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 Children's Health Defense

February 18, 2021 (Children’s Health Defense) — Pfizer’s announcement in November 2020 that clinical trials showed its COVID-19 vaccine was “95% effective” prompted Dr. Sin Hang Lee, a Connecticut pathologist, to question Pfizer’s methodology and petition the U.S. Food and Drug Administration (FDA) to require accurate counts of COVID-19 cases in the Pfizer/BioNTech COVID-19 mRNA vaccine trial before granting the vaccine Emergency Use Authorization (EAU).

As The Defender reported in November, Lee, who is director of Milford Molecular Diagnostics, said:

“Until an accurate count of COVID-19 cases in the vaccinated and placebo groups has been determined for vaccine efficacy evaluation, we are asking the FDA to stay its decision regarding the emergency use authorization for this vaccine.”

Lee’s request was rejected by the FDA on Dec. 11, the same day the agency approved Pfizer’s vaccine for emergency use. On Feb. 8, Lee filed an amended reply

Here’s the sequence of events as they unfolded:

On Nov. 23, 2020, Lee, along with Informed Consent Action Network (ICAN) and its counsel, submitted a Citizen Petition and petition for administrative stay of action to the FDA relating to the phase 3 trial of the BNT162b/Pfizer vaccine to prevent the novel coronavirus SARS-CoV-2

In the petition and stay, Lee requested the FDA amend the study design for the late-stage trial of Pfizer’s COVID-19 vaccine. Specifically, Lee requests:

“Before an EUA or unrestricted license is issued for the Pfizer vaccine, or for other vaccines for which PCR results are the primary evidence of infection, all “endpoints” or COVID-19 cases used to determine vaccine efficacy in the Phase 3 or 2/3 trials should have their infection status confirmed by Sanger sequencing, given the high cycle thresholds used in some trials. High cycle thresholds, or Ct values, in RT-qPCR test results have been widely acknowledged to lead to false positives … All RT-qPCR-positive test results used to categorize patient as “COVID-19 cases” and used to qualify the trial’s endpoints should be verified by Sanger sequencing to confirm that the tested samples in fact contain a unique SARS-CoV-2 genomic RNA.”

The petition makes these requests because the phase 2/3 clinical trial of the Pfizer COVID-19 vaccine uses a presumptive RT-qPCR (“PCR”) diagnostic test, which is known to generate high rates of false-positive results.

In addition, the Pfizer vaccine trial primarily uses a PCR test that employs cycle thresholds up to 44.9 to identify COVID-19 “cases” despite the fact that “positive” results that require cycle thresholds greater than 30 to 35 are usually false positives, according to Lee.

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People of goodwill can disagree about the safety, efficacy and religious implications of a new vaccine for the coronavirus.

But, everyone should agree on this point:

No government can force anyone who has reached legal adulthood to be vaccinated for the coronavirus. Equally, no government can vaccinate minors for the coronavirus against the will of their parents or guardians.

Please SIGN this urgent petition which urges policymakers at every level of government to reject calls for mandatory coronavirus vaccination.

Fear of a disease - which we know very little about, relative to other similar diseases - must not lead to knee-jerk reactions regarding public health, nor can it justify supporting the hidden agenda of governmental as well as non-governmental bodies that have apparent conflicts of interest in plans to restrict personal freedoms. 

The so-called "public health experts" have gotten it wrong many times during the current crisis. We should not, therefore, allow their opinions to rush decision-makers into policies regarding vaccination.

And, while some people, like Bill Gates, may have a lot of money, his opinion and that of his NGO (the Bill & Melinda Gates Foundation) - namely, that life will not return to normal till people are widely vaccinated - should not be permitted to influence policy decisions on a coronavirus vaccination program.

Finally, we must also not allow the rush by pharmaceutical companies to produce a new coronavirus vaccine to, itself, become an imperative for vaccination.

Unwitting citizens must not be used as guinea pigs for New World Order ideologues, or Big Pharma, in pursuit of a vaccine (and, profits) which may not even protect against future mutated strains of the coronavirus.

