by Sharon Rondeau

(Oct. 2, 2021) — Questions The Post & Email posed more than a week ago to the FDA regarding COVID-19 vaccines remain unanswered despite person-to-person contact between this writer and an FDA representative.

On Wednesday, September 22, The Post & Email contacted the FDA’s Center for Biologics Evaluation and Research (CBER) by phone with a media inquiry. Our telephone call was returned the following day, with the representative providing the division’s media email address. We then sent a list of what we believed were four simple questions, anticipating a prompt reply.

On August 23, the FDA reportedly “approved” Comirnaty (“COVID-19 Vaccine, mRNA”) produced by BioNTech Manufacturing GmbH for individuals aged 16 and older. According to the FDA:

…the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.

Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. 

According to one Florida physician, on August 23 the FDA approved only a Biologics License Application (BLA) for Comirnaty and not the product itself. On December 10, the FDA issued its approval under Emergency Use Authorization (EUA) for the “Pfizer-BioNTech COVID-19 vaccine” and another on December 18 for the Moderna vaccine; Johnson & Johnson’s vaccine was approved under the same authorization on February 27.

On January 12, 2021, the National Institutes of Health (NIH) termed coronavirus vaccines “experimental.”

Under Emergency Authorization Use, U.S. law protects pharmaceutical companies from product liability in the event of reported adverse events. Physicians and other medical personnel are required to report adverse events to the VAERS database, although evidence has surfaced indicating at least some government medical providers are not following the mandate.

As the Centers for Disease Control and Prevention (CDC) has reported, COVID-19 infections among the “fully vaccinated” became prevalent as the “Delta variant” arose earlier this year.

In interviews with RedVoiceMedia’s Stew Peters, at least two hospital-employed nurses claimed that COVID/”Delta variant” hospitalizations are in reality vaccine “injuries” and that patients are not receiving effective care. “We’re not talking about fevers, chills, malaise,” an on-camera nurse with two decades’ experience told Peters last month. “We’re talking about strokes, heart attacks, blood clots, severe cognitive impairments, loss of balance and ability to walk, Guillain-Barre…”

The latter nurse left her job as a result of a vaccine “mandate,” she told Peters.

According to Dr. Peter A. McCullough, MD, MPH, who has published 46 peer-reviewed papers on COVID-19, survived the disease and developed a protocol for its several stages, has gone as far as to say that “crimes against humanity” are taking place in the form of physicians failing to treat patients through means other than vaccination.

Rep. Louis Gohmert (R-TX1) agrees.

Atty. Thomas Renz, who represents the organization America’s Frontline Doctors (AFLDS) in a lawsuit filed in July, recently stated he has a number of “whistleblowers” providing data from the Centers for Medicare & Medicaid Services (CMS) showing the CDC is not releasing the actual numbers of deaths reported to VAERS from COVID-19 vaccines.

A slide from Renz’s presentation reads:





On August 24, Dr. Meryl Nass and Robert F. Kennedy, Jr., writing for ChildrensHealthDefense.org, reported:

There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.

EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.

U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.

…The government has created an extremely stingy compensation program, the Countermeasures Injury Compensation Program, to redress injuries from all EUA products. The program’s parsimonious administrators have compensated under 4% of petitioners to date — and not a single COVID vaccine injury — despite the fact that physicians, families and injured vaccine recipients have reported more than 600,000 COVID vaccine injuries.

At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.

On August 30, Dr. Nass wrote:

FDA made some clear but cagey statements about the differences between the Comirnaty vaccine and the Pfizer-BioNTech EUA vaccine.

For example:

“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”

What does that statement mean? What, specifically, are the “certain differences” that make the two vaccines “legally distinct?”

The FDA did not explain this in any of the documents provided last week to the public.

