FDA Approves Pfizer Vaccine (Well, Not Really)

Actually, it is BLM approval.  [Edited 08/25/21]

On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

Notice they’re not approving the Pfizer vaccine they’re distributing under EUA.

Nor is it approving anything for COVID-19. This is for SARs.  SARs and COVID-19 are not the same (or so they say).


Even FDA approval, which apparently they don’t have, has its upside and downside.


Doctors will no longer have to populate text-driven fields in VAERS (a non-federal platform) vying for the attention of the CDC.  Allowing VAERs to be populated by anyone with anything about their experience makes investigations slow and cumbersome at best.  There are no requirements, that I’m aware of, that the FDA or CDC has to do anything with VAERS information other than to monitor it.  They’re not required to do anything with the data.  Some entries don’t even include key information like the patient’s name for follow-up.  

When approval of the Pfizer vaccine is approved, physicians will be able to contact the FDA through multiple avenues to report issues that will be reviewed.  The result could be a “black box” warning which may deter some agencies from requiring the vaccine.

However, it looks like all efforts will be to get Comirnaity approved; not the vaccines operating under the EUA.    

After approval, one of the ways to bypass VAERs, a system that apparently just sits there, you will be able to contact the FDA in a more meaningful way under MedWatch, as the mRNA vaccine falls under “biologics.”

You can also call the FDA and file a report. Biologics include vaccines for humans, blood and blood products, cellular and gene therapy products, tissue and tissue products, and allergenics. https://www.fda.gov/about-fda/fda-basics/what-does-fda-regulate

It’s worth remembering that employers cannot mandate the existing vaccines for which they have NOT received FDA approval.  Unless it says Comirnarity it cannot be mandated.  It looks like it’s going to be a while. before that happens.

Another thing to note:  Comirnaity is for age 16 and older.  It does not include kids under age 16.    

Here are some tips for reporting a problem to the FDA more directly, i.e. bypassing VAERS:  https://www.fda.gov/consumers/consumer-updates/how-report-product-problems-and-complaints-fda


One of the bigger concerns with the mRNA vaccines is potential death due to antibody-dependent enhancement (ADE).  Should this occur, cases won’t surface until the vaccinated are exposed to one of the 7 spike protein coronaviruses in the environment.  (I don’t know this, but it wouldn’t surprise me to learn that the Delta variant is NOT responsible for “break-though cases;” it’s responsible for ADEs that look like breakthrough cases.)

On-going studies will be longitudinal in nature and require the ability to trace the problem back to the vaccine.  This may take some time unless researchers have already been looking into it, which I suspect they are.

One of the greatest downsides of FDA approval is that the government and employers can mandate the vaccine.  No need for passports as the data will be entered directly into a system and made available to everyone unless HIPAA blocks it. 

Normally, vaccine data is managed by the state and considered PHI (private) which may prove to be a barrier in terms of making the data available without your permission.  When signing forms at your provider’s office, be sure to pay attention to what data they can share with whom, and under what conditions.  In many states, you can “opt-out.”  Just cross out the offending language and initial it before you sign your name.   I often write in the margin:  “Information may only be released upon approval of the patient or patient’s legal guardian.”   


The worst-case scenario, which is in the planning stages, is the “shielding” or “green zones” they’re setting up in different places for people to live away from their families and communities; possibly indefinitely for the unvaccinated.  (And this is for a virus that is 99.97% curable and for which there are treatments they have yet to officially investigate.)  https://www.cdc.gov/coronavirus/2019-ncov/downloads/global-covid-19/Interim-Operational-Considerations-Implementing-Shielding-in-Humanitarian-Settings.pdf    

Mrs. M 
* * *  

Nearly a third of FDA-approved drugs had problems, study finds

Patients might think the US Food and Drug Administration’s stamp of approval means that a product is the last word on safety, but about a third of the drugs the FDA approved between 2001 and 2010 were involved in some kind of safety event after reaching the market, according to a study published Tuesday in the Journal of the American Medical Association.

The authors found that in that time, 222 novel therapeutics were approved, and there were 123 postmarket safety events involving 71 products that required FDA action.

Manufacturers needed to add 61 boxed warnings, also commonly called a black box warning, to call attention to serious or life-threatening risks.

Three therapeutics were withdrawn from the market.

Drugs used to treat mental illness and drugs that went through an accelerated approval process had a higher number of “events,” the study found.

“The key message with all new drugs and technology is that there is an ongoing learning process that will continue through the lifetime of the drug,” said author Dr. Nicholas S. Downing, an author of the study and a resident physician of internal medicine at Brigham and Women’s Hospital in Boston.

As the study notes, the majority of these drugs were trialed in 1,000 or fewer patients to get FDA approval. When drugs are used under real-world circumstances in a wider patient population, problems can happen, Downing said, and so scientists need to continuously test the drugs to make sure they work with a wide range of variables.

“Aspirin has been around for hundreds of years. We generally know how it works, for example, but there are still countless new studies coming out, and we learn more about it all the time,” he said.

Although the percentage of safety events may sound high, Downing adds that it is “reassuring” that the system works well enough to catch these problems.

The FDA does perform postmarket monitoring to identify new safety information that may impact product labeling.

David Gortler, a drug safety expert and former FDA official who was not involved in the research, said it is important to note that a lot of the medications in the study are niche drugs used for specialty-type diseases. Blockbuster-type drugs used by many people, such as a cholesterol medication, would typically be tested on a much larger population before approval.

“There is nothing to be alarmed about with this,” Gortler said. He often notes that drugs will work differently in a person who weighs 200 pounds, for instance, versus someone who is 125 pounds. Race, gender, ethnicity and other health problems all can affect how a drug works.

This study comes as the Trump administration has vowed to “slash restraints” on drug development and has promised that the FDA drug approval process will speed up. President Donald Trump mentioned this priority in his first address to a joint session of Congress in January.

