren’t classified that way, as they don’t meet that definition. Indeed, in January 2020, after a period of public feedback, the FDA’s updated guidance to industry explicitly listed several categories of products to which the classification doesn’t apply, including vaccines for infectious diseases.

As mRNA vaccines don’t work by modifying genes – they deliver messages to genes, but don’t try to change them – this seems clear. But some argue that the vaccines should nevertheless have been subjected to gene therapy standards. That would have meant that regulators would have required some additional research.

I found it hard to work out what difference this made. Some of the critical discussion I read about this seemed to be based on a narrow reading, and perhaps misunderstanding of, reports from drug regulators. For example, they might reference only brief FDA public documents and assume if particular studies weren’t specifically discussed there, that it means they weren’t done and the FDA hadn’t taken the issue into consideration. However, some of the kinds of studies critics discuss were reported by the European regulator, for example.

Others go much further than criticizing the regulators’ requirements, claiming that the vaccines do indeed change our DNA. This is a cornerstone, for example, of concerns about risks of cancer and harms on reproduction. I identified 6 sources commonly used to support the claim that mRNA vaccines could enter or otherwise modify DNA:

  • 4 laboratory studies involving cell lines and/or analysis of computerized sequencing data. One of these studies has been retracted.
  • 2 sources without original studies – one is a discussion in a journal by a single author, and the other is a statement by Florida’s State Surgeon General.

Cell lines are cultured from tissue samples from humans or other animals. These cultures are used to study biological processes in cells, including mRNA. Experiments in cell lines include analyzing the effects of drugs on cells. Cell line research does not necessarily reflect what will happen in cells in the complexity of a body in real life. In addition, cell line research can be compromised by a range of quality issues, including contamination.

Another way of studying genetic processes is analyzing sequencing data. DNA and RNA are made up of nucleotides, arranged in sequences. Enormous amounts of this genetic sequencing data are gathered in databases, and can be studied. Some of the problems inherent in this type of research include the risk of mistaking artifacts caused during sample preparation and/or data collection for biological phenomena.

Both these types of studies are several steps removed from establishing effects or phenomena in the human body.

The findings in the 4 studies in this section have either been contradicted or unconfirmed by other laboratory studies, and major issues about the experimental methods and interpretations have been raised. None of the phenomena described in these studies have been confirmed in animal or human studies either.

Let’s start with the retracted paper. It was a cell line study by 2 authors of SARS-CoV-2, not mRNA vaccine (Jiang 2021). The authors concluded that the virus’ spike protein “significantly inhibits DNA damage repair.” If so, that could increase the risk of cancer. There is an explanation for why the publication was retracted in the journal’s retraction notice. One of the authors contacted the journal after publication to say there were problems with the research that affected the integrity of the reported findings.

After investigating, the journal’s editor confirmed that the problems that concerned the author did undermine the reliability of the results and the authors’ conclusions. In addition, no experiments related to a key claim were conducted: “[C]onclusions related to vaccine safety are not validated and lacked experimental support.”

Of the other 3 studies, 2 were published in 2021. Both study the SARS-CoV-2 virus, with the authors arguing that the virus could enter genes, presumably by reverse transcription or a similar process – along the lines of the way retroviruses work. Both these studies involved studying cell lines and analyzing sequencing data. Neither studied mRNA vaccine.

The first, by Ying Yin and colleagues, addressed various coronaviruses and gained less attention (2021). The second was by Liguo Zhang and colleagues, and it’s one of the most commonly referenced experimental studies in the anti-mRNA discourse (2021).

After the Zhang study was published, at least 5 groups of scientists from around the world conducted experiments to test for the phenomena those authors had reported. None confirmed Zhang’s findings. Another group reviewed these, as well as both the Zhang and Yin studies, concluding that it is unlikely that there is “genuine” SARS-CoV-2 genetic integration (Grandi 2021). Rather, there was support for the likelihood of the observed phenomena being artifacts. These are the 5 studies:

  • Yu-Sheng Chin and colleagues (2021) investigated the phenomena in cell lines described by Zhang and Yin, and concluded that SARS-CoV-2 does not integrate into people’s genes.
  • Anastasiya Kazachenka and George Kassiotis (2021) also conducted experiments on the phenomena described by Zhang and Yin. They also came to the conclusion that Zhang likely observed artifacts of sequencing, rather than “genuine reverse transcription.”
  • Rhys Parry and colleagues (2021) conducted experiments in cell lines to test the conclusion by Zhang, and concluded that “It remains unlikely that retrotranscription and integration of the SARS-CoV-2 genome in patients happens at any notable frequency, or even at all.” The authors also argued that the Zhang paper showed “inappropriate interpretation of high-throughput sequencing methods and improper experimental design.” The Zhang group rebutted Parry’s conclusions, re-stating their confidence in their conclusions (2021).
  • Nathan Smits and colleagues (2021) also conducted experiments in cell lines on the phenomena described by Zhang, and “found no evidence of SARS-CoV-2 integration.”
  • Bingyu Yan and colleagues (2021) conducted experiments on the phenomenon described by Zhang and concluded that their findings are likely artifacts of sequencing, not evidence of SARS-CoV-2 fusion with, or integration into, human genomes.

