Researcher Blows the Whistle on Pfizer Vaccine Trials

Texas: Brook Jackson, a regional director for Ventavia Research Group that was conducting trials for Pfizer in Texas, told the British Medical Journal (BMJ) that Ventavia falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. After she repeatedly notified Ventavia of the problems, she emailed a complaint to the US Food and Drug Administration (FDA), and was fired the same day. The FDA failed to inspect Ventavia after Jackson filed the complaint. Jackson blew the whistle and made her complaint to the FDA in September 2020, but the mainstream media has ignored this information. The FDA approved Pfizer’s Covid vaccine on December 11, 2020.

In autumn 2020 Pfizer’s chairman and chief executive, Albert Bourla, released an open letter to the billions of people around the world who were investing their hopes in a safe and effective covid-19 vaccine to end the pandemic. “As I’ve said before, we are operating at the speed of science,” Bourla wrote, explaining to the public when they could expect a Pfizer vaccine to be authorised in the United States.1

But, for researchers who were testing Pfizer’s vaccine at several sites in Texas during that autumn, speed may have come at the cost of data integrity and patient safety. A regional director who was employed at the research organisation Ventavia Research Group has told The BMJ that the company falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events reported in Pfizer’s pivotal phase III trial. Staff who conducted quality control checks were overwhelmed by the volume of problems they were finding. After repeatedly notifying Ventavia of these problems, the regional director, Brook Jackson (video 1), emailed a complaint to the US Food and Drug Administration (FDA). Ventavia fired her later the same day. Jackson has provided The BMJ with dozens of internal company documents, photos, audio recordings, and emails.

Poor laboratory management

On its website Ventavia calls itself the largest privately owned clinical research company in Texas and lists many awards it has won for its contract work.2 But Jackson has told The BMJ that, during the two weeks she was employed at Ventavia in September 2020, she repeatedly informed her superiors of poor laboratory management, patient safety concerns, and data integrity issues. Jackson was a trained clinical trial auditor who previously held a director of operations position and came to Ventavia with more than 15 years’ experience in clinical research coordination and management. Exasperated that Ventavia was not dealing with the problems, Jackson documented several matters late one night, taking photos on her mobile phone. One photo, provided to The BMJ, showed needles discarded in a plastic biohazard bag instead of a sharps container box. Another showed vaccine packaging materials with trial participants’ identification numbers written on them left out in the open, potentially unblinding participants. Ventavia executives later questioned Jackson for taking the photos.

Early and inadvertent unblinding may have occurred on a far wider scale. According to the trial’s design, unblinded staff were responsible for preparing and administering the study drug (Pfizer’s vaccine or a placebo). This was to be done to preserve the blinding of trial participants and all other site staff, including the principal investigator. However, at Ventavia, Jackson told The BMJ that drug assignment confirmation printouts were being left in participants’ charts, accessible to blinded personnel. As a corrective action taken in September, two months into trial recruitment and with around 1000 participants already enrolled, quality assurance checklists were updated with instructions for staff to remove drug assignments from charts.

In a recording of a meeting in late September2020 between Jackson and two directors a Ventavia executive can be heard explaining that the company wasn’t able to quantify the types and number of errors they were finding when examining the trial paperwork for quality control. “In my mind, it’s something new every day,” a Ventavia executive says. “We know that it’s significant.”

Ventavia was not keeping up with data entry queries, shows an email sent by ICON, the contract research organisation with which Pfizer partnered on the trial. ICON reminded Ventavia in a September 2020 email: “The expectation for this study is that all queries are addressed within 24hrs.” ICON then highlighted over 100 outstanding queries older than three days in yellow. Examples included two individuals for which “Subject has reported with Severe symptoms/reactions … Per protocol, subjects experiencing Grade 3 local reactions should be contacted. Please confirm if an UNPLANNED CONTACT was made and update the corresponding form as appropriate.” According to the trial protocol a telephone contact should have occurred “to ascertain further details and determine whether a site visit is clinically indicated.”

Worries over FDA inspection

Documents show that problems had been going on for weeks. In a list of “action items” circulated among Ventavia leaders in early August 2020, shortly after the trial began and before Jackson’s hiring, a Ventavia executive identified three site staff members with whom to “Go over e-diary issue/falsifying data, etc.” One of them was “verbally counseled for changing data and not noting late entry,” a note indicates.

