By Sana Zekri, MD
There has been a letter circulating written by Dr. Frank Shallenberger emphasizing the uncertainty and alleged danger of the COVID vaccine. However, much of the information is either blatantly false or taken out of context. Below is a point-by-point response to the claims of Dr. Shallenberger, including sources.
“Dear Patients and Friends,
Last week I must have been asked 20 times about the new COVID vaccines. Here are my thoughts. Please pass this information onto many as you can. People need to have fully informed consent when it comes to injecting foreign genetic material into their bodies. The COVID vaccines are mRNA vaccines. mRNA vaccines are a completely new type of vaccine. 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 these are the first mRNA vaccines to be deployed. However, this is a culmination of years of research; the tech has been under research as a potential vaccine and cancer fighting methodology for years. Dr. Shallenberger’s claim that ‘we have absolutely no idea what to expect… if it will be effective or safe’ is not true. The short-term safety and efficacy are known because that’s what the clinical trials were for. This is how safety and efficacy of all vaccines and drugs are evaluated. Among the 22,000 people who received the Pfizer vaccine and the 15,000 who received the Moderna vaccine, there were no major safety issues, and the vaccine was ~95% effective at preventing COVID infection. For comparison, if a total of 37,000 people of similar demographics to the vaccine trials were infected with COVID, we would expect more than 350 deaths, based on a case-fatality of 1%, and an unknown number of people with persistent symptoms, respiratory disease, and other organ failures. It is true that the long-term outcomes of the vaccine are not known. But, we also don’t know the long-term outcomes from COVID infection. So, as of right now, based on the data that we have, these mRNA vaccines are much, much safer than getting infected with COVID, by a huge margin. For a more thorough dissection of the safety data on the vaccine as well as a discussion of long-term side effects, see this video.
“Traditional vaccine 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 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, he keeps using the phrase “genetic material,” which is confusing. The vaccines use mRNA, which is very, very, very different than DNA. The injected mRNA encodes for the spike protein of the novel coronavirus. Getting into the details of how our cells convert mRNA to proteins using tRNA and liposomal fusion and whatnot is beyond the scope of this answer. What is important to know is that the mRNA cannot affect our DNA, and it cannot change our genetic code. Dr. Shallenberger also suggests that because the protein is completely foreign, we have no idea what impact it will have. But that’s not a valid argument, because that’s literally the same way that all other vaccines work: all vaccines expose you to “foreign” proteins from the virus, and your immune system responds to the foreign protein, forming immunity to it. This is also how our bodies generally create immunity – the body recognizes foreign proteins or particles (antigens) and the body produces antibodies that are designed to neutralize those antigens. Your body is exposed to foreign proteins constantly; this is why we have immune systems. The last part of his statement is fallacious due to the premise of the first part of his statement.
“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.”
We must first address the quietly asserted idea that mRNA inserts into our DNA. The mRNA does not insert into our DNA. mRNA does not have the capability of inserting into DNA. DNA is scanned to make mRNA, but mRNA is not scanned to produce DNA in the cell. This is basic biology.
Next, we will address the claims regarding polyethylene glycol, or PEG. First, it is important to know, though, that using PEG to coat medicines has been around since the 1970s, and PEGylated medicines have been on the market since 1990, in the United States. PEG can also be used as a laxative when ingested, and is used in facial fillers for cosmetic procedures, and is a common component in beauty products. The medicines that are typically PEGylated are usually administered in much larger amounts than what is used in the vaccine. So there is more PEG dosage with other PEGylated medicines than with these mRNA vaccines. The dosages of PEG in these vaccines are miniscule.
PEG coating allows certain medicines to last longer in our body and prevents those medicines from overstimulating the immune system and degrading quickly, as Dr. Shallenberger accurately posits. The medicines that are usually PEGylated actually become more inert by being PEGylated, because PEGylation tends to limit the amount of immune reaction and cross-reactivity. There are some rare case reports of PEG being associated with different auto-immune problems, but aside from these being so rare that it took thousands and thousands of people to get PEG drugs before these was found to be possible problems, there are no trials that actually demonstrate this effect, only case reports. Regarding his claim about liver toxicity — earlier, less refined versions of PEG were found to sometimes accumulate in the liver, but they did not demonstrate signs of causing liver toxicity. For a discussion of the rare incidences of anaphylaxis after COVID vaccination in individuals with a history of allergies, see this article.
“These new vaccines are additionally contaminated with aluminum, mercury, and possibly formaldehyde. The manufacturers have not yet disclosed what other toxins they contain.”
“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.”
Dr. Shallenberger’s assertion is only partially true. Some viruses do mutate frequently, others do not. The polio vaccine and measles, mumps, rubella vaccine have not significantly changed since they were first introduced because the viruses are so stable. So far, unlike its coronavirus cousins, the novel coronavirus does not appear to undergo rapid mutation, particularly in the important spike protein domain, which is what the mRNA vaccine induces immunity against. For a more detailed discussion of the recent UK strain and what that means for vaccination, check out this article. However, regardless of how long the current vaccines provide immunity, the idea that it is somehow useless, even if immunity doesn’t last forever, is completely false.
“Absolutely no long-term safety studies will have been done to ensure that any of these vaccines don’t cause the cancer, seizures, heart disease, allergies, and autoimmune diseases seen with other vaccines. If you ever wanted to be guinea pig for Big Pharma, now is your golden opportunity.”
