An ‘emergency authorization’ does not mean the COVID vaccines are safe
December 24, 2020 (American Thinker) — There are ongoing reports of the COVID-19 vaccine causing severe allergic reactions in recipients throughout the world. There is information that suggests that such allergic reactions, along with other dangers, were known to be associated with the COVID-19 vaccines but were covered up or wrongly downplayed prior to and during the emergency use authorization process.
Before providing that information, one should be reminded of what "Emergency Use Authorization" means. Another COVID-19 vaccine has received Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). Much of the mainstream media and many public health officials are wrongly portraying the COVID-19 vaccines as "FDA-approved." That is not true. Emergency Use Authorization is not FDA approval. In the FDA's own words:
In the event an [Emergency Use Authorization] is issued for this product, it would still be considered unapproved and would continue under further investigation (under an Investigational New Drug Application). (page 8, emphasis added)
A person who receives one of the two COVID-19 vaccines authorized for emergency use should consider himself in the realm of guinea pigs and human research subjects. (Note also: Public health and pharmaceutical officials are mostly immune to liability if one is injured or killed by the COVID-19 vaccines. Additionally, proving causation is expensive and very difficult.)
There are currently two COVID-19 vaccines that the FDA has authorized for emergency use. One was developed by Pfizer and BioNTech and is named in the literature as "BNT162b2." The other vaccine was co-developed by the U.S. federal government agency led by Dr. Anthony Fauci, the National Institute of Allergy and Infectious Diseases (NIAID), and the pharmaceutical company ModernaTX, Inc. (often simply referred to as "Moderna"). Their COVID-19 vaccine is labeled in the literature as "mRNA-1273."
A previous article discussed the cunning language used by public health and pharmaceutical officials when discussing the dangers of the COVID-19 vaccines. This article elaborates and discovers more significant information. While reading this article, it is important to distinguish between two different types of publications of COVID-19 vaccine data. One is pharmaceutical company data published in the peer-reviewed journal The New England Journal of Medicine (often read by doctors and other health care professionals), and the other is the FDA's COVID-19 vaccine data published in its Emergency Use Authorization briefing documents. There are significant in what is mentioned in the publications; the discrepancies are indications of potential cover-ups.
Again, there have been reports in the news about severe adverse reactions, including anaphylaxis and allergic reactions, to BNT162b2, the first COVID-19 vaccine given emergency authorization by the FDA. Remember, only a few weeks ago, Americans were being told that there are "no serious safety concerns" with Pfizer's and BioNTech's COVID-19 vaccine. When studying the data provided by both the FDA and Pfizer and BioNTech, one discovers that that is not completely true and was apparently known prior to emergency use authorization.
Pfizer and BioNTech published somewhat ambiguous and mostly non-specific safety data for BNT162b2 in The New England Journal of Medicine. The FDA also published data for BNT162b2. There are significant discrepancies in the data, and it appears as though Pfizer and BioNTech did not publish data that suggests that their COVID-19 vaccine may have caused a significant number of allergic reactions.
In the main peer-reviewed article on their COVID-19 vaccine, Pfizer and BioNTech ambiguously, and cunningly, write that a "favorable safety profile" was similar to their first smaller clinical trial and that "reactogenicity was generally mild or moderate." The article does not directly mention anything about hypersensitivity or allergic or anaphylactic reactions that occurred prior to emergency use authorization. Allergic, anaphylactic, or hypersensitive reactions may be serious and life-threatening events characterized by fainting, hives/urticaria, nausea, vomiting, and diarrhea, among other symptoms.
In its briefing document, the FDA uses almost identical language to the vaccine-makers', writing that "[s]afety data ... suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an [Emergency Use Authorization]." (page 6)
Yet here is the discrepancy when compared to the pharmaceutical company's information: in their review of the BNT162b2 COVID-19 vaccine, the FDA writes in a somewhat passing and overly benign manner that "adverse events potentially representing allergic reactions" were discovered "with more participants reporting hypersensitivity-related adverse events in the vaccine group (137 [0.63%]) compared with the placebo group (111 [0.51%])" (page 40) and that "[a]dverse reactions characterized as reactogenicity were generally mild to moderate. The number of subjects reporting hypersensitivity-related adverse events was numerically higher in the vaccine group compared with the placebo group (137 [0.63%] vs. 111 [0.51%])" (page 48).
If vaccine-makers and public health officials were completely truthful, they would describe allergic/hypersensitivity reactions as "severe, potentially life-threatening," and they would be given much more discussion in such an important review. It is extremely noteworthy that the FDA considers potentially deadly allergic and hypersensitive reactions a "favorable profile." If you think you are being protected by the FDA or pharmaceutical companies, you might want to think again.
