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perjantai 31. joulukuuta 2021

As Omicron Surges, Officials Shorten Isolation Times

  • The Covid 'pandemic' is based entirely on RT PCR testing fraud.
  • Who are the Masterminds behind this fraud, which began in December 2019.
  • Deagel 2025 Forecast - Behind The Vax Depopulation Agenda
  • Hot video.

As Omicron Surges, Officials Shorten
Isolation Times for Many Americans 

Hoping to prevent further disruptions to daily life, the C.D.C. reduced the period that certain infected Americans must sequester.



Lining up for coronavirus tests in Queens, New York, last week.
Credit...Janice Chung for The New York Times

Benjamin MuellerIsabella Grullón Paz
By Benjamin Mueller and Isabella Grullón Paz
Dec. 27, 2021

As daily coronavirus cases in the United States soared to near record levels, federal health officials on Monday shortened by half the recommended isolation period for many infected Americans, hoping to minimize rising disruptions to the economy and everyday life.

Virus-related staff shortages have upended holiday travel, leading to the cancellation of thousands of flights, and now threaten industries as diverse as health care, restaurants and retail. Yet health experts warn the country is only in the early stages of a fast-moving surge.

“The Omicron variant is spreading quickly and has the potential to impact all facets of our society,” said Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention.

The agency had previously recommended that infected patients isolate for 10 days from when they were tested for the virus. But on Monday, it slashed that period to five days for those without symptoms, or those without fevers whose other symptoms were resolving. 



Americans leaving isolation should wear masks around others for an additional five days after their isolation periods have ended, officials said. 

The updated guidance comes amid a rising tide of infections that threatens to swamp the U.S. health care system, particularly given that tens of millions remain unvaccinated. The new recommendations “balance what we know about the spread of the virus and the protection provided by vaccination and booster doses,” Dr. Walensky said. “These updates ensure people can safely continue their daily lives.” 


Still, the C.D.C. did not recommend that people take rapid tests before ending their isolation periods, a step that scientists said would offer considerably more reassurance that people were not continuing to spread the virus.

Health officials also shortened the quarantine period for certain uninfected Americans who were exposed to the virus. They said that people who were unvaccinated had to quarantine for just five days after exposure, down from 14 days. That also applied to people who were six months past receiving the primary series of the Moderna or Pfizer vaccines, or two months past a Johnson & Johnson shot, but who had not received booster shots.

Officials also said that uninfected Americans who had received booster shots did not need to quarantine at all after exposure. But people who have been exposed are encouraged to wear masks around other people for 10 days and get tested five days after being exposed. 


Last week, the C.D.C. reduced, in some circumstances, the number of days it recommended that health care workers who test positive must isolate.

The Omicron variant has moved with extraordinary swiftness across the country, from New York to Hawaii, both of which reported more coronavirus cases in the past week than in any other seven-day period of the pandemic. Delaware, Massachusetts, New Jersey and Puerto Rico have also reported record caseloads.

On Sunday, the seven-day national average of new daily cases climbed past 214,000, an 83 percent jump over the past 14 days. Deaths also increased by 3 percent during that time, to a seven-day average of 1,328, according to a New York Times database.

Hospitalizations are up, too, although not as much as cases. More than 71,000 Americans are hospitalized with Covid-19, 8 percent higher than two weeks ago but still well below previous peaks. 


In New York, Mayor Bill de Blasio on Monday implemented what he cast as the most sweeping vaccine mandate for private businesses in the nation. All employers in New York City now have to verify that their on-site workers have received at least one dose of a vaccine. 

In Puerto Rico, new travel guidelines went into effect, requiring all passengers arriving on domestic flights to show a negative Covid test upon arrival or risk a fine. In Massachusetts, where Gov. Charlie Baker has activated the National Guard, 300 members were sent on Monday to acute-care hospitals and ambulance service providers. 

In a conference call with governors on Monday, President Biden spoke of cooperation at various levels of government. Asa Hutchinson, the Republican governor of Arkansas, praised the president’s plan to give away 500 million rapid at-home tests, but said that federal efforts to stanch the infections must yield to state remedies. 