There have been previous efforts to speed drug approval. In 1988, the FDA formalized its “fast track” designation, and in 1992, the agency created the “accelerated approval” process to allow drugs to go ahead with even earlier-stage data if they are intended to treat a life-threatening or serious illness.

On average, it takes about 12 years to get a drug from the research phase to patient. Only five in 5,000 drugs in preclinical testing make it to human trials, and only one in five is ever approved for human use.

A 2015 independent analysis of drugs approved using the accelerated processing time found that the trend toward faster approval “is being driven by drugs that are not first in class and thus potentially are less innovative.”

Other studies have shown that some drugs approved using this quicker process had a large number of adverse events that required additional warning labels.

Downing said the new study is a good argument for continuous monitoring of the safety of drugs “throughout their life cycle.”



  1. As I note here, the Pfizer ‘vaccine’
    does not do that which it is licensed to do:</em?

  2. Submission says

    Dear AAPS Members and Friends,

    We are very pleased to announce a special learning opportunity hosted by MNI Great Lakes ECHO to be held on Tuesday, August 24, 2021, 9pm to 10pm Eastern Time.

    Presentation Title:
    Early Treatment of COVID-19 and Vaccine Failure and Safety Update
    Peter McCullough, MD, MPH
    Date/Time: Tuesday, August 24, 2021, 9pm to 10pm Eastern Daylight Time

    Registration Link: https://conference.greatlakes-echo.com/

    Patient case presentations encouraged and welcomed! Please download form if you have a case study to share & email to mjones@greatlakes-echo.com.

  3. George Michalopulos says

    With regard to the CDC’s “Shielding Approach” (07/29/20), I had to laugh. This sounds a lot like my wife’s plan back in March 2020, only Gail’s would have been a lot more fun and a lot less expensive. (Healthcare network would not have been overwhelmed enabling more to live, business would have thrived, only the most needful would have required subsidies, and vaccines probably wouldn’t have been necessary.)

    CDC’s Shielding Plan :

    The shielding approach aims to reduce the number of severe COVID-19 cases by limiting contact between individuals at higher risk of developing severe disease (“high-risk”) and the general population (“low-risk”). High-risk individuals would . . . would have minimal contact with family members and other low-risk residents. Current evidence indicates that older adults and people of any age who have serious underlying medical conditions are at higher risk for severe illness from COVID-19. In most humanitarian settings, older population groups make up a small percentage of the total population. For this reason, the shielding approach suggests physically separating high-risk individuals from the general population to prioritize the use of the limited available resources and avoid implementing long-term containment measures among the general population. In theory, shielding may serve its objective to protect high-risk populations from disease and death. . . ”

    Gail’s Shielding Plan:

    Incentivize people with lower scores (1-4) to circulate in the population. For example, if someone is “1” or a “2,” e.g. under 50 with no comorbidities known to be associated with mortality from the virus, they would be eligible for vouchers to travel in the United States, stay in hotels and eat in restaurants. Rebates on practically anything they could buy could be exchanged for other goods or used to offset their state tax burden. Cities would be incentivized to organize concerts and festivals. Students and employees, with perfect attendance at their schools or jobs, would be rewarded. Encourage low risk people (those least likely to end up in the hospital) to circulate in the population so they can get the virus immediately, thus eliminating them as potential carriers down the road.

    Incentivize people with higher scores, those who are more likely to require hospitalization (5-10), to stay at home. If they agree to wear an ankle monitor, give them substantially more. (Not to arrest anyone, but to help “Aunt Martha” if she thinks she has to run to the store to pick something up. If the alarm goes off, a volunteer could call her and say, “Aunt Martha, we see that you’re leaving the house. Is there something you need? Can we send someone to get it for you?”) – Offset any financial losses they incur during this period. If they follow recommendations, there would be another payoff at the end. Something like $1,000 for each 4 week period they are required to self-quarantine. This is infinitely cheaper than it would cost to hospitalize them.


    • “Something like $1,000 for each 4 week period they are required to self-quarantine. This is infinitely cheaper than it would cost to hospitalize them.”

      Look through the CDC Shielding plan again with the below in mind.

      MonkeyWerkz, “One thing that is glaringly missing in this plan is the exit of healthy people, it isn’t even mentioned.”

      The thinking is that “high-risk” people are the unvaccinated, all the deaths from death shots will be blamed on them for being the supposed source of new variants, and nobody will leave those camps alive without no longer being “high risk” aka unvaxxed.

  4. but it wouldn’t surprise me to learn that the Delta variant is NOT responsible for “break-though cases;” it’s responsible for ADEs that look like breakthrough cases.

    False. The delta variant does not exist. It’s questionable even if there is a novel coronavirus.

    The worst-case scenario, which is in the planning stages, is the “shielding” or “green zones” they’re setting up in different places for people to live away from their families and communities; possibly indefinitely for the unvaccinated.

    Oh they don’t need that for the virus. They’re just going to do it for political dissent, which they label terrorism.

    I knew that if Harris wins that I will probably go to one of these camps. I made my peace with it long ago. My only worry is that it involves some form of homoerotic torture. My supple little body can’t handle being violated like that.

    Drugs used to treat mental illness and drugs that went through an accelerated approval process had a higher number of “events,” the study found.

    I was on four of these as a prepubescent child. In recent years I looked them up. Two of them no longer exist. Some were actually designed for entirely different things than what I was diagnosed for (which itself was speculative), and one of them caused boys in Pennsylvania to grow breasts.

    Notice it’s mostly just white people who are stupid enough to believe in psychiatrists.

    Race, gender, ethnicity and other health problems all can affect how a drug works.

    I thought race was just the color of your skin and didn’t affect anything else. If psychiatric drugs can affect the minds of different races differently, does that mean that different races are not cognitively equal?

