MCViewPoint

Opinion from a Libertarian ViewPoint

Posts Tagged ‘Emergency Use Authorization’

Federal Judge Rejects DOD Claim That Pfizer EUA and Comirnaty Vaccines Are ‘Interchangeable’ – LewRockwell LewRockwell.com

Posted by M. C. on December 3, 2021

A federal district court judge rejected a claim by the U.S. Department of Defense that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s fully licensed Comirnaty vaccine.

That means no Comirnaty lawsuit protection.

https://www.lewrockwell.com/2021/12/no_author/federal-judge-rejects-dod-claim-that-pfizer-eua-and-comirnaty-vaccines-are-interchangeable/

By Michael Nevradakis, Ph.D.
Children’s Health Defense

A federal district court judge has rejected a claim by the U.S. Department of Defense (DOD) that the Pfizer-BioNTech COVID-19 vaccine being administered under Emergency Use Authorization is interchangeable with Pfizer’s Comirnaty vaccine, which in August was fully licensed by the U.S. Food and Drug Administration (FDA).

In an order issued Nov. 12 in Doe et al. v. Austin, U.S. Federal District Judge Allen Winsor of the U.S. District Court for the Northern District of Florida denied a preliminary injunction requested by 16 service members against the U.S. Military’s COVID vaccine mandate. A hearing is scheduled for Sept. 14, 2022.

However, the judge’s acknowledgment that “the DOD cannot mandate vaccines that only have an EUA” is significant for two reasons.

One reason pertains to the difference in ingredients and manufacturing process between Pfizer’s EUA vaccine and the approved Comirnaty vaccine, and the other pertains to the legal difference between a fully licensed vaccine and an EUA vaccine.

The latter reason would apply not just to the Pfizer-BioNTech vaccine, but also to the vaccines produced by Moderna and Johnson & Johnson (Janssen), both of which are authorized only as EUA products.

Under law, everyone has ‘right to refuse’ EUA product

When the FDA approved Pfizer’s Comirnaty COVID-19 vaccine in August, approval was accompanied by a series of confusing documents and equally confusing public statements.

One such confounding statement reads as follows:

“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”

The FDA provided no explanation as to how the licensed Comirnaty vaccine and the Pfizer-BioNTech EUA vaccine could “be used interchangeably” despite having “certain differences” that make them “legally distinct.”

See the rest here

Be seeing you

Posted in Uncategorized | Tagged: , , | Leave a Comment »

RFK, Jr. to Rutgers President: COVID Vaccine Mandate Violates Federal Law • Children’s Health Defense

Posted by M. C. on March 30, 2021

The announcement last week by Rutgers University that it would require all students to get the COVID vaccine prompted CHD Chairman Robert F. Kennedy, Jr., to remind university officials that federal law prohibits mandating Emergency Use Authorization vaccines.

https://childrenshealthdefense.org/defender/rfk-jr-rutgers-covid-vaccine-mandates-violate-federal-law/

By  Children’s Health Defense Team

Rutgers University last week announced it will require all students enrolled for the 2021 fall semester to be vaccinated for COVID-19.

The announcement prompted Children’s Health Defense (CHD) Chairman Robert F. Kennedy, Jr. to remind university officials that federal law prohibits mandating products approved under the U.S. Food and Drug Administration’s Emergency Use Authorization (EUA).

In a letter to Rutgers President Jonathan Holloway, Kennedy, who also serves as chief legal counsel for CHD, wrote:

“Federal law 21 U.S.C. § 360bbb-3(e)(1)(A)(ii)(III) requires that the person to whom an EUA vaccine is administered be advised, ‘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.’”

The reason for the right of refusal stems from the fact that EUA products are by definition experimental, Kennedy wrote. “Under the Nuremberg Code, no one may be coerced to participate in a medical experiment. Consent of the individual is ‘absolutely essential,’” Kennedy wrote.

Kennedy said forced participation in a medical experiment could result in injury.

Dr. Hooman Noorchashm, who also spoke out against Rutgers’ policy, agreed. Specifically, he said, students should be pre-screened for COVID infection before vaccination.

In an open letter to Rutgers, Noorchashm, a surgeon and patient safety advocate, wrote:

“While I fully agree with your policy of maximal immunity for all students and faculty attending in-person on the Rutgers campuses, you must also remain 100% cognizant of a potential danger of indiscriminate vaccination to some of your students. This potential danger is not only a safety risk, it would also pose a risk of liability to your university.”

Noorchashm has been an outspoken critic of indiscriminate mass vaccination because he believes people already or currently infected with COVID are at risk of severe injury, including death.