Dr. Shallenberger is pointing out that this vaccine does not have long term safety data for it. He is 100% correct. It would be good to acknowledge that other vaccines do have rare adverse events associated with them, and very rarely those adverse cause chronic health problems. However, when you are looking at the risks of the vaccine, you have to weigh them against the risks of the disease it is protecting against. A good case to look at is the relationship between measles infection and the uniformly fatal pansclerosing encephalitis that rarely affects people years after they get measles. People vaccinated against measles don’t die of immediate measles-related disease, and also do not die of late onset pansclerosing encephalitis. Overall, more lives are saved and more morbidity is avoided by vaccinating against measles, despite adverse events from the vaccine, than by letting measles run rampant.
At the end of the day, neither COVID nor the COVID vaccine have long term data, but as a physician, I can personally tell you that people who get COVID and survive don’t always just go back to normal. And we still don’t know the longer-term outcomes associated with infection because… the virus has only been around for a year.
“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.”
I don’t know the context of Dr. Hotez’s quote and couldn’t find the interview where he said that – though I believe it’s something he could have said. Dr. Hotez has been quoted as recently as November 25th that he would take any effective vaccine that was developed including the Moderna one, with the expectation that additional vaccines will also be developed if the vaccine pans out to be less effective in the long term. Dr. Hotez says this not because immunity waning is an expected outcome, but because Dr. Hotez is a super practical man. He was my professor in medical school. Recently, he himself received the Pfizer mRNA vaccine, thus it is inaccurate to suggest he is somehow opposed to these 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 quote from Dr. Michal Linal is taken out of context. What she actually said was that she believes in the safety of mRNA vaccines, though she doesn’t know whether or not there will be prolonged immunogenicity, again, because of the lack of time-based data. Here’s the actual full interview for context.
‘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”.’
I don’t know what to tell you, people make bad bets all the time, including doctors and nurses. Many people were feeling hesitant about the vaccines until the safety data came out, and then made an informed decision based on that data. If the deluge of vaccine selfies in my social media feed is any indication, many health care providers are quite enthusiastic about getting the vaccine.
“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. 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 100% inaccurate in people with no symptoms. This is well established in the scientific literature.”
This statement is blatantly false. Death rates from COVID-19 are consistently and considerably higher than seasonal flu and even the most recent epidemic flu. Also, COVID is not the flu. Furthermore, it’s not just cases that are increasing: hospitalizations and deaths are increasing as well. We have several articles on this very blog where Dr. Panthagani and I write about the difference between COVID and the flu, the difference in the death rate, and also the false assertion regarding ‘false positive pandemic’.
“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.”
I don’t know what the basis of this claim is, but it is also blatantly false. The fact that our hospitals are filling up with COVID patients speaks pretty definitively to the fact that we don’t have enough herd immunity to keep our ICUs and hospitals from filling up.
“Unfortunately, you cannot completely trust what you hear from the media. They have consistently got it wrong for the past year. Since they are all supported by Big Pharma and the other entities selling the COVID vaccines, they are not going to be fully forthcoming when it comes to mRNA vaccines. Every statement I have made here is fully backed by published scientific references.”
He doesn’t include any references.
“I would be very interested to see verification that Bill and Melinda Gates with their entire family including grandchildren, Joe Biden and President Trump and their entire families, and Anthony Fauci and his entire family all get the vaccine.”
“Anyone who after reading all this still wants to get injected with the mRNA vaccine, should at the very least have their blood checked for COVID-19 antibodies. There is no need for a vaccine in persons already naturally immunized.”
This is one of Dr. Shallenberger’s few reasonable points that might hold water. There is a different risk:benefit ratio for those who have already gone through COVID because there is likely a lower risk of infection in these people, and so the benefit of vaccination is lower. It should be noted; however, that there are documented cases where people have gotten COVID more than once and the second time was worse than the first time.
Of course, as has been pointed out before, we do not know if vaccine-mediated immunity to COVID 19 will still be effective a year from now. That’s something only time will tell. Here is what the CDC currently says about the need to get vaccinated after getting COVID:
“Due to the severe health risks associated with COVID-19 and the fact that re-infection with COVID-19 is possible, people may be advised to get a COVID-19 vaccine even if they have been sick with COVID-19 before. At this time, experts do not know how long someone is protected from getting sick again after recovering from COVID-19. The immunity someone gains from having an infection, called natural immunity, varies from person to person. Some early evidence suggests natural immunity may not last very long. We won’t know how long immunity produced by vaccination lasts until we have a vaccine and more data on how well it works. Both natural immunity and vaccine-induced immunity are important aspects of COVID-19 that experts are trying to learn more about, and CDC will keep the public informed as new evidence becomes available.”
“Here’s my bottom line: 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.
Frank Shallenberger, MD, HMD”
There are several problems with this statement. First of all, COVID is far, far, far more dangerous than the vaccine. Second, Dr. Shallenberger keeps calling COVID the flu. It is not the flu. Finally, it should be noted that Dr. Shallenberger’s ‘ozone therapy’ is not in any way a ‘natural treatment’, as it involves injecting ozone gas into the blood (ozone is a free-radical producing oxygen molecule) which does not happen ‘naturally’. Here is what the FDA has to say about ozone. For more information on Dr. Shallenberger’s background, check out this article.
Dr. Sana Zekri, MD is a Family Medicine with Obstetrics Physician. His particular interests are in public health, global health, women’s health and working towards justice in medicine. He is currently an Assistant Clinical Professor at SUNY Upstate, in Syracuse, New York. The views expressed on this website do not necessarily reflect the official views of the author’s employers or affiliated institutions.