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December 10, 2020 (Children’s Health Defense) — A former employee of the U.S. Food and Drug Administration (FDA) whose job it was to inspect vaccine manufacturing plants told Vanity Fair last week that when the FDA ignored his allegations of gross safety violations at a Merck vaccine plant, he blew the whistle — only to be ignored.

Coming amid growing concerns over the safety of COVID vaccines, which are being rushed to market at unprecedented speed, the newly revealed allegations raise questions about how the FDA will oversee safety at COVID vaccine manufacturing operations.

According to Vanity Fair, “the unprecedented effort to actually make the more than 300 million doses that a successful national vaccination effort will require has gotten less attention” than issues related to the safety and efficacy of the actual vaccines themselves.

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Concerns over the health and safety of the human test subjects in Pfizer's European COVID vaccine study have caused two eminent doctors to launch a petition calling for an immediate halt to those studies.

On December 1, 2020, Dr. Michael Yeadon, an ex chief of research at Pfizer and Dr. Wolfgang Wodarg, a lung specialist and former department head of public health lodged an appeal to the EMA, the European Medicine Agency responsible for approving drugs across the EU, asking them to suspend the ongoing Pfizer/BioNtech COVID vaccine study on BNT162b (EudraCT number 2020-002641-42).

LifeSite is joining Drs. Yeadon and Wodarg in their call for an immediate suspension of this study and we are encouraging people to co-sign their petition to the EMA which is to be found in the petition section on this page.

Please SIGN and SHARE this important petition, and then please contact the EMA at the address listed below, in the 'For More Information' section.

In their application to the EMA, Drs. Yeadon and Wodarg give the following reasons why the Pfizer study could pose dangers to the health and safety of the study participants:

  • First, the doctors say that the study design must be improved as the highly inaccurate PCR test is currently being used to detect the presence of COVID in the study participants. This means that the efficacy of the vaccine is in doubt. The doctors recommend changing from the PCR test to Sanger sequencing.
  • Second, and more important, the doctors advocate animal testing of the vaccine to exclude the possibility of the risks to the life and health of human participants from known side-effects of other similar studies on corona viruses.

These side-effects can include: an exaggerated immune response when the subject comes into contact with the "real world" virus; possible infertility of an "indefinite duration" for women; severe allergic responses to polyethylene glycol which is contained in the mRNA vaccine being tested by Pfizer; and, other latent, serious side effects which, because of the short duration of the study, may only become known well after the conclusion of the study.

Because of these unacceptable risks to the life and health of the Pfizer/BioNtech COVID vaccine study participants, we are joining with Drs. Yeadon and Wodarg as co-signers of their petition to the European Medicine Agency, asking for an immediate halt to these studies.

Thank you for SIGNING and SHARING, today!

And, after you have signed this petition, please send the sample email in the section below to the official European Medicine Agency email: [email protected]

FOR MORE INFORMATION:

Actual Petition Text (pdf): https://2020news.de/wp-content/uploads/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits.pdf

Sample Email:

Subject: Please act on the petition of Dr. Wodarg and Dr. Yeadon and stay the Phase III clinical trial(s) of BNT162b

Dear Sir or Madam,

I am hereby co-signing the petition of Dr. Wodarg and Dr. Yeadon to support their urgent request to stay the Phase III clinical trial(s) of BNT162b (EudraCT Number 2020-002641-42) and other clinical trials. The full text of the petition of Dr. Wodarg and Dr. Yeadon can be found here: https://2020news.de/wp-content/uploads/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits.pdf

I hereby respectfully request that EMA act on the petition of Dr. Wodarg and Dr. Yeadon immediately.

Regards, [Your name]

**Photo Credit: Shutterstock.com

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“Vital questions about the FDA’s inspections of vaccine plants have slipped under the radar,” the magazine reported.

Vanity Fair, the first to report on the whistleblower complaint, focused on concerns related exclusively to the manufacturing process. The article dismissed concerns about the actual safety of the vaccine.

In an interview after her article was published, reporter Katherine Eba told PBS NewsHour the “last thing she wanted to do” was contribute to “vaccine hesitancy.”

“You know, the issues we raised in this story have nothing to do with the anti-vaxxer position. They have to do with whether the FDA is doing the job it is supposed to do, which is ensuring that all these manufacturing plants follow good manufacturing practices.”

But many people, including doctors and scientists, have raised a multitude of concerns about the safety of the leading COVID vaccine candidates. In fact, polls consistently show that more people than not, including healthcare workers, won’t sign up, at least not right away, for the vaccines.

Compounding concerns about the safety of the vaccines themselves, are concerns about the FDA’s process for emergency authorization — will the agency prioritize public safety over pharmaceutical industry profits?

According to Arie Menachem, the whistleblower who told his story to Vanity Fair, that’s not been his experience with the FDA, at least not when it comes to the safety of vaccine manufacturing.

Menachem — who according to Vanity Fair holds a master’s degree in biochemistry and worked for 13 years in quality assurance and compliance at several pharmaceutical companies before joining the FDA in 2014 — was a member of the FDA’s Team Biologics.

The “elite” team’s 14 members were responsible for inspecting 280 manufacturing plants that make vaccines and blood products for U.S. patients.

In November 2018, Menachem filed a whistleblower complaint with the U.S. Office of Special Counsel after his initial report detailing a host of disturbing safety violations at a Merck vaccine plant was downgraded by FDA officials.

Menachem’s report — based in part on information provided to him by whistleblowers within the company — included this, according to Vanity Fair:

“The allegations described a biohazard nightmare. Workers appeared to be defecating and urinating in their uniforms, and feces had been found smeared on the floor of the plant’s production area, the letter alleged. In a sterile manufacturing plant, bathroom breaks can be difficult to take because they require additional time, which could serve as one possible explanation for the events inside the Merck plant. Ungowning can take 15 minutes, regowning can take 15 minutes, and on a night shift, there may be no one else to cover an essential worker during that time, Menachem said.”

Vanity Fair said the magazine confirmed Menachem’s account, as well as his description of conflict inside Team Biologics, “through interviews with four current or former FDA employees, including Menachem, a detailed review of documents, and an analysis of Team Biologics inspection data.”

Merck isn’t the only drugmaker whose manufacturing operations have been called into question. As Children’s Health Defense previously reportedEli Lilly, which has been working on a COVID therapeutic drug, recently had a run-in with the FDA over problems with one of its manufacturing plants. Reuters reported that the FDA had cited “serious quality control problems” at an Eli Lilly plant working on an antibody therapy.

A former associate counsel at the FDA told Reuters the violations were “serious enough and have a significant enough impact on the public health that something needs to be fixed.”

When it comes to COVID vaccines, Dr. Joshua Sharfstein, vice dean for public health practice and community engagement at the Johns Hopkins Bloomberg School of Public Health, told Vanity Fair, “There is not a lot of room for error on a COVID vaccine.”

But as Vanity Fair and Bloomberg pointed out, if the FDA, as it’s expected to, grants emergency use authorization for a COVID-19 vaccine, “it is not even clear whether the FDA will require full inspections of manufacturing plants” because transparency has been “notably absent in Operation Warp Speed,” the public-private partnership launched by the Trump administration to rapidly develop and distribute a COVID-19 vaccine.

© December 8, 2020 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense.

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