The same day, Nass and Kennedy were refuted by The Washington Post‘s Glenn Kessler, who quoted a Pfizer spokesman as having told him, “The statement that the products are ‘legally distinct with certain differences’ refers to the differences in manufacturing information included in the respective regulatory submissions. Specifically, while the products are manufactured using the same processes, they may have been manufactured at different sites or using raw materials from different approved suppliers. FDA closely reviews all manufacturing steps, and has found explicitly that the EUA and BLA [biologics license application] products are equivalent.”

The Post & Email’s questions to the FDA are:

1. Is the “Comirnaty” vaccine available in the U.S. now? If not, when is it expected to be?

2. Is the Pfizer/BioNTech vaccine authorized under EUA still being administered in the U.S. given the FDA’s approval of Comirnaty?

3. How often does the FDA review reports in the “VAERS” system from COVID-19 vaccines?

4. To the FDA’s knowledge, do vaccine mandates from government or private organizations apply to vaccines or other drugs authorized under an EUA only?


Updated 10:42 a.m. EDT.

Update, Oct. 3, 2021, 8:55 a.m.:  In a September 23, 2021 interview with Brian Hooker, Ph.D., chief scientific officer of Children’s Health Defense, McCullough said at 36:46, “Recently, our FDA did not approve Pfizer, but gave it continuation of the EUA based on ‘legacy’ data.”

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  1. The Post and Mail, everyone,
    I am posting a link here for everyone to go to, read, and to look specifically at the FDA’s actions regarding the vaccines:
    [ https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine ]
    Once on this site, go to “COMIRNATY Information”, then
    click on “Summary Basis for Regulatory Action”.
    Once the document is open, go to page 14 of the document, Section 4, “Nonclinical Pharmacology/Toxicology”, sub-section “Nonclinical Toxicology”, 2nd paragraph, 1st two sentences.
    THIS is where they make the “legal distinction” between the so-called “approved” COMIRNATY vaccine and the BNT162b2 vaccine. TAKE NOTE that they have placed a (V8) next to the BNT162b2. My opinion, this states that this is the 8th version of the BNT162b2 formulation. SECONDLY, note that they STATE that COMIRNATY has/contains optimized codons. Again, my opinion, this codon optimization would make it a completely different formulation, and therefore would be DIFFERENT FROM the BNT162b2 formulation. While most of the product ingredients could be identical, ADDING optimized codons should alter the formulation just enough to make it “different from”, and not “similar to”.
    In other words, this is a subtle play on words that the FDA folk used.

  2. Anyone who has paid any attention (which are extremely few people) would know immediately the answer to the headline’s question.

    The FDA has been a captured shill and tool of the criminal allopathic medical establishment, serving their interests and agendas, for many decades.

    The much more deeply educational question is why is it that a perceptive 10 year old can see, and could see from the start, that Covid-19 has nothing to do with real science (ie, it’s a crimes against humanity political scam) yet most people even most SO-CALLED intelligent people could not and still CANNOT figure out that the fake Covid pandemic has NOTHING to do with real science but ALL with criminal politics AGAINST POPULATIONS (you and I)?

    This proffers a coherent answer … read “The 2 Married Pink Elephants In The Historical Room –The Holocaustal Covid-19 Coronavirus Madness: A Sociological Perspective  & Historical Assessment Of The Covid “Phenomenon”” by Rolf Hefti at https://www.rolf-hefti.com/covid-19-coronavirus.html

    “Unmasked Lives Matter” (Sol Luckman, Artist & Author)

  3. FDA will not engage in Q&A because they know full well that the entire thing was a mind-control fraud from the jump. They can’t give honest replies in regards to a charade since their false responses would take thousands of years to develop. They may be pretty good salespeople but there are millions around the world who aren’t caving in to their marketing.

      1. Anyone can report to VAERS and many anti-vaxxers are making false reports.
        https://www.bloomberg.com/news/newsletters/2021-04-20/anti-vaxxers-turn-covid-data-into-a-weapon

        “VAERS is a perfect example. Anyone—a doctor, a patient or even an anti-vaccine activist—can post a report about what they perceive as a vaccination side effect. If patterns emerge, the Centers for Disease Control and Prevention and the Food and Drug Administration investigates. The same information is also available to the public, even though it hasn’t been verified or fact-checked.”

