Last week, UncoverDC reported on the FDA and CDC's pause of Johnson & Johnson's (J&J) COVID-19 vaccine due to complications from a severe but rare clotting condition known as cerebral venous sinus thrombosis (CVST), which appeared in combination with a condition called thrombocytopenia (often referred to as immune thrombocytopenic purpura, or ITP).
Essentially, ITP causes the immune system to malfunction and produces antibodies that attack the body's platelets. The most dangerous complication of ITP is bleeding in the brain, causing a cerebral hemorrhage and catastrophic brain damage or death.
In explaining the pause, the CDC reported seven women suffered thrombotic complications following the J&J vaccine. Although evidence establishes a relationship between COVID-19, thrombolysis and clotting, which is one of the main reasons for sudden decline and death with the virus, the connection between clotting and the three available COVID-19 vaccines in the United States—Pfizer-BioNTech, Moderna, and Johnson & Johnson—is less explicit.
As pandemic research continues, scientists concede that vaccine development against SARS-CoV-2 within a timeframe as tight as the ongoing COVID-19 vaccine campaign makes it difficult to thoroughly understand the long-term effectiveness and potential side effects of the current vaccines. Therefore, it is not unexpected to see complications, including death. The United States, in just four months, has administered approximately 212 million COVID-19 vaccines, with 85.3 million people now fully vaccinated, or 25.7% of the population. According to CDC data, around 85% of those receiving the Moderna COVID-19 vaccine experienced some type of reaction.
Armed with the knowledge, or lack thereof, we have thus far; most scientists would agree that when navigating through catastrophic, life-altering events that transpire quickly, it is important to pause, reflect upon, and study "how did we get here" and "what would we do differently?"
The Vaccine Road That Led Us To Where We Are Now
In Jan. 2020, immediately after China released the genetic sequence of SARS-CoV-2, the race to produce a vaccine got underway. There are close to a dozen COVID-19 vaccines currently approved for use around the world. While there are many different kinds and types of vaccines, they all have the same objective—tricking a healthy body into thinking it is under assault by a particular disease so the immune system will learn to create the cells and proteins needed to immediately fight off the disease if it becomes a threat. Simply put, vaccines are designed to create antibodies that allow the body to protect itself from future infections without actually getting sick.
The current COVID-19 vaccines approved for emergency use in the United States (and therefore do not need FDA approval) are manufactured by J&J, Pfizer, and Moderna. They each work by fooling cells into making spike proteins—the sharp bumps that protrude from the surface of the outer envelope of the coronavirus. These proteins are the pathogens needed to cause the immune system to develop resistance to the virus. For this to happen, DNA or RNA must be injected and delivered to the inside of the cells.
Johnson & Johnson and AstraZeneca's vaccines use genetically engineered viruses called adenovirus vectors to serve as a Trojan horse and carry the genetic material to the cells to create spike proteins. The J&J vaccine uses a form of human adenovirus called Ad26, and the AstraZeneca vaccine uses a genetically engineered version of a chimpanzee adenovirus. However, despite being over thirty years in the making, other than for military personnel, no approved adenovirus vaccine is available to the general public, with the technology existing commercially only in a rabies vaccine.
And while not "vaccines" in the traditional sense, using nascent technology, the Pfizer and Moderna shots are gene-modifying agents that insert synthetic, chemically protected mRNA into cells (using a chemical called polyethylene glycol, or PEG). Never before used in an approved vaccine, PEG may be the culprit behind severe allergic reactions in mRNA COVID-19 vaccines. Once in the cell, the synthetic mRNA instructs it to produce a protein matching the spike protein found on the outer surface of a SARS-CoV-2 virus molecule. The cells then eject this protein out, which triggers the creation of COVID-19 antibodies.
Hoping to achieve the same goal, both Pfizer and Moderna, who are fierce competitors, are making every effort to be the first company to bring this synthetic mRNA technology to life in a vaccine against COVID-19.
