Dr Michael Yeadon and Dr Wolfgang Wodarg have filed a petition/motion with the European Medicines Agency (EMA) to stay the Phase III clinical trial(s) of vaccines for COVID-19. The main reasons seem to be related to the validity of the trial protocols and vaccine safety, particularly its effects on women’s fertility.
The document is 43 pages long, including the two (2) exhibits. This is not an attempt to summarize the document. This is merely to highlight what we consider to be a few important parts. Under section C. “Statement of Grounds” are twelve (12) paragraphs, some of which are quoted in part below.
Particularly interesting are paragraphs VIII, X, XI and XII. But first, paragraphs II, III, IV, VII and IX deal with the trial parameters and procedures, including the questioning of the validity of the PCR test.
II. Petitioner deems the current study designs for the Phase II/III trials of BNT162b (“the Pfizer/BioNTech trial”) to be inadequate to accurately assess efficacy. Petitioner also deems the designs of clinical trials of vaccine candidates designed to stop transmission of the virus from the vaccine recipient to others and/or to prevent or mitigate symptoms of COVID-19 for which PCR results are the primary evidence of infection to be inadequate to accurately assess efficacy.
III. If the assignment of cases and non-cases during the course of the trials is not accurate, the vaccines will not have been properly tested. If the vaccines are not properly tested, important public policy decisions regarding its use will be based on misleading evidence.
IV. The Pfizer/BioNTech trial protocol and other trial protocols are currently not designed to determine whether either of those objectives [to reduce COVID-19 disease and deaths] can be met; and even if it was, if cases cannot be reliably identified, neither objective could be reliably met.
VII. Petitioner hereby also incorporates the grounds, facts, arguments and opinions stated in the external peer review of the “Drosten-Test” (Exhibit B). Design flaws of certain RT-qPCR tests that are identical to or modeled after what is sometimes called the “Drosten-Test” can lead to false-positive results in trials designed such that PCR results are the primary evidence of infection.
IX. There are some concerning issues with the trial designs, spelled out by Dr. Peter Doshi in the British Medical Journal. Dr. Doshi focuses on the two biggest issues. First, none of the leading vaccine candidate trials is designed to test if the vaccine can reduce severe COVID-19 symptoms, defined as: hospital admissions, ICU or death. And, second, the trials are not designed to test if the vaccine can interrupt transmission (https://www.bmj.com/content/bmj/371/bmj.m4037.full.pdf).
As mentioned above, paragraphs VIII, X, XI and XII are particularly interesting. Said paragraphs are reproduced in part below.
VIII. For a vaccine to work, our immune system needs to be stimulated to produce a neutralizing antibody, as opposed to a non-neutralizing antibody. A neutralizing antibody is one that can recognize and bind to some region (‘epitope’) of the virus, and that subsequently results in the virus either not entering or replicating in your cells. A non-neutralizing antibody is one that can bind to the virus, but for some reason, the antibody fails to neutralize the infectivity of the virus. In some viruses, if a person harbors a non-neutralizing antibody to the virus, a subsequent infection by the virus can cause that person to elicit a more severe reaction to the virus due to the presence of the non-neutralizing antibody. This is not true for all viruses, only particular ones. This is called Antibody Dependent Enhancement (ADE), and is a common problem with Dengue Virus, Ebola Virus, HIV, RSV, and the family of coronaviruses. In fact, this problem of ADE is a major reason why many previous vaccine trials for other coronaviruses failed. Major safety concerns were observed in animal models. If ADE occurs in an individual, their response to the virus can be worse than their response if they had never developed an antibody in the first place. [Emphasis mine.]
The above highlights the fact that vaccines for coronaviruses have never been successful. This, of course, does not exclude the possibility of future success. But how convenient that the COVID-19 vaccine is being developed at record pace and pushed before it is even proven safe.
X. In the Pfizer/BioNTech mRNA vaccine candidate, polyethylene glycol (PEG) is found in the fatty lipid nanoparticle coating around the mRNA. Seventy percent of people make antibodies to PEG and most do not know it, creating a concerning situation where many could have allergic, potentially deadly, reactions to a PEG-containing vaccine. PEG antibodies may also reduce vaccine effectiveness. Pfizer/BioNTech is also inserting an ingredient derived from a marine invertebrate, mNeonGreen, into its vaccine. The ingredient has bioluminescent qualities, making it attractive for medical imaging purposes, but it is unclear why an injected vaccine would need to have that quality. mNeonGreen has unknown antigenicity. [Emphasis mine.]
The above highlights the “allergic, potentially deadly, reactions to a PEG-containing vaccine”. On top of that, there is the question of an ingredient which in effect can serve as a marker. Could this be related to genetic marking and tracking? Could this be related to what Celeste Solum discussed with David Icke regarding population reduction and control? It would seem the below supports that suspicion.
XI. Several vaccine candidates are expected to induce the formation of humoral antibodies against spike proteins of SARS-CoV-2. Syncytin-1 (see Gallaher, B., “Response to nCoV2019 Against Backdrop of Endogenous Retroviruses” - http://virological.org/t/response-to-ncov2019-against-backdrop-of-endogenous-retroviruses/396), which is derived from human endogenous retroviruses (HERV) and is responsible for the development of a placenta in mammals and humans and is therefore an essential prerequisite for a successful pregnancy, is also found in homologous form in the spike proteins of SARS viruses. There is no indication whether antibodies against spike proteins of SARS viruses would also act like anti-Syncytin-1 antibodies. However, if this were to be the case this would then also prevent the formation of a placenta which would result in vaccinated women essentially becoming infertile. To my knowledge, Pfizer/BioNTech has yet to release any samples of written materials provided to patients, so it is unclear what, if any, information regarding (potential) fertility-specific risks caused by antibodies is included. According to section 10.4.2 of the Pfizer/BioNTech trial protocol, a woman of childbearing potential (WOCBP) is eligible to participate if she is not pregnant or breastfeeding, and is using an acceptable contraceptive method as described in the trial protocol during the intervention period (for a minimum of 28 days after the last dose of study intervention). This means that it could take a relatively long time before a noticeable number of cases of postvaccination infertility could be observed. [Emphasis mine.]
XII. It appears that Pfizer/BioNTech have not yet released any samples of written materials provided to patients, so it is unclear what, if any, instructions/information patients/subjects were given regarding ADE and PEG-related issues and (potential) fertility- or pregnancy-specific issue.
The above highlights the possibility of the vaccine to cause infertility in women and that the trial protocols so far seem to avoid testing on pregnant women. Therefore, there is the practical impossibility of determining fertility-related issues in the short-term.
On a related note, this is not the first time fertility issues have been raised during this so-called pandemic. There are observations of testicular damage due to COVID-19 infection. In February 2020, Caibin Fan et al published “ACE2 Expression in Kidney and Testis May Cause Kidney and Testis Damage After 2019-nCoV Infection”. In May 2020, Ming Yang et al published “Pathological Findings in the Testes of COVID-19 Patients: Clinical Implications”. In June 2020, Youssef Kharbach and Abdelhak Khallouk published “Male genital damage in COVID-19 patients: Are available data relevant?”
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