    After the great depression, people never trusted banks again. Grandpa dies, and the kids can’t sell the house because they know there is $50,000 in coffee cans buried throughout the yard. That is what will happen to the Science industry. Once this is over and all the damage is done, people will never trust scientists and doctors again. It will be generations until people take a doctor’s word at face value.

  5. To the author: I highly suggest reading through this article about the “approval” of something from Pfizer. It appears that the drug that was recently “approved” is not the same one that Pfizer has been using under EUA… We are receiving conflicting information. https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/?utm_source=salsa&eType=EmailBlastContent&eId=62651064-d048-4c3f-8cf5-bbe1920c707e

    • Gail Sheppard says

      This is the BLM approval. Doesn’t look like it’s FDA approval.

      On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.

      Notice they’re not approving the Pfizer vaccine that continues to operate under the EUA. Nor is it approval for COVID-19 vaccines. This is for SARs. SARs and COVID-19 are not the same (or so they say). Weird.


      • I guess the cat’s out of the bag now. The approval for the Pfizer vaccine was for the alpha and beta variants. Now of course, we are supposedly being inundated with the delta variant.

        Isn’t this kind of like that rhetorical cliche, “locking the barn door after the horse has left”?

      • The LOA is very dense bureaucratese. Having read it, I can offer a few clarifications.

        There is only one Pfizer-BioNTech vaccine. The business details of the partnership between Pfizer and BioNTech, which organization applied for the BLA and what the product name of the vaccine was for the BLA versus how it was named in the EUA are irrelevant details. It is the exact same vaccine that was used in the clinical trials. With the proper lab equipment, you can take a dose of the vaccine and read the mRNA sequence it delivers.

        The BLA covers ages 16+. The EUA is still active for administering the vaccine to ages 12-15. Recall that the original EUA (December 11, 2020) was 16+, and there was a later EUA (May 10, 2021) expanding ages to 12+. Once review is complete, the BLA will be amended to be 12+.

        There is still another EUA planned later this year to include younger children. I believe the target is age 5+.

        The BLA was granted because the Pfizer-BioNTech vaccine has proven to be very effective at preventing death or serious disease from SARS-CoV-2.

        If we are being pedantic, and the LOA is nothing if pedantic, SARS-CoV-2 is the virus. Covid-19 is the disease caused by the virus. When you are talking about variants such as “Delta” it is of the SARS-CoV-2 virus, not strictly speaking a “Covid variant”. But in the real world everybody just says Covid.

        The CDC talks about how they conduct genomic surveillance to determine prevalence of specific variants of SARS-CoV-2. Genomic surveillance is conducted by public and private organizations all over the globe.

        • Gail Sheppard says

          Under EUA, companies can change the formulas. Following FDA approval they have to formally request the change.

          BLA is not a product name. Nor does it mean that a vaccine has proven to be effective. It stands for Biologics License Application.

          Don’t know what you mean by “in the real world.” In the scientific world, there are 4 COVID variants: Alpha, Beta, Gamma and Delta. They are different.

          • Alec Haapala says

            “in the real world” just means “in common parlance”. As stated above, the virus is SARS-COV-2. The disease has been named COVID-19. Sure, it would have been much simpler if they had just named the disease SARS2 to distinguish it from SARS.

  6. So it’s a lie that the Covid vaccine is FDA approved now? Face with tears of joy They are just saying so on the MSM?
    A product not currently in production has been approved. Existing jab Still under emergency use and therefore no liability.
    I think I’m correct in saying the FDA have agreed both drugs are similar enough to be interchangeable but new one has no liability exemption.
    ..hoping this news will trick people into getting the current jab because they think it’s approved.

    • Just a dad says

      All of this technical mumbo jumbo has no meaning in “the real world”. The Wokeists leading private industry now have the justification they need to do what they are going to do – mandate vaccines to their employees. Full stop. Take the vaccine or get fired, take the vaccine or pay exorbitant health care premiums, take the vaccine or lose paid time off for illness, etc. United Airlines, now Delta airlines. Deloitte (accounting firm), soon to be followed by KPMG, EY, PwC. Hospitals, banks, financial institutions.

      The floodgate has opened and there is no stopping it now. All the debate and bickering about the name of “you know the thing”, EUA vs FDA approval, Pfizer vs BioNTech, etc is all moot at this point. Take your stand, one way or the other, and prepare for the consequences of your personal decision.

  7. RFK Jnr says it was not approved. He is an attorney.

    Dr Robert Malone says it was not approved. He invented the technology.

    Karen Kingston says it was approved, but there are legal problems.
    She is a former Pfizer employee, marketing expert and biotech analyst.

    Which tale is true will be decided in a court of ‘law’ – eventually [hah!] …

    • Gail Sheppard says

      BLM is an application so I think the mRNA vaccines didn’t work but it looks like people won’t be dying of antibodies. I am delighted about this.

      All this begs the question: If there is something so transmittable, wouldn’t those of us who have been wandering around (mostly unmasked) would have confronted it by now?

      Something else that’s interestting is the Re

      • Just a dad says

        re: “If there is something so transmittable, wouldn’t those of us who have been wandering around (mostly unmasked) would have confronted it by now?”

        Gail, God have mercy but in my opinion you will likely confront it – sooner or later.

        We moved from an OCA parish to a ROCOR parish in April 2020 largely because of all the issues we’ve covered on this blog ad naseum. We were locked out of our OCA parish and welcomed by the ROCOR parish. From May 2020 until earlier this month we attended church 2-3 times a week. Liturgies were always quite full, packed during feasts and special occasions. We joined (and often cooked/served) in the trapeza for lunch after Sunday Liturgy, always shoulder to shoulder and putting as many chairs to a table as we could fit. All of this was done by the personal choice of each layperson and we were always joined by the clergy. We were not focused on social distancing and there were no masks (except some on occasion who chose to wear them during services). I can count on one hand the number of people in our parish who contracted COVID in that time period, and they were infected through non-church activities.

