copenlu/druid huggingface dataset:
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2024-01-01): Safety of residual cellular DNA in vaccines [...] The risks, if any, of residual cellular DNA in vaccines as a result of the production process are theoretically two in number: (i) transmission of latent viruses and other agents; and (ii) incorporation of cellular DNA into host genetic material. These are theoretical safety issues that need to be considered in the scientific decisions underpinning registration of vaccines produced in new cell substrates. GACVS noted that WHO will be setting up a Working Group to consider international specifications for the quantity of residual cellular DNA in vaccines from new cell substrates. The Committee has agreed to serve as a reference point for safety issues for this Working Group.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-11-22): We have covered unsubstantiated claims that residual DNA in mRNA COVID-19 vaccines is considered "adulteration" or integrates into people’s DNA and causes cancer. Representatives from regulatory agencies and various academic experts told us there isn’t reason to believe the small amounts of residual DNA in the mRNA vaccines would integrate into a person’s cellular DNA and cause cancer. And legal experts told us that the residual DNA would not be considered adulteration. [...] With residual DNA, scientists from the U.S. Food and Drug Administration have written that they consider the primary cancer-related concern to be the introduction of DNA encoding an activated cancer-causing gene. There is no residual DNA encoding cancer-causing genes in the mRNA COVID-19 vaccines. [...] In a response sent to us for our prior article on residual DNA in the mRNA COVID-19 vaccines, an FDA spokesperson did in fact make reference to past concerns about DNA integration and cancer, while expressing confidence in the mRNA vaccines.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-07-10): FULL CLAIM: "SV40 has been linked to cancer in humans"; "The finding of DNA [in COVID-19 mRNA vaccines] means the mRNA COVID shots may have the ability to alter the human genome"; "Cytoplasmic transfection can also allow for genetic manipulation, as the nucleus disassembles and exchanges cellular components with the cytosol during cell division"; "Regulatory Agencies Knew There Was a Contamination Problem" [...] Michael Imperiale, a professor at the University of Michigan who studies DNA tumor viruses, told Health Feedback in an email that the results are far from establishing that DNA contamination of COVID-19 mRNA vaccines is widespread. "Since this article has not been peer reviewed, we don’t know if there was truly significant DNA contamination," he explained. [Read Imperiale’s feedback in full here.] [...] In summary, the Epoch Times article’s proposal that DNA contaminants in COVID-19 mRNA vaccines pose a risk of DNA modification and cancer isn’t substantiated by sufficient evidence. While a preprint claimed DNA contaminants were present in an alleged vial of Pfizer COVID-19 mRNA vaccine, this finding came from a vial of unknown origin. Yet this fact is glossed over and the preprint finding is discussed as conclusive evidence of contamination despite this significant limitation.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-11-03): On 27 October 2023, podcaster Charlie Kirk interviewed scientist Robert Malone about the question of residual DNA in COVID-19 mRNA vaccines. This interview was posted to various platforms, including Facebook and Rumble, receiving a total of more than 78,000 views. As previous Health Feedback reviews can attest to, both Kirk and Malone have a long history of propagating misinformation about COVID-19 vaccines. [...] While there is residual DNA in the COVID-19 mRNA vaccines, Malone didn’t mention that the amount of DNA detected in the vaccine vials is well below the World Health Organization and U.S. Food and Drug Administration’s recommended limit of 10 ng DNA/dose . In fact, as a previous Health Feedback review noted, this was acknowledged by the authors of one of the preprints that Malone’s claim relies on. [...] It is also inaccurate to claim that regulators were unaware of residual DNA in the vaccines. Monitoring the presence of residual DNA in biological products and assessing its potential health concerns isn’t new to regulatory agencies[9].
