About That Frank Shallenberger 'Informed Vaccine Consent' Post - Snopes.com

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A letter authored by a controversial physician and alternative medicine practitioner named Frank Shallenberger began making the rounds on social media in December 2020. The initial version of this Snopes article did not confirm Shallenberger's authorship of the letter, which has been shared as copy-and-pasted text across various social media platforms. Following publication of this piece, Shallenberger responded to our request for comment. "I am the author," he told us by email on Dec. 17, 2020, "I sent it out to my patients about a week ago." The post's "bottom line" is this:

I would much rather get a Covid infection than get a Covid vaccine. That would be safer and more effective. I have had a number of Covid positive flu cases this year. Some were old and had health concerns. Every single one has done really well with natural therapies including ozone therapy and iv Vitamin C. Just because modern medicine has no effective treatment for viral infections, doesn't mean that there isn't one.

Shallenberger arrives at these conclusions after listing a litany of purported concerns about COVID-19 vaccination and doubts about the reality of there being a pandemic at all. In this article, we tackle the post in two different ways. First, we fact-check the post's assertions, which are often factually incorrect and misleading, point-by-point. Second, we discuss the purported remedy of ozone therapy for COVID-19 and explain why Shallenberger's authorship should be a red flag.

The 'About Informed Vaccine Consent: Frank Shallenberger' Letter

Written as a letter to friends and patients, its arguments are broken down into a bulleted list of crucial "facts" the author believes people should know before consenting to the COVID-19 vaccine. "People need to have fully informed consent when it comes to injecting foreign genetic material into their bodies," the post begins. Here, we take the letter's assertions point-by-point.

Do We Really Have 'No Idea' What To Expect from mRNA Vaccines?

• "No mRNA vaccine has ever been licensed for human use before. In essence, we have absolutely no idea what to expect from this vaccine. We have no idea if it will be effective or safe."

It is true that mRNA vaccines, which include both the recently approved Pfizer vaccine as well as the Moderna vaccine in the final stages of approval, have never seen widespread human use. To say "we have absolutely no idea what to expect from this vaccine" and that "we have no idea if it will be effective or safe" is to ignore  decades of work that led to the invention of mRNA therapies and the actual efficacy and safety studies performed on the vaccines in question.

When an FDA Expert Panel met to discuss authorization of the Pfizer vaccine (whose technical name is BNT162b2), the panel based approval on clinical trial data involving "approximately 38,000 participants randomized 1:1 to receive either vaccine or placebo." Regarding the vaccine's safety, these data showed that the vaccine "was safe and well-tolerated in participants ≥16 years of age" and that the adverse-events profile of the vaccine group "did not suggest any serious safety concerns." The number of people who experienced severe adverse reactions or quit the trial due to adverse events, these data showed, was low and similar between the vaccinated cohort and the placebo cohort.

In terms of efficacy: Among people without evidence of a SARS-CoV-2 infection before or during their vaccination, eight confirmed COVID-19 cases ended up being detected in the vaccinated cohort, while 162 cases were detected in the placebo cohort. All told, preliminary evidence suggests efficacy against COVID-19 from the Pfizer vaccine is around 95%. While these studies are ongoing, it is patently false to suggest "We have absolutely no idea what to expect from this vaccine" or "we have no idea if it will be effective or safe."

Are mRNA Vaccines 'Completely Different'?

• Traditional vaccine [sic] simply introduce pieces of a virus to stimulate an immune reaction. The new mRNA vaccine is completely different. It actually injects (transfects) molecules of synthetic genetic material from non-humans [sic] sources into our cells. Once in the cells, the genetic material interacts with our transfer RNA (tRNA) to make a foreign protein that supposedly teaches the body to destroy the virus being coded for. Note that these newly created proteins are not regulated by our own DNA, and are thus completely foreign to our cells. What they are fully capable of doing is unknown.

First of all, many so-called "traditional" vaccines exist that do not introduce "pieces of a virus" but instead rely on "material from non-human sources" that have been chemically modified in the lab. Second of all, all vaccines ultimately introduce "foreign proteins'" or "foreign sugars" (i.e., antigens) into the body. If these molecules were not "foreign" then they simply would not lead to an immune response and the creation of antibodies — the entire point of the vaccination process.