As he told The Defender last week, viral antigens persist in the tissues of the naturally infected for months. According to Noorchashm, when the vaccine is used too early after a natural infection, or worse during an active infection, the vaccine force activates a powerful immune response that attacks the tissues where the natural viral antigens are persisting.

“This, I suggest, is the cause of the high level of adverse events and, likely deaths, we are seeing in the recently infected following vaccination,” Noorchashm said.

Holloway last week told The New York Times the vaccine mandate will apply to Rutgers’ three main campuses and that students will have to show “proof of vaccination” before moving into a dorm or attending in-person classes. Students will be able to file for medical or religious exemptions, and those attending online or off-campus programs will also be exempt.

NBC News last week reached out to several universities and colleges, which said they would encourage students to get the vaccine, but hadn’t yet decided on mandates.

Lynn Pasquerella, president of the Association of American Colleges and Universities, told NBC:

“I’m just starting to hear discussion about mandating vaccines, and everyone I’ve talked to has said that they are leaning in the direction of mandating vaccines not just with the students, but with faculty and staff, as well.”

According to CHD President Mary Holland, federal law prohibits employers from mandating EUA vaccines.

In December 2020, CHD published “Vaccine Mandates: An Erosion of Civil Rights?” The downloadable e-book examines the history and consequences of vaccine mandates, and what you can do to protect yourself and your family members as public officials ramp up the pressure for COVID vaccines.

Be seeing you

Posted in Uncategorized | Tagged: , , , , | Leave a Comment »

EXCLUSIVE: Hidden FDA Doc Explains Why “Liar” Fauci Opposes Hydroxychloroquine, Top Doctors Explain

Posted by M. C. on August 6, 2020

The document makes clear that Emergency Use Authorization cannot be used for more than one drug or therapeutic, and the establishment is potentially therefore saving the EUA pre-emptively for vaccines and remdesivir – patently high-value Big Pharma drugs – instead of hydroxychloroquine.

https://thenationalpulse.com/news/leaked-hydroxychloroquine-memo/

Staff Writer

A document no longer available from the U.S. Food and Drug Administration regarding “Emergency Use Authorization” of potential COVID-19 treatments appears to suggest that hydroxychloroquine satisfies the criteria for the classification, but would stand in the way of lucrative other drugs, and a vaccine. 

The possible treatment, shunned by the mainstream media and Big Tech, has far-ranging champions from Yale epidemiologists to frontline doctors to President Trump. Despite this support, corroborated by scientific studies, the medical establishment under the auspices of Dr. Anthony Fauci have refused to grant hydroxychloroquine “Emergency Use Authorization” (EUA).

July 29th documents from a Food and Drug Administration (FDA) presentation reveal, however, that the “qualifying criteria” for extending EUA to the drug appear to have been met: it “may be effective” and that “no adequate, approved, and available alternative” exists.

The document makes clear that Emergency Use Authorization cannot be used for more than one drug or therapeutic, and the establishment is potentially therefore saving the EUA pre-emptively for vaccines and remdesivir – patently high-value Big Pharma drugs – instead of hydroxychloroquine.

Dr. Vladimir Zelenko, who authored a study on the efficacy of hydroxychloroquine, outlined the medical establishment’s campaign against the drug on the War Room: Pandemic show.

He emphasized that Dr. Fauci has “lied to the American people” by insisting that authorizing a treatment for COVID-19 rests on “controlled trials to get anything through the FDA.”

“That is not true. That has never been the historical precedent and almost no other medication has ever had to meet those standards,” Dr. Zelenko continued.

He also noted that due to the sheer existence of hydroxychloroquine – a potential treatment – “available drugs like Remdesevir and the vaccine by [the FDA’s] own internal rules cannot get EUA.”

Such a classification would “facilitate the availability and use” of the drug and represents a fast-track alternative to authorizing potential life-saving treatments during public health emergencies such as the ongoing pandemic.

THE DOCUMENT IN FULL:

Or, as Dr. Zelenko describes, “there’ 150,000 dead corpses, most of which could have been avoided if Dr. Fauci did the moral and correct thing.”

Or, as Dr. Zelenko describes, “there’ 150,000 dead corpses, most of which could have been avoided if Dr. Fauci did the moral and correct thing.”

The eight-page presentation entitled “Considerations for FDA Licensure vs. Emergency Use Authorization of COVID-19 Vaccines” posits two additional prerequisites for EUA: “declaration by HHS Secretary of emergency situation leading to serious or life-threatening disease or condition,” which occurred in January, and that the “known and potential benefits of the product outweigh the known and potential risks of the product.”

Be seeing you

 

Posted in Uncategorized | Tagged: , , , | Leave a Comment »