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-10-30): Experts say there’s no evidence to support Kirsch’s claim that the mRNA COVID-19 vaccines are contaminated or contain ingredients that weren’t disclosed to regulators. [...] Longley said Pfizer’s COVID-19 vaccine was reviewed by regulatory authorities, including the FDA and the European Medicines Agency, and met safety and quality control requirements. Those authorities also approved the development and manufacturing specifications for Pfizer’s COVID-19 vaccine, Longley said, including a method for assessing residual DNA that is outlined by the World Health Organization and the FDA. [...] Experts said there’s no evidence that the mRNA COVID-19 vaccines contain previously undisclosed contaminants. Pfizer said noninfectious SV40 sequences were part of the starting material for the Pfizer vaccine, and the FDA and other regulators approved the vaccine manufacturing process.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-10-21): Experts said there’s no evidence that the mRNA COVID-19 vaccines contain previously undisclosed contaminants. Pfizer said noninfectious SV40 sequences were part of the starting material for the Pfizer vaccine, and the FDA and other regulators approved the vaccine manufacturing process. [...] Health Feedback, Claim that COVID-19 mRNA vaccines contain DNA contaminants based on study of vials of "unknown provenance"; no evidence COVID-19 mRNA vaccines can alter DNA in people, June 23, 2023 [...] Health Feedback, Contrary to viral claim, regulatory agencies knew of residual DNA in COVID-19 mRNA vaccines; no evidence this poses health concern, Oct. 25, 2023
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2024-01-12): Ladapo’s statement did not include any evidence that COVID-19 vaccines have caused "DNA integration," in which DNA fragments in the vaccines combine with a recipient’s DNA. [...] Offit told PolitiFact the discussion of "DNA contaminants" in the COVID-19 vaccines is really one about "utterly harmless manufacturing residuals." Plus, he said people are exposed to foreign DNA all the time, including when they eat animal or plant products.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-06-23): Claim that COVID-19 mRNA vaccines contain DNA contaminants based on study of vials of "unknown provenance"; no evidence COVID-19 mRNA vaccines can alter DNA in people [...] Michael Imperiale, a professor at the University of Michigan who studies DNA tumor viruses, told Health Feedback in an email that the results are far from establishing that DNA contamination of COVID-19 mRNA vaccines is widespread. "Since this article has not been peer reviewed, we don’t know if there was truly significant DNA contamination," he explained. [Read Imperiale’s feedback in full here.] [...] In summary, the Epoch Times article’s proposal that DNA contaminants in COVID-19 mRNA vaccines pose a risk of DNA modification and cancer isn’t substantiated by sufficient evidence. While a preprint claimed DNA contaminants were present in an alleged vial of Pfizer COVID-19 mRNA vaccine, this finding came from a vial of unknown origin. Yet this fact is glossed over and the preprint finding is discussed as conclusive evidence of contamination despite this significant limitation.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-11-21): "EMA has seen no evidence of an association between mRNA vaccines and adverse events that could be linked to the presence of DNA material, nor are we aware of any scientific evidence showing that the very small amounts of residual DNA that may be present in vaccine batches could integrate into the DNA of vaccinated individuals," the Amsterdam-based agency wrote in an emailed statement. The Food and Drug Administration, which regulates vaccines in the U.S., echoed the sentiment, saying no safety concerns about residual DNA in COVID vaccines have been identified, despite more than one billion shots being administered. [...] "There is no evidence to support claims that the Pfizer-BioNTech COVID-19 vaccine contains plasmid DNA that could potentially impact a person’s DNA or be a theoretical cancer risk," the company wrote, referring to DNA materials used to trigger an immune response during vaccine development.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2018-01-12): Cancer mRNA vaccines: clinical advances and future opportunities [...] Table 3 Clinical trials with mRNA vaccines against cancer [...] The requirement for safety in modern prophylactic vaccines is extremely stringent because the vaccines are administered to healthy individuals. Because the manufacturing process for mRNA does not require toxic chemicals or cell cultures that could be contaminated with adventitious viruses, mRNA production avoids the common risks associated with other vaccine platforms, including live virus, viral vectors, inactivated virus and subunit protein vaccines. Furthermore, the short manufacturing time for mRNA presents few opportunities to introduce contaminating microorganisms. In vaccinated people, the theoretical risks of infection or integration of the vector into host cell DNA are not a concern for mRNA. For the above reasons, mRNA vaccines have been considered a relatively safe vaccine format.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2024-01-05): DNA in Covid-19 vaccines: 7 pieces of context missed from Florida Surgeon General’s unnecessary warning [...] What’s the kernel of truth here? There are DNA fragments in Covid-19 vaccines. [...] Multiple regulators across the globe have consistently found vaccines to have acceptable levels of DNA fragments. Even the flawed preprint confirms Covid-19 vaccines’ DNA content is far below any levels indicating a safety or manufacturing concern (see below).
