FDA Fiction — Fictional Approval of COVID-19 Vaccine

As many have correctly noticed, the FDA has not approved any of the COVID-19 vaccines. All currently used Covid-19 vaccines are still under Emergency Use Authorization (EUA). So, the obvious questions are:

  1. Has the FDA approved the BioNTech COMIRNATY vaccine, as alleged?
  2. Why would the FDA approve a vaccine not supplied to the US, instead of approving the equivalent formulation, manufactured and distributed by Pfizer[1], which has been injected in half of the US population, allegedly with enormous success?
  3. Finally, why has the FDA created an artificial legal distinction[2] between batches of the same product, manufactured at different plants?

The FDA Approval Letter in the question is dated by August 23 and is signed by two directors of CBER offices. One of those directors is Marion Gruber, PhD, who has announced her future resignation, due to the CDC’s attempts to force an approval of a COVID-19 vaccine.

The first thing that we notice in the letter is that it lacks the language “We have approved your BLA for <product description> effective <date>”, typically appearing at the beginning of such letters[3]. BLA stands for Biologics License Application. This letter does contain a few sentences authorizing BioNTech to manufacture a COVID-19 Vaccine and approving certain ways and undisclosed locations of manufacturing. It also approves labeling with the name COMIRNATY. This said, such form is used sometimes and is considered as an approval.

The next important fact is that the alleged Approval Letter actually prohibits distribution of the drug named in it:

“Please submit final container samples of the product in final containers together with protocols showing results of all applicable tests. You may not distribute any lots of product until you receive a notification of release from the Director, Center for Biologics Evaluation and Research (CBER).”

This language is not unusual in such approval letters. A company receiving such an approval letter from FDA/CBER considers the drug approved and frequently issues a triumphant press release.

But this case is different. There is already a surplus of Pfizer’s product in the US[4], its manufacturing continues, and its EUA is re-issued on the same day. BioNTech has no intent to distribute COMIRNATY in the US, and probably has no right to do so under its agreement with Pfizer. Therefore, it is unlikely BioNTech would submit to CBER the requested samples and “protocols showing results of all applicable tests”. Pfizer and BioNtech have barely announced the alleged FDA approval in a joint press-release.

The “approval” is incomplete. Each side must take at least one more step to complete the process – BioNTech must ship samples and test results and CBER Director must send a notification of release after that. Neither party is interested in taking these last steps.

This answers our first question as to COMIRNATY being truly approved. No, it is not. The FDA approval letter is a fictitious document. Continue reading FDA Fiction — Fictional Approval of COVID-19 Vaccine

Current COVID-19 vaccines are obsolete

All currently circulating strains of SARS-COV-2 (i.e., Delta sub-variants) have spike mutations L452R & T478K, disabling most vaccine induced antibodies. These strains also have aT19R mutation, disrupting epitopes in spike NTD. Many NTD-directed antibodies are known to cause ADE, especially when the epitopes which they target are disrupted.

These L452R/Q & T478K have been mutations of concern for many months. Pfizer & Moderna have had plenty of time to modify their vaccines and/or make a booster with the new spike mRNA. Surprisingly however, the Biden-Harris regime has not demanded any modifications to improve the vaccine to make it effective against the current SARS-COV-2 variants.

All the side effects and other harms remain.

Medical hypothesis about the evolving Delta variant and its early treatment

2021-09-09,  preprint, self-published Cochrane-style. TreatingEvolvingDelta-Zinc.PDF 

Bullet Points
  • The current coronavirus variant has a shorter incubation period and a higher replication rate than previous variants. This necessitates an earlier start of anti-viral treatment despite the efforts of certain forces to hinder access to the necessary medications.
  • The current coronavirus variant is capable of cell-cell fusion. This may decrease the effectiveness of antibodies and some drugs. One way to compensate for this is with higher amounts of zinc and its ionophores, especially hydroxychloroquine.

Continue reading Medical hypothesis about the evolving Delta variant and its early treatment

Delta Subvariants AY.3, AY.4, and A.25 are Dominant. The CDC Lies.

2021-09-06: updated with the sub-variant AY.25. The situation is changing rapidly. This article is not being updated

The CDC uses W.H.O’s classification of the SARS-COV2 variants. W.H.O has failed to elevate Delta sub-variants into full variants when such a classification is more than warranted. Consequently, what has been called Delta (B.1.617.2) since May 2021 is a mix of many sub-variants with different properties. This confused clinicians and the CDC added to this confusion. Continue reading Delta Subvariants AY.3, AY.4, and A.25 are Dominant. The CDC Lies.

Democrats Sabotage Texas Response to COVID-19

Democrat and Democrat-Socialist politicians control the largest cities and counties in Texas. In the fight against the Wuhan coronavirus, many of these politicians seem to be on the side of the coronavirus. Instead of supporting early treatment to prevent hospitalizations and deaths, they force masking and deceive or even bribe young people into getting the alleged “vaccine”. The “top” three counties leading in COVID-19 deaths, are all Democrat-led. Texas will continue to suffer a disproportionate share of COVID-19 deaths until this sabotage is overcome.