        Then a few weeks ago this latest variant was brought into our house by our youngest son – probably from his gym and certainly not from the church. Our whole house went down hard and I can tell you it has been far worse than anything we’ve experienced before or imagined. We are getting better and, God willing, will be back in church very soon. But my point is that we did not hide from this thing, we did not fear it. But whatever is going around now seems to be more contagious and hits harder than whatever was spreading for the past 18 months. I have several co-workers in the same boat, and now several at church going through the same thing (there is no reason to believe they caught it at church).

        I write this because I’ve read your posts for quite a while and am almost always of like mind. So the question you posed resonated with me: “If there is something so transmittable, wouldn’t those of us who have been wandering around (mostly unmasked) would have confronted it by now?” – my prediction is that this variant (or the one to come after it) will likely continue to spread and everyone will have to deal with it one way or another. Those who are healthy without obesity or other underlying health issues will probably go through a few days of flu-like symptoms, maybe some will experience less, some will unfortunately experience more. My wife and I were down pretty hard for almost 2 weeks. I do hope you don’t confront it – but one thing that helped us was being prepared with a protocol we hoped we would never need to pull out, but were thankful we did.

        God bless the work you and George are doing here, and I wish you the best.

        • Gail Sheppard says

          Being prepared is extremely important. I’m so sorry you were all so sick.

          • Gail Sheppard says

            P.S. My question was more about the virus. George and I fully expect to get it. I just assumed it would be before now.
            I think we’d survive it and perhaps have gotten it unknowingly.

            In my case, I have no cytokines (or they’ve been turned off, I’m told). So no “storm” for me. I am also HLB A-27. (I don’t have ankylosing spondylitis, thankfully.) But I would probably survive COVID as well as Ebola. My struggle is with Fibermyalgia and I have an $8000 test to prove it! I’m in optimal health, otherwise. Perhaps I had SARs a long time ago and that’s what’s protecting me.

            As a pharmacist, George has been around this from the beginning. If his body were going to succumb, I think it would have done so by now. I did make him take hydroxychloroquine when he came home with a dry cough he couldn’t shake after a few days. Whatever he had was cleared up by that and the antibiotic that goes with it.

            I think it makes a LOT of sense to plan on getting it at some point and make sure you’re prepared.

            It would be a nightmare to get caught up “in the system” in my opinion.

            Generally, viruses run out of steam within a population. After two years, I would think that should have happened by now.

      • “I think the mRNA vaccines didn’t work but it looks like people won’t be dying of antibodies.”

        Could you explain ? I understand what you mean about the mRNA vaccines not working , but when you say “looks like people won’t be dying of antibodies” , what does that mean ?

  8. Could you please recap preparations we should make . I read last night that white pine needle tea is good. Among other things.

    Thank you

  9. Italian doctor A. Melucci: “Politicians are vaccinated
    with placebo – They have suggested me too”


    ‘ Italian psychiatrist Alessandro Melucci made a shocking complaint, claiming that politicians are being vaccinated with fake vaccines.

    The Italian politician (MP and Senator for two parliamentary terms) spoke at an event on “Active Health” in San Marino, Alessandro Melucci did not chew his words: “To politicians and VIP vaccines are fake (placebo – placebo = virtual medicine), they have suggested it to me too … »!

    Speaking at the event, he said: “From a specific social sphere onwards, fake vaccines are given. Only “laoutzikos” [hoi polloi] should be like a guinea pig for genetic serums that do not cause any benefit, as in Israel and the United Kingdom, but to date in the European Union thousands of deaths and almost two million with side effects of which 50% serious side effects , according to official EU data “.

    Alessandro Melucci also points out: “This practice is of unprecedented seriousness, with criminal charges, as these ‘privileged groups’ knew they were taking placebo with the certainty that they would escape any adverse effects or even death.

    But even more serious is that these privileged groups without having tried the experimental vaccine on their bodies appear on television to reassure citizens that the vaccine is “safe and effective” because they did so (fictitiously), thus approving its adoption. distinctive “green pass” (Green pass) which they definitely hold. “Issues that the judiciary must investigate in depth and in a wide range.”

    It should be mentioned that Alessandro Melucci, born in Naples in 1955, is a graduate of the School of Medical Surgery, a member of the Communist Party of Italy, the Socialist Party of Italy, but also of the right. ‘

    Why am I not surprised?

  10. Mark E. Fisus says

    Hundreds of millions have already got the jab without incident. The risk of getting COVID outweighs the risk of vaccine side effects.

    COVID vaccines are needed for the same reason we take any other vaccine for contagious illnesses, such as for polio, smallpox — to get to herd immunity. It’s worth noting that widespread vaccination for polio and smallpox has defeated those scourges in the US.

    [Editor Note: The owners of the blog do not share this opinion.]

    • Hundreds of millions have already got the jab without incident. The risk of getting COVID outweighs the risk of vaccine side effects.

      I know you would like to believe this, and frankly, so would I. When you can show me a five year study that proves this, my opinion may change, although my desire to be vaccinated with an mRNA vaccine will not change for reasons other than its supposed (and as yet thoroughly unproven) effectiveness.

      COVID vaccines are needed for the same reason we take any other vaccine for contagious illnesses, such as for polio, smallpox — to get to herd immunity. It’s worth noting that widespread vaccination for polio and smallpox has defeated those scourges in the US.

      1. This is a Corona virus, the same type of virus that causes the common cold. Yet there has never been an effective vaccination against the common cold. What makes you (or anyone) think herd immunity of the type you are describing (either natural or via this particular mRNA vaccination) is possible? Show me the evidence. You can’t because there is none.