Equally noteworthy is that Pfizer's and BioNTech's peer-reviewed journal article does not appear to even mention hypersensitivity or allergic or anaphylactic reactions in their COVID-19 vaccine recipients. This is a big deal; it suggests the possibility that the allergic reactions were known but were covered up or downplayed prior to or during the emergency use authorization process.
Then there is the COVID-19 vaccine co-developed by the NIAID and Moderna, known in the literature as "mRNA-1273." There are more significant discoveries in the literature with this COVID-19 vaccine that suggest that public health and pharmaceutical officials are not being completely truthful. Only a few will be mentioned in this article.
There are multiple ongoing clinical trials evaluating the NIAID/Moderna COVID-19 vaccine. One of the first clinical trials began with 45 participants on March 16, 2020 (the date is noteworthy; on February 4, the government provided "liability immunity for activities related to medical countermeasures against COVID-19" when there were only 11 active cases of COVID-19. Within a month, Dr. Fauci's NIAID had already begun a COVID-19 vaccine trial in human beings.)
A peer-reviewed report with results from that first clinical trial was published in The New England Journal of Medicine. The authors (from NIAID and Moderna) wrote that "[n]o serious adverse events were noted." But at least one person in that study experienced urticaria (hives) in both legs, which was related to the vaccine. Again, urticaria may be indicative of a potentially life-threatening allergic/hypersensitive reaction known as anaphylaxis.
That is not all. Remember, in the aforementioned article describing the NIAID/Moderna COVID-19 vaccine in only 45 participants, the authors wrote that "no serious adverse events were noted." But conveniently placed in the Supplementary Appendix (as of this writing, the previous link was not working; one may also find the Supplementary Appendix here) is the description of a participant who
had severe fever, onset the evening of the second vaccination, along with severe chills and mild fatigue, myalgia, and headache. In the early morning of the day after vaccination the participant developed recurrent severe fever, chills, fatigue, and headache, moderate myalgia and nausea, and mild arthralgia. The participant was evaluated in an urgent care center and received symptomatic treatment prior to discharge. A nasal swab specimen was negative for SARS-CoV-2 by polymerase chain reaction and positive for adenovirus by a fluorescent antibody assay. After sleeping for several hours at home, upon standing the participant was lightheaded and nauseous, vomited, and then fainted. … The unsolicited adverse events of lightheadedness and fainting (syncope) were judged as severe and related to vaccination and were classified as MedDRA® system organ class nervous disorders (Table S3). (page 12, emphasis added)
The vaccine-makers misleadingly wrote in the main article that "no serious adverse events were noted" but then conveniently discuss a person with a severe fever who fainted, described as "severe and related to vaccination," in the Supplementary Appendix. This is the type of cunning and/or negligence observable in public descriptions of COVID-19 vaccine dangers: the vaccines are wrongly publicized as having "no safety concerns," but upon reading the data, one finds safety concerns "severe and related to vaccination".
The previously mentioned participant who fainted is significant for another reason: the fainting (syncope) and lightheadedness were classified as "nervous system disorders." Here it is necessary to briefly switch back to the FDA's review of Pfizer's and BioNTech's COVID-19 vaccine — the FDA provides Table 19, which shows a significantly higher number of COVID-19 vaccine recipients experiencing "nervous system disorders" than those who did not receive the vaccine (1,158 compared to 460). But there is not much further explanation specifying what is meant by "nervous system disorders." Did any of those persons experience lightheadedness and/or fainting, and they are not mentioned because they are considered only "mild or moderate"?
Space does not permit a complete discussion, but the FDA is also misleading in its description of the lack of safety of the NIAID/Moderna COVID-19 vaccine. Its evaluation of the NIAID/Moderna COVID-19 vaccine apparently excludes mentioning the serious adverse event of the person fainting mentioned above; the FDA used a different study as "the focus" of their Emergency Use Authorization review for the NIAID/Moderna COVID-19 vaccine (page 12). This omission is suggestive of either a cover-up or a serious error.
The FDA does mention, however, that "the possibility that the vaccine contributed to" rheumatoid arthritis (the painful and debilitating disease in which one's immune system attacks one's joints) "cannot be excluded" (page 44). A large number of COVID-19 vaccine recipients in both the Pfizera and BioNTech (page 36) and NIAID and Moderna (page 50) trials experienced joint pain. Because neither vaccine has been studied long-term, one can reasonably state that rheumatoid arthritis as a major long-term effect of the COVID-19 vaccines also "cannot be excluded."
Vaccines are long-acting substances, and the COVID-19 vaccines have not been studied for, in most cases, longer than two months. Those who are studying the vaccines appear to be not entirely truthful about even their short-term dangers. The aforementioned information, along with other unmentioned information, suggests that the dangers of the COVID-19 vaccines are being covered up or wrongly downplayed by public health and pharmaceutical officials.
Published with permission from the American Thinker.
LifeSiteNews has produced an extensive COVID-19 vaccines resources page. View it here.