At several points during the late September meeting Jackson and the Ventavia executives discussed the possibility of the FDA showing up for an inspection (box 1). “We’re going to get some kind of letter of information at least, when the FDA gets here . . . know it,” an executive stated.

Read full article here…




Explosive Video from Group Representing 500 Doctors and Scientists Exposes Pfizer Vaccines

The Canadian Covid Care Alliance (CCCA), a group of more than 500 independent Canadian doctors, scientists, and health care practitioners, blows the lid off of Pfizer’s clinical trials, the vaccine roll out based on bad science, and Pfizer’s conflicts of interest.

Link for video on Bitchute:  https://www.bitchute.com/video/RaQkNEzpAdQo/

Link for PDF:   https://www.canadiancovidcarealliance.org/wp-content/uploads/2021/12/The-COVID-19-Inoculations-More-Harm-Than-Good-REV-Dec-16-2021.pdf

Summary by JW Williams

The Canadian Covid Care Alliance (CCCA) is a group of more than 500 independent Canadian doctors, scientists, and health care practitioners who are committed to providing quality, evidence-based information about Covid-19 to the public. CCCA published a ground breaking analysis of the Pfizer shot and the company’s clinical trial and reports.

Pfizer claimed the shots were safe and showed 95% efficacy 7 days after the 2nd dose. But CCCA points out that the 95% figure is deceptive because it compares the number of people diagnosed with Covid from both groups, 8 people in the vaccinated group, contrasted with 162 people in the unvaccinated group, which appears to show quite a reduction in risk, but the sample size is minuscule because it was taken from a population of more than 36,000 volunteers. This inaccurate method is called the Relative Risk Reduction (RRR). The Absolute Risk Reduction (ARR) is more exact as it considers the total population of 36,000 participants and shows that the vaccine provides a risk reduction of less than 1%. CCCA asks how many people would have gotten the vaccine if they knew it would provide less than 1% protection from Covid.

During the first two months of the clinical trial, 15 people from the vaccinated group died and 14 people from the placebo group died. Pfizer, after only two months into the clinical trials, ‘unblinded’ the study and informed the participants whether they had received a vaccine or a placebo. Pfizer then encouraged those who got the placebo to take the Pfizer shot, and most of them did. After the placebo group was vaccinated, 5 more people died.

Pfizer’s own 6-month report data on its COVID-19 inoculation shows that greater illness and death in the inoculation group than the placebo group. Pfizer had a poor trial design,  was missing data, failed to track biomarkers and had numerous other problems with their clinical trial and reports.

Pfizer never tested their shot for spread reduction or transmissibility, therefore, vaccine passports, which are purported to reduce the spread of Covid by separating the vaccinated from the unvaccinated, are not justified.

This video is overflowing with shocking evidence of harm caused by Pfizer’s vaccine. Dr. Robert Malone, who says he invented mRNA, was reported to be permanently kicked off of Twitter after posting this video.




Moderna and Pfizer Eliminated Safety Study by Removing Placebo Group

Moderna and Pfizer vaccine clinical trials involve tens of thousands of volunteers and were conducted in the customary way with a control group being given a placebo so the number and types of adverse reactions can be compared to those who received the real vaccine. However, during the trial, the companies decided to break protocol and tell everyone in the control group they were not vaccinated and offered them a choice of staying in the study or accepting the vaccine. Virtually all them asked for the vaccine. The final FDA authorization and approval for the vaccines are based on the outcome of these trials, but the control group had been removed, which means a safety study was never conducted. This is such a gross violation of standard scientific procedure that could not have been accidental. -GEG

According to NPR, the doctors lost the control group in the Johnson County Clinicial Trial (Lexena, Kansas) on purpose: “Dr. Carlos Fierro, who runs the study there, says every participant was called back after the Food and Drug Administration authorized the vaccine. “During that visit we discussed the options, which included staying in the study without the vaccine,” he says, “and amazingly there were people — a couple of people — who chose that.”

He believes those individuals were spooked by rumors about the vaccine’s safety. But everybody else who had the placebo shot went ahead and got the actual vaccine. So now Fierro has essentially no comparison group left for the ongoing study.  “It’s a loss from a scientific standpoint, but given the circumstances I think it’s the right thing to do,” he says. (read more)

Just so we are clear, the final FDA authorization and approval for vaccines is based on the outcome of these trials.  As noted in the example above, the control group was intentionally lost by saying it was “the right thing to do”, so there is no way for the  effectiveness or safety of the vaccine to be measured.

