How MedShadow fakes it to discredit Dr Simone Gold – Part 3: Animal Testing
This post is the third (see parts 1 and 2 here and here) in a series responding to an attack against America’s Frontline Doctors (AFLDS) Founder Dr. Simone Gold. In an article on the website MedShadow, president and founder of the site, Suzanne Robotti, made 12 claims about Gold’s statements and activities, based on a video featuring Dr. Gold. As we have previously shown, Robotti often falsifies what Gold said, as well.[mfn]As was noted in Part 2, Robotti never provided a link or video title to her readers so that they could listen to Dr. Gold themselves.[/mfn] This attack is part of a growing trend of attacking, vilifying, and censoring any doctor who does not conform to the establishment medicine perspective on COVID-19. Many highly qualified physicians, virologists, vaccinologists, epidemiologists, and others have been maligned in this way. Astute and critical readers should make sure that an author substantiates his/her claims, and provides references that actually prove the point they are claiming it does; Robotti fails to “prove” her claims as any reader who checked her references would know. Assuming that a link or footnote is accurate without viewing it allows authors to mislead others and propagate a false narrative. Her references in her 4th claim that we are now responding to are no different.
Claim 4. Were there animal studies?
MedShadow:
Gold claims that the COVID-19 vaccines were never tested in animals. which, if true, would be concerning. Fortunately for us, her claim is false. A simple Google search of “are there any animal studies for COVID-19 vaccine?” found published animal studies in Nature.com, Cell Journal and at the NIH and was reported in FierceBiotech.com.
AFLDS: MedShadow author Suzanne Robotti must have “misunderstood” Dr. Gold. Gold never claimed that animal testing wasn’t done. What she said was (emphasis added):
“There is no independently published animal study. One of the companies said they do have animal studies, but they haven’t published any data on it. There’s been a complete rush to put this to market and you simply cannot do this safely without published data on animal studies, because animals often will die at the end, and unless we know that, we don’t know if it’s safe to give to humans.”
This is in accordance with America’s Frontline Doctors' White Paper on Experimental Vaccines For COVID-19[mfn]"America’s Frontline Doctors White Paper on Experimental Vaccines For COVID-19 - America's Frontline Doctors". Americasfrontlinedoctors.Org, 2021, https://americasfrontlinedoctors.org/2/files/americas-frontline-doctors-white-paper-on-experimental-vaccines-for-covid-19. We learn about these studies only from the company itself.[/mfn] which states:
No Independently Published Animal Studies. Most other previous vaccines have performed and published results on animal studies prior to giving to humans. This is critical because deadly effects are often not seen until this step. Vaccines that have been given to humans prior to animal trials have frequently resulted in deaths that caused the governments to yank the vaccines. Most scientists believe that human death is inevitable if there are no prior peer-reviewed animal studies.
Let’s look at the references that Robotti provided to prove that Gold was wrong. The first link (Nature.com) opens to an article published in January 2018, almost 2 years before COVID-19 appeared on the scene. The paper’s discussion about mRNA vaccines tested for other viruses does not tell us anything about how animals would fare if tested for a vaccine against SARS Cov-2. The second one (Cell), also about mRNA Vaccines, addressed the H10N8 and H7N9 flu viruses. It was published in June 2017, about 2.5 years before SARS Cov2 appeared. With the third and fourth links (NIH and FierceBioTech) MedShadow validates Gold’s contention, since neither of them were independently published studies. The NIH study reported on Moderna’s animal testing. The NIH is an umbrella government agency; many of the agencies for which the authors/researchers on this study work are part of the NIH and one researcher works for Moderna. In fact, not only does the NIH have an interest in the intellectual property patent on the vaccine[mfn]Herman, Bob. "The NIH Claims Joint Ownership Of Moderna's Coronavirus Vaccine". Axios, 2021, https://www.axios.com/moderna-nih-coronavirus-vaccine-ownership-agreements-22051c42-2dee-4b19-938d-099afd71f6a0.html [/mfn], but the NIAID (National Institute of Allergy and Infectious Diseases), also under the NIH and headed by Anthony Fauci, was involved in the Moderna vaccine trials.