Monday, December 19, 2022

The Bible

I have done a bit more writing about Bible topics. My latest is about Methuselah. See here


FDA’s Peter Marks Starts Recognizing the Failures of the COVID-19 Vaccines

A controversial figure of late, Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) has been front and center in the regulatory agency’s aggressive greenlights associated with the COVID-19 vaccines during the pandemic.

Among other things, the agency has been criticized for dropping its rigorous standards during the COVID-19 Public Health Emergency at least, when applied to the mRNA vaccines targeting SARS-CoV-2.

Interestingly, Dr. Marks has now gone on the record in a piece published in JAMA Network titled “Urgent Need for Next Generation COVID-19 Vaccines” in a clear recognition that the current “version 1.0”, first generation COVID-19 vaccines are no longer viable to protect the American public. This media has labeled the COVID-19 vaccines as novel, version 1.0 since the late spring of 2021, when it became very apparent that vaccine durability challenges coupled with a mutating virus (which was called out by critical scientists from the start) represented a challenge for vaccine durability.

While TrialSite maintains the COVID-19 vaccines partially blunted the sharp edge of the pandemic, initially they did so at a severe cost. The vaccines were bundled in a program precluding any serious embrace of early care with repurposed drugs, orchestrated government censorship of media and social tech, and harassment of doctors that dared question any moves by Washington DC or industry all representing perhaps, one of the greatest public health failures in modern history. More people died in America from SARS-CoV-2 than any other nation despite the vast trillions, sophisticated technologies and supposed state-of-the-art vaccines.

From the start influencers such as the Food and Drug Administration, National Institutes of Health, and Centers for Disease Control and Prevention, not to mention academic medicine, big hospital administration, and industry all bought in hook, line, and sinker into the scheme that mass COVID-19 vaccination would control and eradicate SARS-CoV-2, the virus behind COVID-19.

In fact, the World Health Organization (WHO) specifically established the 70% vaccination rate as a target threshold to achieve herd immunity. But from near the start this media, and a minority of independent, critical scientists questioned aloud that logic. Could a dynamic RNA virus that mutates like say, HIV or influenza, be controlled by a novel mass vaccination scheme? Has the flu been controlled out of existence?

This seemed a crap shoot at best, yet the U.S. federal government and its health agencies along with other of the world’s richest most sophisticated economies bet the proverbial farm on novel technology in a way that was guaranteed to not work as intended. Was this a totally desperate move or part of some orchestrated response to advance a biomedical platform?

While the vaccines worked to induce antibodies for short bursts, they did save lives, especially earlier on. But within months (Delta appeared by spring of 2021) of the mass vaccination program it was apparent that they failed to control the spread of the pathogen, exhibited poor durability, and were associated with a disturbing safety signal in the Vaccine Adverse Event Reporting System.

While by the summer of 2021 the whole program should have been under investigation President Biden ordered mandates across the board by September 2021. Now two years later since they were first released on the market Peter Marks initiates a dialogue paving the way to sunset these products, thinking ahead for a next generation of more effective, safety COVID-19 vaccine. But that’s not enough.

Now on the record, that while issues of “vaccines access and hesitancy present throughout the pandemic are partially responsible,” the relentless, or in his words “ceaseless progression of increasingly transmissible variants, recently including BF.7 and BQ.1.1 presents a major challenge to medical interventions, particularly vaccines.”

TrialSite recently showcased a couple studies that indicate real trouble when it comes to the recently authorized bivalent Omicron BA.4/BA.5 vaccine booster effectiveness against subvariants such as BQ.1.1. Put simply, these vaccines don’t work very well against a continuously evolving virus.

To date, the original primary series (2 dose) regimen (mRNA vaccines from Pfizer-BioNTech and Moderna) was introduced by December 2020, followed by two additional booster doses due to waning effectiveness. Then by September, the FDA cleared on an emergency basis without clinical data the bivalent Omicron BA.4/BA/5 booster vaccine in a response to mutated subvariants that evade vaccine-induced antibodies with ease. The FDA sought to respond to the ongoing genetic evolution of SARS-CoV-2 seemingly, the best way it could with the latest booster doses from both Pfizer-BioNTech and Moderna.

The market demand has been very weak for the bivalent booster products and yet the FDA has continued to evidence questionable behavior, such as ongoing promotional campaigns that attempt to create tension among family members who aren’t yet boosted. See “FDA Uses Little Girl to Market Moderna and Pfizer Bivalent Jabs—Crosses a Line Yet Again.”

With no definitive clinical data, Marks continues to promote the current products, declaring in his piece that the bivalent boosters may not only reduce morbidity and mortality but also “may also reduce the amount of symptomatic disease and associated health care use.” But he conveys throughout the article that the time has come to move on from these current products.


COVID Report Raises Further Questions About Confidence in Virus Origins, and Intelligence Community

On Wednesday night, as Sarah covered, Fox News revealed a report from Republicans on the House Intelligence Committee looking into the origins of the COVID-19 virus. The report was released by minority staff members of the House Permanent Select Committee on Intelligence. In a press call held Thursday afternoon, Rep. Brad Wenstrup, (R-OH), a doctor who is a member of the committee, declared that such a report is "just the beginning."