As described in detail in an earlier fact check regarding the possibility of mRNA vaccines to alter human DNA, the way mRNA COVID-19 vaccines work is by sending small bits of mRNA code capable of reaching the outer section of a cell that contains the ribosome — a sort of protein creating factory. This "factory" responds to that mRNA by producing a few specific proteins found on the SARS-CoV-2 virus responsible for their infective spikes.

It is unclear what Shallenberger is trying to argue with regards to "proteins not regulated by our own DNA." The language seems to suggest that these spike proteins' creation, because they were created without the involvement of chromosomal DNA, would result in some sort of vigilante, anarchist protein cabal. Not so. They are proteins created by the same cellular processes our body constantly performs. It is true that there is no point in which DNA is involved in this vaccine, but this is not a liability, it is a safety feature. The mRNA is incapable of crossing the nuclear envelope of the cell where that human DNA lives. It means the vaccine cannot alter human DNA. Science may not know everything, but we do know some important things about what mRNA vaccines are not "capable of doing."

Are the mRNA Vaccine's Nanoparticle Lipids Dangerous?

• The mRNA molecule is vulnerable to destruction. So, in order to protect the fragile mRNA strands while they are being inserted into our DNA they are coated with PEGylated lipid nanoparticles. This coating hides the mRNA from our immune system which ordinarily would kill any foreign material injected into the body. PEGylated lipid nanoparticles have been used in several different drugs for years. Because of their effect on immune system balance, several studies have shown them to induce allergies and autoimmune diseases. Additionally, PEGylated lipid nanoparticles have been shown to trigger their own immune reactions, and to cause damage to the liver.

As "naked" RNA and DNA degrade rapidly without the protection of a cell (another reason not to be worried about errant RNA from the vaccine contaminating your body), they do indeed require a lipid nanoparticle coating for delivery. In the Pfizer vaccine, one of the four lipids used is PEGylated (attached to the chemical polyethylene glycol).

There is some risk that humans can develop antibodies to this lipid shell following vaccination, or that previous exposure to PEG chemicals in things like beauty products have already imparted some antibodies against them. Both situations could in theory reduce the efficacy of the vaccine, and the latter could result in an immune response to the lipids in the vaccine. These are the types of reactions scientists monitored in clinical trials and continue to monitor as the vaccine is distributed.

While lipids like those in the vaccine would collect in the liver, it is unclear what research shows actual liver damage from lipid nanoparticle technology. Many of the drugs developed with this technology are specifically designed to treat liver problems.

Do COVID-19 mRNA Vaccines Contain 'Aluminum, Mercury, and Possibly Formaldehyde'?

• These new vaccines are additionally contaminated with aluminum, mercury, and possibly formaldehyde. The manufacturers have not yet disclosed what other toxins they contain.

This is false on both accounts. Pfizer published the vaccine's ingredients on Dec. 12, 2020. The vaccine contains no preservatives and it contains no aluminum, no mercury, and no formaldehyde. It contains mRNA, a mixture of those aforementioned lipids, sodium phosphate, sodium chloride, and sucrose. Following the initial publication of this piece, Shallenberger told Snopes his assertion in this bullet point represented a "possible" mistake. "There may not be aluminum or mercury in the vaccines," Shallenberger wrote, "I read that online, but cannot find the reference."

Will This Year's Coronavirus Vaccine Be Useless in a Year?

• Since viruses mutate frequently, the chance of any vaccine working for more than a year is unlikely. That is why the flu vaccine changes every year. Last year's vaccine is no more valuable than last year's newspaper.

This statement requires one to ignore a great deal of modern medicine. Hepatitis A and B, rotavirus, chickenpox, polio, HPV, measles, mumps, rubella, among others, are all virus-caused diseases prevented by vaccines whose composition or method does not change year-to-year. Coronaviruses are not influenza viruses, and the mRNA vaccines used to combat COVID-19 differ from influenza vaccines. The latter generally attempts to include attenuated versions of whatever influenza strains are most prevalent each year, a process that is sensitive to mutations across the whole viral genome. The former targets one extremely small and specific region of an (unrelated) virus that is functionally responsible for infecting cells. While there are still unanswered questions about the vaccine's ability to impart lasting immunity, comparing the influenza vaccination program to the coronavirus mRNA vaccines is deceptive.

