UPDATE 15. November 2021: URGENT !! DR. PETER MCCULLOUGH CALLS FOR IMMEDIATE VAXX HALT !! MUST WATCH !! GET SHARING !!

UPDATE 14. November 2021: Taiwan suspends Pfizer COVID inoculations for children + Covid-19 Vaccines Not Preventing Deaths in Ireland

Update 13.November 2021: Over a 60X increase in pro sports adverse events since the vaccines rolled out

UPDATE 12. November 2021: Swedish Doctors Want Pfizer’s Covid-19 Vaccine Banned After Subcontractor Fraud Exposed + JUST IN: Appeals Court Re-Affirms Halt on Biden’s Covid Vaccine Mandate for Private Businesses – Cites ‘Severe’ Risks +Austrian Brothel Offers Free Sex Session with ‘Lady Of Your Choice’ If You Get Vaccinated At Their Clinic (VIDEO)

UPDATE 11.November 2021: Project Veritas under fire for vaccine revelations and Biden daughter's diary - Breaking — Federal court orders DOJ to ‘stop extraction’ of files from James O’Keefe’s phone…

UPDATE 09. November 2021: The Zinc, Hydroxychloroquine, Azithromycin COVID-19 Antidote + Ever Wonder Why the Media Doesn’t Tell the Truth About COVID? Here’s Why + NEW - French Health Authority (HAS) no longer recommends the Moderna COVID-19 vaccine for people under 30 years of age.

UPDATE 08. November 2021: FDA DOCUMENTS SHOW CV19 VAX PRODUCES A BIOWEAPON: KAREN KINGSTON INTERVIEWED BY GREG HUNTER + Breaking Pfizer Whistleblower Scandal of Nov 6th 2021

UPDATE 07. November 2021: Here Are the Arguments That Persuaded the 5th Circuit To Block OSHA's Vaccine Mandate for Private Employers - The appeals court said the rule, which was published on Friday, raises "grave statutory and constitutional issues."

UPDATE 06. November 2021: Federal court FREEZES Biden’s vaccine mandate for businesses + SEN. RON JOHNSON CHAIRS SENATE HEARING ON VACCINES AND THEIR ADVERSE EFFECTS - PARTS 1-4

UPDATE 05. November 2021: FBI RAIDS PROJECT VERITAS ~ THE DEEP STATE IS ATTACKING THE JOURNALIST OF TRUTH~ 1ST AMENDMENT DEAD + Was Pfizer's Covid-19 vaccine trial "compromised"? + EFFECT OF PFIZER VACCINE ON HUMAN BLOOD: INTERVIEW WITH KEVIN MCCAIRN & RECAP OF RESEARCH + MUST WATCH: COVID-19 VACCINE MANDATES FROM OUR GOVERNMENT ARE COERCIVE AND BREAKS NUREMBERG CODE

UPDATE 04. November 2021: Study shows dramatic decline in effectiveness of all three COVID-19 vaccines over time + NURSE SPEAKS OUT - HOSPITALS ARE HIDING COVID-19 VACCINE INJURIES…

UPDATE 03. November 2021: THEY'VE GOT DIFFERENT JABS FOR BLACKS & WHITES: IS THERE A RACIAL ELEMENT IN THIS GENOCIDE? 

ADDENDA: MUST WATCH: PETER DOSHI, PhD DESTROYS VACCINE LIES - U.S. SENATOR RON JOHNSON HOLDS PANEL IN DC ON COVID-19 VACCINE MANDATES AND INJURIES [BACKUPS SICE IT WAS DELETED BY THE CRIMINAL GooTube CENSORS!] + THE FLU CONUNDRUM

ICYMI: 'Falsified Data': Pfizer Vaccine Trial Had Major Flaws, Whistleblower Tells Peer-Reviewed Journal + Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

I was born a human and will die a human.
You go ahead and become a GMO, if you wish. I will remain human.

Company That Managed Pfizer Vaccine Trial Sites ‘Falsified Data’: Whistleblower

A vial and syringe are seen in front of the Pfizer logo in this illustration. Photo: Reuters/DadoRuvic

By  - 03. November 2021

  • Ventavia, a subcontractor for Pfizer’s COVID-19 vaccine phase 3 clinical trial, allegedly falsified data, unblinded patients and was slow to follow up on adverse events.
  • Brook Jackson reportedly brought these problems up with her superiors – but was fired shortly after she emailed a complaint to the US Food and Drug Administration.
  • The FDA didn’t follow up on Jackson’s complaint – and Pfizer, which has known of the problems at Ventavia, has hired the company for four more trials.

New Delhi: A researcher who was employed by a company that oversaw three clinical trial sites of Pfizer’s COVID-19 vaccine has made shocking revelations about poor practices at the facilities that call the integrity of Pfizer’s data into question and also raise concerns about lax regulatory oversight.

Curiously, the media report has been seized upon by multiple outlets of the Russian media, including the Russian news agency TASS and the Twitter account for the Sputnik vaccine.

Brook Jackson, a regional director who was employed by Ventavia Research Group, told British Medical Journal that the company “falsified data, unblinded patients, employed inadequately trained vaccinators, and was slow to follow up on adverse events” reported in the pivotal phase III trial of the Pfizer-BioNTech vaccine.

Despite Jackson repeatedly notifying Ventavia of the problems, the company reportedly took no corrective action. This prompted Jackson to send a complaint by email to the US Food and Drug Administration (FDA) – the country’s top regulatory body – in September 2020. But less than 24 hours later, Ventavia fired her in an apparent reprisal.

In a further surprise, the FDA did not follow up on Jackson’s complaint either. Though the regulator claims it doesn’t have the manpower to actively monitor and investigate all clinical trials, one person told the BMJ she was surprised that the agency didn’t inspect Ventavia even after an employee had filed a complaint.

“You would think if there’s a specific and credible complaint that they would have to investigate that,” Jill Fisher, a former Ventavia employee, said.

The revelations reported in the BMJ article are limited to three of more than 150 trial sites, which enrolled only 1,000 of around the 44,000 overall participants.

However, the problems at Ventavia could have wider ramifications, including on efficacy data.

Another employee, on condition of anonymity, told BMJ that Ventavia didn’t have enough people to collect swab samples from trial participants who had reported symptoms that were consistent with COVID-19. Because the trial’s endpoint was to identify laboratory-confirmed symptomatic COVID-19, the revelations suggest the data could have been skewed by samples not being collected from participants who had had COVID-like symptoms.

Jackson’s time at Ventavia

Jackson, a regional director, had 15 years of experience in clinical research coordination and management at the time of her employment with Ventavia. However, her stint at the company lasted only two weeks, in September 2020 – in which time she said she witnessed “poor laboratory management, patient safety concerns, and data integrity issues”.

According to her, her superiors may have been aware of these problems even before she was hired. According to BMJ, in a list of “action items” circulated among Ventavia leaders in early August 2020, one executive reportedly identified three site staff members with whom the company needed to “go over e-diary issue/falsifying data, etc.” One of the staff members was also “verbally counseled for changing data and not noting late entry,” a note indicated, according to the report.

Jackson also recorded a meeting with two Ventavia directors in late September 2020 – in which one of them admitted 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”. The executive adds, “In my mind, it’s something new every day.”

After realising that Ventavia was unlikely to perform a course-correcting, Jackson said she was frustrated and documented several matters late one night, taking photos on her mobile phone. She said she also provided dozens of internal company documents, photos, audio recordings and emails to BMJ.

ICON, the contract research organisation with which Pfizer had partnered for the trial, may also have been aware of problems at Ventavia. ICON reportedly sent an email to Ventavia in September 2020 highlighting over 100 outstanding queries older than three days whereas “[the] expectation … is that all queries are addressed within 24 hrs”.

FDA complaint

Concerned about the scale of problems at the three trial sites, Ventavia executives seemed to expect an FDA inspection. During the meeting that Jackson recorded in late September, one executive reportedly said, “We’re going to get some kind of letter of information at least, when the FDA gets here … know it.”

On September 25, 2020 – which was the following morning – Jackson said she called the FDA and warned the agency about unsound practices in Pfizer’s clinical trial at Ventavia, and also articulated her concerns in an emailed complaint. Ventavia fired her that afternoon.

According to BMJ, she then listed a dozen concerns, including the following (quoted verbatim):

1. Participants placed in a hallway after injection and not being monitored by clinical staff

2. Lack of timely follow-up of patients who experienced adverse events

3. Protocol deviations not being reported

4. Vaccines not being stored at proper temperatures

5. Mislabelled laboratory specimens, and

6. Targeting Ventavia staff for reporting these types of problems

Jackson received an email from the FDA acknowledging her complaint. The email said the agency couldn’t comment on any investigation that might result from her complaint. She reportedly also received a call from an FDA inspector a few days later to discuss her report, but hasn’t heard  anything more since.

Separately, Pfizer had submitted documents to the FDA that included details of a briefing on December 10, 2020, but didn’t mention the problems at the Ventavia sites.

The FDA published a summary of its inspection of the company’s trial in August 2021, after it had given the Pfizer vaccine full (not emergency) authorisation. According to BMJ, the FDA officials had inspected nine of the trial’s 153 sites – none were Ventavia’s.

Empty vials of the Pfizer-BioNTech COVID-19 vaccine are seen in Toronto, Canada, January 4, 2021. Photo: Reuters/Carlos Osorio

Former employees corroborate allegations

Paul D. Thacker, the author of the BMJ article, also spoke to two former Ventavia employees who, he wrote, “confirmed broad aspects of Jackson’s complaint”.