      2. None of the other vaccines you mention were/are mRNA.

    • “[Editor Note: The owners of the blog do not share this opinion.] “

      Look , I remain deeply concerned about the efficacy and safety of the current mRNA vaccines, to the point that I have not yet been convinced to get one , but I don’t think that what Mark E. Fisus posted was just his “opinion”. Is it not a fact that “Hundreds of millions have already got the jab without incident.” ? That’s not an opinion, that’s a fact. Yes, thousands may have had serious side effects or even death (and if some of the alarmists are correct, it’s going to get worse very soon) , but compared to the millions of vaccines given , it’s a small percentage.

      No doubt the vaccines were developed quickly and sloppily , not going through the usual trial periods. Indeed , at this point I’m more confident about the therapeutics that are being developed (or currently exist , such as re-purposed drugs like ivermectin , or Monoclonal Antibody treatments. ) However, it seems that overall the vaccines are working somewhat , though certainly not as efficaciously as first claimed and not without a small percentage of people experiencing serious side effects .

      To my knowledge, almost all of my non-Orthodox family (including some elderly , 70 – 85 years ) and most of my non-Orthodox (and also many Orthodox) friends have been vaccinated and I know of only one who has experienced a serious reaction (and that was to the J & J one-dose vaccine ; thanks be to God, she recovered after 3 weeks of experiencing serious flu-like symptoms). Of course my anecdotal evidence about my circle of friends and relations proves nothing , but that’s been my experience to date. So maybe all these people are carrying a ticking time bomb in their bodies which will doom them in the near future (?), but at the moment they are all doing fine and they have not been reinfected four – to – eight months after having been vaccinated.

      I’m interested in those of you who are convinced that the vaccines are worse than Covid, how long until your dire predictions of widespread death from the vaccines are no longer credible ? 3 more months ? 6 more months ? Another year ? Two years ? Candidly, a lot of this starts to have the odor of “Last Days Madness” , like a certain segment of evangelical protestants with their Rapture Fever … it’s always just beyond the horizon … “soon” … it’s going to happen … just you wait … it’s coming … don’t say we didn’t warn you … “soon” now.

      • Jean: ‘Candidly, a lot of this starts to have
        the odor of “Last Days Madness”.’

        Adverse events occur over short, medium and long terms.

        ‘Short term’ covers events like anaphylaxis, miscarriage, stroke etc.
        Such events show themselves in the first few weeks after injection.
        The VAERS (US), MHRA Yellow Card (UK) and EUDRAVIGILANCE (EU)
        databases show horrific numbers of such events.
        [NB: only about 1% (US) – 10% (UK/EU) of these are actually reported,
        so the true numbers are at least 10x to 100x greater than those recorded.]

        ‘Medium term’ runs from a few months to about three years after injection.
        While we do not have the hard data yet, we have indications; eg:
        Dr Charles Hoffe, a family doctor in Lytton, BC in Canada states that 62%
        of his vaccinated patients have micro blood clots in their capillaries.
        He says they will die from right-side heart failure within three years. See:

        For the ‘long term’ effects, obviously there are no human data available yet.
        However, to illustrate possible dangers, I refer you the following paper:
        COVID-19 RNA Based Vaccines and the Risk of Prion Disease:

        There is plenty more out there if you but care to look…

        PS: Everybody laughed at Noah – until it rained.

      • “…how long until your dire predictions of widespread death from the vaccines are no longer credible ?”


        This is a reasonable question. Speaking only for myself, I neither accept nor discount these dire predictions. I give them precisely the same weight as those who insist the vaccine is safe and effective. Neither position is “science” as such. Both are merely reasonably educated speculation. No one truly knows if there will or will not be long-term effects (Only time will tell), though we do now know with reasonable certainty that being “fully vaccinated” doesn’t provide long-term protection as the politicians (though NOT the scientists) more or less promised. (Dr. Fauci and others like him have given a whole new meaning to the term “political science.”)

        For science to be science it must be both provable and repeatable. Precious little that we have been told about these vaccines is either. As far as any long term effects (or lack thereof) real science can offer nothing truly informative at this juncture.

        Please know that I write this as one who hopes and prays that the doomsayers are eventually proven wrong.

        • Jean,

          To underline the above concerning what it means for science to be science I refer you to this site that contains all the information on the Pfizer vaccine – directly from the NIH. While I would agree that reported serious short-term reactions are relatively few in comparison to the number of doses administered, it is nevertheless true that we are in the midst of a very real (and truly scientific) experiment on the actual efficacy and safety of this product.


          There are several things I would call to your attention.

          “Information is not yet available about potential long-term sequelae. ”

          Postmarketing data demonstrate increased risks of…”

          “The safety evaluation in Study 2 is ongoing.”

          These sorts of things are true of every drug that is approved by the FDA (EUA or otherwise), so I do not mean to suggest that these statements by themselves imply that terrible things are sure to occur. It does, however, demonstrate the “known unknowns.” Much like the efficacy that seemed to indicate a high degree of protection in clinical trials while time in actual use demonstrated otherwise, only time will demonstrate the true level of safety. How much time remains to be seen.

          This is how the FDA works. They approve medications/vaccines based upon data in clinical trials. Sometimes in actual use they prove to be safe and effective. Sometimes they don’t and are pulled from the market – either by the FDA or by the manufacturers themselves as they see data that exposes them to potential unacceptable levels of liability.

          But the simple fact is that only when a product is in use for an extended period of time is the experiment completed and and any given product is scientifically deemed to be “safe and effective.” This is also why a great many physicians refuse to be “on the cutting edge” of new products, preferring to wait to prescribe them until the their safety and efficacy in actual use is well demonstrated by the passage of time. These physicians are the ones who actually “trust science” in the interest of their patients (not to mention their own liability), for they know that clinical trials and short-term use are not reliable indicators of things like safety and efficacy.