A Closer Look At Moderna, Bill Gates, and Dr. Anthony Fauci
For years, Moderna, under the leadership of Stéphane Bancel (who, along with Pfizer CEO Albert Bourla, just announced that a booster shot will probably be necessary for the company's mRNA vaccines), has been quietly working on advanced protein therapies—a multi-billion dollar industry responsible for drugs like Humara. Confident its technology would level the playing field by creating therapeutic proteins inside the body instead of in a lab and manufacturing facility, Moderna's mission has hinged on one feat that no biotech facility has successfully accomplished—harnessing mRNA.
National Institutes of Health Director Dr. Francis Collins and National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci meet with Bill Gates of the Bill and Melinda Gates Foundation to discuss research opportunities in global health in June 2017 at NIH. Credit: National Institutes of Health | FlickrCC
Long before the pandemic, Moderna (who shares ownership of its vaccine with Dr. Fauci's National Institute of Allergy and Infectious Disease, or NIAID) received awards from the federal government, including DARPA, to conduct research on mRNA. In 2016, the notoriously secretive Moderna—a Flagship Pioneering company since 2010, with twenty-one mRNA programs in its pipeline—announced a partnership with the Bill and Melinda Gates Foundation.
According to Moderna, the purpose of its collaboration with the Gates Foundation (who also funds the pandemic policy-dictating entity the Institute for Health Metrics and Evaluation, tied to Dr. Anthony Fauci) is "to advance the development of a novel, affordable combination of mRNA-based antibody therapeutics to help prevent HIV infection," with the potential for future follow-on projects of up to $100 million to "support the development of additional mRNA based projects for various infectious diseases." At the time of the partnership, Moderna was valued at close to $5 billion, making it worth more than any other private biotech lab in the country.
The Bill and Melinda Gates Foundation, along with the Johns Hopkins Center for Health Security and the World Economic Forum, sponsored the 'Global Pandemic Exercise' Event 201 on Oct. 18, 2019. The pandemic tabletop exercise "simulated a series of dramatic, scenario-based facilitated discussions, confronting difficult, true-to-life dilemmas associated with response to a hypothetical, but scientifically plausible, pandemic." Three days prior, on Oct. 15, 2019, the Coalition for Epidemic Preparedness Innovations (CEPI) launched a call for proposals to attract funding applications for ground-breaking platform technologies in order to:
Interestingly, CEPI—which supported the production of Moderna's vaccine candidate for the Phase 1 clinical trial and is supported by the Biden administration's National Strategy—was co-founded in 2017 by the governments of Norway and India, the Bill & Melinda Gates Foundation, Wellcome, (funded in part by Gates, Wellcome has a £29.1 billion investment portfolio, and is a partner with the ChanZuckerberg Initiative) and the World Economic Forum. Dr. Richard Hatchett, CEO of CEPI, had this to say of the initiative:
"We can be sure that another epidemic is on the horizon. It is not a case of if, but when. We need to be prepared. We need to invest in platform technologies that can be used to quickly respond to the emergence of a pathogen with epidemic potential."
For decades, Dr. Anthony Fauci, Director of the NIAID, has been conducting research on the coronavirus, which was first characterized in the 1960s. Throughout the current pandemic, there have been critical observations surrounding a controversial type of research banned in the U.S. by the Obama administration in 2014, called gain-of-function. The risky research requires taking wild viruses and passing them through live animals until they mutate into a form that could pose a pandemic threat. According to Dr. Peter Navarro, this research genetically engineers a virus to make it more deadly and dangerous—"to weaponize it."
Effectively side-stepping Obama's ban on gain-of-function research, Dr. Anthony Fauci and Dr. Francis Collins, at the expense of the U.S. taxpayer, intentionally moved the experiment to China. In fact, an expanding body of evidence suggests that Dr. Fauci funded scientists at the Chinese Communist Party's Wuhan Institute of Virology and other institutions to work on gain-of-function research on bat coronaviruses.