One person who had worked on over 50 clinical trials in her career said she had “never experienced such a ‘helter skelter’ work environment” as at the Ventavia-managed Pfizer’s trial sites.

“I don’t think it was good clean data,” the employee said of the numbers Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

The second employee also described the environment at Ventavia as unlike anything she had experienced in her 20 years of research. She added that after Jackson was fired, Pfizer had been notified of problems at Ventavia and that an audit took place.

Pfizer has since hired Ventavia as a research subcontractor for four other vaccine clinical trials. These include trials on COVID-19 vaccines for children and young adults, pregnant women, and a booster dose.

Author:

Also Read:

How Covaxin Trial Participants in Bhopal Were Misled

Vaccines at ‘Warp Speed’: The Difference Between the US and India

===

===

THE FLU CONUNDRUM

"It’s not uncommon for one or two people who live or work together to get the flu at the same time. But if there is no such thing as a viral disease, how is this possible? Before we discuss why or how this is possible, it’s very important to understand what the FLU is. Influenza, which is commonly known as the flu, is classed as an infectious disease by mainstream science. But, as we have already established, modern science and medicine is flawed. So, we need a brief history lesson.

"Before 1889, flu had the same characteristics for thousands of years. People knew influenza as an unpredictable disease that came; and without warning. At times, it wouldn’t be seen for years or even decades. This is the reason people called it "influenza," because they believed the comings and goings of this mysterious disease was governed by the "influence" of the stars. However, from 1889, influenza took on different characteristics.

"For one, it became a YEARLY disease that appeared more or less at the same time each year, and broke out in widely separated parts of the world. Doctors also couldn’t understand some of the symptoms, including mental issues, stillbirths, birth defects, neurological disorders etc.

"Equally, influenza seemed to target a particular age group, which was between 21 - 50 years old. But the most important thing they observed is that influenza was NOT contagious because it was physically impossible for people in different parts of the world to be sick at the same time WITHOUT having come into contact with others, especially if the breakout was within a day or two of each other. There were no planes, of course.

"In 2001, a team of three experts, including two physicians and the Canadian astronomer Ken Tapping, found that, for at least 300 years, influenza pandemics have most likely occurred during peaks of solar magnetic activity, which is at the height of each eleven-year sun cycle.

"Johannes Mygge, a Danish physician , also noted that influenza had something to do with electricity. In fact, 1889 was the YEAR man-made electrical disturbances of the earth’s atmosphere took on a global character. It was the year the modern electrical era opened and central power stations were commercially possible.

"R. Edgar Hope-Simpson, one of the world’s authorities on influenza, also pointed out that there was no evidence that influenza can be transmitted from person to person. Through his research, Hope-Simpson found that there are variations in solar radiation, and that it’s electromagnetic in nature.

"Like Hope-Simpson, many experts who looked at the evidences, and did not have any financial incentives to lie, came to the same conclusion: influenza is not a virus, but an electric disease. So this begs the question, how can one person "infect" another?

"There are two ways that two or more people can simultaneously get the "flu" around the same time. Firstly, the atmosphere affects different people at the same time. So, if there’s an increase in electromagnetic radiation, this will affect different people in a local or worldwide scale. But why does it affect some people and not the others?

"As explained in the Terrain Theory, if our body’s internal environment is healthy, then we won’t be affected or easily affected by environmental toxicity. If, however, someone has a compromised immune system, they become more susceptible to these toxins.

"Another reason why some get the flu is because of the FEAR factor. Countless studies show that chronic fear has a significant effect on the immune system, which manifests in illness. This happens when we’re anxious around others who are sick, and fear getting sick ourselves. When we already have a compromised immune system and add fear to it, this can be a recipe for disaster.

"According to Hope-Simpson, another possibility is that the flu remains "latent" in humans until it’s reactivated by an environmental trigger, especially electromagnetic radiation. This is why, even if one or two people in the same family have the flu, other members of the family do not get it. If it was contagious, as claimed by modern science, everyone in the same household would get it.

"For instance, during the "Hong Kong Flu" pandemic, in 1968, it was also observed that only one person in a household had the flu; and even if a second person came down with the flu, it was clear they did not catch it from each other because they caught it on the same day.

| https://archive.org/details/you-cant-catch-a-virus

Experiments to prove it:
| https://stacks.cdc.gov/view/cdc/67902
| https://t.me/terraintheorychat/150

Additional detail:
| https://www.bitchute.com/video/PAZL8bnPKp7i

When You Face Your Fear It Will Disappear!

People need to know what's going on please share this video please watch this video.

84,330 PEOPLE HAVE DIED FROM THE FLU SHOT IN 2021. ARE THEY STILL FLU SHOTS? Please share this video https://www.bitchute.com/video/3YGlis7UB8Tn The CDC itself Has stated that they only receive 1% of reports... That is to say according to their own statistics the correct numbers are in the lines of 8,433,000. Then again who really knows what's going on.. Please share this videohttps://www.bitchute.com/video/3YGlis7UB8Tn

84,330 PEOPLE HAVE DIED FROM THE FLU SHOT IN 2021. ARE THEY STILL FLU SHOTS? Please share this video https://www.bitchute.com/video/3YGlis7UB8Tn/

PLEASE... GET THIS TO... DOCTOR CARRIE MADEJ. I HOPE THIS HELPS YOU.
https://www.bitchute.com/video/kpyXadvmMPkr/

NEVER BEFORE SEEN: BLOOD DOCTOR REVEALS HORRIFIC FINDINGS AFTER EXAMINING VIALS
https://www.bitchute.com/video/3s4qYKSYCVN7/

IF THE FORMULA DIFFERENT THAN FDA APPROVED COMIRNATY FORMULATION. CAN YOU SMELL THE LAWSUITS.??? https://www.bitchute.com/video/QFqPQU7WkNO5/

THE GOVERNMENT IS EXEMPT FROM THE COVID-19 VACCINES.https://www.bitchute.com/video/8qEi2QGC1rKP/

16,362,076 REPORTED VACCINE INJURIES. GO AHEAD... TELL ME THERE SAFE. https://www.bitchute.com/video/XOLP0XDEvyku/

IF COVID-19 EXISTS THEN WHY IS DR. TIM O'SHEA OFFERS $5000 REWARD STILL UNCLAIMED?https://www.bitchute.com/video/IDkFbf6MYsoO/

FAKE VACCINE INJECTIONS. Compilation https://www.bitchute.com/video/HAbQVTPAVmKs/

===

We’re Not in a ‘Pandemic of the Unvaccinated,’

DELETED BY THE CRIMINAL GooTube CENSORS! 

HERE ARE THE BACKUPS

PETER DOSHI, PhD - U.S. SENATOR RON JOHNSON HOLDS PANEL IN DC ON COVID-19 VACCINE MANDATES AND INJURIES

First published on BITCHUTE November 16th, 2021.

Peter Doshi, Ph. D. an associate professor of Pharmaceutical Health Services Research at the University of Maryland School of Pharmacy, spoke out against vaccine mandates during a five-minute testimony he gave at a panel held by Senator Ron Johnson R-WIS., chair of the Senate Homeland Security and Governmental Affairs Committee, on Capitol Hill.

Editor Peter Doshi gave a groundbreaking presentation. Doshi, editor of one of the world's premiere medical journals, summarised and critically evaluated empirical information on COVID-19 'vaccination'.

Peter Doshi, PhD and U.S. Senator Ron Johnson Holds Panel in DC on COVID-19 Vaccine Mandates and Injuries
https://www.ronjohnson.senate.gov/2021/10/media-advisory-sen-johnson-holds-expert-panel-on-federal-vaccine-mandates-and-vaccine-injuries

https://www.weau.com/2021/11/03/sen-johnson-hosts-panel-highlighting-people-claiming-be-harmed-by-covid-19-vaccines/

SenatorRonJohnson
https://rumble.com/vokrf7-sen.-johnson-expert-panel-on-federal-vaccine-mandates.html

LONGER EXCERPT OF THE HEARING

video image

That's in the "vaccine"

===

We’re Not in a ‘Pandemic of the Unvaccinated,’ Peter Doshi Explains During COVID Panel

By CHD - 05. November 2021

Peter Doshi, a senior editor at The BMJ, and Retsef Levi, a professor at the Massachusetts Institute of Technology, told a panel of experts the COVID vaccines’ trial data doesn’t support the narrative that the vaccines are safe and effective.

Peter Doshi expressed doubts about COVID vaccine efficacy and the failures of the scientific community.

U.S. Sen. Ron Johnson (R-Wis.) Tuesday held a roundtable discussion on federal COVID vaccine mandates with a panel of people injured by COVID vaccines and scientists from some of the most prestigious research organizations in the world, including The BMJ and Massachusetts Institute of Technology (MIT).

Peter Doshi, a senior editor at The BMJ and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, and Retsef Levi, a health system and analytics professor at MIT, expressed doubts about COVID vaccine efficacy and the failures of the scientific community. 

“I’m saddened we’re super-saturated as a society right now in the attitude of ‘everybody knows,’ which has shut down intellectual curiosity and led to self-censorship,” said Doshi.

Doshi said we’re not in a “pandemic of the unvaccinated.” If hospitalizations and deaths are almost exclusively occuring in the unvaccinated “why would booster shots be necessary?” Doshi asked. “And why would the statistics be so different in the UK, where most COVID hospitalizations and deaths are among the fully vaccinated?”

