Tag: pfizer

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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HIDDEN PFIZER TRIAL DATA SHOWS THAT ALL “VACCINATED” WOMEN IN PREGNANCY LOST THEIR UNBORN BABIES

A lawsuit filed by Public Health and Medical Professionals for Transparency produced documents from Pfizer showing that its Wuhan coronavirus (Covid-19) “vaccine” caused all of the pregnant mothers on whom it was tested to miscarry.

Entitled, “Cumulative Analysis of Post-authorization Adverse Event Reports,” a report from Pfizer describing events reported up to February 2021 – you can download that report – shows that not a single pregnant woman who took the Pfizer jabs delivered a live baby.

Table 6 of the report, titled “Missing Information,” reveals under the first topic of “Use in pregnancy and lactation” the following statement:

“Pregnancy outcomes for the 270 pregnancies were reported as spontaneous abortion (23), outcome pending (5), premature birth with neonatal death, spontaneous abortion with intrauterine death (2 each), spontaneous abortion with neonatal death, and normal outcome (1 each). No outcome was provided for 238 pregnancies (note that 2 different outcomes were reported for each twin, and both were counted).”

Taken at face value, this would suggest that of 270 pregnancies, there were 23 spontaneous abortions, five “outcomes pending,” two premature births with neonatal death, two spontaneous abortions with intrauterine death, one spontaneous abortion with neonatal death, and one normal outcome. However, there is also that tricky statement: “no outcome was provided for 238 pregnancies.”

“So really we have no idea what happened with 243 (5 + 238) of the pregnancies of these injected women; they have just not been included in the report,” reported Principia Scientific International.

“What we do know is that of 27 reported pregnancies (270 subtract 243), there are 28 dead babies! This appears to mean that someone was pregnant with twins and that 100 percent of the unborn babies died.”

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COVID COVER-UP: Pfizer INTERFERES Just Days Before Massive FOIA Vaccine Data Drop, FDA Claims The Vaccine Manufacturer Must Help Review and Redact Documents Before Public Release

Who does the US FDA answer to? Well, apparently it’s Pfizer, the German-based Big Pharma megalith.

Just days before the FDA was set to release over 12,000 documents related to the experimental Covid-19 vaccines, Pfizer asked a federal court to allow it to intervene before any information is released to the public.

Unsurprisingly, the FDA wholeheartedly agreed, asking the court to allow the vaccine maker to ‘help’ curate the documents, which would also buy the agency more time to release the much anticipated, and likely damning, data.

Conflict of interest? What’s that?

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