The final laboratory study in this category was published in February 2022 by Markus Aldén and colleagues (2022). Along with the Zhang paper, this is a highly cited experimental study in anti-vax discourse. It is another cell line study, but this time, the BNT/Pfizer vaccine was investigated, not SARS-CoV-2. The cells were from human liver cancer, not healthy cells. Aldén concluded that their analysis showed reverse transcription, but not integration into DNA.

The journal published a commentary on this paper, by Hamid Merchant (2022). Merchant argued that there were several reasons this finding could not be seen to apply to vaccination in human beings. The particular cell line, he wrote, was not representative of what happens in the complexity of the human body and it was known to act in unusual ways. The dosage of vaccine used in the experiment was also unrepresentative – it was far too high, based on calculations derived from studies that weren’t appropriate for that purpose, according to Merchant. If the phenomenon occurred in the human body, the affected cells would trigger an immune response and likely be cleared, so ongoing impact would also be unlikely.

If you’re interested in a more detailed discussion of this article, it was reviewed by Science Feedback here.

That leaves 2 sources that don’t contain original experimental data. The first is the discussion article by Tomislav Domazet-Lošo (2022), and it includes consideration of the papers by Yin, Zhang, and Aldén. Domazet-Lošo is clear that the issues raised remained hypothetical: “Whether the current vaccine mRNAs could integrate into the genome, and by which frequency, has to be ultimately demonstrated using experiments.”

The final commonly referenced source is a media statement and December 2023 letter to the FDA by Joseph A. Ladapo, Florida State Surgeon General. The only experimental study referenced in this letter is one which is included below in the section on contaminants. There is a series of questions, including questions about DNA integration into reproductive cells. The FDA responded to these questions in December.

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Claims that vaccinated people “shed” dangerous genetic material onto unvaccinated people

This claim was a major feature of the anti-vaccination campaign in Japan, scaring some business owners into barring vaccinated people from their premises. It was the trigger for me to prepare this post: I found it deeply perplexing, and wanted to understand where such a fear could come from. So in this section, I’ve dug into the speculative hypotheses, as the claims, of course, didn’t include evidence that the vaccinated cause harm to the unvaccinated.

Fact-checkers typically described this claim as stemming from a phenomenon rarely associated with live vaccines, where a person gets infected with the live virus that’s meant to vaccinate them. So the counter-argument offered is simply, these vaccines don’t contain full, live virus.

However, when I dug down into the scare-mongering about vaccinated people being a danger to the unvaccinated, it was quite complicated. This claim builds on some tenets of general fear-mongering about the vaccines – that the risk of serious harm from mRNA vaccines is very high, that the partial spike protein in the vaccine is more dangerous than the full virus, and that scientists aren’t concerned enough with preventing harm. The major fear played on effectively here is about “shedding” genetic material that could have who-knows-what terrible implications.

I found claims about “shedding” 2 types of genetic material, each based on a string of speculative hypotheses:

  • Claiming that cells with lingering mRNA and malformed spike protein could be shed by the vaccinated, and the genetic material in those cells could theoretically generate harm in the unvaccinated if inhaled or touched.
  • Speculating that the vaccine is contaminated with harmful levels of DNA fragments during manufacturing, which enters cells. When those cells are shed, goes the hypothesis, they too could shed genetic material that could cause harm to others.

The first point: mRNA

The primary source material I saw referenced for this was a discussion by Stephanie Seneff (a computer scientist) and Greg Nigh (a naturopath) early in the pandemic (2021). It’s in an anti-vaccine journal (see Wikipedia), and Seneff is one of the journal’s associate editors. Although the abstract of the article says the authors “present a brief review of studies supporting the potential for spike protein ‘shedding’….resulting in symptoms in [unvaccinated people],” they don’t. In the “shedding” section of their article, they only present a speculative hypothesis, plus a suggestion that underpins a conspiracy theory.