“There’s a disconnect there, and something to be curious about,” Doshi said. “There’s something not adding up.”

Doshi argued the public was lied to in early 2021, when health officials including Dr. Anthony Fauci, claimed COVID vaccine trial data proved the vaccine saved lives.

After presenting the trial data for the vaccines authorized for use in the U.S., Doshi pointed out “there were similar numbers in the vaccine and placebo groups.” He argued those “who claimed the trial showed the vaccine was highly effective in saving lives were wrong” and that “the trials did not demonstrate this.” 

Doshi talked about anti-vaxxers and criticized the official definition of the term. He presented the panel the official Merriam-Webster definition of anti-vaxxer: “A person who opposes the use of vaccines or regulations mandating vaccination.”

“The second part [of the definition] stunned me,” said Doshi. 

“There are entire countries from the United Kingdom to Japan which do not mandate childhood vaccines,” he said. “There are no mandates, and I would wager that perhaps a majority of the world’s population meet this definition of an anti-vaxxer.”

Doshi told the panel that “vaccine” is another definition “worth checking on.”

“I argue these products which everyone calls MRNA vaccines are qualitatively different from standard vaccines,” Doshi said. “So I found it fascinating to learn that Merriam Webster changed the definition of vaccine early this year.”

“mRNA products did not meet the definition of vaccine that has been in place for over 15 years, but the definition was expanded such that mRNA products are now vaccines,” Doshi said.

He then argued that just because we’re calling the COVID shot a “vaccine” doesn’t mean “these new products are just like all other childhood vaccines which get mandated.”

“Each product is a different product, and if people are OK with mandating something simply because it’s a vaccine, I believe it’s time to inject some critical thinking into the conversation,” Doshi said. 

He also criticized the fact that society is vaccinating and mandating the vaccine for large portions of the public despite the raw data on the safety and efficacy of the vaccines not being available yet.

“So while we are told to keep following the science, what we are following is not a scientific process based on open data, we are following a process where the data are secret, and in my view there is something very unscientific about that,” Doshi said.

Levi told the panel “scientists in the most prestigious journals assert that the vaccine is safe, failing to report on serious side effects such as deaths.”

He explained that national emergency services calls in Israel for cardiac arrest among young individuals under 40 years old saw a dramatic increase — more than 25% — in parallel to the COVD vaccination campaign. 

“We wrote an academic paper raising concerns regarding these statistics and called on the authorities to check on this … needless to say they never got back to us.” 

Levi claimed the government attempted to censor the research by calling its credibility into question. “They called the research fake,” Levi said. 

Levi warned the panel: 

“These vaccines have serious and unknown side effects, and we need to use them with caution.”  

Watch here (Doshi starts at 1:18:40 and Levi starts at 1:49:07):

FULL >3h VERSION OF THE HEARING

Re-published on BITCHUTE November 3rd, 2021.

U.S. Senator Ron Johnson Holds Panel in DC on Federal COVID-19 Vaccine Mandates and Vaccine Injuries - Nov 2 2021
https://www.ronjohnson.senate.gov/2021/10/media-advisory-sen-johnson-holds-expert-panel-on-federal-vaccine-mandates-and-vaccine-injuries

https://www.weau.com/2021/11/03/sen-johnson-hosts-panel-highlighting-people-claiming-be-harmed-by-covid-19-vaccines/

===

- earlier info see:  & THE VACCINE CONUNDRUM II​​​​​ & THE VACCINE CONUNDRUM III​​​​​ & THE VACCINE CONUNDRUM IV &  &  & THE VACCINE CONUNDRUM VII & THE VACCINE CONUNDRUM VIII &  &  &  &  & THE VACCINE CONUNDRUM XIII & THE VACCINE CONUNDRUM XIV & THE VACCINE CONUNDRUM XVTHE VACCINE CONUNDRUM XVI & THE VACCINE CONUNDRUM XVII &  + MUST READ AND DISTRIBUTE: 

===

UPDATES:

URGENT !! DR. PETER MCCULLOUGH CALLS FOR IMMEDIATE VAXX HALT !! MUST WATCH !! GET SHARING !!

First published on BITCHUTE November 15th, 2021.

The story of this fall has been the story of “breakthrough” infections. It turns out vaccines don't work and nobody actually believes in them. There’s no reasoning, no actual research, no cost-benefit analysis, not a single rational thought from any of the highly-trained and highly-paid professionals who have made themselves the dictators of our lives. Nobody understands this better than Dr. Peter McCullough, a cardiologist, internist, and epidemiologist, who has been a steadfast advocate for alternative Covid treatments like hydroxychloroquine.

SHARE THIS WITH EVERYONE

===

===

 

Covid-19 Vaccines Not Preventing Deaths in Ireland

By  - 14. November 2021

Data from Ireland’s Health Protection Surveillance Centre (HPSC) shows that Covid-19 vaccines are failing to prevent deaths, as promoted.

Of 606 Covid-19 deaths reported April 1 to November 6, 2021, 292 deaths, or 48.1%, of deaths were in the fully vaccinated and 60% in people with at least 1 dose. The unvaccinated made up 243 of 606 deaths, or 40.1%.

If Covid-19 vaccines are showing clear evidence of failing protection, why are govts aggressively forcing vaccination through job loss and removal of constitutional freedoms?

 

===

Swedish Doctors Want Pfizer’s Covid-19 Vaccine Banned After Subcontractor Fraud Exposed

By  - 12.November2021 

Brazil to purchase Pfizer vaccine after trials conclude ...

As we have previously reported, a Pfizer subcontractor is being accused of falsifying data, unblinding patients, hiring inadequately trained vaccinators, and failing to follow up on reported adverse reactions during the company’s Covid-19 vaccine trials.

These shocking revelations were reported in a paper published in the British Medical Journal (BMJ), revealing that the company, called Ventavia Research Group, heavily manipulated the phase III study for Pfizer’s covid vaccine during the autumn of 2020, just months before it was rushed into production and distribution.

This incriminating information was sent to the BMJ by a company whistle-blower, which in turn prompted a group of 16 Swedish doctors and researchers to circulate a petition calling on the Pfizer vaccine to no longer be administered in the Nordic country.

Sputnik News reported: “The staff who performed quality checks were reportedly overwhelmed by the amount of problems they discovered. The BMJ (study) concluded that the trial raised questions about data integrity and regulatory oversight.”

The 16 signatories of the petition called the revelations “extremely serious,” adding that the adverse reactions associated with Pfizer’s jabs are “gigantic.”

“For instance, in Sweden alone during the ten months that vaccination has taken place wholly 83,744 suspected side effects have been reported – which is more than ten times more than all side effects reported for all drugs and vaccines per year in the immediately preceding years, for a total of about 25,000 substances, the authors emphasised,” Sputnik explained.

The 16 Swedish researchers say that it is clear that Pfizer’s phase III clinical trial was “not performed in a scientifically acceptable manner.” This also means that its results “cannot be considered reliable:

“… combined with the large extent of reported suspected adverse reactions after vaccination, including many of serious nature, makes us, doctors, researchers and immunologists deeply concerned, not least for children who are at extremely low risk of serious COVID-19 disease, but who are at risk of serious side effects,” the signatories added.

Until a proper risk-benefit analysis can be conducted on the Pfizer vaccine, the signatories are calling for an immediate moratorium on the drug for all age groups.

Since speaking out, the whistle-blower, Brook Jackson, has been fired from her position as regional director at Ventavia, which is based in Texas. Jackson’s firing reportedly occurred almost immediately after she filed a complaint with the US Food and Drug Administration (FDA) about the situation.

Jackson provided the BMJ with tons of internal company documents, photos, audio recordings, and emails that substantiate her claims. However, the FDA was not interested in her complaints.

===

NEW - French Health Authority (HAS) no longer recommends the Moderna COVID-19 vaccine for people under 30 years of age.

===

JUST IN: Appeals Court Re-Affirms Halt on Biden’s Covid Vaccine Mandate for Private Businesses – Cites ‘Severe’ Risks

By Cristina Laila - 12. November 2021

In September the Biden Regime dropped the iron fist on the private sector and mandated all employees get jabbed or tested weekly for Covid… OR ELSE.

 

In addition to telling all 2.1 million federal employees to get jabbed or face firing, the Biden regime mandated all companies with 100+ employees to either test workers or prove they are vaccinated.

Small businesses that do not comply with the Biden Regime’s new Covid mandates will face hefty fines.

The mandate was supposed to go into effect January 4, 2022.

However, last week an appeals court issued a stay and temporarily halted Joe Biden’s vaccine mandate for businesses with 100 or more employees.

The ruling in the U.S. Court of Appeals for the Fifth Circuit came after several Republican state attorneys general filed lawsuits against the administration.

The court said that they found “grave statutory and constitutional” issues with the mandate.

The Biden Regime was directed to respond to the request for a permanent injunction against the ruling by Monday evening.

On Friday the US Appeals Court for the Fifth Circuit upheld its decision to put a halt on Biden’s vax mandate for businesses with 100 employees.

The court said the mandate “exposes [petitioners] to severe financial risk” and “threatens to decimate their workforces (and business prospects).”

Texas Attorney General Ken Paxton celebrated the win on Friday.

Author:

Cristina Laila began writing for The Gateway Pundit in 2016 and she is currently the Associate Editor.

===

“CONGEALED BULLSHIT!"

