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Minutes of a US Food & Drug Administration advisory committee meeting titled, “Vaccines and Related Biological Products,” presented online on October 22, 2020, included a 27 slide powerpoint
presentation by Steve Anderson, PhD, MPP Director, Office of Biostatistics & Epidemiology, Center for Biologics Evaluation and Research (CBER). Slide 16 of his presentation included a “DRAFT Working
list of possible adverse event outcomes” associated with the imminent rollout of COVID-19 vaccines subject to FDA safety surveillance, showing that death, as well as 21 other conditions (most of which are possibly life-threatening), are listed as possible adverse outcomes of the COVID-19 vaccines.
Possible adverse reactions shown in the FDA working list include:
- Guillain-Barré syndrome
- Acute disseminated encephaloymelitis (“Characterized by a brief but widespread attack of inflammation in the brain and spinal cord that damages myelin – the protective covering of nerve fibers,” according to NIH.)
- Transverse myelitis
- Encephalitis/ myelitis/ encephalomyelitis/ meningoencephalitis/ meningitis/ encepholaphathy
- Convulsions/seizures
- Stroke
- Narcolepsy and cataplexy
- Anaphlyaxis
- Acute myocardial infarction
- Myocarditis/pericarditis
- Autoimmune disease
- Deaths
- Pregnancy and birth outcomes
- Other acute demyelinating diseases
- Non-anaphylactic allergic reactions
- Thrombocytopenia
- Disseminated intravascular coagulation
- Venous thromboembolism
- Arthritis and arthralgia/joint pain
- Kawasaki disease
- Vaccine enhanced disease
The list also notes “Multisystem Inflammatory Syndrome in Children” as one possible outcome following vaccination.
The implications of this presentation are highly concerning. FDA staff are clearly aware of the possibly lethal side effects of the COVID-19 vaccines and are preparing in advance to be on the look out for such adverse outcomes through “post-marketing survellience.” This approach violates the precautionary principle, which requires that a medical intervention be proven safe before being released onto the market. If it is known that the product may cause harm, and especially death, in advance, and still released without the public being fully informed of these risks, this constitutes an egregious violation of the medical ethical principles established through the Nuremberg code in order to prevent human rights violations.
While potentially fatal adverse reactions to mRNA vaccines were generally discussed throughout the meeting, the slide presentation's contents were not covered in-depth although such a lengthy list of potential problems would, in any other circumstances be enough to cause the product to be denied any level of approval. Given the extremely low Infection to fatality rate (IFR) of COVID in all but the very old or those with serious long term medical conditions one has to wonder what agenda was served by the emergency use approvals granted to the Pfizer and Moderna vaccines.
The meeting came while the FDA was considering granting emergency use authorization to Pfizer and Biontech’s experimental jab although as we can now see that approval was a foregone conclusion no matter how strong the case might be for denying these amoral and piratical corporations to unleash their untested, experimental products on the general public.
Despite the long list of known possible side effects, the FDA granted Pfizer emergency use authorization on December 11, 2020, about two months after the meeting.
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