The authors’ speculated chain of events involve vaccinated people exhaling particles containing misfolded (malformed) spike proteins that have travelled to their lungs from their spleen. They include only one reference here, and it’s not directly relevant. It’s a study of particles in the lining of the airways that are exhaled by people with non-infectious respiratory diseases (severe asthma or COPD – chronic obstructive pulmonary disease). Others have used studies of the way SARS-CoV-2 is spread to support shedding claims: See this American Family Physician fact check, for example.

(If you’re interested in the evidence about particles circulating in our bodies after mRNA vaccination, there’s a discussion in Sellers 2024.)

That leaves only the speculation that launched conspiracy theories. It is based on a section in the protocol for the big trial of the BNT/Pfizer vaccine, which began with a phase 1 trial very early in the pandemic. In that, the developers set out data collection and safety provisions that might typically be undertaken for, say, a live vaccine or gene therapy. I presume, though I don’t know, that this was incorporated before the developers were sure about what the drug regulators’ requirements were going to be, and it was there just in case.

However, Seneff and Nigh wrote that it “implied” that BNT “anticipated the possibility of secondary exposure to the vaccine,” such as via exhalation. This speculation about the protocol is used in the discourse to imply a conspiracy – that the developers in particular are hiding their knowledge of the risk of “shedding,” and failing to release data showing it happens and/or refusing to do studies that show it doesn’t happen.

The second point: DNA fragments

This is the claim that “shedding” of genetic material could come from DNA fragments contaminating mRNA vaccines. There were no studies to support this “shedding” claim, and 2 studies claiming the vaccines have dangerously high levels of DNA fragments. Both studies are by the same group of people, and both are reported in preprints (McKernan 2023 and Speicher 2023).

Both studies have been fact-checked by Germany’s regulatory authority for vaccines, the Paul Ehrlich Institute (PEI). PEI pointed out that the vaccines don’t contain high levels of DNA fragments, and concluded that “there is no evidence to suggest that any adverse events could be associated with residual DNA levels in authorised COVID-19 mRNA vaccines.” Non-animal DNA is used during the development of the active mRNA substance in the vaccines, and is almost completely digested in the process.

The PEI document explains that manufacturers are required to conduct methodologically sound testing for DNA fragments in accordance with international guidelines. The results for each batch tested for local use is sent to the relevant regulators for scrutiny. In Germany, the results are cross-checked by PEI. Drug regulators apply a threshold PEI describes as “very conservative,” below which DNA fragments are deemed harmless “as they cannot code for functional proteins.”

PEI explains that methodologically sound testing requires: (a) testing on unopened, properly stored vials of vaccine that have not expired; (b) a suitable method, including testing on the active mRNA substance only as the LNPs can interfere with the tests; and (c) a method that has been validated to ensure reliable results. According to PEI, the McKernan and Speicher studies don’t meet these criteria, and there is not enough information provided on the method they used. As a Science Feedback review on this points out, the McKernan preprint says the authors received the vaccine vials “anonymously in the mail without cold packs.” In the Speicher preprint, they report that 24 of the 27 vials they examined were past their expiry date.

The first of the studies is based on testing 4 vials of mRNA vaccine. In the second, the 27 vials they tested came from only 12 production lots of vaccines. In that second preprint, the authors also report on a further analysis they did, which is not covered in the PEI statement. The authors took the varying levels of fragments they reported in their study, and searched the VAERS database for serious adverse events reported for people vaccinated from the same lots. They concluded they had found a dose-response relationship with serious adverse events (the more fragments, the more serious events). This does not prove actual harm: It’s unreliable data trawling of adverse events data.

These authors’ studies appear again in the following section, on cancer.

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Scares about cancer and “turbo cancer”

These scares are fueled by a range of speculative hypotheses and database-trawling. Cancer is particularly vulnerable here, because the groups of people at higher risk of cancer coincide with those at higher risk from Covid, who are therefore priority groups for vaccination. The pandemic disrupted health care dramatically in many areas, too, with the potential for delaying access to screening, diagnosis, and treatment. On top of that, ageing Boomers are swelling the population at risk of cancer, and that alone could increase diagnoses.

You can see how these factors come together in a Science Feedback review of one of the scares, that began with data from 2 Croatian hospitals (Pavic 2024). There’s a deep dive, too, by David Gorski that digs into the fear-mongering about cancer and the origins of the claims of “turbo cancer.” Wikipedia describes “turbo cancer” as “an anti-vaccination conspiracy theory.”

