Reality Check: 4 Things Everyone Should Know About the FDA Approval of the Pfizer Covid Vaccination

Craig HueyBureaucracy, Current Events, Government, Healthcare24 Comments

The Food and Drug Administration is a federal government bureaucracy. The FDA approved the Pfizer covid vaccination.

Immediately the media and the medical establishment praised the FDA and told everyone – don’t worry it’s safe now, so just get the shot.

Are they right?

Here are 4 things you should know about this FDA approval.

Reality Check #1: This is the fastest FDA approval of a drug in America’s history.

I’m a critic of the FDA bureaucracy because it’s so expensive and so slow in getting FDA approval of new drugs – especially for critical life-saving drugs.

But in this case, the shortcuts and compromises in the FDA approval of the Pfizer covid vaccination compromised science and testing safety.

Reality Check #2: Because the FDA approves a drug, it still may not be safe.

The FDA over the years has approved many pharmaceutical drugs that later the FDA orders to be taken off the market.

The FDA pulled Duract off the market after four deaths.

The FDA pulled Lotronex off the market in less than a year after five deaths.

The FDA pulled Omniflox off the market after three deaths.

Now the COVID injections have been connected to around 14,000 deaths (at least 3,079 have known connections to Pfizer) and nearly 600,000 adverse reactions to the drug.

Reality Check #3: Already two top FDA executives involved in the approval, quit in protest.

These top executives felt so strong that the FDA was making compromises and shortcuts, they gave up their huge salaries and total job security.

This is a loud warning cry.

Reality Check #4: The FDA along with the CDC is compromised.

They are compromised by big Pharma.

They are compromised by big government/socialist ideology.

They are compromised by politics…pro-socialist Democrat politics.

Whether you had the vaccine or not.

Whether you’re going to have more – the never-ending boosters or not.

Whether you’re thinking of getting the vaccine or never – don’t make a decision upon this FDA approval.

It’s compromised.

Let me know what you think. Email me at craig@electionforum.org.

24 Comments on “Reality Check: 4 Things Everyone Should Know About the FDA Approval of the Pfizer Covid Vaccination”

  1. Well done, Craig. I think some people still trust the FDA. I think people have to ask themselves why the FDA would pull drugs off the market for a few deaths, but approve this vaccine which has resulted in around 14,000 deaths and it has only been in use for less than a year. This is absolute insanity!

  2. Thanks. I had two Moderns vaccination. Now I am having leg pain and leg weakness. It is interfering greatly in trying to work and just walk. I also tested positive for blood clots but they did not find anything with the ultrasound. However, I now feel like a leper when I mention it. Why we cannot find anything wrong in our tests. Why it is just you getting older, I am 66. More of the same. Nothing has helped it either.

  3. After much research I have concluded that you are correct that the vaccine is risky and the damage it causes is under-reported. Definitely the most dangerous vaccine ever distributed widely. However, Covid is still a much higher risk for the elderly. There is enough data to show the vaccine is lower risk for people over 65. Definitely doesn’t make sense to give to young people. The best course for most people is to just get the virus and get early treatment with IVM or HCQ w/zinc.

  4. Not only are these “vaccines” dangerous, but the FDA has approved hundreds, if not thousands, of substances that are dangerous to our health. Case in point is Aspartame and MSG, both excitotoxins that damage the brain, and there are many others. And of course, there are pesticides and herbicides, one of which is Paraquat, which the company knew caused Parkinson’s BEFORE they put it on the market. My husband, who has Parkinson’s, participates in a study from UCLA, and the doctors administrating the study have found this information and there is an ongoing lawsuit against the company. Other countries have banned these substances, but not the USA. The FDA is NOT your friend! I don’t trust anything they say or do!

  5. I think the FDA has good intent, but tries to over simplify and generalize. One mistake they made early on was to tell American’s to restrict fats knowing full well that some fats are extremely beneficial such as olive oil and avocado. They simplified instead of giving us full information since most Americans were eating fats that were not healthy. Yes, they did make huge mistakes such as telling us butter was bad and not knowing that the alternatives had transfats which were later proven to be much worse. The only reason they are lying about the vaccine and early treatments as they really do think the benefit is greater than the risk. The NIH is the only really evil organization now that it is proven they funded the virus and covered it up.

