Madison Area Lyme Support Group

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-19mRNA 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.

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.

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**Comment**

You may recognize Dr. Lee due to the following posts:

• https://madisonarealymesupportgroup.com/2018/08/15/milford-pathologist-fires-broadside-at-cdc-motion-to-discuss/
• https://madisonarealymesupportgroup.com/2018/09/26/cdc-resorts-to-politically-motivated-false-science/
• https://madisonarealymesupportgroup.com/2017/09/25/speaking-of-fake-science-fifty-seven-million-anti-trust-lawsuit-against-cdc-lyme-tests/
• https://madisonarealymesupportgroup.com/2018/05/15/news-release-on-57-1-million-lyme-disease-lawsuit-filed-against-cdc/
• https://madisonarealymesupportgroup.com/2020/11/29/stay-of-action-filed-against-fda-to-stop-approval-of-covid-vaccine-for-using-faulty-pcr-tests-in-trials/
• https://madisonarealymesupportgroup.com/2018/12/08/manufactured-crisis-film-on-hpv-hype-horror-and-vaccine/
• https://madisonarealymesupportgroup.com/2018/09/29/shocking-flaws-in-gardasil-trial-design-prevents-safety-assessment/  Lee confirmed the presence of HPV-16 L1 gene DNA in the girl’s post-mortem blood and spleen tissue — the same DNA fragments found in the vaccine. According to Lee, the fragments were protected from degradation by binding to the aluminum adjuvant used in the vaccine. He suggested their presence might offer a plausible explanation for the high immunogenicity of Gardasil, meaning that the vaccine tends to provoke an exaggerated immune response. He pointed out that the rate of anaphylaxis in girls receiving Gardasil is far higher than normal — reportedly five to 20 times higher than any other school-based vaccination program.  Also, According to Lee, vaccines target 70% of HPV strains (though new version targets more strains), and if vaccines were 100% effective, ONE death would be prevented out of 100,000 vaccinated women; 1.3 with newer versions.  Cost to vaccinate 1 girl is about $700.  $350 for vaccine & $350 for doctor visit.  Cost to vaccinate 100,000 girls is approximately $70 million.

Associate Professor of Health Sciences Adam MacNeil at Brock University, Canada and his Ph.D. student Jeremia Coish were among the earliest to warn, last June, of the dangers of not looking very carefully at the possibility that vaccines might trigger antibody-dependent enhancement(ADE) of disease. This could mean that people who are vaccinated might, paradoxically, suffer more severe disease when exposed to the wild virus than if they hadn’t been vaccinated.

In their aptly titled article, “Out of the frying pan and into the fire? Due diligence warranted for ADE in COVID-19,” published in the journal Microbes and Infection in June 2020, MacNeil and Coish argue that ADE is well known to be a risk for coronavirus-mediated infections, as well as dengue.

For those not already familiar with ADE, it is the paradoxical immune response that makes a person who was previously exposed to the disease, or a vaccine targeting it, more — not less — susceptible in the event that they’re subsequently infected.

Proceed with caution

Seemingly countering this view, in August 2020, was viral epidemiologist Leah Katzelnick Ph.D., a dengue and zika specialist now in the employ of the National Institute for Allergy and Infectious Diseases headed by Dr. Tony Fauci. Along with co-author Scott Halstead,. Katzelnick argued that ADE shouldn’t be something to be feared. Katzelnick and Halstead proposed that the fundamental differences between SARS-CoV-2 infection that can cause COVID-19 and other diseases, for which ADE has been shown, meant that ADE would be highly unlikely.

They supported their arguments with evidence from cases of classic, intrinsic ADE, notably infectious peritonitis, a coronavirus infection in cats, as well as from respiratory syncytial virus, dengue and SARS — suggesting significant differences in the pathology, epidemiology and immune responses involved in these diseases as compared with COVID and SARS-CoV-2 infection.

Careful readers of Halstead and Katzelnick’s paper will note that while the authors largely dismiss the ADE risk, they very clearly identify a risk of vaccine hypersensitivity (or VAH), a closely related immunological hyper-reaction that was first identified in the late 1960s when children developed atypical measles following measles vaccination.

Many who’ve used the paper to dismiss ADE risks may only have read the title and abstract and not picked up that Katzelnick and Halstead dismiss only intrinsic ADE or iADE (i.e. the risk of disease enhancement on re-infection in the absence of vaccination).

They also may not have read the sombre advisory in the paper’s last sentence:

“Given the magnitude of the repertoire of COVID-19 problems and the need for an effective vaccine, the full force of worldwide investigative resources should be directed at unravelling the pathogenesis of VAH.”