Canadian Govt Under Reporting Post-Covid-19-VaXXine Deaths

After the Canadian govt claimed October 15, 2021, that there were 195 post-vaxxine deaths, Dr. Roger Hodkinson, an outspoken and eminent pathologist, responded without mincing words about the “congealed bullshit!” through Dr. Mark Trozzi’s site: https://drtrozzi.org/2021/10/20/dr-hodkinson-message-dr-phillips-update-and-a-laugh/
~Bright Light News



Feds say 195 Canadians dead after getting COVID shot:
https://westernstandardonline.com/2021/10/feds-say-195-canadians-dead-after-getting-covid-shots/

===

===

PROLOGUE: Project Veritas under fire for vaccine revelations and Biden daughter's diary

Breaking — Federal court orders DOJ to ‘stop extraction’ of files from James O’Keefe’s phone…

By Kane 11. November 2021

BREAKING! The federal court has just ordered the DOJ to STOP extracting data from our client, journalist James O’Keefe’s phone, and ordered a hearing. Counsel for Project Veritas asked the court to do this yesterday! pic.twitter.com/nBrmf4myuj

— Harmeet K. Dhillon (@pnjaban) November 11, 2021

Nice win for O’Keefe but it may be too late.

Merrick Garland signed the warrant

 

Journalists and whistleblowers have to wear now bulletproof vests.

===

The Zinc, Hydroxychloroquine, Azithromycin COVID-19 Antidote

Azithromycin can be substituted with Doxycycline

By Dr. Vladimir (Zev) Zelenko -  09. November 2021

Pfizer and Moderna have brilliantly figured out that the Zelenko Protocol is and has always been the correct approach to treat Covid-19.

Pfizer and Moderna are touting unverified results from their trials of oral repurposed HIV drugs, Paxlovid and molnupiravir, claiming decrease in hospitalization rates of 89% and 50%, respectively. 

This is consistent with Dr. Zelenko’s observations since 3/2020, that early prehospital treatment with antiviral medications reduces hospitalization and death by 84%. 

Dozens of peer reviewed papers have corroborated Dr. Zelenko’s observations with an average decrease in hospitalization of 85%. 

Pfizer and Moderna have still not discovered the clinical benefit of patient risk stratification and use of zinc, which are essential components of the Zelenko Protocol.

Pfizer and Moderna have not commented on the significant side effects of these repurposed hiv drugs. 

Another major difference of Pfizer / Moderna drugs versus the Zelenko Protocol is cost. Big pharma drugs will cost $700 a person vs $30 for the Zelenko Protocol. 

Perhaps, Pfizer and Moderna are hoping that touting their expensive and unproven drugs will mitigate the horrendous side effects of the covid-19 vaccines.

REFERENCE:

 2020 Dec; 56(6): 106214.

Published online 2020 Oct 26. doi: 10.1016/j.ijantimicag.2020.106214

PMCID: PMC7587171

PMID: 33122096

COVID-19 outpatients: early risk-stratified treatment with zinc plus low-dose hydroxychloroquine and azithromycin: a retrospective case series study

Roland Derwand,a,1 Martin Scholz,b,1, and Vladimir Zelenkoc

Author information Copyright and License information Disclaimer

This article has been cited by other articles in PMC.

Abstract

The aim of this study was to describe the outcomes of patients with coronavirus disease 2019 (COVID-19) in the outpatient setting after early treatment with zinc, low-dose hydroxychloroquine and azithromycin (triple therapy) dependent on risk stratification. This was a retrospective case series study in the general practice setting. A total of 141 COVID-19 patients with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the year 2020 were included. The main outcome measures were risk-stratified treatment decision and rates of hospitalisation and all-cause death. A median of 4 days [interquartile range (IQR) 3–6 days; available for n = 66/141 patients] after the onset of symptoms, 141 patients (median age 58 years, IQR 40–67 years; 73.0% male) received a prescription for triple therapy for 5 days. Independent public reference data from 377 confirmed COVID-19 patients in the same community were used as untreated controls. Of 141 treated patients, 4 (2.8%) were hospitalised, which was significantly fewer (P < 0.001) compared with 58 (15.4%) of 377 untreated patients [odds ratio (OR) = 0.16, 95% confidence interval (CI) 0.06–0.5]. One patient (0.7%) in the treatment group died versus 13 patients (3.4%) in the untreated group (OR = 0.2, 95% CI 0.03–1.5; P = 0.12). No cardiac side effects were observed. Risk stratification-based treatment of COVID-19 outpatients as early as possible after symptom onset using triple therapy, including the combination of zinc with low-dose hydroxychloroquine, was associated with significantly fewer hospitalisations.

Keywords: SARS-CoV-2, COVID-19, Outpatients, Zinc, Hydroxychloroquine, Azithromycin

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7587171

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Ever Wonder Why the Media Doesn’t Tell the Truth About COVID? Here’s Why.

09.November 2021

Some people wonder why the media never tells the truth about COVID-19. Some people may find a certain detail or piece of information that runs contrary to what the media tells them about the virus and they wonder why it was that way. They wonder why the media keeps telling you at best, half-truths and at worst, blatant lies. Well, for those of you who still don’t get it, here’s the reason why the media doesn’t tell you the truth about COVID-19.

Now you know why? It is simple. The media doesn’t tell you the truth about COVID-19 because it is bought and paid for by Big Pharma. Not just the media but also…

Your government. And….

Your medical agencies that are supposed to regulate Big Pharma! Isn’t that interesting?

So are you still wondering why the media, the government and the medical establishment (FDA, CDC, WHO) all are in favor of measures and policies (vaccine mandates and vaccine passports) that would happen to….

endlessly boost Big Pharma’s revenue stream?

Some of you might be wondering: “Well, Big Pharma’s incentive is money. What’s the media and the government’s incentive?”

Well, it’s simple.

As we see here and from the video, the media’s incentive is also money to pocket for themselves while mainly gatekeeping for the government and the establishment (Big Pharma, MIC, Big Oil, Big Tech) in training you to believe that what they’re doing is in you and your country’s best interest when in reality, it is really in their best interest.

This image has an empty alt attribute; its file name is 9o7072icxxq41.jpg

The media’s job is to train you to think the way that the government wants you to think; not to tell you the truth. If you think otherwise, why did the media never tell you the truth about there being no weapons of mass destruction in Iraq instead of lying and saying that there was? Why does the media never tell you the truth about the chemicals and pesticides in your food? It is because the media is not there to tell you the truth; it is to make you believe in the lies that gives the government and the establishment their power, money and control over you. The media’s job is to train you to create your own slavery and to think that it is in your best interest.

And…the government’s incentive?

Police check health passes at a café in France.

Power and control over you.

The government trains you through the media to put the leash around your neck that they will then use to guide you into the direction that they see fit; a one-way road to totalitarianism where you own nothing and they own everything; including your children.

Are you still wondering why the media, the government and the medical establishment doesn’t tell you the truth about COVID-19 or do you see things for what it is now?

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Breaking Pfizer Whistleblower Scandal - Nov 6th 2021

November 8th, 2021

The BMJ has investigated a whistleblower report from a person engaged in Pfizer's Covid-19 vaccine trial. This person alerted the BMJ to a serious problem involving data recording in Pfizer's vaccine trial:
https://www.bmj.com/content/375/bmj.n2635?utm_source=twitter&utm_medium=social&utm_term=hootsuite&utm_content=sme&utm_campaign=usage
Data integrity in the clinical has been compromised and the trial conclusions concerning vaccine efficacy cannot be trusted.
This should be a major scandal because millions of people have taken this drug based on performance promised which cannot be supported by any data. Among those people is a London cardiologist, Aseem Malhotra who is interviewed on the UK's LBC news channel.
https://twitter.com/MaajidNawaz/status/1457024954680107015?s=20

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JUST IN - Pfizer CEO: People who "spread misinformation" on the COVID-19 vaccines are criminals (CNBC). Will he now arrest himself?

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FDA DOCUMENTS SHOW CV19 VAX PRODUCES A BIOWEAPON: KAREN KINGSTON INTERVIEWED BY GREG HUNTER

First published on BITCHUTE November 8th, 2021.

Greg Hunter: https://usawatchdog.com

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VACCINE MANDATES

Here Are the Arguments That Persuaded the 5th Circuit To Block OSHA's Vaccine Mandate for Private Employers

The appeals court said the rule, which was published on Friday, raises "grave statutory and constitutional issues."

By  - 07. November 2021

reason-vaccine3

( Felipe Caparros Cruz/Dreamstime.com)

The U.S. Court of Appeals for the 5th Circuit yesterday stayed the Biden administration's brand-new COVID-19 vaccine mandate for private employers, which took effect on Friday, when it was published in the Federal Register. The appeals court said the arguments made by the petitioners—a Louisiana supermarket chain and six employees of a Texas company that makes kitchen ventilation systems—"give cause to believe there are grave statutory and constitutional issues with the Mandate."

The vaccine rule, which was announced in early September but was not unveiled until last Thursday, gives businesses with 100 or more employees two options: They can adopt a "mandatory vaccination policy" with limited exceptions, or they can require unvaccinated employees to wear face masks and undergo weekly COVID-19 testing. The White House described the mandate as part of a broader effort to boost the nationwide vaccination rate. The aim, it said, is to "reduce the number of unvaccinated Americans by using regulatory powers and other actions to substantially increase the number of Americans covered by vaccination requirements."

But the federal government has no general authority to protect public health, control communicable diseases, or require vaccination, all of which are primarily state responsibilities. The administration therefore presented the vaccine mandate as an "emergency temporary standard" (ETS) issued by the Occupational Safety and Health Administration (OSHA), which is charged specifically with protecting employees from workplace hazards. As the 5th Circuit indicated, that legal strategy leaves the mandate open to challenge on both statutory and constitutional grounds.