        1. If you read the article carefully, it does not say that false reports have been identified. If and when that is verified by the CDC, The Post & Email will report it. If we miss it, please bring it to our attention.

      2. Here are examples of some of the nonsense reported on VAERS:

        “To show that VAERS listings should not be taken at face value to mean that the vaccine caused the reported event, I trawled through the database’s reports on the COVID-19 vaccines. There were many, many reports of fever and injection site reactions (to be expected), but there were also, shall we say, head-scratching reports. A woman reported a large bald spot on top of her head following vaccination. Someone simply wrote in, “Nosebleed.” I saw a report of “anal leakage.” More than one person complained of suddenly becoming impotent. Meanwhile, at the other end of the spectrum, the funniest report I saw stated, “My penis swelled to ten times its size.”
        https://www.mcgill.ca/oss/article/covid-19-critical-thinking-health/dont-fall-vaers-scare-tactic

        The problem is not so much the false reports like these as is the misuse of the data by anti-vaxxers to claim thousands have died from being vaccinated. However, a report of a death on VAERS does not prove causation. To date there is no confirmed link between the mRNA vaccines and death from investigations of medical records, autopsies and death certificates conducted by the CDC.

        1. The system should never be used as a weapon, and there should be a penalty for entering false information. However, the article does not definitively say that inaccurate information has been entered into VAERS; it acknowledges that the CDC follows up on each report to verify it and that “ani-Vaxxers” are drawing attention to it. In a recent presentation, Atty. Thomas Renz claimed to have proof from “whistleblowers” that VAERS currently reflects only a fraction of the actual deaths which have occurred from COVID vaccines based on data from CMS: https://rumble.com/vn12v1-attorney-thomas-renz-we-got-them.-fact-check-this-all-new-whistleblower-inf.html

        2. There have been numerous articles about the misuse of the VAERS database. That it is a crime to make a false report doesn’t mean there have been no false reports in VAERS. (Robbery is illegal is every state, and robberies still occur.)

          The FDA explicitly disclaims the accuracy of the the data in the database. Data is not presumed to be accurate because in appears in VAERS.

          https://www.reuters.com/article/uk-factcheck-vaers-idUSKBN2AE0QQ

          The FDA has VAERS FAQ:

          https://www.fda.gov/vaccines-blood-biologics/vaccine-adverse-events/vaccine-adverse-event-reporting-system-vaers-questions-and-answers

    1. Fred Muggs, stop spreading misinformation and conspiracy theories. You have no proof of your statement and it is irresponsible. You should be ashamed. A vast majority of VAERS reports are from physicians. Most physicians are not generating the reports they should be because it takes over 30 minutes and a patient chart to complete. It is illegal to make a false report into the system.

    1. Good question. If I had to guess it would be the International Court.

      But therein lies the kicker. The Nuremberg Code is a voluntary agreement. So there is pretty much nobody to uphold it. The idea was to never allow a mechanism by which the atrocities that occurred, would again occur.

      I read this on another site. They were debating the legalities of vaccine mandates. There was a SCOTUS case where it was determined that forced vaccination was legal, at the state level.

      “In the Jacobsen case – an Individual can be forced to take a vaccine IF the greater good of society can be protected through it. MEANING, the vaccine must provide sterilising immunity and it must prevent that individual from becoming infected and from transmitting it. If it does not, there is no for the greater good test met.

      None of the current vaccines prevent the individual from becoming infected and certainly protect nobody in society around that individual. In which case there is no legal case that allows any employer or state to mandate medical treatment!”

      That’s why I think this might backfire. But that’s IF the SCOTUS will hear it. Which if I had to put money on it, they will keep deferring to lower courts. I have zero faith in the SCOTUS to do the right thing.