There is not much to suggest that this advisory has been heeded, other than the fact that thousands of volunteers have been put through Phase 3 trials and there has been no evidence of spikes in more severe reactions among those vaccinated with the real thing, as opposed to the placebo.

Herbert Virgin, Ann Arvin and colleagues, writing in Nature, one of the most influential journals in the world, made a not dissimilar call for caution back in July. These authors discuss the great difficulties in identifying the incidence and frequency of ADE (and VAH) and suggest that “… it will be essential to depend on careful analysis of safety in humans as immune interventions for COVID-19 move forward.”

Transparency is key

This requires full transparency of surveillance data so that cases of infection and reinfection post-vaccination can be correlated against severe reactions following infection or vaccination. It also requires time — much more time than we’ve had so far.

Presently, data released by VAERS (Vaccine Adverse Event Reporting System) in the U.S. and the MHRA (Medicines and Healthcare products Regulatory Agency) in the UK don’t come close to telling us anything about the ADE or VAH risk. In fact, there will have to be a lot more re-infection before we know conclusively one way or another. And will we be able to find out if there are genuine issues with ADE or VAH, or will the authorities manage to keep a lid on it by just not communicating them given many reactions will be substantially delayed following vaccination?

Timothy Cardozo from New York University and Ronald Veazy from Tulane University took it a step further in their article in the International Journal of Clinical Practice published in October, when Phase 3 trials for the COVID frontrunner vaccines were in full swing. They argued not only that vaccine-mediated ADE (i.e. VAH) risks were more than just theoretical, they also suggest that the risks may be greater following particular types of mutations in the circulating viruses.

In their discussion on SARS-CoV-2, they discuss how very tiny changes, such as changes in the conformity (shape) of its spike protein both before and after fusion with host cells, via ACE2 receptors might impact those who’ve been vaccinated. Several months on with emerging evidence that some variants are able to evade the immune response that has been trained to offer protection against the original Wuhan variants, there is cause for even greater concern. This risk also can’t be dismissed on the basis of the results of the Phase 3 trials

What Cardozo and Veazy also suggest is another point we’ve long been concerned about. That relates to the fact that trial subjects — let alone members of the public who’re now lining up for COVID vaccines — are just not being informed of these potential risks, and the delayed nature of possible ADE/VAH reactions.

What about vaccinees who become ill several months after being vaccinated, suffering the classic range of symptoms associated with many respiratory diseases (including COVID), such as fever, chills, cough, shortness of breath, headache, fatigue, and so on? Will they know that these symptoms might be related to enhanced COVID disease mediated by the vaccination given to them months before, something that didn’t occur to them because they thought the vaccine gave them protection from COVID?

Cardozo and Veazy then show how informed consent forms for volunteer subjects in vaccine trials fail to meet the required ethical standards for informed consent. While ADE is mentioned, it is generally added at the end of the list of possible risks and its implications and identification are unlikely to be adequately understood by the lay public.

With a tick in the box and a sense from regulators and vaccine makers that they’ve successfully negotiated the hurdle of ADE/VAH risks, there’s been no further discussion of the issue. The vast majority of pre-vaccinees lining up as part of the global mass vaccination roll out simply have no idea of the risk — because they’re not being told.

Could ADE be a ticking time bomb?

Does non-disclosure as part of the informed consent process constitute not only a breach of medical ethics, but also a breach of law? In our view, that’s highly likely and should evidence accrue in the future, this will be something the courts will need to grapple with.

Presently there is no evidence of any significant ADE/VAH signal — but it is too early to tell and many cases could have gone undetected.

Is it possible that some instances of ‘long COVID’ could be a form of ADE? This is a possibility we have been considering. Typically people who get long COVID don’t test as positive from nasopharyngeal swab tests. But in deep seated systemic infections the mucosa may not show evidence of viral multiplication, whereas the infection may become systemic in certain tissues and be enhanced. This possibility cannot easily be dismissed.

Could the problem increase with new variants of SARS-CoV-2? Yes, as explained above.

What you can do:

1. Anyone who is deciding to have the vaccine should inform themselves of the ADE and VAH risk, where there could be a considerable delay between vaccination and the experience of disease symptoms that may be more severe than those that would occur without the vaccine.
2. Let those you know who are considering or planning to have the COVID vaccine of this risk. Read and share our article, “Informed consent — is this fundamental right being respected?“
3. Share this article widely.

Originally published by Alliance for Natural Health International.