[mfn]Fernandez, Marisa. "Experimental Coronavirus Vaccine To Be Tested On Humans". Axios, 2021, https://www.axios.com/coronavirus-vaccine-human-clinical-trial-ff89108d-87b0-4948-a299-59ee3369eb83.html [/mfn] Funding for the study came from the various government agencies to which the researchers belong and a Burroughs Wellcome fund. Burroughs Wellcome is a pharmaceutical company. This was not an independently published study. FierceBioTech’s link opens to an article that discusses a primate study done for Pfizer’s vaccine; 52 of the 61 authors/researchers listed work for Pfizer or BioNTech, the makers of the vaccine. Competing interests include authors who are inventors on patents and patent applications related to RNA technology and COVID-19 vaccine and who hold stock and stock options in Pfizer or BioNTech. This, too, was not an independently published study. A similar study about animal testing for the Janssen vaccine was also not independently published.[mfn]Weintraub, Arlene, "J&J COVID-19 Vaccine Candidate Protects Monkeys After Single Dose". Fiercebiotech, 2020, https://www.fiercebiotech.com/research/j-j-covid-19-vaccine-candidate-protects-monkeys-after-single-dose, Mercado, Noe B., et al, “Single-shot Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques”, Nature.Com, 2021, https://www.nature.com/articles/s41586-020-2607-z_reference.pdf[/mfn] Authors/researchers for this study worked for Harvard and Janssen, among other companies. Johnson and Johnson (Janssen) was a major contributor to Harvard, funding a 2 year grant in 2014 to collaborate on a tuberculosis related project.[mfn]"Johnson & Johnson Announces New Grant to Harvard Medical School To Combat Drug-Resistant Tuberculosis | Johnson & Johnson". Content Lab U.S., 2021, https://www.jnj.com/media-center/press-releases/johnson-johnson-announces-new-grant-to-harvard-medical-school-to-combat-drug-resistant-tuberculosis [/mfn] 2018-2019 donors to Harvard included the Bill and Melinda Gates Foundation, which awarded the university $50 million for particular projects.[mfn]Burstein, Ellen M., and Caldera, Camille G., "Bloomberg, Gates, UAE Government Number Among Top Harvard Donors From 2018-2019 | News | The Harvard Crimson". Thecrimson.Com, 2021, https://www.thecrimson.com/article/2020/2/26/donor-honor-roll [/mfn] Bill Gates, a major funder of vaccines and global vaccination campaigns, declared in early 2020, that the entire world would need to be vaccinated against Covid-19. Competing interests include authors who are listed as co-inventors on provisional vaccine patents and who hold stock in Johnson and Johnson. Any time an organization receives this kind of “gift”, it is to be understood that they will not want to do anything to jeopardize their relationship with their donors, not wanting to bite the hand that feeds them. Here's some more of what we know about animal testing for COVID-19 vaccines.
Biodistribution studies
When Dr. Valerie Donaldson couldn’t find any biodistribution studies for the Pfizer, Moderna, or J&J vaccines online after 20 hours of research, she turned to her colleagues at Penn State in the Materials Research Institute; they, too, could not find any biodistribution studies online. She pointed out that the Pfizer EMA (European Medical Assessment) does make note of a biodistribution study, however, it was not included in the document. It was obtained from the Japanese government only after being requested.[mfn]"Biodistribution Of Pfizer Covid-19 Vaccine | Regenerative Medicine Center - Dr. Valerie Donaldson MD Pittsburgh, Pennsylvania PA". Web.Archive.Org, 2021, https://web.archive.org/web/20210626122319/https:/regenerativemc.com/biodistribution-of-pfizer-covid-19-vaccine/ [/mfn] The Moderna EMA[mfn]Assessment report, COVID-19 Vaccine Moderna Ema.Europa.Eu, 2021, https://www.ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf#page=47 [/mfn]also mentions an animal biodistribution study, though not one made for their Covid-19 vaccine which uses mRNA 1273. The study they referred to used mRNA 1647 and was performed in a non-GLP (Good Laboratory Practice) lab, yet they based their understanding of the biodistribution of their Covid-19 vaccine on it. This study, like the Pfizer study, was not included in the document, although it did include information about it.