Is Vaccine Doctor Peter Jay Hotez Worried About mRNA Vaccine Safety?

• Many experts question whether the mRNA technology is ready for prime time. In November 2020, Dr. Peter Jay Hotez said of the new mRNA vaccines, "I worry about innovation at the expense of practicality because they [the mRNA vaccines] are weighted toward technology platforms that have never made it to licensure before." Dr. Hotez is Professor of Pediatrics and Molecular Virology & Microbiology at Baylor College of Medicine, where he is also Director of the Texas Children's Hospital Center for Vaccine Development.

This quote misrepresents concerns about practicality as if they were concerns about safety. Hotez, it bears mentioning, is involved in the development of another COVID-19 vaccine which, he told Houston Chronicle, has been developed using "very old, tested vaccine technology. In Hotez's view, mRNA vaccines are new, flashy, and exciting, but due to their novelty could become hard to scale up, expensive, and difficult to transport. In December, Hotez described mRNA COVID-19 vaccines as "exciting" and, as far as we can find, has not argued against people receiving mRNA vaccines. He has argued that humanity will need at least five different COVID-19 vaccines to manage the pandemic. 

Is Biochemist Michal Linial Against mRNA Vaccines? 

• Michal Linial, PhD is a Professor of Biochemistry. Because of her research and forecasts on COVID-19, Dr. Linial has been widely quoted in the media. She recently stated, "I won't be taking it [the mRNA vaccine] immediately – probably not for at least the coming year. We have to wait and see whether it really works. We will have a safety profile for only a certain number of months, so if there is a long-term effect after two years, we cannot know."

This is a misleading excerpt that misrepresents Linial's views of mRNA vaccines. While she did say she would probably wait on mRNA vaccines to see their efficacy, she also — in literally the same article from Jerusalem Post — argued for the treatment's safety while pushing back against some of the same specific fears about random bits of RNA in the body that the viral post raised:

Pfizer's and Moderna's vaccine candidates are both messenger RNA (mRNA) vaccines. If approved, these will be the first-ever vaccines of this type brought to market for human recipients. These vaccines use a sequence of genetic RNA material produced in a lab that, when injected, enters the cells and sparks production of the viral components that subsequently train the immune system to fight the virus.

Michal Linial, a professor of biological chemistry at the Hebrew University of Jerusalem, told the Post she believes there is no cause for concern. Linial explained that "mRNA is a very fragile molecule, meaning it can be destroyed very easily… If you put mRNA on the table, for example, in a minute there will not be any mRNA left over. …

She said the worry should not be that the mRNA won't get into the cells and will stay outside, floating in the body and causing some kind of reaction. Rather, the concern should be that if it doesn't enter the cells, it will disintegrate and will not be effective. She said that while Moderna and Pfizer base their vaccine candidates on new technologies, they are asking our bodies to do something they do every day: protein synthesis, the process in which cells make proteins.

Using a source who explicitly stated the fears you raise "are no cause for concern" in a way that implies that source agrees with you, is, to put it mildly, disingenuous.

Did Washington Post Report On Frontline Health Care Workers' Concerns About the COVID-19 Vaccine?

• In November 2020, The Washington Post reported on hesitancy among healthcare professionals in the United States to the mRNA vaccines, citing surveys which reported that: "some did not want to be in the first round, so they could wait and see if there are potential side effects", and that "doctors and nurses want more data before championing vaccines to end the pandemic".

Indeed, this is what a November 2020 Washington Post article stated. It also stated that "government, academic, and health-care officials say that significant numbers of providers want more data about the vaccine before it is deployed." Now, in December 2020, we have more data about the vaccine, its efficacy, and its safety.

Has the Pandemic Been Over Since September 2020?

• Since the death rate from COVID resumed to the normal flu death rate way back in early September, the pandemic has been over since then. Therefore, at this point in time no vaccine is needed.

To be clear, Shallenberger is attempting to assert that a pandemic currently killing over 3,000 Americans every day is "over." This is neither true nor supported by anything resembling empirical evidence. For comparison, the Centers for Disease Control and Prevention (CDC) "estimates that the burden of illness during the 2018–2019 season included an estimated 35.5 million people getting sick with influenza, 16.5 million people going to a health care provider for their illness, 490,600 hospitalizations, and 34,200 deaths from influenza."