“Look, there is no federal solution,” Mr. Biden replied. “This gets solved at the state level.” 

“Ultimately it gets down to where the rubber meets the road, and that’s where the patient is in need of help or preventing the need for help,” he added.

On Monday, some business owners said the new C.D.C. guidance was helpful in addressing staffing shortages, as waves of workers fall sick. But they said that it still left employers and their workers with the challenge of determining how long people should isolate on a case-by-case basis.

“It’s a common-sense change, but it doesn’t really take the burden away,” said Barbara Sibley, who runs four restaurants in New York City and is currently isolating with Covid. 

Unions warned that companies could use the guidance as a pretext to rush employees with symptoms back to work, exacerbating the pressures on workers resulting from a lack of paid sick leave. “We cannot allow pandemic fatigue to lead to decisions that extend the life of the pandemic or put policies on the backs of workers,” said Sara Nelson, the president of a flight attendants union. 

With Americans wearying of pandemic restrictions and cases rising, some scientists said that narrowing isolation periods for infected people was overdue. 

Dr. Ashish K. Jha, dean of the Brown University School of Public Health, said that people were generally some days into their infections by the time they tested positive, shortening the period afterward during which they remained infectious. 

He also said that the personal and social costs of 10-day isolation periods were considerable, citing the difficulty facing single parents, for example. He worried that some people, especially those relying on hourly wages, had been resisting getting tested in the first place because of the toll of missing work. 

“It’s hugely harmful asking people to unnecessarily isolate,” Dr. Jha said. “If you can shorten that isolation in a clinically responsible way, I think it does lower the bar for people to go ahead and get tested.” 

Dr. Jha said he wished that the C.D.C. had recommended negative rapid test results before people ended their isolation. “But given that tests are not widely available,” Dr. Jha added, “this is a reasonable approach.” 

But Dr. Michael Mina, an immunologist and expert on rapid tests, called the C.D.C.’s new guidance “reckless.” Studies have demonstrated wide variations in the periods during which people remained contagious. 

And with more people now testing regularly, other scientists said, some may be catching their infections in the very early stages. In those cases, five days may be insufficient to stop people from spreading the virus.

“I think this is a remarkable policy shift,” said Joseph Fauver, a genomic epidemiologist at the University of Nebraska Medical Center. “I’m a little surprised at them cutting it in half without having a testing requirement associated with it or based on vaccine status.” 

A study that Dr. Fauver co-authored on the duration of infections with an earlier variant in N.B.A. personnel established that vaccinated people cleared the virus sooner, he said. But he said that the change of tack from the C.D.C. had not been accompanied by data backing up the agency’s assertions. 

Vaccination is still a strong protector against severe illness. Unvaccinated people are five times as likely to test positive, and 14 times as likely to die of Covid, compared with vaccinated patients, according to the C.D.C. 

Still, only 62 percent of Americans are fully vaccinated, and the nation’s medical infrastructure is dangerously frayed two years into the pandemic as hospitals contend with staff shortages fueled by burnout and early retirements.

Public health experts warned that the most severe disruptions could still be ahead.
Past surges of the coronavirus have been regional, allowing states to reallocate resources like monoclonal antibodies, while this wave threatens to overtake the country at once, said Michael Osterholm, a professor and director of the Center for Infectious Disease Research and Policy at the University of Minnesota. 
“With this one, all 50 states are in the soup at the same time. It’s like every state is being hit by a viral hurricane,” he said.
Dr. Osterholm predicts that in the next three to five weeks, a substantial share of health care workers will get infected and be unable to work, straining an overburdened system. “We’re already stretched so thin,” he said.

Scientists said those staffing shortages — in hospitals and nursing homes, but also in restaurants, retail stores and airline workforces — had increased the urgency of re-evaluating isolation periods. And at-home rapid tests had given people the ability to get a rough, if imperfect, measure of whether they were contagious.

Still, only 62 percent of Americans are fully vaccinated, and the nation’s medical infrastructure is dangerously frayed two years into the pandemic as hospitals contend with staff shortages fueled by burnout and early retirements. “With this one, all 50 states are in the soup at the same time. It’s like every state is being hit by a viral hurricane,” he said. 