The plaintiffs in BST Holdings v. OSHA, who are represented by the Chicago-based Liberty Justice Center and Louisiana's Pelican Institute for Public Policy, argue that the ETS exceeds the agency's authority under the Occupational Safety and Health Act. Even if it didn't, they say, empowering OSHA to issue such a sweeping order would exceed the federal government's power to regulate interstate commerce and violate the nondelegation doctrine, which constrains lawmaking by executive agencies.

The ETS option, which OSHA rarely uses, allows the agency to circumventthe usual rule making process, which typically takes years, by imposing regulations that take effect immediately upon publication. But to avoid the public notice, comment, and hearing requirements that ordinarily apply to OSHA rules, the agency has to identify a "grave danger" to employees "from exposure to substances or agents determined to be toxic or physically harmful or from new hazards." It also has to show the emergency standard is "necessary to protect employees from such danger."

As a general matter, the plaintiffs in the 5th Circuit case argue, the ETS goes beyond OSHA's mission to protect "occupational health and safety" because "it is not related to the workplace." The agency "has authority over workplace-related hazards," they say, "not any hazard one might encounter anywhere in the world."

The plaintiffs' 5th Circuit brief notes that "OSHA has never attempted to implement a rule this broad." Although the agency has been mulling an "Infectious Diseases Regulatory Framework" covering "airborne infectious diseases" since 2010, it "has repeatedly shelved the suggestion, leaving it to languish on the agency's no-action agenda." The only previous OSHA standard dealing with vaccination was much narrower, requiring that "employers whose workers could be exposed to blood or other potentially infectious materials at work offer free Hepatitis B vaccination to employees." Even that standard did not require vaccination, and it did not deal with a general, population-wide threat from a communicable disease.

More specifically, the plaintiffs argue that "COVID-19 is not a toxic substance or agent," adding that "OSHA cannot attempt to shoehorn this disease into the phrase 'new hazards.'" That phrase, they say, should be understood in context to exclude airborne viruses: "Because Congress expressly allowed for an ETS to be issued for 'substances or agents determined to be toxic or physically harmful,' the catch-all phrase to encompass other hazards must be read in light of, and limited to, items similar to those that come before it."

Otherwise, the brief says, OSHA "would have unbridled power to promulgate any regulation that would have the arguable effect of preventing the spread of a communicable disease." Such measures could include "a shutdown of an entire
industry [such as meatpacking] that might harbor a high [incidence] of COVID-19," "a nationwide shutdown of all employers engaged in interstate commerce," "a nationwide mask mandate on all customers visiting OSHA-regulated businesses," or even "a rule mandating [an] appropriate regimen of vitamins" aimed at boosting employees' immune responses.

The Supreme Court has cautioned against assuming that Congress intended to authorize executive actions with broad economic implications if it did not explicitly say so. "When an agency claims to discover in a long-extant statute an unheralded power to regulate a significant portion of the American economy," the Court said in 2014, "we typically greet its announcement with a measure of skepticism. We expect Congress to speak clearly if it wishes to assign to an agency decisions of vast 'economic and political significance.'"

The plaintiffs' brief says OSHA's claim that it is responding to a "grave danger" justifying an emergency standard is belied by the timing of the ETS. The regulation was published nearly two years after the beginning of the pandemic, nearly a year after the Food and Drug Administration (FDA) first approved COVID-19 vaccines for "emergency use," and more than two months after the FDA gave the Pfizer vaccine its full approval. "The extended timeframe for the ETS undermines any claim of exigence," the plaintiffs say. "And the real kicker is the same day the ETS was released, November 4, the White House also announced it was delaying its federal contractor vaccination mandate from December 8 to January 4, again undermining its assertion of exigency." That is also the deadline for private employers to start complying with the ETS published on Friday. The plaintiffs suggest that "truly 'grave dangers' do not wait to spread until after the holidays."

The brief also questions whether the ETS for private employers is "necessary" to protect against the threat posed by COVID-19. When OSHA issued a COVID-19 ETS for the health care industry in June, the rule did not include a vaccination requirement. "The fact that OSHA's previous ETS, issued just months ago, did not find the need for a vaccine mandate even for healthcare workers, who treat COVID-19 patients, undermines OSHA's assertion now that such a requirement is necessary," the plaintiffs say. They also note that OSHA supported in-person instruction of public school students even when the vast majority of them were not vaccinated, which suggests that other safeguards may suffice.

The brief argues that the new ETS is "underinclusive" because weekly testing can miss COVID-19 carriers, because employees who are vaccinated can still carry the virus but don't have to be tested or wear masks, and because the rule does not apply to customers or other visitors who may transmit COVID-19 in the workplace. At the same time, the plaintiffs say, the rule is "overinclusive" because it "does not account for vulnerability related to age or preexisting health conditions," because it does not accept naturally acquired immunity as a valid reason to forgo vaccination, and because, while the ETS "excuses remote and outdoor workers from its scope," it "covers every other employee even while acknowledging employees in different roles face vastly different risk levels."

The brief says several of the individual plaintiffs "rarely interact with colleagues in person and should not be required to vaccinate or show a negative COVID-19 test since they are highly unlikely to spread COVID-19 to colleagues they may only see a few times a year." And since the ETS "applies to every workplace of an employer of 100 or more employees," the plaintiffs say, it "does not consider the different degrees of risk associated with differing workplaces." Yet "it cannot be considered 'necessary' as to all such workplaces."

Even if Congress wanted to give OSHA the authority it claims, the plaintiffs say, doing so would run afoul of the nondelegation doctrine, which aims to preserve the separation of powers by requiring an "intelligible principle" to guide regulation by executive agencies. Under OSHA's reading of the law, the brief argues, the agency has "plenary power to establish whatever legal requirements [it] wishes, regardless of how attenuated" their relationship to workplace safety may be. According to the government, "OSHA's newfound authority empowers it not simply to set safe levels of potential carcinogens in the workplace, or require safety equipment and employee trainings, but to regulate the off-site medical decisions of employees completely disconnected from work." If OSHA "can require that companies mandate vaccines," the brief asks, "what can it not require?"

The plaintiffs also argue that Congress itself does not have the authority to demand that private-sector employees choose between vaccination and testing plus masking. According to the Supreme Court's understanding of the Commerce Clause, the federal government can regulate "activities having a substantial relation to interstate commerce," even when those activities themselves do not cross state lines. In deciding whether a given regulation meets that test, courts are supposed to consider "the economic character of the intrastate activity"; whether the regulation contains a "jurisdictional element" that may "establish whether the enactment is in pursuance of Congress' regulation of interstate commerce"; congressional findings regarding the regulated activity's impact on interstate commerce; and whether that impact is too "attenuated" for the regulation to pass muster under the Commerce Clause.

In this case, the regulated "activity"—the decision to forgo vaccination—is not only not "economic"; it is not even an "activity." The plaintiffs argue that forgoing vaccination is analogous to refraining from purchasing government-approved medical insurance, a decision that a majority of the Court agreed could not be reached under the Commerce Clause in the 2012 Obamacare case National Federation of Independent Business v. Sebelius. "If Congress can regulate employees' individual health decisions under the Commerce Clause," the plaintiffs say, "then it can mandate that employers require their workers to attend the gym weekly or to eat broccoli"—a reference to a famous hypothetical in the Obamacare case.

What about a "jurisdictional element"? The plaintiffs' brief notes that "the mandate's limit to employers with 100 or more employees does not actually limit its reach to interstate activities," since "some employers with more than 100 employees do not engage in interstate activities at all," while "some employers with fewer than 100 employees engage in extensive interstate activity."

Nor did OSHA (or Congress) "make any findings regarding the effect of COVID-19 vaccinations and testing on interstate commerce." The agency's avowed aim is to protect unvaccinated employees from the risk posed by their own choice to remain unvaccinated. If those choices can be said to affect interstate commerce, the plaintiffs say, it is only by "pil[ing] inference upon inference," which the Supreme Court has said is not permissible as a justification for federal regulation, since it would "bid fair to convert congressional authority under the Commerce Clause to a general police power of the sort retained by the States."

At this early stage in the case, it is not clear which of these arguments the 5th Circuit found most persuasive, although the wording of its stay implies that it perceives both statutory and constitutional reasons to doubt the legality of OSHA's rule. The court gave the government until 5 p.m. on Monday to "respond to the petitioners' motion for a permanent injunction." The petitioners, in turn, "shall file any reply" by 5 p.m. on Tuesday.

The vaccine mandate faces additional challenges, including lawsuits backed by the attorneys general of 26 states, in the 5th, 6th, 8th, and 11th circuits. Last week The New York Times reported that "legal experts say" OSHA "has the authority to introduce a vaccine mandate." Judging from the 5th Circuit's stay and all the other litigation contesting OSHA's authority, that assessment seems premature.

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Federal court FREEZES Biden’s vaccine mandate for businesses

By RT - 06 November 2021

A US federal appeals court has issued a stay on President Joe Biden's vaccine mandates for employers, freezing the requirement over constitutional concerns.

Biden's mandate says companies with 100 or more employees must require their workers to either get the Covid-19 vaccine or be tested weekly.

FILE PHOTO: New York City Fire Department protest against the city's COVID-19 vaccine mandates in New York, US, on October 28, 2021. © REUTERS / Mike Segar 

Numerous Republican states and companies, such as conservative outlet Daily Wire, had already presented legal challenges to Biden's controversial mandate before the United States Court of Appeals for the Fifth Circuit stepped in.