Read full article here…




Report: Maddie, a 12-Year Old Girl Enrolled in a COVID-19 Vaccine Trial for Children, Has Severe Injuries

COVID-19 vaccine manufacturers are now conducting clinical trials on children age 6 months to 12 years old. The children are volunteered by their parents who sign them up for the unethical trials. A young woman on Youtube, whose channel is called WhatsHerFace, reported on Facebook posts and her communications with the family of a 12-year old girl named Maddie who was severely damaged after taking part in a COVID-19 vaccine trial. Maddie’s injuries include paralyzation from the waist down, inability to urinate on her own, a bowel obstruction, excruciating pain, fainting episodes and other neurological problems. It was unclear which vaccine, Pfizer, Moderna or Johnson and Johnson, she received.




India Challenges Pfizer to Perform Clinical Trial on Its Covid Vaccine, Pfizer Drops Out


Pfizer has withdrawn an application for emergency-use authorization of its COVID-19 vaccine after India asked for a small, local trial on the vaccine’s safety. Indian health officials say they generally ask for these trials to determine if a vaccine is safe and if it generates an immune response in its own citizens, whose genetic makeup can be different from people in Western nations. Two other vaccines – from AstraZeneca and Bharat Biotech – have been approved. Pfizer claims that its application was supported by data from a global study that showed an overall efficacy rate of 95% with no vaccine-related, serious safety concerns – but they were not willing to allow a new trial to prove it. -GEG

Pfizer Inc has withdrawn an application for emergency-use authorisation of its COVID-19 vaccine in India that it has developed with Germany’s BioNTech, the company told the Reuters news agency on Friday.

The United States company, which was the first drugmaker to apply for emergency use authorisation of its COVID-19 vaccine in India, had a meeting with the country’s drugs regulator on Wednesday and the decision was made after that, the company said.

Read full article here…




NYT: 2 Alaska Healthcare Workers Given Emergency Treatment After Taking Pfizer’s COVID-19 Vaccine

After taking Pfizer’s experimental mRNA Covid-19 vaccine, one worker at Bartlett Regional Hospital in Juneau, Alaska suffered from a potentially life-threatening allergic reaction and had to be injected with epinephrine and steroids and was also hospitalized. A second worker at the same hospital had to be taken to the ER and treated with epinephrine and other drugs. Pfizer’s Covid-19 vaccine is an experimental vaccine that received emergency-use authorization, and it has not been fully tested. -GEG

From the New York Times:

Two health care workers at the same hospital in Alaska developed concerning reactions just minutes after receiving Pfizer’s coronavirus vaccine this week, including one staff member who was to remain hospitalized until Thursday.

Health officials said that the cases would not disrupt their vaccine rollout plans and that they were sharing the information for the sake of transparency.

The first worker, a middle-aged woman who had no history of allergies, had an anaphylactic reaction that began 10 minutes after receiving the vaccine at Bartlett Regional Hospital in Juneau on Tuesday, a hospital official said. She experienced a rash over her face and torso, shortness of breath and an elevated heart rate.

Dr. Lindy Jones, the hospital’s emergency department medical director, said the worker was first given a shot of epinephrine, a standard treatment for severe allergic reactions. Her symptoms subsided but then re-emerged, and she was treated with steroids and an epinephrine drip.

When doctors tried to stop the drip, her symptoms re-emerged yet again, so the woman was moved to the intensive care unit, observed throughout the night, then weaned off the drip early Wednesday morning, Dr. Jones said.

Dr. Jones had said earlier Wednesday that the woman was set to be discharged in the evening, but the hospital said late Wednesday that she was remaining another night.

The second worker received his shot on Wednesday and developed eye puffiness, lightheadedness and a scratchy throat 10 minutes after the injection, the hospital said in a statement. He was taken to the emergency room and treated with epinephrine, Pepcid and Benadryl, although the hospital said the reaction was not considered anaphylaxis. The worker was back to normal within an hour and released.

Read full article here…




Brazil: Volunteer in Covid-Vaccine Trial Dies

A volunteer has died in Brazil’s safety trial of AstraZeneca’s experimental coronavirus vaccine. The Brazilian health department says there was no reason to stop the trial. Authorities are refusing to disclose whether the volunteer who died took the vaccine or a placebo. Vaccine advocates say volunteers in clinical trials can die for any number of reasons that may not be related to the vaccine, but they fail to say what the cause was.

