patrick.net

@VigilantFox
‘Unavoidably Unsafe’:
@RobertKennedyJr
Reveals the Untold Truth Why Vaccines Have Liability Protections

After getting sued heavily for the DTP vaccine, Wyeth (now Pfizer) went to the Reagan White House and demanded liability protections with the threat of getting out of the vaccine business.

President Reagan asked Wyeth why they couldn’t make safer vaccines.

And Wyeth answered that they couldn’t because vaccines are “unavoidably unsafe.” And that phrase, “unavoidably unsafe,” is in the preamble of the VICP statute.

“And so, anybody who tells you vaccines are safe and effective, the industry itself got immunity from liability by convincing the President and Congress that vaccines are unavoidably unsafe,” denoted @RobertKennedyJr

https://slaynews.com/news/covid-mrna-shots-bypassed-laws-protecting-americans-expert-warns/

Covid mRNA Shots Bypassed Laws Protecting Americans, Expert Warns

... The warning comes from a new analysis on the creation of the mRNA shots by Debbie Lerman, a graduate of Harvard and retired science writer.

Lerman uncovered evidence showing that the vaccines, that were purported to help victims fight the COVID-19 virus, were imposed on Americans by bypassing all of the “laws or regulations that we count on to protect us from potentially harmful, or deadly, medical products…”

In a report on her analysis, Lerman charges:

“The COVID-19 mRNA vaccines were acquired and authorized through mechanisms designed to rush medical countermeasures to the military during emergencies involving weapons of mass destruction (WMD).”

“These mechanisms did not require the application of, or adherence to, any laws or regulations related to vaccine development or manufacturing,” she adds.

“The Food and Drug Administration’s (FDA) Emergency Use Authorization for the vaccines was based on clinical trials and manufacturing processes conducted with no binding legal standards, no legally prescribed safety oversight or regulation, and no legal redress from the manufacturer for potential harms. (This last point is being challenged in multiple court cases, so far to no avail.)”

In the aftermath of Covid, there has been confirmed an epidemic of people dying “suddenly” or “unexpectedly.”

There are epidemics of heart-related deaths, caused by myocarditis or pericarditis, and “turbo cancers.”

The government’s own data from the Centers for Disease Control and Prevention’s (CDC) VAERS database shows spikes in heart problems among the young and soaring injuries and deaths among the vaccinated.

“What all of this means is that none of the laws or regulations that we count on to protect us from potentially harmful, or deadly, medical products was applied to the COVID-19 mRNA vaccines,” Lerman warns.

“The assertion of ‘safe and effective’ was based entirely on the aspirations, opinions, beliefs, and presumptions of government employees.”

Murder is a State level offense. So is conspiracy to commit murder.

There simply is not even one person in the entire country brave enough to bring charges against any of the conspirators.

Nothing is safe. Your best bet is water, some carbs and protein. Veggies and fruits are fine as well. I wouldn't put anything else in my body beside beer or wine because.. well I want a beer. Avoid hard liquors.

I'm not anti vaccine for those that are proven with minimal side effects. I'm not taking a vaccine for what was the common cold or even less for me. Too many people are also on bull shit prescriptions that cause more harm than good. If you need BP meds eat better and not be fat. I was never fat, but I lost weight and BP is now within a reasonable range.

I worry less about Covid vaccines though than the rest of the shit 90% of Americans ingest daily. Those other meds are exponentially worse.

https://sashalatypova.substack.com/p/memo-re-eua-countermeasures-to-send

Purpose: Clarify the legal status of EUA Medical Countermeasures (MCMs)

Pursuant to Section 564 of the FD&C Act, as amended by PAHPRA, 2013, and the Supremacy Clause of the United States Constitution (Article VI, Clause 2), EUA MCMs have potentially been exempted from testing using Good Laboratory Practices, Good Clinical Practice, including informed consent, and from being assessed to determine if Risk Evaluation and Mitigation Strategies (REMS) are necessary.

Safety regulations governing the manufacture, shipment, holding, dispensing, administration and labeling do not necessarily apply to MCMs, rather, they are subject to an opinion by FDA and HHS officials without proper Congressional or judicial review for the duration of HHS-declared emergency. The declaration of emergency is likewise without properly defined stopping criteria, nor Congressional or judicial review.

Under federal law, FDA must approve any new drug product prior to a manufacturer introducing it into interstate commerce.[1] This process requires manufacturer to open an Investigational New Drug application and obtain an exemption from the FDA for its use in regulated investigational clinical research (trials). This normal regulated process is therefore referred to as an “investigational” regulatory pathway. It requires a manufacturer to conduct regulated clinical research (trials) under the IND, obtaining Institutional Review Board’s (IRB) approval for clinical trial protocols, independent safety monitoring oversight, and properly executed informed consent from clinical trial volunteers. In addition, manufacture of the drugs and biologics subject to the investigational status is regulated by the current Good Manufacturing practices (cGMP)[2]

EUA Medical Countermeasures are a radically different, defined in law as non-investigational drugs, biologics and devices deployed under FDA’s authorization power known as the “Emergency Use Authorization” (EUA) process[3].

The EUA process is used only when the United States Secretary of Health and Human Services declares an emergency[4].

By law, the EUA process is non-investigational[5]: while the manufacturers may choose and FDA may ask to undertake some of the activities typically expected from an investigational clinical trial and manufacturing validation process, none of the typical regulatory standards are applicable in an enforceable way.

FDA has the discretion to issue an EUA if the applicant shows that its product “may be effective” in treating the relevant disease or condition[6]. It is important to emphasize the no other criteria for approval apply in an enforceable way.

FDA will approve EUA products on incomplete information so long as the applicant shows that the “known and potential benefit of the product” merely “outweigh[s] the known and potential risks”[7] and considers it unlikely that “comprehensive effectiveness data” will be available before an EUA grant. In contrast, for an investigational drug (under normal regulatory approval process) the FDA “shall” deny approval if the applicant “do[es] not show that such drug is safe.”[8]

Therefore, the EUA status of an MCM precludes collection of the investigational (subject to IRB and informed consent) clinical trial data and thus precludes reliable, valid scientific knowledge of risks and benefits associated with the EUA Countermeasure.

The EUA process precludes meaningful informed consent from the recipients of the product: while Congress mandated that FDA directly inform health care professionals and product recipients of any “significant known and potential benefits and risks,”[9] formal regulated clinical trials are neither required nor possible for a non-investigational EUA product. Thus, there is no reliable and scientifically valid information on risks and benefits of an EUA, especially for extremely novel technologies such as mRNA shots.

Furthermore, there are no required standards for quality-control in manufacturing; no inspections of manufacturing procedures; no lot-release testing and no prohibition on wide variability among lots; no prohibition on adulteration; and no required compliance with Current Good Manufacturing Practices (cGMP). EUA products, even though unregulated and non-standardized, “shall not be deemed adulterated or misbranded.”[10]

In summary, the process through which the EUA products enter interstate commerce and claims about their safety, efficacy or contents are based solely on the HHS Secretary opinion, which requires no supporting scientific evidence. Misrepresentation of safety, efficacy or contents of EUA products is allowed by federal law. Thus, claims provided by the federal health authorities or manufacturers cannot be considered reliable sources of information.

WookieMan says

I'm not anti vaccine for those that are proven with minimal side effects.

Which vaccines are proven safe and effective?

None of the childhood vaccines have been tested.
https://naturalselections.substack.com/p/childhood-vaccines-arent-tested-against