The court put a hold on the mandate on Saturday before its January deadline over “grave statutory and constitutional concerns.”

The petition to the appeals court came from businesses and multiple states including Texas.

Yesterday, I sued the Biden Admin over its unlawful OSHA vax mandate.WE WON. Just this morning, citing “grave statutory and constitutional issues,” the 5th Circuit stayed the mandate. The fight is not over and I will never stop resisting this Admin’s unconstitutional overreach! pic.twitter.com/okt2vkNRKo

— Texas Attorney General (@TXAG) November 6, 2021

“Emergency hearings will take place soon,” Texas Gov. Greg Abbott tweeted about the decision after his state's attorney general celebrated the temporary victory over the federal mandate. “We will have our day in court to strike down Biden’s unconstitutional abuse of authority.”

BREAKING: The Federal Court of Appeals just issued a temporary halt to Biden’s vaccine mandate. Emergency hearings will take place soon. We will have our day in court to strike down Biden’s unconstitutional abuse of authority. pic.twitter.com/8utmU05vw3

— Greg Abbott (@GregAbbott_TX) November 6, 2021

The court's stay on Biden's vaccine mandate is not an actual end to the requirement, and critics will have a process to go through before they can celebrate any actual victory. The decision is a temporary stay until “further action” is taken by the court after hearing arguments in emergency hearings that will be part of an “expedited judicial review.”

According to the court's decision, the government has until Monday to respond to the “permanent injunction” being requested by the petitioners.

ALSO ON RT.COMBiden’s vax mandate may have new targets

Biden first announced his controversial mandate in September, and the specifics of the plan were released earlier this week amid backlash. The requirement, issued by the Occupational Safety and Health Administration (OSHA), concerns tens of millions of Americans, promises thousands in fines for companies that violate the mandate, which also requires companies to pay for weekly testing (if an employee chooses this option), and provides paid time off for employees to actually get vaccinated. 

Conservative lawmakers and pundits have used the latest court decision to promise further action against the mandate, though others have accused Texas and other states of putting selfishness” above the common good.”

Biden’s vaccine mandate is illegal, unconstitutional, unscientific, immoral, and hurtful.But there’s another big reason it should be nullified immediately: More than half of the states oppose it already.https://t.co/XxQJo1T4Lv

— Thomas Massie (@RepThomasMassie) November 6, 2021

BREAKING: In a major win for liberty, the 5th Circuit U.S. Court of Appeals just halted Biden's mandate on businesses with 100 or more workers. This is a stay. We will continue to see this case through. The gov't should not force, or coerce, medical procedures. #lalege#lagov

— Jeff Landry (@JeffLandry) November 6, 2021

Why does the right have a problem with vaccines? People lined the streets for Polio vaccines and that was 60-65 years ago

— John (@johnnielee1953) November 6, 2021

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SEN. RON JOHNSON CHAIRS SENATE HEARING ON VACCINES AND THEIR ADVERSE EFFECTS - PART-1

Re-published on BITCHUTE November 5th, 2021.

Nov 2, 2021: At last the truth is coming out about these so-called vaccines, first-hand testimonies of some of the Adverse Effects AND experts speaking out about GROSS censorship and coverups and malfeasance at ALL levels. As this was 3.20 hours we are presenting a series of clips of some of these speakers.
Original here: https://www.thethinkingconservative.com/senator-johnson-expert-panel-on-federal-vaccine-mandates-and-vaccine-injuries/

I'm just sharing this info because I know many are still unaware of the danger that we are in. First, let me say that corona is defined as the radiant crown around the sun which is literally the origin of radiation and virus in latin means poison so coronavirus=radiation poison or look up corona effect if you don't believe me. That explains why they are putting a superconductor (graphene) in everything from the Fauci ouchy to the meat and cereal in the grocery store the masks, and who knows what else. They do this because it makes us susceptible to their EMF radiation poison and control. I need to get this info out because recently I discovered my chest was magnetic and I haven't had the shot. This was not funny to me at all. So a heavy metal nanoparticle detox should be an essential protocol for EVERYBODY to minimize the amount of this nano inside us all because ALL of us are full of this crap and we're under attack from every direction. I hope this helps anyone not aware. I got rid of my magnetism with zeolites and N-acetyl cysteine. Be careful where you buy these from also because who knows if they aren't contaminating these products they know we use. I personally use these people and I trust them because it works or I wouldn't recommend them. To learn more visit https://zeolitecleanse.com/3AknAg1 Be vigilant people this isn't a joke or theory

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U.S. SENATE HEARING ON VACCINES AND THEIR ADVERSE EFFECTS - CONVENED BY SEN. RON JOHNSON - PART-2

Re-published on BITCHUTE November 6th, 2021.

All Mainstream Media, tech giants, CDC, FDA, NIH were invited to attend - NONE accepted. Yet MSNBC reported Sen. Johnson was spreading yet another "Conspiracy Theory". URBAN Milwaukee news slammed him for promoting "vaccine disinformation". Watch the video and YOU be the JUDGE! Full video & details here: https://www.thethinkingconservative.com/senator-johnson-expert-panel-on-federal-vaccine-mandates-and-vaccine-injuries

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U.S. SENATE HEARING ON VACCINES AND THEIR ADVERSE EFFECTS - CONVENED BY SEN. RON JOHNSON - PART-3

Re-published on BITCHUTE November 7th, 2021.

As mainstream media and medical “authorities” continue to ignore devastating Adverse Effects from the so-called “vaccines” this Senate Panel presents conclusive evidence that could not be ignored by any normal human being! Please share these videos far and wide.
Full video & details here: https://www.thethinkingconservative.com/senator-johnson-expert-panel-on-federal-vaccine-mandates-and-vaccine-injuries

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U.S. SENATE HEARING ON VACCINES AND THEIR ADVERSE EFFECTS - CONVENED BY SEN. RON JOHNSON - PART-4

Re-published on BITCHUTE November 8th, 2021.

Four professionals speak on this portion of the hearing, and they all have “concerns” (to put it mildly) about the vaccines. Sen. Johnson describes how mainstream reported this hearing as spreading conspiracy theories. The last speaker goes into some detail about Pfizer and how they operate. Full video & details here: https://www.thethinkingconservative.com/senator-johnson-expert-panel-on-federal-vaccine-mandates-and-vaccine-injuries

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FBI RAIDS PROJECT VERITAS ~ THE DEEP STATE IS ATTACKING THE JOURNALIST OF TRUTH~ 1ST AMENDMENT DEAD

First published on BITCHUTE November 5th, 2021.

FBI RAIDS PROJECT VERITAS ~ THE DEEP STATE IS ATTACKING THE JOURNALIST OF TRUTH~ 1ST AMENDMENT DEAD 
https://www.bitchute.com/channel/F8mYE7wkVdT4/

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Was Pfizer's Covid-19 vaccine trial "compromised"?

Gravitas:  Nov 5, 2021

WION

Was Pfizer's Wuhan Virus vaccine trial compromised? A whistleblower who worked for the company Vendavia hired to run the trial spotted several lapses, speaks out. She was allegedly fired after she sent a complaint to US FDA. Palki Sharma brings you a report.

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EFFECT OF PFIZER VACCINE ON HUMAN BLOOD: INTERVIEW WITH KEVIN MCCAIRN & RECAP OF RESEARCH

First published on BITCHUTE November 5th, 2021.

6h Full Interview w/ Dr. Kevin McCairn On Blood Test, Vaccine Contaminants, Bacteria In Vials & More

Check out the 1.53 Billion dollar computer software you paid for that both Trump and Biden want everyone to be injected with (At Warp Speed) on the moderna website ("Trust the plan?") Rand Paul even says he wants another operation warp speed. -> https://www.modernatx.com/mrna-technology/mrna-platform-enabling-drug-discovery-development

This site has a link directly to the manufacturers website that admits that the V contains luciferase (Sm-102) quantum dot tech for absolute undeniable proof.
https://truthinplainsight.com/moderna-vaccine-contains-sm-102/

Undeniable evidence straight from Columbia University's website proving that injectable microchips are a current day reality, much to the contrary to the main stream media narrative. Maybe this helps explain why people are finding out the qr code readers on smart phones can read UPC numbers if they scan where they got Trump's warp speed juice injected.
https://www.engineering.columbia.edu/press-releases/shepard-injectable-chips-monitor-body-processes

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COVID-19 VACCINE MANDATES FROM OUR GOVERNMENT ARE COERCIVE AND BREAKS NUREMBERG CODE

First published on BITCHUTE November 5th, 2021.

Dr. Ponesse is the Canadian professor who was fired last month as punishment for her vocal and public opposition to forced Covid-19 Vaccinations. Consider these facts: 
1) COVID-19 has an infection facility rate not even 1% that of smallpox (and it poses even less risk to children)
2) a number of safe, highly effective pharmaceuticals exist to treat it (including monoclonal antibodies, Ivermectin, fluvoxamine, Vitamin D and Zinc), AND
3) The vaccines have reported more adverse events (including innumerable deaths) than every other vaccine on the market over the last 30 years.
In light of these facts, I have so many questions: Why are the vaccinated granted vaccine passports and access to public spaces, when the Director of the CDC has stated that the COVID-19 vaccines cannot prevent transmission? 

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Study shows dramatic decline in effectiveness of all three COVID-19 vaccines over time

A study of 780,000 veterans shows a dramatic decline in effectiveness for all three COVID-19 vaccines in use in the U.S.