  6. The article: “Reality Check: 4 Things Everyone Should Know About the FDA Approval of the Pfizer Covid Vaccination” seems a bit one-sided to me. My thoughts are as follows:

    “Fastest FDA approval of a drug in America’s history”. While this may be true, we need to look at the context of this “fastest approval”. That was what Operation Warp Speed was all about under the Trump Administration. Massive governmental funding was unleashed, based on warnings (at the very beginning of the pandemic) from epidemiologists and medical professionals (from the Right, the Left and everywhere in between, statistically speaking) regarding the public-health emergency that the USA and the world were about to see. This massive funding contributed tremendously to the record short EUA (Emergency Use Authorization) times. However, to say “shortcuts and compromises in the FDA approval of the Pfizer Covid vaccination compromised science and testing safety” is a mischaracterization of the facts, in my opinion. The standard for EUA from the FDA is extremely high. Example 1: the EUA for the Pfizer vaccine was secured after 44,000 study participants’ data (literally truckloads of documentation) were analyzed, scrutinized, and the vaccine was deemed to be “effective” enough and “safe” enough by the FDA staff (again, from the Right, the Left and everywhere in between, statistically speaking) for public consumption. I would not characterize this as “experimental”. Now that we have literally hundreds of millions of data points many months later, the field experience is not inconsistent with the initial study findings. As much as I want to believe that early treatments (ie using hydroxychloroquine, ivermectin, monoclonal antibodies, etc.) are safe and effective (beyond a reasonable doubt), the available/reliable data from any of the above “treatment” protocols are still FAR INFERIOR to the data available from 44,000 study participants in the Pfizer vaccine. Example 2: AstraZeneca’s vaccine is not yet approved by FDA for public use in the US, even with a 76% effectiveness rate from data obtained from about 32,000 trial participants. Even though AstraZeneca’s vaccine is approved for public use in the UK and several European Union countries, FDA says basically: “Nope, not good enough.” In addition, mRNA vaccine technology had been in development for nearly 30 years, since the early 1990’s, when the pandemic initially hit. The last few missing pieces of this technology were enabled by Operation Warp Speed. A fairer statement re mRNA vaccine would be to say it took nearly 30 years for FDA approval.

    “Because the FDA approves a drug, it still may not be safe.” “Safe” is a relative term. FDA tries to maximize benefits and minimize risks. While no vaccines are risk free, developing and using the vaccine (even with the associated side effects) was deemed by most medical experts to be “safer” than the alternative of (a) having an uncontrollable pandemic and massive human death toll in our hands, and (b) having our health care system fail us due to sharply higher health care needs of the general public during a pandemic. I personally have heard of surgeries for cancer patients cancelled, and patients with heart conditions dying because help wasn’t available in time due to too many Covid-19 patients in the hospital. That’s sad.

    “Two top FDA executives involved in the approval quit in protest.” Again, we need to have the proper context on this statement. It was reported that Dr. Marion Gruber and Philip Krause are stepping down from the FDA, largely in part because of what is being perceived as the Biden White House getting ahead of and putting pressure on the entity to approve vaccine boosters, and also shifting the focus away from the FDA, which is largely in charge of this, to the CDC and the CDC’s advisory panel. In my opinion, these 2 resignations should NOT be interpreted as casting doubt on the efficacy and safety of the 2-dose Pfizer vaccine.

    “The FDA along with the CDC is compromised”. This is an opinion statement that needs substantiation. FDA has nearly 15,000 employees, consisting of individuals from the Right, the Left, and everything in between. CDC has over 10,000 employees, consisting of individuals from the Right, the Left, and everything in between. Both the Trump and Biden administrations have been accused of using “heavy-handed, top-down strategy” approaches to unduly influence the FDA and the CDC to “further” each party’s respective political agenda. The FDC and the CDC are supposed to be independent institutions from the “White House”. To be unduly influenced by the White House, no matter Trump or Biden, is wrong, in my opinion. These two institutions were set up to protect the general public. Unless there is overwhelming evidence (beyond a reasonable doubt and evidence that can withstand rigorous cross-examination) that the FDA and the CDC are compromised as alleged, I think it is best NOT to undermine these institutions that are put in place to protect us. These two institutions are NOT infallible, but they have been right far more than they have been wrong.

      1. Charles: Thank you for your kind words. It has been a lonely journey, trying to expose misinformation and misleading partial truths about Covid-19 and the vaccine that have infected the church.

