Tag: vaccines

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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Texas Middle School Teacher Caught on Video: ‘Those Conservative Christian People, They Need to Die. They Need to Get COVID and Die’

A Texas middle school teacher was allegedly caught telling two other women that “conservative Christians” needed to “get COVID and die” because of their political opposition to coronavirus mandates, which she says has “impacted” the “rest of [her] life.”

Radio host Dana Loesch reported that a “Colleyville Middle School teacher identified by school parents as Lisa Grimes” was captured making the remarks and that the video was “provided by a family of the school who asked to not be identified at this time.”

“We have a political system that will not allow us to [inaudible] so we’re vaccinating like the flu, which is, you know, get the flu vaccine if you want, but you can’t — don’t ‘tread on me,’” the woman in the video states.

“But it’s too late. It would have had to have been immediate. If we had done it immediately, it’d already be gone. That’s what’s frustrating. The rest of my life is impacted because of politics? Because of conservative Christian crap? I’m telling you, those conservative Christian people, they need to die. They need to get COVID and die.”

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Bill Gates-Linked Lab Developing Vaccine That Spreads Like a Virus To Vaccinate Anti-Vaxxers

A team of Bill-Gates linked research scientists have announced they are developing a needle-less vaccine that spreads itself like a virus, meaning people will “catch” the vaccine like they would a cold or flu, without the need for needles and injections.

The research is being subsidised by high-profile funding organisations, including the U.S. National Institutes of Health (NIH), which has longstanding financial ties to the Bill & Melinda Gates Foundation.

An international team of researchers are working on an experimental self-spreading vaccine that could stop the virus leaping from rats to humans — a phenomenon scientists call zoonotic spillover.

The drive to develope self-spreading vaccines is not without controversy. The DHSC paper notes: ‘Self-spreading vaccines are less lethal but not non-lethal: they can still kill.

‘Some people will die who would otherwise have lived, though fewer people die overall.

‘The other issue is there is no consent (for vaccination) from the majority of patients.’

But some ethics experts say there are parallels for ‘treating’ mass populations for public health issues without first getting individual consent.

For example, the fluoridation of mains drinking water to prevent tooth decay already happens in some parts of the UK and the Government is considering extending it to all of England.

‘Nobody is asked whether they give consent, even those who disagree with it,’ says Professor Dominic Wilkinson, a medical ethics specialist at Oxford University. ‘Instead, we entrust elected officials to examine the likely health benefits and make decisions based on the evidence.

‘I don’t think that there is anything intrinsically different when it comes to the idea of self-spreading vaccines.’

However, some scientists have serious misgivings about the risk that weakened viruses could mutate into a more potent form once they are free to spread in the population.

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New JAMA paper show Ivermectin blows the COVID vaccines out of the water

Remember that “horse dewormer” that the FDA, CDC, NIH, CNN, and Sanjay Gupta all told you not to use? A new paper recently published in the Journal of the AMA (JAMA) shows that Ivermectin works way better than the COVID vaccine in keeping you from dying from COVID.

This was an open-label randomized trial done in Malaysia with around 250 patients in each arm. One arm got IVM + standard of care, the other arm got the standard of care.

Of course, JAMA never would have published this if they thought that people would actually look at the data. The abstract says: “The study findings do not support the use of ivermectin for patients with COVID-19.” You are supposed to read the abstract and believe that ivermectin has no effect.

In fact, that’s exactly what people do even when you tell them expressly to ignore that.

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Scotland Stops Publishing Covid Vaccine Death Statistics, Blames ‘Anti-Vaxxers’ For Raising Alarm

Public Health Scotland has announced it will no longer publish information about deaths and hospitalizations related to Covid-19 vaccination status, citing concerns the data is being “misused” by anti-vaccination campaigners.

Scotland’s public health watchdog announced the sudden change in policy last week in its most recent Covid-19 report, saying the frequency and content of the data would be reviewed.

Instead, officials will focus on publishing more complex data that promotes the idea of vaccine effectiveness.

Remarkably, Public Health Scotland officials admitted they will no longer publish the vaccination status of deaths in the country due to the activities of anti-vaccination campaigners.

The report published last week will be the last weekly publication to include data which includes information on death rates, broken down by the number of doses received.

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Bill Gates: ‘Sadly Omicron Has Done a Better Job Than the Vaccines’

During an event at the Munich Security Conference, Bill Gates said that “sadly” Omicron is a “type of vaccine” and has “done a better job getting out to the world population than we have with vaccines.”

The Microsoft co-founder made the remarks after being asked to assess where the world was at in its fight against COVID-19.

“Sadly, the virus itself, particularly, the variant called omicron, is a type of vaccine, that is it creates both B-cell and T-cell immunity, and it’s done a better job getting out to the world population than we have with vaccines,” Gates lamented.

The billionaire went on to point out that 80 per cent of Africans have either been vaccinated or infected with one of the variants (with the minority having been vaccinated).

“That means the chance of severe disease, which is mainly associated with being elderly and having obesity or diabetes, those risks are now dramatically reduced because of that infection, exposure,” said Gates.

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 CDC Has Withheld COVID Data From Americans To ‘Prevent Vaccine Hesitency’

The New York Times reported this past weekend that the CDC has chosen not to publish huge amounts of COVID data, instead keeping it secret, because it fears that the information would cause ‘vaccine hesitancy’ among the American public.

The report notes that the withheld data includes information on boosters, hospitalizations, wastewater analyses, as well as critical information on COVID infections and deaths broken down by age, race, and vaccination status.

The justification for holding the information back?  Fears that the data would be “misinterpreted” and lead to “vaccine hesitancy,” according to the report.

In other words, it didn’t fit into the narrative that everyone must get vaccinated and boosted no matter who they are and what their situation is.

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