In just the 2 1/2 months from the beginning of September (when Shallenberger alleges the pandemic to have ended) to the time of the publication of this piece, the U.S. has had over 115,600 COVID-19 deaths. In total, the U.S. has had over 300,000 deaths —  an entire order of magnitude more than from influenza in the previous season.

Is the Pandemic Really Just Caused by PCR Test False Positives? 

• The current scare tactics regarding "escalating cases" is based on a PCR test that because it exceeds 34 amplifications has a 100% false positive rate unless it is performed between the 3rd and 5th day after the first day of symptoms. It is therefor [sic] 100% inaccurate in people with no symptoms. This is well established in the scientific literature. The weekly death rates in the US are now lower than they normally are during an average flu season.

The problem with PCR testing does not rest with false positives, though there are unresolved questions about the accuracy of COVID-19 tests in general. Rather, its limitation is that it detects only the presence of specific SARS-CoV-2 RNA, and the presence of this RNA is not necessarily indicative of being infected or contagious with SARS-CoV-2. This is not a false positive for COVID-19, it is a true positive for the presence of SARS-CoV-2 RNA. Still, the argument goes, deaths attributed to COVID-19 (discussed above) stem from falsely attributing COVID-19 as the cause based merely on the trace presence SARS-CoV-2 in people with unrelated health conditions. 

To suggest the pandemic is caused by false positives is an untenable position. That's because evidence of the pandemic in the form of excess mortality (the number of deaths compared to the number of deaths on average for any given period of time) is not sensitive to whatever result a person received on a PCR test prior to death. The figure below shows weekly deaths (from all causes) in the United States from 2017 to the present compared to the average number for that week. It shows that deaths have significantly exceeded a normal year's totals every week since April 2020 and have been rising rapidly in just the last few weeks.

It goes without saying, but this is also a big blow to the "weekly death rates in the US are now lower than they normally are during an average flu season," line.

Are COVID-19 Vaccines Unnecessary Because of Herd Immunity?

• The other reason you don't need a vaccine for COVID-19 is that substantial herd immunity has already taken place in the United States. This is the primary reason for the end of the pandemic.

As previously discussed, the pandemic is not over. It is, in fact, getting worse.

Who Is Frank Shallenberger?

Shallenberger is both an M.D., licensed by the Nevada Board of Medical Examiners, and an alternative medical practitioner. The Nevada Board of Medical Examiners has reprimanded him twice. Prior to setting up a practice in Nevada, he was forced to surrender his earlier California license in response to several allegations against him. In addition to the ozone therapy claims made in this letter, Shallenberger has also recommended a related alternative treatment that involves breathing nebulized hydrogen peroxide as a COVID-19 cure in a March 2020 newsletter article.

At the end of the "Informed Vaccine Consent" post, Shallenberger wrote "you cannot completely trust what you hear from the media" because "they are all supported by Big Pharma and the other entities selling the COVID vaccines." By this logic, his recommendation of "ozone therapy" shouldn't be trusted either due to his own financial interest. Shallenberger considers himself to be the "godfather of ozone therapy in the United States," owns a medical practice that specializes in the treatment, and he is the developer of a proprietary form of ozone treatment named Prolozone. He receives money certifying other alternative practitioners in the use of ozone.

Hailed on Shallenberger's clinic's website as a cure for virtually anything and everything (but not COVID-19 explicitly), ozone treatment under his care involves removing a small amount of blood, adding gaseous ozone to it, and then reinjecting this gasified blood back into the body. Such a treatment, in contrast to COVID-19 mRNA vaccines, lacks any peer-reviewed study demonstrating efficacy against the disease, and the Department of Justice has taken action against people who tout ozone treatment as a cure for COVID-19. The FDA considers ozone to be "a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy," noting that, "In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals."

All of this is to say that Shallenberger may not be the best source for unbiased information regarding the efficacy of ozone treatment in COVID-19 cases. As he claims the pandemic ended in September, he is probably not a great source for information on COVID-19 in general, either.