A particularly memorable finding is that the virus may have origins through a Chinese bio weapons program. It becomes even more memorable in that Rep. Wenstrup mentioned during the call that a report from the intelligence community claims there is supposedly agreement that the virus was not developed as such a weapon.

The congressman is especially interested in knowing who came up to what he referred to as this "broad agreement," and as to what level of confidence there was. The certainty of that level of confidence was not included in the report, though, nor was the basis for why the report indicated as much.

Wenstrup spoke further about this supposed "broad agreement" when taking a question from Townhall, confirming that there is an expectation to just take the report's word for it, though he does hope to get to the bottom of that basis. "Where's the accountability for who's making those comments," the congressman wondered. While he agreed that those putting out such a report should have to answer for it, he confirmed that they haven't done so.

When asked during a follow-up about what such lofty and entitled expectations mean for trust in the intelligence community, the congressman acknowledged trust becomes a problem and "is greatly diminished." This acknowledgment comes from both sides of the aisle, with Democratic members indicating as much as well, the congressman confirmed.

"The way you develop trust and confidence is through transparency," Wenstrup offered. When it comes to entitlement, if anyone is entitled, it ought to be the members of this select committee. "There's nothing they should be keeping from us," the congressman insisted, a point he would make throughout the call, especially when it comes to fulfilling their duties. "It's our job to ask these questions and have that type of understanding," the congressman would say during the call as well. Findings about COVID origins are "something I think we're entitled to understand" he said.

When it comes to that trust, the congressman also shared that they have a responsibility of oversight on the committee. "When we're not getting our questions answered, there is a breakdown of trust," something the committee hopes to dispel.

As to other theories for COVID origins, Wenstrup mentioned that, other than the article hypothesizing as much, he hasn't seen evidence that the virus came from nature. One such theory propagated, to the point that those who dare to mention a lab leak or bio weapon have been ostracized, is that it originated at a wet market. While the congressman noted that the wet market could have been the first super spreader, that doesn't mean that's where the virus came from. While the origin of a virus usually can be found within the animal world, that was not the case when it comes to the animals that were tested for this virus.

Transparency, Wenstrup spoke to, is also crucial when it comes to America being prepared for any future viruses and pandemics. We can do that "by learning what is going on and what our adversaries are doing," especially if it comes to China having a bio weapon and/or developing their own virus along with their own vaccine. This is a matter of national security as well.

The press call was billed to be about sharing bombshells, and the stunning lack of transparency from the intelligence community report was not the only revelation. For instance, China having its own vaccine is not merely a hypothetical, as they looked to have a vaccine patent so quickly after the virus was unleashed, something Wenstrup mentioned was not all too common and "you scratch your head over."

A lack of transparency was, unfortunately, a theme and point of concern throughout the call. On the ever-pressing issue of gain-of-function and taxpayer funding of it through the grants involved, Wenstrup lamented that they "haven't had the right people in front of us" to answer questions.

Other pressing issues and potentially damning revelations lie with China's accountability. In answering a question from a reporter as to if the Chinese Communist Party (CCP) appears to be emboldened by the lack of accountability, Wenstrup believes that they likely have, especially since it appears they can get away with it. A lack of accountability "would embolden anybody who is in this situation," he offered. If China did in fact create the virus, Wenstrup pointed out, they would have something to lose on the world stage.

"If there was negligence, we certainly should hold someone accountable," the congressman offered.

When it comes to the lack of accountability, and how the CCP is indeed feeling emboldened by this, the mainstream media deserves some of the blame too, in insisting on the theory that occurred in nature, for instance. Who can forget how ostracized Sen. Tom Cotton (R-AR) was for daring to suggest early on that the virus may have been manufactured in a lab? The New York Times in February 2020 declared it to be "a fringe theory," for instance.

"If our own media is saying you can't tell the other story, that's a problem," Wenstrup mentioned. Thus, China becomes further emboldened if "they feel America can't do anything about this."

There may even be issues for President Joe Biden, as brought up by a reporter on the call, especially when it comes to transparency issues and how the president has (or has not been) discussing COVID with Xi Jinping. Despite how much Biden has touted his relationship with the Chinese leader, the president appears to have failed to discuss the virus' origins of the virus, as Katie highlighted at the time about the two leaders meeting last month.

While the congressman wished to stick to how he was looking "into the science of" the virus as a physician, there was an acknowledgment that transparency concerns with Biden "might be part of a bigger picture."

Wenstrup also sought to emphasize that there is a bipartisan quest for truth on this. Even those who want to find out the origins of the virus without getting into the blame game yet, with Wenstrup mentioning being part of those group of people, there is nevertheless "a lot of evidence that raises eyebrows."

The congressman told reporters he hopes for the classified report to ultimately be declassified.




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