But the scarcity of those tests over the holiday period made loosening isolation recommendations significantly more fraught, scientists said. Several experts, including Dr. Jha, said that two negative rapid tests on consecutive days would offer more reassurance that someone was not contagious. A lack of widespread access to tests, some scientists said, had made changing isolation policies more difficult.

“I think it’s tricky, because they’re trying to prepare for a crisis situation,” Jeremy Kamil, a virologist at Louisiana State University Health Sciences Center Shreveport, said of federal health officials. “There are so many unknowns.” 

Data out of South Africa and some European countries suggest that Omicron infections have been milder and are producing fewer hospitalizations. But experts warn that might not be true everywhere.

"We cannot assume the same things will happen to the U.S.,” said Akiko Iwasaki, an immunologist and researcher at the Yale School of Medicine. “That is not a reason to relax our measures here, and we still need to vaccinate those pockets of people who are unvaccinated.” 

Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health, cautioned that it remained unclear how well rapid tests measured contagiousness with Omicron, given the possibility that lower levels of virus could initiate infections.
But he said that vaccinated people may only shed the Omicron variant “in large amounts for a short period.” He added that the variant’s rapid spread could quickly shut workplaces: “We don’t want that in health care.” 


Reporting was contributed by Albert Sun, Emma Goldberg, Giulia Heyward, Joseph Goldstein, Michael D. Shear, Sabrina Imbler and Lauren Hirsch.

Benjamin Mueller is a health and science reporter. Previously, he covered the coronavirus pandemic as a correspondent in London and the police in New York. @benjmueller 


Isabella Grullón Paz is a reporter covering breaking news and a member of the 2021-2022 New York Times fellowship class. @igrullonpaz 

A version of this article appears in print on Dec. 28, 2021, Section A, Page 1 of the New York edition with the headline: Isolation Period Cut to Five Days for the Less Ill. Order Reprints | Today’s Paper | Subscribe


https://www.nytimes.com/2021/12/27/health/omicron-cdc.html#commentsContainer

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Is The Zionist Tribe Behind The Vax Depopulation Agenda?

Posted on November 14, 2021

3 minute vid.

Yeah, it is. Throughout history, there used to be a competition between the British monarchy, the Jesuit / Vatican mafias, Freemasons, and these guys. Not anymore. They are all working together to bring us down, trying to get their Great Reset / Social Credit System pushed through like the Roman Catholic Great Inquisition and medieval witch hunts. It really comes down to whether or not most of you can get past this single point of contention.

This Jewish website has a list of over 1,000 times the tribe has been expelled by countries all over the world. They see it as a badge of courage. Me, not so much. Zionist agenda has been around for around 250 years or so, but Jewish trouble-making has been around a lot longer than that. Learn about Zionism and Orthodox Judaism, sheep, and you tell me if they have the best interests of us Gentiles at heart.

- Video deleted - https://www.bitchute.com/video/zbjdk5P0Wr4y/
The same video below.

https://verumetinventa.wordpress.com/2021/11/14/is-the-zionist-tribe-behind-the-vax-depopulation-agenda/

-

ANTHONY NESCI - Covid is Communism Rebranded as a Deadly Virus | 17 Oct 2021


https://brandnewtube.com/v/PbZL4R

Who are the ones behind the COVID-VAX depopulation agenda


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Deagel 2025 Forecast - Behind The Vax Depopulation Agenda

 On The Shocking 2025 ‘Deagel’ Forecast.

  • A look at the Deagel website, which is quite sophisticated, makes it clear we’re not dealing with some blogger concocting outrageous clickbait.
  • It seems to be well-connected with defense contractors and government agencies like the CIA.
According to some sources, Deagel has partnered with:
  • National Security Agency, North Atlantic Treaty Organization (NATO).
  • Organization for Economic Co-operation and Development (OECD).
  • OSCE, Stratfor, The World Bank, United Nations (UN).
  • Russian Defense Procurement Agency.