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-05-16): Myocarditis is a rare side effect of mRNA COVID-19 vaccines, which have been used with great success as protection against the SARS CoV-2 virus and its variants. Generally, the condition is highly treatable, but it has caused concern in some quarters about the vaccines’ safety. We spoke with Carrie Lucas, PhD, associate professor of immunobiology at Yale School of Medicine, and Akiko Iwasaki, PhD, Sterling Professor of Immunobiology, about their recent study which uncovers clues to why this complication can occur. [...] Why can the mRNA vaccine affect the heart?
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-12-14): TALLAHASSEE, Fla. – On December 6, Florida Surgeon General Joseph Ladapo sent a letter to the U.S. Food and Drug Administration (FDA), asking questions about a recent preprint documenting the detection of billions of DNA fragments per dose in the approved Pfizer and Moderna COVID-19 mRNA vaccines; Simian Virus 40 (SV40) promoter/enhancer DNA was also found in Pfizer vials. In the letter, Dr. Ladapo points out that the vaccines use lipid nanoparticles to efficiently deliver mRNA into human cells, so the vaccines may be equally efficient at delivering the DNA contaminants into human cells. [...] Dr. Ladapo told Alachua Chronicle that this is primarily an ethical issue because evaluations of these risks are necessary precursors to the use of the mRNA COVID-19 vaccines. He continued, "The point of what we do is to bring honesty to insanity. There’s a pattern to the things that happened in the pandemic, and it’s crazy stuff that people want to pass off as sane and normal. A great example is this idea that somehow masking two- or three-year-olds does anything other than waste money, waste time, and annoy the kids." He said masking toddlers and distributing vaccines with billions of fragments of DNA in each dose are both "crazy." He emphasized that the research discovering these DNA contaminants has been duplicated by other scientists and acknowledged in communications from the FDA: "It’s truly insane for us to be using [these vaccines] without any sense of what those risks of integration are."
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-10-26): Kevin McKernan, chief scientific officer and founder of Medicinal Genomics — who identified the presence of SV40 contaminants in the mRNA vaccines — explained during an episode of "Good Morning CHD" how the contaminant plasmids got into the vaccines, and how he thinks Pfizer hid the contamination from regulators. [...] Did Pfizer deliberately deceive regulators about contamination of its COVID-19 vaccine? Yes, according to Kevin McKernan, chief scientific officer and founder of Medicinal Genomics. Appearing on CHD.TV with Children’s Health Defense (CHD) President Mary Holland and Brian Hooker, Ph.D., CHD’s senior director of science and research, McKernan explained how Pfizer’s COVID-19 vaccine is contaminated with plasmid DNA, which should not be present in an mRNA vaccine.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2024-10-01): Early in 2023, genomics scientist Kevin McKernan made an accidental discovery. While running an experiment in his Boston lab, McKernan used some vials of mRNA Pfizer and Moderna Covid vaccines as controls. He was ‘shocked’ to find that they were allegedly contaminated with tiny fragments of plasmid DNA. McKernan, who has 25 years’ experience in his field, ran the experiment again, confirming that the vials contained up to, in his opinion, 18-70 times more DNA contamination than the legal limits allowed by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-10-25): Factually inaccurate: Health Canada stated that it was aware of residual DNA in COVID-19 mRNA vaccines before the vaccines were authorized. A dossier submitted by BioNTech to the European Medicines Agency in 2020 also showed that data on residual DNA was made known to the regulator. [...] It’s incorrect to claim that regulatory agencies were unaware of residual DNA in the COVID-19 mRNA vaccines until now, as the same document submitted to the European Medicines Agency indicated that residual DNA was among the impurities quantified by the manufacturer ("Process- and product-related impurities including host cell genomic DNA, RNA, proteins, endotoxins, bioburden and plasmid isoforms, for the plasmid DNA, are routinely quantified"). [...] In brief, the claim that regulatory agencies like Health Canada hadn’t known about residual DNA in COVID-19 vaccines or that vaccine manufacturers didn’t disclose the presence of residual DNA in the vaccines is inaccurate.