There are also well-documented concerns, examined by Dr. David E. Martin, surrounding COVID-19 and pre-pandemic research, patents, and associations between the NIAID, the University of Chapel Hill (UNC), Harvard University, Emory University, Vanderbilt University, University of Pennsylvania, and Tsinghua University. Martin's investigation also points to many other research institutions and their commercial affiliations, including that of Peter Daszak, a self-proclaimed "virus hunter" and long-time president of EcoHealth Alliance, a New York-based non-profit whose claimed focus is the business of pandemic prevention.
FDA Aware of Concerns over Clotting after mRNA Vaccines
A Dec. 17, 2020 FDA Briefing Document from Moderna stated numerous times that there were "no known neurologic, neuro-inflammatory, and thrombotic events, that would suggest a causal relationship to the Moderna COVID-19 vaccine."
Prior to that, on Dec. 8, 2020, in response to an FDA request for comments regarding Pfizer-BioNTech's COVID-19 vaccine, Patrick Whelan, M.D., Ph.D., submitted a report intended to alert the agency to the possibility that, instead of creating immunity, COVID-19 mRNA vaccines have the potential to cause injury when instructing the body to make spike proteins. In his letter to the FDA, Whelan, who urged particular caution in the mass vaccination of children before actual safety data is available, stated:
"I am concerned about the possibility that the new vaccines aimed at creating immunity against the SARS-CoV-2 spike protein (including the mRNA vaccines of Moderna and Pfizer) have the potential to cause microvascular injury (inflammation and small blood clots called microthrombi) to the brain, heart, liver, and kidneys in a way that is not currently being assessed in safety trials of these potential drugs."
The CDC and the FDA have not issued another statement following their announcement pausing the Johnson & Johnson vaccine.
Researchers Indicate Possible Connection Between Vaccines & Clots
Scientists have offered no conclusive answer to the exact cause of COVID-19 or the reason why a handful of thrombotic events following the receipt of COVID-19 vaccines completely shut down two vaccine trials. Immediately following the pause of its vaccine, J&J released a statement that was met with criticism, declaring:
"We are aware that thromboembolic events including those with thrombocytopenia have been reported with all COVID-19 vaccines."
Well‐documented cases of ITP have been reported following other drugs and vaccinations, including MMR. However, research suggests that in the absence of testing pre‐vaccination platelet counts prior to COVID-19 vaccination, combined with the time it takes to discover thrombocytopenia, it is difficult to accurately estimate the percentage of secondary ITP incidences following vaccination.
Most recently, on April 16, the New England Journal of Medicine issued an article indicating the cause of blood clots may be linked with certain coronavirus vaccines, adding that their findings have important implications for treating the condition, regardless of whether vaccines cause it. Even though the link is not yet firm, they're calling the condition vaccine-induced immune thrombotic thrombocytopenia or VITT. It's characterized by unusual blood clotting combined with a low number of platelets. Patients suffer from dangerous clots and, sometimes, hemorrhaging at the same time.
Where Does All of This Leave Us Right Now?
On average, it takes between ten and twelve years to develop a safe and effective vaccine. In fact, researchers have been searching for a vaccine against HIV—a project supported by the Bill and Melinda Gates Foundation, CEPI, BARDA, and Dr. Anthony Fauci—since the early 1980s. Unfortunately, so far, they have not been successful. Citing the pandemic, scientists have raced to shorten the time to find a COVID-19 vaccine and suggest accelerating or limiting the typical time it takes to get vaccines approved. Once COVID-19 vaccines are FDA approved and produced, researchers will begin observing the progress of the vaccinated patients, which is Phase IV of vaccine development.
As the current clinical trials on current COVID-19 vaccines continue and new emerging variants spark talks of new vaccines, the bigger question remains—what other circumstances and side effects, besides blood clots, are we overlooking or not yet fully aware of?