      • George Michalopulos says

        Jean, thank you for your insights. I appreciate the fact that you see some distinctions and that there are honest people on both sides of this debate.

        However, from my point of view, I think the scales are tipping more and more towards the anti-mRNA vaccine side of things. Today, I went for my yearly ocular check-up and spoke with my doctor. He admitted that he had taken the Moderna 2-dose regimen and he suffered horribly. I asked him if he was going to take a booster (because that’s coming down the pike) and he said “absolutely not”.

        I realize that what I’m about to say is non-scientific, but there you go. There are literally thousands of stories like that which are tipping the scale against mRNA vaccination.

      • Here’s something else to consider:

        Dr. Ghauri, a parent and doctor, speaks
        at the Pennsbury School Board meeting.


        [Video – 05:56]

        Refreshing clarity… 🙂

      • Jean, my daughter received the J&J vaccine in March. She was very sick for 24 hours following it. For the past 6 months her menstrual cycle has been totally out of whack. She has been as regular as clockwork all of her life. Both she & her husband regret getting it.

        • Athanasia – Yes, as I mentioned in my other post, the one bad reaction to a vaccine among people I know personally was a friend of mine who took the J&J vaccine. She was very sick for weeks after taking it. On the other hand, my wife had the Moderna vaccine (both doses) and other than feeling a bit ‘under the weather’ for a day or two (went to bed and slept 14 hours the first day), has felt no further ill effects. My three sons each had the Pfizer with no ill effects. My elderly (75 or older) aunts and uncles had Pfizer and are doing fine. Grandmother , who is 95, had the Pfizer in late January 2021 and has experienced no apparent problems from the vaccine. Being unvaccinated , I am the exception in my family (in more ways than one; i.e. most of my family are not Orthodox) , other than a cousin who had a pre-existing condition which prevented her from getting the vaccine . She caught the virus and was treated with ivermectin . She recovered. I don’t go around asking people if they have been vaccinated (that’s an abominably rude, invasive behavior that should be rejected by everyone , either pro-vax or anti-vax) , but from people who have volunteered the information my impression is that the majority of the people in my parish have been vaccinated. I remain skeptical about the safety and (long-term) efficacy of the vaccines , but I must admit that in my circle of family and friends there is only one adverse reaction to a vaccine that I know about.

    • First off, herd immunity is never built on vaccines, ever. This is a lie that has been perpetuated for years by proponents of vaccinations. Herd immunity is achieved only by masses of people actually getting ill and recovering.

      Second, there is plenty of evidence nowadays to show that childhood diseases are needed to grow the immune system in order to prevent negative health outcomes later in life. As we have continued to “help” people out with vaccines, we have worse and worse chronic disease in this country.

      Third, to say that vaccines are needed is to say that God purposely created us in a state of lack – defective – and we needed to “hold on” for thousands of years to finally (Phew! Thank goodness!) get to the era of toxic vaccines.

      Fourth, there is NO proof and no testing of vaccines that proves that they are effective.

      Fifth, there are control groups in the populations of the Amish and in the Homefirst medical practice of the late Dr. Mayer Eisenstein, MD, JD, in Chicago (30,000 kids, largely unvaccinated, all in great health, including an incidence of asthma so low that one of the insurance companies was convinced that it was being coded incorrectly by the practice, but nope, it’s just that they have virtually no asthma. Or autism…).

      Sixth, attributing declines of any disease to vaccines is absurd: http://www.vaclib.org/intro/present/fivedecline.jpg

      And finally, who in their right mind is going to sign on to a product that has no accountability behind it – the only such product I can think of that leaves you and dry if you are injured and for which you have no legal recourse to sue? And also, it is a FACT, as Gail stated, that these are NOT vaccines in the first place. You ought to do some non-Google searching relative to graphene oxide, DNA as fractal antenna, and 5G. The picture of what is happening here becomes crystal clear.

  11. Phanar head: There is no reasonable excuse
    for refusing to be vaccinated


    ‘ According to Patriarch Bartholomew, pandemic and vaccination deniers “do not think right, do not think logically and do injustice to themselves and their fellows”.

    Patriarch Bartholomew of Constantinople, in an interview with the Greek television channel Mega TV, said that it is absurd to be afraid of vaccination and urged everyone to get vaccinated, reports romfea.gr.

    “It is completely absurd and unfair for some people to be afraid to get the vaccine. There is no reasonable excuse. I call again on everyone to be vaccinated without reservation to avoid possible serious dangers that will lead them to death,” the Patriarch noted.

    “We as a church, as a religion, as the Ecumenical Patriarchate in particular, respect science, the representatives of science, the findings and discoveries of science and conform our lives to them,” he added.

    Regarding the pandemic deniers and the vaccinators, Patriarch Bartholomew said that “they do not think correctly and do not think logically and do injustice to themselves and their fellow human beings. Because they can transmit the coronavirus to their fellow human beings without realizing it. There is a great danger.” … ‘

    Perhaps Bartholomew should read some more…

    21,766 DEAD Over 2 Million Injured (50% SERIOUS) Reported in European Union’s Database of Adverse Drug Reactions for COVID-19 Shots

    1,135,579 Injuries 1,559 DEAD in the UK Following COVID-19 Injections According to UK Government

    CDC Records … 12,791 deaths, 16,044 permanent disabilities, 70,667 emergency room visits, 51,242 hospitalizations, 13,139 life threatening events, among 682,873 reported injuries from 571,831 cases.