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-04-18): No signs of DNA mutation or COVID-19 vaccine-induced cancer have been reported to date for the Pfizer-BioNTech COVID-19 vaccine. This refutes claims made on September 12, 2023 during a Pandemic Preparedness Listening Session hosted by the Senate Medical Affairs. During the session, the Committee heard remarks pertaining to the Pfizer-BioNTech messenger RNA (mRNA) COVID-19 vaccine, incorrectly stating that the vaccine could potentially impact a person’s DNA and be a theoretical cancer risk. There is no evidence to support these claims. Specifically, these claims allude to SV40, which stands for Simian Virus 40, a naturally occurring DNA virus originating with monkeys. In the 1960s, some polio vaccines were found to be contaminated with infectious SV40 virus, exposing those receiving the contaminated vaccines to infectious virus. Infectious SV40 virus is not in the Pfizer-BioNTech COVID-19 vaccine. To make the spike mRNA in the COVID-19 vaccine, plasmid DNA is used as a building block, or what is called starting material. Non-infectious fractions of a SV40 sequence are present in the starting material used by Pfizer and BioNTech. The DNA starting material does not contain oncogenes, which are genes that may have the potential to cause cancer. Many vaccines contain small amounts of DNA, otherwise known as residual DNA, for which regulatory authorities have established limits. As is required for all vaccines, the amount of residual DNA present in the Pfizer-BioNTech COVID-19 vaccine is within the amount permitted by standard regulatory guidance.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-11-14): As with many medical products, the mRNA COVID-19 vaccines may contain trace amounts of residual DNA from the manufacturing process. It is not considered adulteration, and the Food and Drug Administration is not "required" to pull the vaccines from the market, contrary to viral claims online. [...] Recently, some people have claimed that the residual DNA in some mRNA COVID-19 vaccine vials is above the regulatory limit — and that some of the short sequences could be harmful and cause cancer if they integrated into a person’s genome. But as we have written, there isn’t reliable evidence that the residual DNA in the vaccines is too high, nor is there evidence that the DNA integrates, much less that it causes cancer or any other health problem. [...] Health Canada told us in an email that the "SV40 promoter enhancer sequence was found to be a residual DNA fragment in Pfizer-BioNTech COVID-19 vaccine," but that the "fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators." It iterated that this was not a safety concern.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-11-03): Small amounts of DNA from the manufacturing process may remain in the mRNA COVID-19 vaccines. Purification and quality control steps ensure any leftover DNA is present within regulatory limits. There isn’t reason to think that this residual DNA would alter a person’s DNA or cause cancer, contrary to claims made online. [...] Various experts also told us that it is unlikely that residual DNA in the vaccines could integrate into DNA or cause cancer, even in theory. And as we have previously written, there isn’t evidence to date that the vaccines cause cancer or have led to an increase in cancer. [...] Reports of residual DNA in the mRNA COVID-19 vaccines and its purported dangers spread further after a Sept. 12 South Carolina Senate committee listening session. One speaker, molecular biologist and cancer geneticist Phillip Buckhaults from the University of South Carolina, shared his own findings that DNA pieces were present in leftover vaccine in the bottom of used Pfizer/BioNTech vials.
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2023-12-12): In a December 6 letter, Ladapo said he believed the drug delivery system used by mRNA vaccines could be an "efficient vehicle for delivering contaminant DNA into human cells." He said that because DNA integration could theoretically affect oncogenes—the genes that have the ability to "transform a healthy cell into a cancerous cell"—that DNA contaminant could cause cancer in vaccine recipients. [...] "In general, with regard to the mRNA vaccines, while concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the minute amounts of residual DNA do not cause cancer or changes to a person's genetic code," the FDA said. Paul Offit, an internationally recognized infectious disease expert and the director of the Children's Hospital of Philadelphia's Vaccine Education Center, told Newsweek that although there can be trace levels of fragmented DNA from COVID vaccines, Ladapo's suggestion that it could cause cancer is "fanciful."
Claim: Regulatory agencies didn’t know of residual DNA contamination in COVID-19 RNA vaccines; residual DNA could integrate into our DNA and cause cancer (Steve Kirsch, 2023-10-25)
Evidence (2017-11-22): The plasmid DNA is not intended to be part of the final mRNA vaccines. However, very small amounts of DNA fragments may remain. EMA has seen no evidence linking the residual DNA to side effects. EMA has set limits for the level of broken-down DNA in mRNA vaccines. The manufacturing process is carefully designed and controlled to ensure safe and acceptable levels, and the vaccines’ quality is routinely checked. [...] COVID-19 mRNA vaccines can sometimes contain truncated (shorter) or modified mRNA molecules. These are considered impurities and are not expected to affect safety or efficacy.