Tag: covid-19

Just Released Documents by Pfizer Show BioNTech Paid FDA $2,875,842.00 “Drug User Fee” for COVID-19 Vaccine Approval

As the news cycle continues to focus on the Ukraine situation, the FDA complied with a court order to begin releasing 55,000 pages of Pfizer data per month that was used to authorize their COVID-19 vaccine produced with BioNTech, with the first batch quietly released yesterday, March 1st.

There are 150 documents that the public can now download here.

One of the documents released was the “Prescription Drug User Fee Payment” that BioNTech paid to the FDA on 4/20/2021 for the “COMIRNATY COVID-19 mRNA Vaccine” which the FDA subsequently approved in August of 2021.

That “Prescription Drug User Fee Payment” was $2,875,842.00. (Source.)

Another interesting document I found was the “EXTERNAL DATA MONITORING COMMITTEE” found here.

Here is the stated purpose of this “External Data Monitoring Committee”:

This External Data Monitoring Committee (E-DMC) (hereafter referred to as “the committee”) is a single, external,  independent, expert advisory group established to oversee safety and efficacy data from the BNT162 Vaccine Program. The  primary rationale for establishing the committee is to make certain that appropriate external safeguards are in place to help ensure the safety of subjects and to maintain scientific rigor and study integrity while the trial is on-going.

The committee will review accumulating safety data across all studies, as well as efficacy data in the Phase 2/3 portion of the C4591001 study. The committee will advise Pfizer regarding the safety of current participants and those yet to be recruited, as well as the continuing scientific validity of the trial. In addition to safety review by the committee, qualified Pfizer personnel will review safety data as specified in the safety surveillance review plan and will inform the committee of  significant findings. Efficacy data from the C4591001 study will be available to the committee when there is a planned  interim analysis of efficacy or if this is considered necessary to conduct a risk-benefit assessment.

And to make sure that this Committee is doing their job properly to ensure “the safety of subjects and to maintain scientific rigor,” who at the FDA is responsible to make sure this happens?

Well, that would be no one. Pfizer is the one who was responsible, and BioNTech funded it.

“Pfizer is responsible for conducting this study. BioNTech is the regulatory sponsor of this study.”

The committee members are to be free from “conflicts of interest.”

The committee members will complete a CT22-GSOP-RF01 Independent Oversight Committee Member Conflict of Interest Form. Committee members should be free of apparent significant conflicts of interest. Any potential conflict of interest that develops during a member’s tenure on the committee must be disclosed by the committee member.

And who at the FDA is responsible for assuring that this committee who is overseeing “safety and efficacy data” is free from conflicts of interest?

Well, that would be no one. Again, Pfizer is responsible for that.

“Pfizer will determine if any potential conflict requires termination of committee membership.”

The question that then begs to be answered here is, what role did the FDA play, if any, in the “external” monitoring of the data to ensure integrity and safety of a new vaccine about to be injected into hundreds of millions people in the U.S.?

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Public Health Erred on the Side of Catastrophe

Throughout the Covid-19 pandemic, proponents of lockdowns, shelter-in-place orders, mask mandates and other coercive government interventions have characterized these measures as benevolently “erring on the side of caution.” 

Now, as the grim toll of those public health measures comes into ever-sharper focus, it’s increasingly clear those characterizations were terribly wrong. 

What’s less readily apparent, however, is how the very use of the “erring on the side of caution” framing was injurious in itself—by thwarting reasoned debate of public health policies, diverting attention from unintended consequences, and buffering the Covid regime’s architects from accountability.

To understand how the misuse of “erring on the side of caution” performed a sort of mass hypnosis that coaxed populations into two years of submission to disastrous, overreaching policies, consider how the expression is typically used. 

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A FEMA document about nuclear explosions reveals the utter fatuousness of our bureaucracy

No matter the purpose for which they’re established, bureaucracies often become ends in themselves, self-perpetuating entities that generate paper to justify their existence.  That seems to be the case with FEMA, at least insofar as its rules for nuclear disasters go.  Some poor desk drone was given the task of updating FEMA documents to reflect the CDC’s ridiculous COVID requirements.  That drone worked hard, with the result being that the FEMA guidelines for a nuclear explosion now include masks and social distancing in bomb shelters.

Once again, Libs of Tik Tok has the news on her irreplaceable Twitter account.  She (or someone with whom she communicates) felt that, with Putin threatening to start a nuclear war, it might be useful to check out the government’s guidance for responding to the fallout from a nuclear attack.  That’s how we learn that someone at FEMA laboriously updated FEMA guidelines with CDC requirements about social distancing and masks.

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Biden claims COVID-19 keeps Americans from seeing ‘things have gotten so much better for them’

President Joe Biden claimed the COVID-19 pandemic has made it psychologically difficult for Americans to feel happy despite their improving economic circumstances.

During an extensive interview with Brian Tyler Cohen that aired Saturday, the progressive host asked Biden to address frustration that some Democrats might feel that the party’s agenda is not moving forward quickly enough despite Democrats controlling both Congress and the White House.

Biden replied by suggesting that the psychological toll of COVID-19 prevents some Americans from seeing the progress that has been made under his administration.

“I think the biggest impact of the psychology of the country has been COVID,” said Biden, pointing out how more than 1 million Americans have died from the virus.

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Bill Gates says we could prevent the ‘next’ pandemic if everyone acts like Australia did

We’ve done quite a few posts on the draconian measures Australia has taken to fight the spread of COVID-19. The country locked down hard, and fenced-in quarantine camps were built to contain anyone who might have been exposed.

At the Munich Security Conference earlier this month, Gates said that the next pandemic could be avoided if every country followed Australia’s example.

Megan Sauer reports:

Gates cited Australia’s Covid response as the gold standard to follow. The country reopened its international borders this week for the first time since March 2020. Over the course of the pandemic, returning citizens and approved international travelers have been required to quarantine in hotels guarded by police and military members. Australia’s states even periodically locked down their respective borders.

…

There’s reason to believe Australia’s blueprint may have been less successful elsewhere: Its population of nearly 26 million is relatively small, and it’s an island without any land borders. But Gates still called it a “true outlier.”

“They orchestrated diagnostics, they executed quarantine policies, and they have a death rate in a different league than other rich countries,” Gates said. “And everybody had the capability to do that.”

The entire continent has a population under 26 million.

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