On The Shocking 2025 ‘Deagel’ Forecast:

  • There are 182 countries listed below. View year 2013 listing.
  • GDP: Gross Domestic Product (in USD millions)
  • Mil. Exp.: Military Expenditures (in USD millions)
  • PPP: Power Purchase Parity (in USD)
  • $: U.S. Dollar (USD)

https://graviolateam.blogspot.com/p/deagel-2025-forecast-behind-vax.html

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sunnuntai 26. joulukuuta 2021

Facebook now censoring The British Medical Journal because new science goes against Pfizer’s lies and deception


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

Facebook now censoring The British Medical Journal because new science goes against Pfizer’s lies and deception
12/22/2021 / By Ethan Huff / Comments 

Fiona Godlee, the editor of The British Medical Journal (BMJ), has written a letter to Facebook (Meta) CEO Mark Zuckerberg blasting him for the social media platform’s “inaccurate, incompetent and irresponsible … fact-check” protocols that we now know are just a censorship tool.

One of the oldest and most highly respected scientific journals in the world, The BMJ recently published a report entitled, “Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial” that calls into question the “science” behind Pfizer’s Wuhan coronavirus (Covid-19) “vaccine.” Because the report does not unquestioningly praise the jabs as “safe and effective,” Facebook “fact checked” it and deemed it as containing “false information.”

Starting on November 10, Facebook users who tried to share the article encountered problems. Many were unable to share it at all while others say the post was flagged with a warning that stated: “Missing context … Independent fact-checkers say this information could mislead people.” Still others were prompted with warnings advising them to not try to share “false information.”

It turns out that Facebook contractor “Lead Stories” was responsible for all this censorship. After learning what had happened, Godlee ripped Zuckerberg a new one, highlighting the following points about the so-called “fact check” in her letter to him:

  • It did not present any assertions of fact that The BMJ article supposedly got wrong.
  • It used the following nonsensical title: “Fact Check: The British Medical Journal Did NOT Reveal Disqualifying And Ignored Reports Of Flaws In Pfizer COVID-19 Vaccine Trials.”
  • The first paragraph inaccurately labeled The BMJ a “news blog.”
  • A screenshot of The BMJ report that Facebook posted with a “Flaws Reviewed” stamp over the top of it failed to identify anything false or untrue.
  • It published the story on its website under a URL that contains the phrase “hoax-alert.”
  • Lead Stories was contacted by The BMJ concerning these and other issues but the company refused to make any changes.
  • The BMJ also tried to contact Facebook directly about removing the “fact check,” but was refused.


Instagram (owned by Facebook) caught censoring article by Cochrane

If this was just one random incident, one might argue that it was just a mistake or “flaw” in Meta’s fact-checking system. The problem is that this is not an isolated incident at all.

Meta’s other brand, Instagram, has also been caught censoring similar content by plastering “fact-check” warnings over the top of peer-reviewed articles published in reputable journals like The BMJ.

Recently, Instagram censored an article by Cochrane, for instance, which is well-known in the scientific and medical community as providing high-quality reviews of medical evidence.

This is simply unacceptable, and Godlee really made that known to Zuckerberg in her letter. She called on him to “act swiftly” to correct the error related to The BMJ article and to also review the internal processes that continue to allow this type of thing to happen.

“This fully exposes the complete fact that is the ‘fact checkers!'” wrote one commenter at Reclaim the Net. “Most people already know it’s a snow job that is really meant to censor any narrative they don’t want people to know!”

In response to a Natural News piece we published about how Facebook recently admitted in court that its “fact checks” are really just third-party opinions, another commenter wrote that “fact check” simply means “truth that they do not want you to know.”

“Anyone with an ounce of purity in their soul would have the common sense to have already detected and know this,” commented another.

More related news about Big Tech censorship can be found at Censorship.news.

https://newstarget.com/2021-12-22-facebook-censoring-bmj-science-pfizer-lies-deception.html

Sources for this article include:

ReclaimTheNet.org

NaturalNews.com 

, , , , , , , , , , , , , , , , , , ,  

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Feature BMJ Investigation

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

  1. Paul D Thacker, investigative journalist
    Author affiliations

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.

Box 1

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; NCT04816643, NCT04754594, NCT04955626, NCT05035212). 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

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View Abstract
https://www.bmj.com/content/375/bmj.n2635
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