        1. From the attached article it seems that every organized denomination already believes in the vaccine narrative. There are only a few independent churches going against the narrative. The common ground should be against the mandates. I, for one, believe the vaccine is helpful for some people but shouldn’t be forced on all. Christianity may be true, but I am not going to force it with the sword. https://www.post-gazette.com/news/faith-religion/2021/09/18/Many-faith-leaders-say-no-to-endorsing-vaccine-exemptions/stories/202109180040

          1. Vaccine mandate is currently a VERY HOT topic for debate. I’m against government mandates in most instances, with VERY FEW exceptions. The Covid-19 Pandemic would be one of my exceptions. My thoughts are guided mainly by (a) the 1905 Supreme Court decision, in which it upheld the constitutionality of a state law requiring compulsory vaccinations against smallpox, and (b) the teachings of the Bible.

            For (a), the court declared, “Upon the principle of self-defense, of paramount necessity, a community has the right to protect itself against an epidemic of disease which threatens the safety of its members.” The court explicitly REJECTED the claim that “liberty” under the Constitution includes the right of individuals to make decisions about their own health in instances where those decisions could endanger others. Does our current Covid-19 pandemic fit the criteria for mandating vaccines? I vote “YES”.

            For (b), the Bible teaches us to protect the weak. Pro-lifers, including me, use this same line of thinking to argue against abortion. The Bible teaches us to protect the weak to the best of our ability. Jesus said in Matthew 12:30-31, “Love the Lord your God… and … Love your neighbor as yourself. There is no commandment greater than these”. My neighbors include the weak. The weak include children, elderly, immune-suppressed people, people with disability, etc. By wearing a mask and taking the vaccine, I help increase the chances to life for the weak. As an individual, I won’t have a measurable effect on public health. However, collectively, the 100 million currently unvaccinated people in the US will have a tremendous positive impact on the plight of the weak if most choose to get vaccinated. As a father with a developmental disabled son, I am fairly well connected with the disabled community. Around 15% of the population experience some form of disability. Another 10% are under 12 years of age. Around 2.7% are immune-compromised. Around 16.5% are over 65 years of age. Eliminating duplications, the 4 groups above (the “weak”) make up nearly 40% of the population. I know many, many members in the “weak” group. Of the weak members that I know, The vast majority of them can’t understand why so many would choose not to wear a mask or choose not to get vaccinated. Most don’t think society cares much for them. According to the CDC, a growing body of evidence suggests that COVID-19 vaccines reduce asymptomatic infection and transmission.

            Let’s pretend that you and I are acquaintances, and I am an immune-suppressed heathen who has had a rough life and don’t think anybody loves me. You and I know each other well enough to know that I am fully vaccinated and you chose not to get vaccinated. Let’s say that the Lord placed in your heart to share the Gospel with me. How well do you think I would accept your “well-intentioned” Gospel message? I may conclude, rightly or wrongly so, that you’re a hypocrite! Here you are preaching the Gospel message of love to me, and yet your behavior (choosing not to get vaccinated) doesn’t appear like “loving your neighbor” to me. Here are some “food for thought” for everyone.

  7. I am truly trying to follow the science and am still not vaccinated, but follow and fully appreciate your comments as you hope you do to mine

  8. There are many claims of deaths relating to Covid-19 vaccines. Virtually all such misguided claims are based on oversimplified or wrong interpretations of data from the Vaccine Adverse Event Reporting System (VAERS). The claim: “COVID injections have been connected to around 14,000 deaths (at least 3,079 have known connections to Pfizer)” is just one example. Below are some data for your analysis:

    Deaths/100,000 population in USA per year (2016-2017) from ALL causes: 869.7
    Fully Vaccinated individuals (7-months from Jan-Aug, 2021): 166 Million
    Average length of time since full vaccination: 3.5 months
    Deaths expected in fully-vaccinated group over 3.5 months from all causes: 421,080 deaths
    Deaths reported on VAERS from Jan-August, 2021: 14,000 (approx.)

    If every death of a fully-vaccinated person (166 million, 3.5 months average) was reported on VAERS over this 7-month time period, the number of deaths of the fully-vaccinated population (from ALL causes) should be around 421,000 by statistics alone. The “14,000 deaths” figure reveals that the number of deaths in the 166 Million fully-vaccinated group from ALL causes (as reported on VAEARS) was grossly underreported.

    How many of the 14,000 deaths (from the 166 million fully-vaccinated group) were attributable to “natural causes” not related to Covid-19 or the vaccine? This cannot be determined without more data and analysis.

    How many of the 14,000 deaths were “CONNECTED WITH” the vaccine? 14,000. They were all fully-vaccinated. By definition, they were all “connected with” the vaccine.

    How many of the 14,000 deaths were “CAUSED BY” the vaccine? This cannot be determined without more data and analysis.

