Recent Study Questions Safety of COVID mRNA Vaccines
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Researchers call for COVID vaccines to be removed from the market based on their review of studies and reports of adverse events, including death.
A summary of research entitled “Review: Calls for Market Removal of COVID-19 Vaccines Intensify as Risks Far Outweigh Theoretical Benefits” published on January 25, 2025 in the journal Science, Public Health Policy, and the Law evaluates data from the VEARS reporting system, scientific studies, as well as an array of calls for market removal from multiple sources. According to the authors of the peer-reviewed study, the documented risks of the COVID vaccine far outweigh the benefits.
The review’s corresponding author, Nicolas Hulscher, is an epidemiologist who holds a Master of Public Health from the Michigan School of Public Health. Hulscher took questions from me for this in February 2025, only weeks after his research was published.
VAERS Data
VAERS is an acronym for “Vaccine Adverse Event Reporting System” and is a tool for healthcare professionals and others to report side effects of vaccines. The reporting system is co-managed by the CDC and FDA.
Hulscher noted that the VAERS reporting system is not one that is easily abused, because “you cannot lie to the VAERS system, it is criminal to lie on VAERS. These reports are usually from physicians or companies who think that the vaccine caused the death.” As the reporting guidelines warn, “knowingly filing a false VAERS report is a violation of Federal law (18 U.S. Code § 1001) punishable by fine and imprisonment.”
Excessive Death Rate
The review compares the numbers of reported deaths of 10 recalled vaccines to the COVID-19 vaccines (see Figure 1). For example, the Cutter Polio vaccine was associated with 10 deaths in 1955, a swine flu vaccine was linked to 53 deaths in 1976, and the vaccine Rezulin was connected to 659 deaths before it was recalled in the year 2000.
According to VAERS data through April 2024, the number of deaths associated with COVID-19 vaccines in all countries reporting was 37,544, a number that has “greatly surpassed” the FDA’s threshold for a Class I recall.
In the U.S., reported deaths amounted to 19,028 as of September of 2024. The reports indicate that of those, 1,175 deaths occurred on the same day of vaccination, and 1,250 deaths the day after.
Recall of COVID Vaccines Overdue
Based on the above VAERS numbers, deaths which health care professionals believe were caused by a COVID vaccine exceed the same criteria that led to past vaccine withdrawals by as much as 375,340%.
While recognizing the limitations of the calculations and reported findings of adverse events across the wide array of COVID vaccine studies, Hulscher’s review concludes that based on the “profound concerns about the safety and public health impacts of COVID-19 vaccination programs”, the recall of COVID vaccines is well overdue.
What Role Does the FDA Play in Recalling a Drug?
An FDA Class I recall is “defined as a situation where the use or exposure to a violative product poses a reasonable probability of causing serious adverse health consequences or death. While a recall is often initiated by the manufacturer itself, in the case of vaccines and especially biologics, the FDA has the authority to mandate a recall.
Figure 1: Reported Deaths for Major Drug/Vaccine Recalls Versus Total COVID-19 Vaccine Deaths Reported to VAERS.
*Figure reprinted from Rhodes and Parry, who obtained permission from VAERS Analysis to use their figure. Permission to use this figure has been granted in accordance with the open access Creative Common CC BY-NC 4.0 license. Above figure and references reprinted from Hulscher et al with permission.
Conflict of Interest Within Regulatory Agencies
When asked why he thinks the COVID vaccine has not been pulled from the market, Hulscher notes “the pharmaceutical capture of our regulatory agencies.” He explained that while some politicians get campaign money from pharmaceutical companies, in other cases, “people on the FDA advisory boards have worked or do work with Pfizer or Moderna” and therefore have an interest in keeping the product on the market.
Hulscher pointed out that Scott Gottlieb, the former FDA commissioner, went to work for Pfizer after his term. Moreover, in January 2025, Patrizia Cavazzoni began a career as the chief medical officer for Pfizer after leaving her position as a top regulator in the drug division of the FDA.
Hulscher believes that these close financial ties with pharmaceutical companies lead regulators to look the other way when it comes to alarming information, such as the high death rate reported to VAERS with respect to COVID vaccines.
When asked about what interest there is in keeping the product on the market, Hulscher said, “They’re all implicated in this debacle, they don’t want to get in trouble. They keep pretending everything is fine.”
Vaccine Recipients Likely to get Sicker than Non-vaccinated
According to the review, “[m]ultiple studies have demonstrated that COVID-19 vaccinated individuals may face a higher risk of infection compared to unvaccinated individuals.” This phenomenon is known as “negative efficacy”.
No Long-Term Control Group in Clinical Trials
The review highlights an omission made in the scientific process wherein clinical trial recipients were “unblinded”, meaning that they were told within months that they had received the placebo and offered the mRNA injection. This eliminated the ability of the pharmaceutical company to compare the “control” group which had received the placebo to the group which had received the experimental injection over the long term.
DNA Contamination
The review cites 12 publications by scientists worldwide that have found DNA contamination in vials of mRNA type COVID vaccines produced by Pfizer and Moderna.
Of the 12 studies, 11 revealed levels of DNA impurities well over regulatory limits, leading to concerns of adverse events or even gene integration - meaning that the DNA could be incorporated into the genome (genetic code) of an individual taking the vaccine.
One of the studies cited in the review explains that one reason DNA impurities have been found in the mRNA vaccine vials is that DNA templates must be used to synthesize the mRNA in the manufacturing process, and that the DNA “must be removed before the products can be used as drugs.”
The authors (Brigitte König and Jürgen O. Kirchner) explain that removing DNA impurities from mRNA vaccines is problematic because “contaminating DNA and active ingredient mRNA are both nucleic acids and therefore chemically so similar that separation is far more difficult than separating DNA” compared to other types of protein-based vaccines.
König and Kirchner note that the contaminating DNA is more stable than the active mRNA, and like the mRNA that is the active ingredient of the vaccine, contaminating DNA is also enclosed in lipid nanoparticle which aids in the delivery of the genetic material to the cells of the individual.
Simian Virus 40 Impurities
Hulscher’s review references studies that specifically detected a gene sequence called “SV40” (Simian Virus 40). SV40 has been detected in human tumors, causing researchers to suspect that the virus could play a role in promoting certain cancers.
According to Hulscher, “They use SV40 for the production of the mRNA that goes into the shot, but the problem is that they don’t clean it out, so it’s still in the vials. It is a cancer-promoting type of DNA.” Hulscher clarified that the role of SV40 in promoting cancer needs more investigation, but that “regardless, you don’t want these possibly carcinogenic DNA fragments in your vaccine, over the regulatory limits. Way over the limits.” He stressed that this contamination is just one facet that should lead to the withdrawal of COVID vaccines from the market.
Public Statements Calling for Removal
The review summarizes the numerous calls for market removal of COVID-19 vaccines issued by various sources worldwide. The sources range from scientists and doctors to organizations and public figures. The authors cite five manuscripts, 19 organizations, 228 U.S. politicians, 4 members of the European parliament, and 8 Australian elected officials who have publicly called for removal of COVID-19 vaccines.
Response from the Media
Hulscher says that while his review has gotten “millions of views” via social media, it has been shunned by conventional news outlets. ”The mainstream media has completely ignored [the review] - that’s expected. They have ignored all of our past 15 studies. [Our work] does not reach CNN or FOX news.”