BY MELISSA HEALY - 04. November 2021

As the Delta variant became the dominant strain of the coronavirus across the United States, all three COVID-19 vaccines available to Americans lost some of their protective power, with vaccine efficacy among a large group of veterans dropping between 35% and 85%, according to a new study.

Researchers who scoured the records of nearly 800,000 U.S. veterans found that in early March, just as the Delta variant was gaining a toehold across American communities, the three vaccines were roughly equal in their ability to prevent infections.

But over the next six months, that changed dramatically.

By the end of September, Moderna’s two-dose COVID-19 vaccine, measured as 89% effective in March, was only 58% effective.

The effectiveness of shots made by Pfizer and BioNTech, which also employed two doses, fell from 87% to 45% in the same period.

And most strikingly, the protective power of Johnson & Johnson’s single-dose vaccine plunged from 86% to just 13% over those six months.

The findings were published Thursday in the journal Science.

Study shows dramatic decline in effectiveness of all three COVID-19 vaccines over time

1,626,495 views - 09 Nov 2021

Los Angeles Times

A study of 780,000 veterans shows a dramatic decline in effectiveness for all three COVID-19 vaccines in use in the U.S.

The United States is in the midst of a maternal health crisis, specifically a Black maternal health crisis. Is help on the way?

The three vaccines held up better in their ability to prevent COVID-19 deaths, but by July — as the Delta variant began to drive a three-month surge of infections and deaths — the shots’ effectiveness on that score also revealed wide gaps.

Among veterans 65 and older who were inoculated with the Moderna vaccine, those who developed a so-called breakthrough infection were 76% less likely to die of COVID-19 compared with unvaccinated veterans of the same age.

Older veterans who got the Pfizer-BioNTech vaccine and subsequently experienced a breakthrough infection were 70% less likely to die than were their unvaccinated peers.

And when older vets who got a single jab of the J&J vaccine suffered a breakthrough infection, they were 52% less likely to die than their peers who didn’t get any shots.

For veterans younger than 65, the Pfizer-BioNTech and Moderna vaccines provided the best protection against a fatal case of COVID-19, at 84% and 82%, respectively. When younger veterans inoculated with the J&J vaccine suffered a breakthrough infection, they were 73% less likely to die of COVID-19 than were their unvaccinated peers.

Johnson & Johnson representatives did not immediately respond to requests to discuss the study’s findings.

The Centers for Disease Control and Prevention has recommended booster shots for everyone who got the Johnson & Johnson vaccine at least two months earlier.

Boosters are also recommended six months after a second dose of the Moderna or Pfizer vaccines for everyone 65 and older; those with medical conditions that make them more vulnerable to a serious case of COVID-19; those who live in nursing homes or other group settings; and those who live or work in high-risk settings such as hospitals or prisons.

In addition, all people with compromised immune systems are advised to get a booster shot if it’s been at least 28 days since their vaccine took full effect.

With millions of vaccinated Americans pondering whether they need a boost, the new study offers the most comprehensive comparison yet of how the three vaccines have performed across the nation this year.

It tracked 780,225 veterans of the U.S. armed forces from Feb. 1 to Oct. 1. Close to 500,000 of them had been vaccinated, while just under 300,000 had not.

Hailing from across the country, all were cared for by the Department of Veterans Affairs’ unified system, which provides healthcare to 2.7% of the U.S. population. While the group under study was ethnically and racially diverse, the record-keeping that researchers relied upon was uniform.

Because these were veterans, the study population comprised six times as many men as women. And they skewed older: about 48% were 65 or older, 29% were between 50 and 64, and 24% were younger than 50.

Though older veterans were more likely to die than younger vets throughout the study period, the decline of the vaccines’ protection against illness and death was seen in both young and old.

The study was conducted by a team from the Public Health Institute in Oakland, the Veterans Affairs Medical Center in San Francisco, and the University of Texas Health Science Center.

Dr. Barbara Cohn, the study’s lead author, said in addition to its comparison of COVID-19 vaccines, the group’s analysis provides “a lens for making informed decisions around primary vaccination, booster shots, and other multiple layers of protection.” That includes mask mandates, coronavirus testing and other public health measures aimed at countering viral spread.

Strong evidence of the vaccines’ declining power should prompt even states and locales with highly vaccinated populations to consider retaining mask mandates, the authors said. And the findings strongly support the CDC’s recent recommendation that all recipients of the J&J vaccine get a booster.

The study concluded that the Delta variant, which drove a wave of infections and deaths across the country over the spring and summer, was probably the factor that most eroded the protection of vaccines.

Other researchers have found similar evidence of declining vaccine effectiveness. But they have suggested that the immune system’s defenses against SARS-CoV-2 simply fade with time, and that waning vaccine effectiveness would probably have been seen with or without the arrival of a new, more transmissible strain.

 

Author:

Melissa Healy is a health and science reporter with the Los Angeles Times writing from the Washington, D.C., area. She covers prescription drugs, obesity, nutrition and exercise, and neuroscience, mental health and human behavior. She’s been at The Times for more than 30 years, and has covered national security, environment, domestic social policy, Congress and the White House. As a baby boomer, she keenly follows trends in midlife weight gain, memory loss and the health benefits of red wine.

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A nurse administers the Pfizer COVID-19 vaccine to a patient in Santa Ana, Calif.

Pfizer vaccine’s protection wanes over time, and not because of Delta, study says

SCIENCE Oct. 4, 2021

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Why are COVID-19 booster shots needed anyway?

SCIENCE Aug. 18, 2021

Los Angeles , CA - May 14: Alma Sevilla preparers Pfizer COVID-19 vaccine vial at a mobile vaccine clinic held at Roosevelt Park on Friday, May 14, 2021 in Los Angeles , CA. (Irfan Khan / Los Angeles Times)

Big gap between Pfizer, Moderna vaccines seen for preventing COVID hospitalizations

SCIENCE Sept. 17, 2021

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NURSE SPEAKS OUT

HOSPITALS ARE HIDING COVID-19 VACCINE INJURIES…

MAINSTREAM MEDIA MUM

First published on BITCHUTE November 4th, 2021. See also on ODYSEE

Nurse Speaks Out Hospitals are hiding Vaccine injuries…The “vaccines” are useless, they are dangerous, and they’re being used to implement the Great Reset. None of this is about public health or a pandemic, and it hasn’t been for quite some time.

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THEY'VE GOT DIFFERENT JABS FOR BLACKS & WHITES: IS THERE A RACIAL ELEMENT IN THIS GENOCIDE?

First published on BITCHUTE November 3rd, 2021.

This video needs to go viral, the majority of blacks already don't trust the jab, they remember Tuskegee when the government infected them with syphilis. Learning that there they're assigning different injections for Blacks & Whites will send them over the top like a massive wake-up call

Watch: https://neopoprealismjournal.wordpress.com/2021/11/04/covid-19-and-vaccine-call-them-what-they-are/

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ICYMI:

'Falsified Data': Pfizer Vaccine Trial Had Major Flaws, Whistleblower Tells Peer-Reviewed Journal

By TYLER DURDEN - 02. November 2021

A whistleblower involved in Pfizer's pivotal phase III Covid-19 vaccine trial has leaked evidence to a notable peer-reviewed medical publication that poor practices at the contract research company she worked for raise questions about data integrity and regulatory oversight.

Brook Jackson, a now-fired regional director at Ventavia Research Group, revealed to The BMJ that vaccine trials at several sites in Texas last year had major problems - including falsified data, broke fundamental rules, and were 'slow' to report adverse reactions.

When she notified superiors of the issues she found, they fired her.

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, 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. -The BMJ

Poor laboratory management

Jackson, a trained clinical trial auditor with more than 15 years' experience, says she repeatedly warned her superiors of poor laboratory management, patient safety concerns, and data integrity issues. After she was ignored, she started documenting problems with the camera 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.

The unblinding was potentially far more severe as well. Per the trial's design, unblinded staff prepared and administered either Pfizer's Covid-19 vaccine or a placebo. This was done to preserve the blinding of trial participants and other staff - including the principal investigator. At Ventavia, however, Jackson says that drug assignments were left in participants' charts and accessible to blinded personnel. The breach was corrected last September, two months into the trial at which point there were around 1,000 participants already enrolled.

Jackson recorded a September 2020 meeting with two Ventavia directors, at which an executive can be heard saying that the company couldn't quantify the types and number of errors with their testing.

"In my mind, it's something new every day," they said, adding "We know that it's significant."

According to the report, Ventavia also failed to keep up with data entry - as a Sept. 2020 email from Pfizer partner ICON reveals.

"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.”

FDA Inspection woes

Other documents provided to The BMJ reveal that Ventavia officials were worried about three employees . In an email in early August 2020, an executive identified three site staff members with whom they need to "Go over e-diary issue/falsifying data, etc."

One of the employees was "verbally counseled for changing data and not noting late entry," a note reveals.

During the September meeting, Ventavia executives and Jackson discussed the potential for the FDA to show up for an inspection. On former Ventavia employee told The BMJ that the company was petrified over the potential for an FDA audit, and were in fact expecting one over the Pfizer vaccine trial.

"People working in clinical research are terrified of FDA audits," Jill Fisher told the journal, adding however that the agency rarely does anything except review paperwork - usually months after a trial is over. "I don’t know why they’re so afraid of them," she added - saying that she was surprised that the agency failed to inspect Ventavia following an employee complaint.