In July, AstraZeneca paused its global trials after another volunteer was found to have “an undiagnosed case of multiple sclerosis” that also was said to be unrelated to the vaccine. In September, the vaccine manufacturer paused its global trials again when a 37-year old woman experienced an inflammation of the spinal cord after receiving her second dose of the vaccine and had to be hospitalized. The trial has resumed in the UK, but is on hold in the US. -GEG

A volunteer in Brazil’s trial of AstraZeneca’s experimental coronavirus vaccine has died, the Brazilian health agency Anvisa announced on Wednesday, but organizers said there was no reason to stop the trial — an indication that the death is not linked to the vaccine.

Anvisa said that it was notified of the death on Monday but the International Evaluation and Security Committee overseeing the trial recommended that the trial continue. It was not clear whether the volunteer received the vaccine or a placebo shot as part of the trial, and Anvisa said no more information was being released for reasons of medical privacy.

“All significant medical incidents, whether participants are in the control group or the Covid-19 vaccine group, are independently reviewed. Following careful assessment of this case in Brazil, there have been no concerns about safety of the clinical trial and the independent review in addition to the Brazilian regulator have recommended that the trial should continue,” Oxford University told CNN in an emailed statement on Wednesday.

Read full article here…




South Africans Against COVID Vaccine Trials Tell Gates “We Are Not Your Lab Rats”


South Africa: Demonstrators rallied against the Bill and Melinda Gates Foundation’s GAVI Alliance that will conduct the continent’s first COVID-19 vaccine clinical trials on 2,000 volunteers. The protest’s organizer said that while she’s not anti-vaccine, she fears the country’s uninformed population may be exploited and she cited French researcher Jean-Paul Mira who in April proposed, “Shouldn’t we be doing this study in Africa where there are no masks, no treatment, no intensive care, a little bit like we did in certain AIDS studies or with prostitutes?”

On its website, even GAVI admits the African people are skeptical because of their history of being used as guinea pigs in previous scientific experiments: “Vaccine trials in Africa are a sensitive and potentially controversial issue, because of instances of Western researchers conducting unethical trials in African countries, and scientists undertaking medical experiments on people of African origin in the USA.”

Demonstrators in South Africa Wednesday rallied against COVID-19 test trials being carried out by the Bill and Melinda Gates Foundation’s GAVI Alliance.

Protesters standing in front of the University of the Witwatersrand in Johannesburg where the tests will take place burned their face masks and carried signs blasting GAVI’s choice of the South African people for the continent’s first clinical trials.

“#Gates we are not your lab rats,” one sign read, adding, “AFRICA is not your playground.”

“#No to Gates poison… we don’t want the gates of hell here,” another sign stated.

“We NOT guinea pigs… NO unsafe VACCINE,” declared another protest sign.

Another sign, simply said, “#Fuck the Vaccine.”

While Reuters described them as “anti-vaccine protesters,” one demonstrator said he argued instead for informed consent.

“Even if people are going to consent, it has to be informed consent,” said protest Sean Goss. “It’s a form of a violation of a person’s body.”

“But however, logic should tell me,” he continued, “if you want to test, test in the areas which they call the epicenters of the world, NOT the epicenter of South Africa.”

The protest’s organizer, Phapano Pasha, also told the Associated Press she’s not anti-vaccine, but feared the country’s uninformed population was being taken advantage of.

“I believe in science,” Pasha said. “And I believe that science has managed to solve most of the problems society is faced with. I’m not against vaccinations, I’m against profiteering.”

The trial seeks 2,000 volunteers between the ages of 18-65.

“The people chosen as volunteers for the vaccination, they look as if they’re from poor backgrounds, not qualified enough to understand” she said. “We believe they are manipulating the vulnerable.”

“The narrative we got is our continent is a dumping ground,” said Pasha, pointing to comments by French researcher Jean-Paul Mira earlier this year, who asked, “Shouldn’t we be doing this study in Africa where there are no masks, no treatment, no intensive care, a little bit like we did in certain AIDS studies or with prostitutes?”

The African resistance to COVID trials is causing a headache for the vaccine pushers, with GAVI CEO Seth Berkley telling a vaccine conference last week that anti-vaccine sentiment in the continent is “the worst I’ve ever seen.”

Read full article here…