    To simply blame the 14,000 deaths on the vaccine, and not something else, would be ludicrous! Unfortunately, that’s what many, many people seem to be doing today.

    1. Thank you for sharing the video featuring Dr. Jessica Rose. I watched the first part of this video, and I did not find it very intellectually fulfilling, as she mentioned things in the video that I can debunk just from my understanding of Covid-19 science, but I won’t get into that here.

      For most topics, including Covid-19 vaccines, you will find experts on both sides of the argument. The two sides have irreconcilable differences. The only way to reach a scientific/medical consensus is to look at the weight of the evidence on each side.

      In the Covid-19 vaccine debate, we have the likes of Dr. Jessica Rose, Dr. Simone Gold, and Dr. Jane Orient, and groups like Association of American Physicians and Surgeons, America’s Frontline Doctors arguing against vaccines, and you have the FDA, CDC, American Medical Association, and many medical professionals with equally-impressive-sounding names that argue in favor of vaccines. On the surface, the credentials on each side appear equally impressive and distinguished. However, when one digs deeper, differences in the trustworthiness of each side begin to emerge.

      We just need to look at the weight of evidence on each side, much like in a court of law. Are the verbal claims of each side published and peer reviewed and scrutinized? On this count, I found the evidence on the side against vaccines woefully inadequate, and quite robust on the side in favor of vaccines.

      In a court of law, if a juror was to hear only the defendant’s side of the argument, said juror would most likely be easily convinced to agree with the defendant’s side of the story. I see this happening with the vaccine debate. Many listen to only one side of the argument, since it is so much more satisfying to hear someone validate my belief system. I was guilty of mostly listening to one side of the debate for many months. With our internet today, it is so easy to go down a “rabbit hole” of information that reinforces one’s beliefs, rightly or wrongly so. Fortunately, I was able to dig myself out of the “rabbit hole” and looked at this issue from a more balanced perspective. I would encourage everyone to take the balanced approach in his/her research.

      If anyone is interested, the below YouTube link is an informative, balanced, and scientifically sound treatment of many of the most common questions many people have on Covid-19 and vaccines. Hope you enjoy it.

      https://www.youtube.com/watch?v=pp-nPZETLTo

  9. True there are 2 sides but one is amplified by big government, big tech and big pharma and the other is so suppressed that there is virtually no debate. Yes, there are some anti-vax nuts out there but I put up the credentials of Dr. Robert Malone, Dr. Paul Marik, Dr. Pierre Kory or Dr. Peter MCullough up against any bureaucrat in the FDA. Robert Malone is the inventor of mRNA but spoke out against the mandate and his LinkedIn account was cancelled until there was a massive grass root protest. The vaccine may be fine for some elderly and at risk people but it is up to the individual and their doctor and not the government to mandate. It is a terrible decision for children and people with natural immunity. The huge some of money spent to artificially make IVM look bad could have been spent to run a huge clinical trial and settle it. Early treatment is the key to treat the vaxed and unvaxed. The NIH has no credibility after getting caught funding and covering up gain of function research in Wuhan

    1. You are certainly entitled to your opinion that big government, big tech and big pharma amplifies one side of the argument, and the other side is suppressed. I would say, forget big government, big tech and big pharma, and study evidence from the myriad of sources that are independent of the above.

      As for Dr. Robert Malone, characterizing him as the inventor of mRNA is incomplete and misleading. There were literally hundreds of researchers that worked on different aspects of mRNA technology over the years. We need to give credit to where credit is due, and Dr. Malone is certainly NOT the only one that is entitled to the credit. The fact that he contributed to mRNA research does not make him an expert in public health policy; ie speaking out against the vaccine mandate. There are compelling arguments on both sides of the vaccine mandate debate, and his contribution to mRNA research does not, in my mind, make him a compelling expert in arguing against the vaccine mandate.

      As for Dr. Paul Marik and Dr. Pierre Kory, two founding members of Front Line COVID-19 Critical Care Alliance (FCCCC Alliance), I have no doubt that they have contributed a lot to medical science in the past. However, when it comes to Covid-19 science and vaccine information, my opinion is that these 2 doctors fall short. My research reveals that they are not well-respected by their peers in the medical community when it comes to their views on Covid-19. FCCCC Alliance has been labeled as a major source of Covid-19 and vaccine misinformation. I would challenge you to do some independent research on them, perhaps talk with some doctors you know who are well-versed in Covid-19 science, and see what they think of FCCCC Alliance and these two doctors.