And it goes without saying that the production of vaccines using aborted babies for cell replication is a total non-starter, as the technique is gravely immoral.

However, if after sufficient study of the issue, a person who has reached the age of majority wishes to be vaccinated with a morally produced vaccine, along with his children, that is his business.

But we cannot and will not permit the government to make that decision for us.

Thank you for SIGNING and SHARING this petition, urging policymakers at all levels of government to reject mandatory coronavirus vaccination.

FOR MORE INFORMATION:

Bill Gates: Life won’t go back to ‘normal’ until population 'widely vaccinated' - https://www.lifesitenews.com/news/bill-gates-life-wont-go-back-to-normal-until-population-widely-vaccinated

COVID-19 scare leads to more digital surveillance, talk of mandatory vaccine 'tattoos' for kids' - https://www.lifesitenews.com/news/covid-19-scare-leads-to-more-digital-surveillance-talk-of-mandatory-vaccine-tattoos-for-kids

Trudeau says no return to ‘normal’ without vaccine: 'Could take 12 to 18 months' - https://www.lifesitenews.com/news/trudeau-says-no-return-to-normal-without-vaccine-could-take-12-to-18-months

Trudeau mulls making coronavirus vaccine mandatory for Canadians - https://www.lifesitenews.com/news/trudeau-mulls-making-coronavirus-vaccine-mandatory-for-canadians

US bishop vows to ‘refuse’ COVID-19 vaccine if made from ‘aborted fetal tissue' - https://www.lifesitenews.com/news/us-bishop-vows-to-refuse-covid-19-vaccine-if-made-from-aborted-fetal-tissue

** While LifeSite opposes immorally-produced vaccines using aborted fetal cell lines, we do not have a position on any particular coronavirus vaccines produced without such moral problems. We realize many have general concerns about vaccines, but also recognize that millions of lives have been saved due to vaccines.

*** Photo Credit: Shutterstock.com

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Lee offered to re-test the residues of tested samples in his laboratory if Pfizer is unable to do so in order to confirm Pfizer’s stated vaccine efficacy rate of 95%. 

Lee’s Sanger sequencing-based method for molecular diagnosis of SARS-CoV-2 was published in International Journal of Geriatrics and Rehabilitation.

On Dec. 11, 2020, the same day the FDA granted Pfizer Emergency Use Authorization for its COVID-19 vaccine, the FDA responded to Lee’s petition and request for stay.  The agency “conclude[d] that the petitions do not contain facts demonstrating any reasonable grounds for the requested action” and denied the petitions.

The FDA, among other things, stated that “PCR testing does not need to be followed by Sanger or other sequencing for purposes of clinical diagnosis. Currently, reverse real-time PCR (RT-PCR) tests can both amplify and confirm the identity of viral genetic material in a single reaction, without a separate sequencing step.”

On Feb. 8, Lee, through ICAN’s counsel, submitted a detailed and thoroughly cited reply to the FDA’s denial of his petition and stay. This reply points out the inaccuracies, contradictions and omissions in the FDA’s denial of the petition. 

Lee wrote that the FDA’s letter denying the petition and stay “shows that the FDA has not conducted an adequate evaluation of the Pfizer vaccine’s efficacy, especially concerning issues about the accuracy of RT-qPCR testing of SARS-CoV-2 in clinical specimens.”

Lee’s detailed response, which can be read in full here, goes on to say:

“The FDA has misled the public. The key misleading statements are analyzed below point-by-point according to the sequence of their presentation in the Letter but under the following four categories for the convenience of the readers:

“A. Cherry-picking to eviscerate the guidance for issuance of an EUA for a COVID-19 vaccine.

B. Knowingly promoting inaccurate PCR tests for SARS-CoV-2.

C. Finding excuses for using PCR tests with high false-positive rates for this vaccine trial.

D. Glossing over potential risks of an mRNA vaccine while concealing its true efficacy.”

Lee, ICAN and others are weighing possible future actions.

© February 17, 2021 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. Your donation will help to support us in our efforts.

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