[mfn]They stated that “[i]t is biologically plausible that the distribution of the mRNA vaccine is determined by the lipid nanoparticle content, whereas the influence of the mRNA itself is considered very limited. Therefore, it is acceptable that the biodistribution study was performed with the same lipid nanoparticles containing another mRNA (i.e. mRNA-1647).” Note that they stated that it is “plausible”. That means they are guessing, not conducting tests to learn if this is actually what occurs in with the nano-lipid containing the Moderna mRNA. Even so, they found that the lipid nano-particles which encase the mRNA were found in the liver, as is common with such particles, the spleen, eye, “heart, lung, testis and also brain tissues, indicating that the mRNA/LNP platform crossed the blood/brain barrier…”. These tests were only performed on male rats, not female, so we could not see uptake into the ovaries; a huge amount of mRNA was found in the ovaries of test animals in the Pfizer biodistribution study (see Pmda.Go.Jp, 2021, https://www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf#page=16.[/mfn] Janssen’s EMA[mfn]Assessment report, COVID-19 Vaccine Janssen Ema.Europa.Eu, 2021, https://www.ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar-public-assessment-report_en.pdf#page=50 [/mfn] also refers to a biodistribution study which was not done with their Covid-19 vaccine formulation.[mfn]The J&J vaccine is an adenovirus vector vaccine, which uses a different mechanism to insert the mRNA into the vaccinee’s cells than the Pfizer and Moderna vaccines. The referenced biodistribution studies (for other vaccines) showed accumulation in the lymph nodes and spleen. They claimed: “Considering the removal of regions in the genome necessary for replication and the results of the two distribution studies performed with Ad26 platform, it is considered unlikely that the vector will replicate in human tissues. Notably, no biodistribution in gonads (ovaries and testes) was detected.”[/mfn] [caption id="attachment_12716" align="aligncenter" width="550"]
"Were The COVID-19 Vaccines Rushed? Here's How The Vaccines Were Developed So Fast". Nebraskamed.Com, 2021 https://www.nebraskamed.com/COVID/were-the-covid-19-vaccines-rushed.[/caption]
Important animal studies were skipped.
A STAT News article entitled “Researchers rush to test coronavirus vaccine in people without knowing how well it works in animals”[mfn]Boodman, Eric, "Coronavirus Vaccine Clinical Trial Starting Without Usual Animal Data- STAT". STAT, 2020, https://www.statnews.com/2020/03/11/researchers-rush-to-start-moderna-coronavirus-vaccine-trial-without-usual-animal-testing/[/mfn] explains that even though vaccines are normally tested on animals to see if they actually prevent infection before trialing it in human volunteers and putting them at risk, this wasn’t happening with the COVID-19 vaccines.
“I don’t think proving this in an animal model is on the critical path to getting this to a clinical trial,” said Tal Zaks, chief medical officer at Moderna, a Cambridge, Mass.-based biotech that has produced a COVID-19 vaccine candidate at record speed. He told STAT that scientists at the National Institutes of Health are working on nonclinical research in parallel.” Meanwhile, the clinical trial started recruiting healthy participants in the first week of March. That isn’t how vaccine testing normally happens. Regulators require that a manufacturer show a product is safe before it goes into people, and while it isn’t enshrined in law, researchers almost always check that a new concoction is effective in lab animals before putting human volunteers at potential risk.
Here is what the NIAID wrote about animal testing of the Moderna vaccine:
Preclinical data with Moderna’s mRNA vaccine produced promising results in animal models. Mouse experiments demonstrated that a low dose of the vaccine induced a robust neutralizing antibody response and a high-level protection against SARS-CoV-2. Moreover, vaccination of nonhuman primates with the mRNA vaccine induced robust SARS-CoV-2 neutralizing activity and notably, rapid protection in the upper and lower airways, similar to safety and immunogenicity results subsequently observed in a phase I human clinical study.