      As for Dr. Peter McCollough, his story shares much in common with Dr. Marik and Dr. Kory. His credentials look impressive: American cardiologist, vice chief of internal medicine at Baylor University Medical Center, professor at Texas A&M University, among other accomplishments. In April 2020, he led a study on hydroxychloroquine as a treatment for COVID-19. However, an August 2020 article (observational study) he co-authored, and misinterpreted by social media groups as an endorsement of hydroxychloroquine as a treatment of COVID-19, was widely criticized by his peers. What seemed to be “hopeful speculations” in the summer of 2020 has subsequently been shown to be untrue. Again, he would not be one of my “go-to” sources for COVID-19 information.

      The 4 doctors you mentioned sincerely believe in their work in COVID-19 and vaccines. I do not question their sincerity. However, I believe the strength of evidence is not on their side, not according to the medical/scientific consensus today.

      I am curious about your comment: “It (the vaccine) is a terrible decision for children and people with natural immunity.” Please provide me your source data that led you to this conclusion.

      I am also curious about your comment: “The huge sum of money spent to artificially make IVM (Ivermectin?) look bad” Again, your source data, please. Thank you!

    1. Hi, David! Below are two online comments about TrialSiteNews.com which reflected my sentiments about information from this website.

      u/simmelianben Jun 12 ’21
      A few things stand out to me. First is that anyone with an account approved by them can submit an article. So it’s basically a large crowd sourced blog, not really news or reporting per se.
      Second, I glanced at a couple covid articles and noticed they were tilted towards the “be afraid” side of the spectrum. The UK yellow card article especially is written poorly because it says how the adverse vaccine reports are likely nothing “but could be something”.
      For my two cents, it’s a waste of time to debunk the site’s claims because they are both poorly sourced and a mixture of vague innuendo, interpretation, and fear mongering disguised as “but maybe…”.
      If the articles there have any merit folks will publish them with their real names behind them and not hide behind “staff” titles. That alone is enough for me to think it’s not trustworthy. Good science and news uses their names.

      u/ImScaredofCats Jun 14 ’21
      I’m a clinical trials professional and I’ve been working on COVID vaccine trials since December 2020, I can say without a doubt that this website is a load of bs.

      I also found the following FYI.

      HealthFeedback.org reviewed 2 articles from TrialSite News and concluded the following:

      Claim: Post-vaccination deaths reported to VAERs are caused by the vaccine (Published by TrialSite News on 7/23/21) Verdict: Misleading.

      Claim: The ovaries get the highest concentration of (lipid nanoparticles from RNA vaccines). This turns the ovaries into a very large manufacturing plant to turn out toxic spike protein. (Published by TrialSite News on 6/24/21) Verdict: Inaccurate.

      For me, the evidence in favor of taking the Covid-19 vaccines is much better than the evidence in favor of taking Ivermectin.

  10. I am still searching for the truth myself so appreciate your insight. How do you reconcile the huge spike up in VAERs after the mRNA vaccines were introduced? Being that the vaccine is leaky and is not going to ever get us to herd immunity why should it it be forced on those that don’t want it? Why are 3rd world countries with early treatment doing so much better than the USA with our world class hospitals? Why are all early treatments being restricted?

    1. Hi, David! I responded to your questions above on your Facebook page. Have you had a chance to read my write-up?

  11. If we are going to get to the truth we need to allow debate. Joshua should be allowed to speak even if you don’t agree with him. I don’t agree with him but would not want to shut him down. I was surprised to learn that his posts were being censored by Election Forum as he has disagreed with me but been very civil and polite. This is, of course, what happened to Front Line Doctors and FLCCC.

  12. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events:

    Per above article, out of 390 million people who received doses of the Covid vaccine 8164 deaths were reported. That is 0.0021% which may be even smaller because not in all deaths is it clear that the vaccine was the cause. 0.0021% is pretty good odds and the possibility of contracting the virus if unvaccinated, ending up in an IC U and even of dying from it are much greater. So get vaccinated, not just for yourself, but to protect your family, your children and grandchildren, friends and neighbors. You are doing it for others. To not do so is a selfish act, in my opinion.

    1. How does it protect others to get the vaccine? My understanding is that your symptoms are reduced so you are more likely to spread it unknowingly instead of staying in bed. Additionally, if everyone is vaccinated the virus is more likely to mutate around the vaccine. Similar to everyone taking anti-antibiotics. The best is for the weak to take it and the rest to develop natural immunity. Early treatment is also key for the vaccinated and unvaccinated to reduce the viral load.

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