Are health authorities legally allowed to withhold critical COVID vaccine info?
February 4, 2021 (LifeSiteNews) — Some may find it difficult to believe that the U.S. federal government would falsify information or otherwise deceive millions of Americans. Others may determine the opposite. Such persons may conclude, for example, that based on the actions of the FBI and the Department of Justice (DOJ) during the “Russia collusion hoax,” even the most powerful U.S. federal government bureaus and departments may deceive millions of Americans for multiple years at a time. Further studying the methods of such entities, one will discover that, indeed, “ruses or ploys” and “strategic deceptions” “are used often” by the FBI (p. 132). Other documents from the FBI and DOJ also admit to the use of deception as a method.
But would public health officials deceive Americans? Would entities like the National Institutes of Health (NIH) and the CDC and FDA deceive Americans regarding published COVID-19 data or COVID-19 vaccine data? Some have been questioning the honesty of such entities regarding COVID-19 death counts and information about serious adverse events caused by COVID-19 vaccines that were given “emergency use authorization” in the U.S. Falsifying such information, or not publishing important information, could result in serious harm, including death, for many people; thus, Americans would expect complete honesty from public health officials, vaccine-developers, the NIH, the CDC, and the FDA.
But there is significant information in U.S. public health law that suggests otherwise. Section 801 of the Food and Drug Amendments Act of 2007 requires some clinical trial results of studied drugs (including biological products and vaccines) to be published. A complete discussion of that law is not possible here; a summary discussion of the law is here. But the law clearly states that government entities and drug- and vaccine-developers may not publish certain clinical trial results — apparently including certain results describing life-threatening adverse events and deaths — in “extraordinary circumstances” “consistent with the protection of public health” or “in the interest of national security.”
The law’s statement that the U.S. federal government may not provide certain factual drug or vaccine information is surprisingly and subtly described; it is so subtle that one may read over it without thinking twice and without realizing how huge of a deal the statement is. After describing clinical trial results which are to be submitted to the U.S. federal government for public posting, the law states:
(H) WAIVERS REGARDING CERTAIN CLINICAL TRIAL RESULTS.—The Secretary [Secretary of the U.S. Department of Health and Human Services (HHS)] may waive any applicable requirements of this paragraph for an applicable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary circumstances justify the waiver and that providing the waiver is consistent with the protection of public health, or in the interest of national security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was granted.
(I) ADVERSE EVENTS […] (121 STAT. 915; emphasis added.)
The Final Rule requirements permit the same waiver. (§11.54(a)(2)(iii))
The law does not need to be completely explained to understand the significance of the emphasized information. What need to be understood, though, are a few important distinctions that are subtly implied in the emphasized text.
Again, the intent of the law in general is to require the publication of certain clinical trial results so that patients, clinicians, and scientists are provided with knowledge. In other words, the law is saying that patients, clinicians, and scientists should be able to know certain clinical trial results.
But the emphasized text clearly states that there are “extraordinary circumstances” that are “consistent with the protection of public health, or in the interest of national security” where patients, clinicians, and scientists should not know certain clinical trial results - and where both the U.S. federal government and drug or vaccine developers are permitted to not give such information to Americans. This is a big deal.
And it is also a big deal to note that “good” clinical trial results are typically published as much as possible. Drug or vaccine developers would most likely not request a waiver to be permitted to not publish good or positive clinical trial results which would result in more people utilizing the studied drug or vaccine or improve the overall reputation of the drug or vaccine company.
Instead, it is more likely that drug or vaccine developers would request to not publish “bad” clinical trial results. And U.S. public health law apparently allows this - if the reasons are “consistent with the protection of public health, or in the interest of national security”.
So, again, one would not expect there to be “public health” or “national security” reasons to not publish “good” clinical trial results. It seems reasonable to conclude that the law is referring to “public health” or “national security” reasons where bad clinical trial results may not be published.
And what “public health” or “national security” reasons would require Americans to not be given, or not know, certain bad clinical trial results? The law itself seems to hint at what is meant. The law first mentions “extraordinary circumstances” “consistent with the protection of public health, or in the interest of national security” which may be sufficient to request a waiver to not publish certain clinical trial results.
The law then proceeds directly into discussion of clinical trial results of “Adverse Events”, which includes life-threatening adverse events and deaths.
This is a big deal; it seems pretty clear that the U.S. federal government does indeed say that there are extraordinary circumstances “consistent with the protection of public health, or in the interest of national security” where Americans may not be provided with clinical trial results discussing one or more adverse events, potentially including deaths and life-threatening adverse events.
And it seems reasonable to conclude that the reason for not publishing those clinical trial results is so that large numbers of people in the U.S. (which is implied in the law’s mentioning of “public health” and “national security”) do not refuse whatever drug or vaccine the government determines is necessary for “public health” or “national security”. There do not appear to be many other conceivable reasons, or other “extraordinary circumstances” “consistent with the protection of public health, or in the interest of national security”.
In their documents discussing the emergency use authorization applications for the COVID-19 mRNA vaccines, the FDA writes:
the Secretary of HHS [declared] that the COVID-19 pandemic constitutes a public health emergency with a significant potential to affect national security or the health and security of United States citizens living abroad […] (Page 8 and Page 8)
Both COVID-19 vaccines being distributed throughout the U.S. remain unapproved and it is unclear if any clinical trial results from those vaccines are required for public posting. What is clear, though, is that U.S. public health law describes the possibility that the U.S. federal government may not provide certain clinical trial data, including potentially life-threatening adverse events resulting from some studied drugs or vaccines, to Americans.
Throughout the last year or so, some have rightly wondered whether the U.S. federal government and public health officials have been disingenuous regarding the provision of COVID-19 death data, COVID-19 vaccine safety data, and other public health data. As the law mentioned above clearly states, when “national security” or “public health” is involved, government public health officials and others may be somewhat misleading with data. This is important information to keep in mind.