Here is the NIH stance on animal testing of COVID-19 vaccines as described in an article on the website, the Ecologist, entitled “Animal testing and the coronavirus crisis”. [mfn]Saunders, Samantha, "Animal Testing And The Coronavirus Crisis". The Ecologist, 2021, https://theecologist.org/2020/apr/16/animal-testing-and-coronavirus-crisis [/mfn]
The most forward-thinking coronavirus researchers are forgoing cruel and archaic tests on animals in favour of cutting-edge human-relevant methods. The US National Institutes of Health (NIH) decided to speed up the development of a possible vaccine by bypassing a lengthy animal testing phase in favour of testing it directly in humans. While some tests on animals were still involved in this case, NIH's decision is a huge step towards safe, straight-to-human vaccine trials in the future.
Moderna’s May 2017, White Paper - mRNA Vaccines: Disruptive Innovation in Vaccination lists rapid testing in small animals as part of a benefit of RNA vaccines over traditional vaccines.[mfn]Modernatx.Com, 2021, https://www.modernatx.com/sites/default/files/RNA_Vaccines_White_Paper_Moderna_050317_v8_4.pdf[/mfn]
Animal testing was not the only part of vaccine development to be skipped over
Hallie Levine, writing for Johnson and Johnson about their vaccine[mfn]Levine, Hallie. "The 5 Stages Of COVID-19 Vaccine Development: What You Need to Know About How A Clinical Trial Works". Content Lab U.S., 2020, https://www.jnj.com/innovation/the-5-stages-of-covid-19-vaccine-development-what-you-need-to-know-about-how-a-clinical-trial-works[/mfn] describes five steps before bringing a Covid-19 vaccine to market; animal testing wasn’t one of them. (As we saw above, the biodistribution study they depended on was not specific to their Covid-19 vaccine.) The first step was Phase 1, their Preclinical Stage: How will this vaccine work? While they claim that this is the stage to find the proper antigen (which they say can take up to 4 years), they never explained how they found the antigen to use, only that they will use the adenovirus vector to deliver the antigen. They used the adenovirus vector for their Ebola virus vaccine and investigational HIV and RSV vaccines. In Step 2 they went straight to testing on people and combined Phase 1 and Phase 2a studies which are ordinarily done separately. Phase 1 is for testing the vaccine in a small group of adults, to evaluate its safety and measure the immune response it generates. Phase 2a studies are to determine the most effective dose and learn more about safety. By combining what are ordinarily sequential steps, J&J compressed into just a few months what would ordinarily take years. Janssen acknowledges that vaccine development usually takes up to a decade from discovery. When this article was written in September 2020, they had already begun phase 3 clinical trials and hoped to have a safe and effective vaccine in 2021. Now we know how they produced it so quickly, but can we really know that it’s safe and effective?
The consequences of rushing a vaccine to market
Under the section heading “Unique challenges of vaccine trials for COVID-19: Potential implications for liability”, a law firm addressing Covid-19 vaccine manufacturers [mfn]"Accelerated Covid-19 Vaccine Clinical Trials | JD Supra". JD Supra, 2021, https://www.jdsupra.com/legalnews/accelerated-covid-19-vaccine-clinical-95853/#_ednref8[/mfn] pointed out that
… prior to clinical testing in healthy volunteers, there is usually extensive testing of safety in non-human primates. In addition, the transition from animal studies to the progression from phase 1 through phase 3 clinical testing is usually sequential and cautious because of prior historical experience of unanticipated safety issues during vaccine development. … In the acceleration of vaccine development for COVID-19, there are also potential safety risks related to shortening and overlapping the safety evaluation processes that are usually sequential, including very rapid exposure to large populations of healthy people and contemporaneous testing in animals. … Companies should also consider including a statement in their informed consent documents explaining the accelerated nature of the clinical trial and noting the potential additional risks inherent to the abbreviated timeline. For example, human trials may be proceeding without the benefit of data normally gathered from animal studies …
And what will be the consequence of this rushed development of the vaccine where animal testing is abbreviated, clinical studies are rushed and overlapping, and independent studies are lacking?
… ethicists aren’t so sure that the eventual benefits of rushing this unproven vaccine into clinical trials will outweigh the risks. “Outbreaks and national emergencies often create pressure to suspend rights, standards and/or normal rules of ethical conduct. Often our decision to do so seems unwise in retrospect,” wrote Jonathan Kimmelman, director of McGill University’s biomedical ethics unit …[mfn]See footnote 13[/mfn]
Dr. Gold was right to be concerned about the lack of independently published animal studies.