The major strands of mRNA-specific anti-vax discourse on cancer include speculative hypotheses about mRNA and specific features of cancers, as well as these broad themes:

  • Claims that mRNA enters or otherwise alters our DNA (discussed above) – and that this, if it were to occur, could be carcinogenic.
  • That the claimed high levels of DNA fragments discussed above could be carcinogenic.
  • Claims that SV40 is a known carcinogen, and it is has been identified in mRNA vaccines.
  • That the fatty shells (LNPs) that protect the mRNA could also be a vehicle or accelerant for these carcinogens.

Some of the sources that are particularly commonly referenced for those last 2 claims have already appeared in other sections of this post:

  • The studies also claiming dangerously high levels of DNA fragments, include claims related to SV40 (McKernan 2023 and Speicher 2023).

SV40, or simian virus 40, can infect monkeys and people. It can cause tumors in some animals, but has never been shown to do so in humans. Nevertheless, Wikipedia describes it as cause célèbre for anti-vaccine activists ever since it was found to contaminate some batches of polio vaccine back in the 1950s and 1960s.

The authors of the 2 DNA fragment studies reported that they found a particular gene sequence that also occurs in SV40. A Science Feedback review points out that only the full virus has been found to cause cancer in animals, not a piece of it. But the technical language in those studies and the anti-vax discourse could give that impression. The gene sequence is a promoter, which refers to its role in the process of producing an RNA molecule. The way the term tends to be used in this context, though, can give the impression of promoting or accelerating cancer.

The FDA’s response to Ladapo’s questions is categorical: “No SV40 proteins are encoded for or are present in the vaccines.” Further, data from animal studies including the minute traces of DNA fragments show no signs of genotoxicity (which could theoretically cause malignancies) – and there has been no sign of genotoxicity or increased cancer in surveillance since more than a billion doses of the vaccine have been injected. And the vaccine in both the animal studies and general population use include the LNPs. Further, as with PEI above, the FDA pointed out that they monitor fragment levels. Similarly, they stress that the vaccines do not alter people’s DNA.

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Organ damage, miscarriage, and other claims

This is a miscellaneous section: It’s not a reflection on the importance of the health issues included here. The sources here were either not as common in the materials I checked, or they simply did not fit the themes of the earlier sections of this post.

  • Organ damage, claimed to be proven via autopsies are cited, usually relying heavily on the unpublished work of Arne Burkhardt (discussed here). There is a Science Feedback review on this here.
  • Claims that mRNA vaccination causes miscarriage because the spike protein in the vaccines is similar to syncytin-1, a protein in the human placenta, and the immune system would attack it too, preventing the establishment of viable pregnancy. This apparently originated in a letter to the EMA (Europe’s equivalent to the US FDA) by Wolfgang Wodarg and Michael Yeadon (2020). A Science Feedback review points out that if true, this would have affected women who get Covid, too. However, these proteins are not similar enough. (See also the fact check from Reuters.)
  • Claims about innate and adaptive immune responses, which include claims that this makes these vaccines unnecessary and unsafe for children. Viral claims about this are covered by a Science Feedback review.
  • Claims about mRNA vaccines producing “junk proteins.” A common reference here is a paper by Thomas Mulroney and colleagues (2023). David Gorski unpacked this, and associated conspiracy theories, here.

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You can keep up with my work at my newsletter, Living With Evidence. I’m active on Mastodon: @hildabast@mastodon.online, and less so on Bluesky.

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Disclosures: My interest in Covid-19 vaccine trials began as a person worried about the virus, as my son was immunocompromised: I have no financial or professional interest in the vaccines. I have worked for an institute of the NIH in the past, but not the one working on vaccines (NIAID). More about me.

The cartoon is my own (CC BY-NC-ND license). (More cartoons at Statistically Funny.)

References for anti-vax sources:

I don’t want to enable wider circulation of sources with extensive misinformation and conspiracy theorizing. However, I want the statements I make in this post about this discourse generally to be referenced. So I include below some of the starting points for my hunt through the material in major anti-vaccine movement hubs, and the sources they reference. This is not an exhaustive list of material I analyzed. I do not link to anti-vax sources below, although there are some links to provide information on the authorship and/or publishers.

Wikipedia pages on vaccine shedding and “turbo cancer.”

The Pfizer Papers: Pfizer’s Crimes Against Humanity. The War Room/DailyClout, edited by Naomi Wolf, foreword by Stephen Bannon.

mRNA Vaccine Toxicity. Doctors for COVID Ethics. Foreword and contributing author, Mary Holland, CEO of Children’s Health Defense (Robert F. Kennedy Jr‘s anti-vaccine base).

Joseph Mercola on SubStack.

August 2024 statement on replicon Covid vaccine by the Japan Nursing Ethics Association. (Discussion and link in my October post on the campaign against self-amplifying mRNA in Japan.)

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