    CDC’s Own Stats Show 1,270 Premature Fetal Deaths Following COVID Shots but Recommend Pregnant Women Get COVID Injections

    Over 32,000 People DEAD in Brazil Following COVID-19 Vaccines

    Kurt Vonnegut: And so it goes…

    • “Regarding the pandemic deniers and the vaccinators, Patriarch Bartholomew said that ‘they do not think correctly and do not think logically and do injustice to themselves and their fellow human beings. Because they can transmit the coronavirus to their fellow human beings without realizing it. There is a great danger.’ ”

      More confirmation that the “pandemic” is the biggest fraud in history, and the injections are the danger.

      • It’s all about the “science” and only the science.

        BTW, a strange position for the head of an organized religion to take.

      • Antiochene Son says

        I seem to recall early in the pandemic hierarchs were calling on the clergy and the faithful not to opine about things they know nothing about. Now they are ascribing malice to the unwitting victims of a viral infection.

        His High Exaltedness needs to take some of his own medicine.

        I am so sick of the phrase “respect science.” Science is a deductive method or process, nothing more. “Respecting” science is as meaningless as respecting the process of getting dressed in the morning. “I respect the fact that I have to put one leg into each pant leg, and I conform my life to it.” Stupidity.

        The scientific method has revealed that the vaccines do help people, and they also harm people. The choice as to which path is a more acceptable risk should be left solely to the individual as a free human being in Christ. The Church should be informing our consciences so we can make our own decision, not put us on one-sided guilt trips. (The EP in particular has no moral authority to tell anyone when to jump.)

  12. US COVID-19 Vaccines Proven to Cause More Harm
    than Good Based on Pivotal Clinical Trial Data Analyzed
    Using the Proper Scientific Endpoint,
    “All Cause Severe Morbidity”


    Three COVID-19 vaccines in the US have been released for sale by the FDA under Emergency Use Authorization (EUA) based on a clinical trial design employing a surrogate primary endpoint for health, severe infections with COVID-19. This clinical trial design has been proven dangerously misleading. Many fields of medicine, oncology for example, have abandoned the use of disease specific endpoints for the primary endpoint of pivotal clinical trials (cancer deaths for example) and have adopted “all cause mortality or morbidity” as the proper scientific endpoint of a clinical trial. Pivotal clinical trial data from the 3 marketed COVID-19 vaccines was reanalyzed using “all cause severe morbidity”, a scientific measure of health, as the primary endpoint. “All cause severe morbidity” in the treatment group and control group was calculated by adding all severe events reported in the clinical trials. Severe events included both severe infections with COVID-19 and all other severe adverse events in the treatment arm and control arm respectively. This analysis gives reduction in severe COVID-19 infections the same weight as adverse events of equivalent severity. Results prove that none of the vaccines provide a health benefit and all pivotal trials show a statically significant increase in “all cause severe morbidity” in the vaccinated group compared to the placebo group. The Moderna immunized group suffered 3,042 more severe events than the control group (p=0.00001). The Pfizer data was grossly incomplete but data provided showed the vaccination group suffered 90 more severe events than the control group (p=0.000014), when only including “unsolicited” adverse events. The Janssen immunized group suffered 264 more severe events than the control group (p=0.00001). These findings contrast the manufacturers’ inappropriate surrogate endpoints: Janssen claims that their vaccine prevents 6 cases of severe COVD-19 requiring medical attention out of 19,630 immunized; Pfizer claims their vaccine prevents 8 cases of severe COVID-19 out of 21,720 immunized; Moderna claims its vaccine prevents 30 cases of severe COVID-19 out of 15,210 immunized. Based on this data it is all but a certainty that mass COVID-19 immunization is hurting the health of the population in general. Scientific principles dictate that the mass immunization with COVID-19 vaccines must be halted immediately because we face a looming vaccine induced public health catastrophe. ‘

  13. As Vaccines Continue to Not Work as Promised – Ivermectin Continues to Work – This Secret is Getting Out
    By Joe Hoft

    Published September 2, 2021 at 3:30pm


    • Christopher M says

      Just like all of the vaccines, Ivermectin was developed through testing on human cell lines (HEK293), and as such cannot be used by an Orthodox Christian. That is not to say that it is a “vaccine”, but that is similarly tainted by terrible sin. Fr. Alexander Webster has written about this in this blog. Unfortunately, hydroxychloroquine falls in the same basket.

      • Gail Sheppard says

        Do you know why they developed these cell lines? So there would be no more aborted fetuses used for testing.

        • Yes, but as Fr. A Webster explains, this does not mitigate the sin of their origins, and participating in this makes us complicit. Why would we tow the line when it comes to vaccines, but make an exception for a different type of drug? There is no difference.

      • Steven J. M. says

        Christopher M or anyone else, would you please provide your source/s for saying Ivermectin and hydroxychloroquine have been tested on aborted foetal cell lines? Thanks

        • Gail Sheppard says

          The cell lines they usually use is HEK 293. Google Ivermectin HEK 293


          • Steven,

            Unlike Ivermectin, I don’t believe Christopher was associating hydroxychloroquine with testing on aborted foetal cell lines. His concerns are, I believe, related to this:


            I don’t discount his concerns – not at all. However, the drug itself existed well well before this was done.

        • Gail Sheppard says
          • Steven J. M. says

            Terrific. Thanks Gail and Brian

            Also, I found at least this site which includes everything but the kitchen sink, including ivermectin and hydroxychloroquine. I can’t vouch for it’s credibility, though.


            Brian, you said that ivermectin was developed before testing on HEK 293. What are your thoughts (or anyone else’s) on what that says about it being able to be used by Orthodox Christians? I see you say that you don’t discount Christopher’s concerns – and maybe that’s my answer there – but I still thought I’d ask.