Continue reading Democrats Sabotage Texas Response to COVID-19

Importance of Oral and Nasal Hygiene in COVID-19 Pandemic

We are constantly reminded to wash our hands with soap or alcoholic solutions that kill the coronavirus. But the coronavirus does not live on hands. COVID-19 starts in the upper respiratory tract (URT). The largest load develops in the nasopharynx. From there, it spreads into the lungs through the pharynx mucosal surfaces. Therefore, it stands to reason that we should frequently cleanse the upper respiratory tract: nasal cavity, oral cavity, nasopharynx, and oropharynx. The most promising antiseptic is Povidone-Iodine (PVP-I), because it has been used for this purpose in dentistry and otolaryngology for decades. Continue reading Importance of Oral and Nasal Hygiene in COVID-19 Pandemic

C19 Vaccines are not for Immune Persons. Prophylaxis before C19 Vaccine? Mucosal Immunity?

C19 Vaccines were not formulated for people who have recovered from COVID-19

The clinical trials for the mRNA vaccines excluded participants who were seropositive for COVID-19. Thus, the trials safety and efficacy results are applicable only to individuals seronegative for COVID-19 antibodies. Seropositive persons already have antibodies to COVID-19 and are therefore likely immune.  Thus, they do not need the mRNA vaccine and they are likely to have stronger adverse effects from vaccination.

Based on the CDC’s own data, most people <65 who receive are now being vaccinated already have natural immunity.

Antiviral Prophylaxis with Vaccine?

2021-08-26. Vaccination decreases innate immunity for some time after the each shot. For COVID-19 in adults, this decrease in the innate immunity is likely compensated by the vaccine-elicited adaptive immunity. This compensation might become sufficiently effective as soon as 10 days after the first shot, although some estimates are longer.

COVID-19 vaccination is conducted in areas where the disease is present, and the person might be already infected in time of vaccination, or become infected within those 10 days. Notice that the vaccine elicited immunity is less effective against the Delta variant, and is likely to be even less effective against future variants. Continue reading C19 Vaccines are not for Immune Persons. Prophylaxis before C19 Vaccine? Mucosal Immunity?

The Health Harms and Risks of Face Masks

August 23, 2021, preprint, self-published Cochrane-style. F-Masks.PDF

The Health Harms and Risks of Face Masks

Leo Goldstein[1]

Introduction

In debates about the putative benefits of facemasks, the harms and risks receive very little consideration.

Originally, facemasks were proposed as a temporary measure. Also, people were expected to wear them only for short times. Now, face masks are being mandated, for undefined periods of time, and for many hours a day.  Very few studies of masks safety have been published since the beginning of masks wearing. The few studies that were published, and observational data shows very significant downsides of masks. That does not stop mask proponents from expanding the proposed mandates, not sparing even children.

Wearing facemasks might have been the first healthcare intervention in a half-century, introduced without any testing of its efficacy or safety. When proposing any new treatment or intervention, the top priority is to demonstrate safety; at least, to show that the risks are commensurate with its benefits. This was not done for facemasks. Continue reading The Health Harms and Risks of Face Masks

Oronasal Hygiene with PVP-I for COVID19

August 18, 2021, preprint.  PVPI.pdf

Oronasal Hygiene with PVP-I for COVID19

Leo Goldstein[1]

Bullet points
  • Mouth rinsing, gargling, and nasal irrigation with Povidone-Iodine (PVP-I) is safe and effective for prophylaxis, early treatment, and prevention of transmission of COVID-19
  • PVP-I has been used for decades as a broad-spectrum antiseptic in dentistry and otolaryngology, so its use for COVID-19 is not re-purposing
  • PVP-I has been widely used in India to prevent nosocomial transmission of COVID-19
  • In clinical trials, PVP-I was up to 90% in prevention hospitalizations and deaths from COVID-19
Abstract

Application of 0.5%-1.0% PVP-I solution to the nasal cavity, oral cavity, nasopharynx, and oropharynx, 2-4 times per day, is an excellent prophylaxis and adjuvant treatment of early COVID-19. Its use would also prevent or sharply decrease transmission of the virus from contagious persons. Povidone-Iodine (PVP-I) is available over the counter.

This is the conclusion from the available literature, including physicians’ recommendations. Continue reading Oronasal Hygiene with PVP-I for COVID19

Proposed Protocol for Self-Immunization against COVID-19

Proposed Protocol for Self-Immunization against COVID-19

PREPRINT, August 12-15, 2020; v3.  PDF  (archived v2)

Leo Goldstein [1]

Abstract

Prophylactically taking a small, less than preventative, dose of Hydroxychloroquine can improve an individual’s odds against COVID-19 upon accidental exposure. This allows the individual to lead a normal life and acquire broad natural immunity through a mild infection. The infection should be detected and terminated by appropriate anti–SARS-COV-2 medicines as soon as possible to minimize asymptomatic spread by that individual.

This is the proposed hypothesis. It is accompanied by a sample regimen suitable for a clinical trial. Continue reading Proposed Protocol for Self-Immunization against COVID-19