"You would think if there’s a specific and credible complaint that they would have to investigate that."

FDA notified

Jackson sent a Sept. 25 email to the FDA in which she wrote that Ventavia had enrolled over 1,000 participants at three sites, out of the full trial's 44,000 participants across 153 sites which included various academic institutions and commercial companies. She raised concerns over issues she had witnessed, including:

  • Participants placed in a hallway after injection and not being monitored by clinical staff

  • Lack of timely follow-up of patients who experienced adverse events

  • Protocol deviations not being reported

  • Vaccines not being stored at proper temperatures

  • Mislabelled laboratory specimens, and

  • Targeting of Ventavia staff for reporting these types of problems.

Hours later, the FDA emailed her back, thanking her for her input but notifying her that they would not comment on any investigation which may result.

That said, in August of this year, the FDA published a summary of its inspections of Pfizer's pivotal phase III trial. They looked at just nine out of the trial's 153 sites, and did not look at any of Ventavia's operations. Further, no inspections were conducted following the December 2020 emergency authorization of the vaccine.

Other employees corroborate Jackson's complaints

Two former Ventavia employees spoke with The BMJ anonymously, and confirmed 'broad aspects' of Jackson's account.

One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.

I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.” -The BMJ

The second employee told The BMJ that working at Ventavia was unlike any environment she had experienced in 20 years of research.

Since her firing, Jackson has reconnected with several Ventavia employees who either left or were fired themselves. One of them sent her a text message, which reads "everything that you complained about was spot on."

Meanwhile, since Jackson reported issues with Ventavia to the FDA in September 2020, Pfizer has contracted with the company for four other vaccine clinical trials.

One has to wonder - if the FDA is auditing less than 10% of trials, how many more potential whistleblowers could there be?

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Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635

By Paul D Thacker - 02. November 2021

Revelations of poor practices at a contract research company helping to carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about data integrity and regulatory oversight. Paul D Thacker reports

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, 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.

A history of lax oversight

When it comes to the FDA and clinical trials, Elizabeth Woeckner, president of Citizens for Responsible Care and Research Incorporated (CIRCARE),3 says the agency’s oversight capacity is severely under-resourced. If the FDA receives a complaint about a clinical trial, she says the agency rarely has the staff available to show up and inspect. And sometimes oversight occurs too late.

In one example CIRCARE and the US consumer advocacy organisation Public Citizen, along with dozens of public health experts, filed a detailed complaint in July 2018 with the FDA about a clinical trial that failed to comply with regulations for the protection of human participants.4 Nine months later, in April 2019, an FDA investigator inspected the clinical site. In May this year the FDA sent the triallist a warning letter that substantiated many of the claims in the complaints. It said, “[I]t appears that you did not adhere to the applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects.”5

“There’s just a complete lack of oversight of contract research organisations and independent clinical research facilities,” says Jill Fisher, professor of social medicine at the University of North Carolina School of Medicine and author of Medical Research for Hire: The Political Economy of Pharmaceutical Clinical Trials.

Ventavia and the FDA

A former Ventavia employee told The BMJ that the company was nervous and expecting a federal audit of its Pfizer vaccine trial.

“People working in clinical research are terrified of FDA audits,” Jill Fisher told The BMJ, but added that the agency rarely does anything other than inspect paperwork, usually months after a trial has ended. “I don’t know why they’re so afraid of them,” she said. But she said she was surprised that the agency failed to inspect Ventavia after an employee had filed a complaint. “You would think if there’s a specific and credible complaint that they would have to investigate that,” Fisher said.

In 2007 the Department of Health and Human Services’ Office of the Inspector General released a report on FDA’s oversight of clinical trials conducted between 2000 and 2005. The report found that the FDA inspected only 1% of clinical trial sites.6 Inspections carried out by the FDA’s vaccines and biologics branch have been decreasing in recent years, with just 50 conducted in the 2020 fiscal year.7

RETURN TO TEXT

The next morning, 25 September 2020, Jackson called the FDA to warn about unsound practices in Pfizer’s clinical trial at Ventavia. She then reported her concerns in an email to the agency. In the afternoon Ventavia fired Jackson—deemed “not a good fit,” according to her separation letter.

Jackson told The BMJ it was the first time she had been fired in her 20 year career in research.

Concerns raised

In her 25 September email to the FDA Jackson wrote that Ventavia had enrolled more than 1000 participants at three sites. The full trial (registered under NCT04368728) enrolled around 44 000 participants across 153 sites that included numerous commercial companies and academic centres. She then listed a dozen concerns she had witnessed, including:

  • Participants placed in a hallway after injection and not being monitored by clinical staff

  • Lack of timely follow-up of patients who experienced adverse events

  • Protocol deviations not being reported

  • Vaccines not being stored at proper temperatures

  • Mislabelled laboratory specimens, and

  • Targeting of Ventavia staff for reporting these types of problems.

Within hours Jackson received an email from the FDA thanking her for her concerns and notifying her that the FDA could not comment on any investigation that might result. A few days later Jackson received a call from an FDA inspector to discuss her report but was told that no further information could be provided. She heard nothing further in relation to her report.

In Pfizer’s briefing document submitted to an FDA advisory committee meeting held on 10 December 2020 to discuss Pfizer’s application for emergency use authorisation of its covid-19 vaccine, the company made no mention of problems at the Ventavia site. The next day the FDA issued the authorisation of the vaccine.8

In August this year, after the full approval of Pfizer’s vaccine, the FDA published a summary of its inspections of the company’s pivotal trial. Nine of the trial’s 153 sites were inspected. Ventavia’s sites were not listed among the nine, and no inspections of sites where adults were recruited took place in the eight months after the December 2020 emergency authorisation. The FDA’s inspection officer noted: “The data integrity and verification portion of the BIMO [bioresearch monitoring] inspections were limited because the study was ongoing, and the data required for verification and comparison were not yet available to the IND [investigational new drug].”

Other employees’ accounts

In recent months Jackson has reconnected with several former Ventavia employees who all left or were fired from the company. One of them was one of the officials who had taken part in the late September meeting. In a text message sent in June the former official apologised, saying that “everything that you complained about was spot on.”

Two former Ventavia employees spoke to The BMJ anonymously for fear of reprisal and loss of job prospects in the tightly knit research community. Both confirmed broad aspects of Jackson’s complaint. One said that she had worked on over four dozen clinical trials in her career, including many large trials, but had never experienced such a “helter skelter” work environment as with Ventavia on Pfizer’s trial.

“I’ve never had to do what they were asking me to do, ever,” she told The BMJ. “It just seemed like something a little different from normal—the things that were allowed and expected.”

She added that during her time at Ventavia the company expected a federal audit but that this never came.

After Jackson left the company problems persisted at Ventavia, this employee said. In several cases Ventavia lacked enough employees to swab all trial participants who reported covid-like symptoms, to test for infection. Laboratory confirmed symptomatic covid-19 was the trial’s primary endpoint, the employee noted. (An FDA review memorandum released in August this year states that across the full trial swabs were not taken from 477 people with suspected cases of symptomatic covid-19.)

“I don’t think it was good clean data,” the employee said of the data Ventavia generated for the Pfizer trial. “It’s a crazy mess.”

A second employee also described an environment at Ventavia unlike any she had experienced in her 20 years doing research. She told The BMJ that, shortly after Ventavia fired Jackson, Pfizer was notified of problems at Ventavia with the vaccine trial and that an audit took place.

Since Jackson reported problems with Ventavia to the FDA in September 2020, Pfizer has hired Ventavia as a research subcontractor on four other vaccine clinical trials (covid-19 vaccine in children and young adults, pregnant women, and a booster dose, as well an RSV vaccine trial; NCT04816643NCT04754594,NCT04955626NCT05035212). The advisory committee for the Centers for Disease Control and Prevention is set to discuss the covid-19 paediatric vaccine trial on 2 November.

Footnotes

  • Provenance and peer review: commissioned; externally peer reviewed.

  • Competing interests: PDT has been doubly vaccinated with Pfizer’s vaccine.

This article is made freely available for use in accordance with BMJ's website terms and conditions for the duration of the covid-19 pandemic or until otherwise determined by BMJ. You may use, download and print the article for any lawful, non-commercial purpose (including text and data mining) provided that all copyright notices and trade marks are retained.

https://bmj.com/coronavirus/usage

References

  1. Bourla A. An open letter from Pfizer chairman and CEO Albert Bourla. Pfizer.https://www.pfizer.com/news/hot-topics/an_open_letter_from_pfizer_chairman_and_ceo_albert_bourla.

  2. Ventavia. A leading force in clinical research trials. https://www.ventaviaresearch.com/company.

  3. Citizens for Responsible Care and Research Incorporated (CIRCARE). https://www.circare.org/corp.htm.

  4. Public Citizen. Letter to Scott Gottlieb and Jerry Menikoff. Jul 2018. https://www.citizen.org/wp-content/uploads/2442.pdf.

  5. Food and Drug Administration. Letter to John B Cole MD. MARCS-CMS 611902. May 2021.https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jon-b-cole-md-611902-05052021.

  6. Department of Health and Human Services Office of Inspector General. The Food and Drug Administration’s oversight of clinical trials. Sep 2007. https://www.oig.hhs.gov/oei/reports/oei-01-06-00160.pdf.

  7. Food and Drug Administration. Bioresearch monitoring. https://www.fda.gov/media/145858/download.

  8. FDA takes key action in fight against covid-19 by issuing emergency use authorization for first covid-19 vaccine. Dec 2020. https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19.

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