            • Gail Sheppard says

              This study on ivermectin used the HEK 293 cell lines in testing: https://bpspubs.onlinelibrary.wiley.com/doi/10.1111/j.1476-5381.2012.01987.x

            • Ivermectin was not so much ‘developed’ as,
              like penicillin and aspirin, ‘found in nature’.
              See: Ivermectin: From Soil to Worms, and Beyond

            • Steven,

              The only way I know to answer your question honestly is as follows:

              We are literally immersed in an extremely sinful society that has completely ignored and disregarded God and His commandments – except, I would add, in cases where some specific commandment can be used as lever to deceive us into even further iniquity. “Thou shalt not judge” and “love Thy neighbor” are examples of specific commandments that are almost universally subtly distorted to achieve the desired overall outcome the Great Deceiver and his unwitting minions hope for.

              Because we are immersed in the iniquity of this world, we cannot avoid being tainted by its sin no matter how hard we may try. One way or another, directly or indirectly, we participate in – and benefit in some way from – the evils of this world (war, slavery, exploitation, medical ‘advancements’…you name it). To imagine that we can completely remove ourselves from the evils of this world is, quite frankly, delusional. Like it or not (and unpopular a truth though it is) we share in the sin of the world. We are not, and can never be, morally pure as long as we live in this world.


              What separates the sheep from the goats (as it were) is constant turning to God, constant repentance, constant asking for mercy, constant looking to Him as our life, and constant personal struggle to live according to the truth against the deception and evil of this world. The sheep know they are not perfect, but they struggle to know God by keeping His commandments. Those who do this perfectly usually die a Martyr’s death, which is witness enough against our (my) own imperfection.

              Our holy Fathers, including no doubt those whom you have quoted, knew/know that the ‘moral perfection’ so many seek to achieve by always making ‘perfect’ moral choices is not possible in this world. But the struggle is all, and the struggle is what makes us sheep.

              Goats, on the other hand, blithely go to get along for the sake of comfort and safety, taking the path of least resistance at every turn, accepting everything unquestioningly, struggling against nothing, paying no heed to the commandments.

              I know this doesn’t directly answer your question, but I think you can guess how I would hope to answer honestly.

              • Steven J. M. says

                Brendan, thanks for that interesting info. And Brian, thanks to you too for the effort you’ve put in with that thoughful response. It’s perhaps because of the reason you’ve provided that no saints or holy elders – that I’m aware of – have mentioned anything about the connection between medicines (more generally) and aborted foetal cell lines, which you’d expect they knew/know all about. Thanks, again.

            • Steven, Brian has answered your question for himself, but if I might add my two cents…

              I would draw a line between drugs/other products that have used fetal cells in their development, and those that have been tested on fetal cells after the drug/product is in use. As a commenter on another blog said (I’m afraid I’ve forgotten exactly where, so I can’t provide a link), it would be possible to obtain a sample of HEK 293 cells and test the effects of salt on them. That testing in itself might be immoral, but it wouldn’t have any bearing on the origins of salt or the morality of using it. That’s how I look at it at any rate.

              • Steven J. M. says

                Mark, I appreciate your input. Having thought about it for a while, it’s occurred to me to say that while testing salt on HEK293 for, say, the treatment of infections wouldn’t make salt for use on meat immoral, it probably would still make it immoral to go ahead and use it for treating infections. In other words, while substances may be moral at their inception, they could still become immoral based on their testing and subsequent function.

                • Steven,

                  I would be careful to qualify that line of reasoning. Only that which man does with substances can be immoral. All creation is good, and it remains good in itself even when man corrupts it.

                  “And God saw every thing that he had made, and, behold, it was very good.”

                  And God saw that the wickedness of man was great in the earth, and that every imagination of the thoughts of his heart was only evil continually. And it repented God that he had made man on the earth, and it grieved him at his heart. And God said, I will destroy man whom I have created from the face of the ground; both man, and beast, and creeping things, and birds of the heavens; for it repenteth me that I have made them…. And the earth was corrupt before God, and the earth was filled with violence. And God saw the earth, and, behold, it was corrupt; for all flesh had corrupted their way upon the earth. And God said unto Noah, The end of all flesh is come before me; for the earth is filled with violence through them; and, behold, I will destroy them with the earth.”

                  … if my people, who are called by my name, shall humble themselves, and pray, and seek my face, and turn from their wicked ways; then will I hear from heaven, and will forgive their sin, and will heal their land.

                  … to fulfil the word of the Lord by the mouth of Jeremiah, until the land had enjoyed its sabbaths: for as long as it lay desolate it kept sabbath, to fulfil threescore and ten years.

                  … If my land crieth out against me, And the furrows thereof weep together…

                  The wilderness and the dry land shall be glad; and the desert shall rejoice, and blossom as the rose. It shall blossom abundantly, and rejoice even with joy and singing; the glory of Lebanon shall be given unto it, the excellency of Carmel and Sharon: they shall see the glory of the Lord, the excellency of our God.

                  Thou shalt no more be termed Forsaken; neither shall thy land any more be termed Desolate: but thou shalt be called Hephzi-bah, and thy land Beulah; for the Lord delighteth in thee, and thy land shall be married.

                  And I brought you into a plentiful land, to eat the fruit thereof and the goodness thereof; but when ye entered, ye defiled my land, and made my heritage an abomination.

                  How long shall the land mourn, and the herbs of the whole country wither? For the wickedness of them that dwell therein, the beasts are consumed, and the birds; because they said, He shall not see our latter end.

                  Many shepherds have destroyed my vineyard, they have trodden my portion under foot, they have made my pleasant portion a desolate wilderness.

                  And first I will recompense their iniquity and their sin double, because they have polluted my land with the carcasses of their detestable things, and have filled mine inheritance with their abominations.

                  For the land is full of adulterers; for because of swearing the land mourneth; the pastures of the wilderness are dried up. And their course is evil, and their might is not right…

                  For the creature was made subject to vanity, not willingly, but by reason of him who hath subjected the same in hope, Because the creature itself also shall be delivered from the bondage of corruption into the glorious liberty of the children of God.