Dr. Joseph Mercola, DO, FACN, wrote an article on or about November 12, 2020, which was prior to the FDA Emergency Use Authorization of the Pfizer and Moderna COVID-19 Vaccines. But what Dr. Mercola wrote at that time is as topical today as it was when he wrote it. He explained how the (then proposed) COVID-19 vaccines were being administered to trial subjects without informing them of the known and very real danger of a debilitating and potentially deadly side effect called “antibody-dependent enhancement” (ADE).
Dr. Mercola cited a study that revealed the startling facts that:
COVID 19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated. Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE).
The study found that COVID-19 vaccine trial study subjects were not adequately informed of the ADE risk.
The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.
What is ADE? Dr. Mercola explains:
In a nutshell, it means that rather than enhance your immunity against the infection, the vaccine actually enhances the virus’ ability to enter and infect your cells, resulting in more severe disease than had you not been vaccinated. This is the exact opposite of what a vaccine is supposed to do, and a significant problem that has been pointed out from the very beginning of this push for a COVID-19 vaccine.
The ADE can be deadly. Dr. Mercola explains that on or about 2002 four COVID vaccines were tested. “Of those, the four best vaccine candidates were then given to ferrets, which are the closest analogue to human lung infections. … While the ferrets displayed robust antibody response, which is the metric used for vaccine licensing, once they were challenged with the wild virus, they all became severely ill and died.” That unsuccessful outcome is a rather ominous harbinger of things to come for those who have received the COVID-19 vaccine.
The graphic below is from one such study. It illustrates the two ways enhancement of disease can occur.
Indeed, we are seeing throughout the world today that persons getting the COVID-19 vaccine are subsequently finding themselves being infected with COVID-19. On April 11, 2021, the Daily Mail reported:
The mutant South African Covid-19 variant can ‘break through’ the Pfizer jab, a study has found.
Scientists studied 400 people who had tested positive for coronavirus at least 14 days after receiving one or two doses of the jab – and 400 who tested positive with no vaccine.
The variant was eight times more prevalent in those who had two jabs than none. It was seen in 5.4 per cent of people with two doses – but 0.7 per cent of people without any.
Below is a graphic from an NBC news report of the many incidents of subsequent infection with COVID-19 by people who had already been vaccinated.
Even more damning is the admission that a fully vaccinated person still poses a “potential risk of transmitting the virus to others if they become infected.”
But this is a very real moral and legal issue for the vaccine manufacturers. That is because the COVID-19 vaccines are “investigational vaccines” that have been authorized under an emergency use authorization (EUA) by the FDA. An investigational vaccine is essentially an experimental vaccine. Investigational vaccines being used under an EUA are “still in the testing and evaluation phase and are not licensed for use in the general public.”
An unapproved vaccine that is still undergoing experimental trials can be authorized for use in an emergency by the FDA. Moderna, one of the COVID-19 vaccine manufacturers, explains in their information page, the EUA legal status of the COVID-19 vaccines. “The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There is no FDA-approved vaccine to prevent COVID-19.”
Here is the rub. It is required by the EUA statute that recipients of an EUA vaccine be informed of the dangers posed by the EUA vaccine prior to administration. The statute requires informed consent for experimental vaccines being administered under an EUA. The FDA acknowledges that it is not exempt from the Federal law that requires informed consent for an EUA under 21 U.S. Code § 360bbb–3, which is the law governing the emergency use authorizations of experimental vaccines. That statute requires the following before administration of a vaccine under an EUA:
Appropriate conditions designed to ensure that individuals to whom the product is administered are informed—
(I) that the Secretary has authorized the emergency use of the product;
(II) of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown; and
(III) of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks.
21 U.S. Code § 360bbb–3(e)(1)(A)(i) (emphasis added)
The FDA thinks that providing a fact sheet to the recipients of the COVID-19 vaccines is sufficient. “Therefore, FDA recommends that a request for an EUA include a “Fact Sheet” for recipients that includes essential information about the product.”
Below are the recipient fact sheets provided by each of the vaccine manufacturers.
The problem with the fact sheets is that there is no mention in them of the known side effect of “antibody-dependent enhancement” (ADE). That side effect sensitizes vaccine recipients to be more likely to come down with COVID-19. In addition, ADA causes the recipient subject to more severe diseases than if they were not vaccinated.
Omitting any mention of ADE renders the informed consent not truly informed consent. The vaccine manufacturers, being aided and abetted by the FDA, are skirting the federal law that requires recipients of an EUA vaccine to be fully informed “of the significant known and potential benefits and risks of such use, and of the extent to which such benefits and risks are unknown.”