Safe and Effective®

CBS;

The Food and Drug Administration is telling Pfizer and Moderna to expand the warning labels on their COVID-19 vaccines about the risk of a possible heart injury side effect linked to the mRNA shots, primarily in teen boys and young men, citing findings from a study published last year and new agency data.

Orders to expand the warnings were posted Wednesday by the FDA, in letters dated April 17 to Pfizer and BioNTech about their Comirnaty vaccine and Moderna about its Spikevax vaccine.

More: Sen. Ron Johnson just released subpoenaed records exposing a damning timeline of what officials knew and when.

49 Replies to “Safe and Effective®”

  1. probably who the chinese targeted to begin with . though in canaduh no young male wants to join the army

  2. People, including Ron Johnson, are trying to play this up as if the possibility of myocarditis was something the pharmaceuticals were keeping secret.

    In fact it was well publicized right from the start, including many times in this forum.

    So why wasn’t the medical community up in arms? Because the risk and severity of myocarditis from COVID was far greater than from the vaccines. GIven that the vaccines both reduced the odds of getting COVID, and reduced the severity of symptoms if you did get COVID, it’s plausible that the vaccines reduced the overall chances of getting myocarditis, although I don’t know of any study that tried to determine that explicitly.

      1. If I were insane, it would be easy to rebut my opinions with facts and logic.

        I see very little of that in this forum. Mostly posters don’t even try, resorting instead to personal attacks.

      1. Vaccine: a preparation that is administered (as by injection) to stimulate the body’s immune response against a specific infectious agent or disease.

        Which part of that does not apply to mRNA vaccines? Or do you have a different definition in mind?

        1. Har har!
          I remember when “vaccine” meant an inactive or weakened form of the pathogen, way back in 2019, before aholes like yourself, states and Big Pharma decided that the dictionary was really just part of a marketing campaign.
          Not some mRNA delivered into the interior of a cell to replicate like a virus, and burst through the cell walls to get into the bloodstream where the immune system will hopefully do something about it, obviously damaging cells as it goes.
          You one of the worst propagandist hacks ever to stain the internet.

          1. The definition of vaccine in 1800 was (Oxford English Dictionary)…

            The disease cowpox, esp. when regarded as a source of material used in vaccination against smallpox.

            Given that the Latin name for cow is vacca, one can see the origins of the name.

            By your logic, the polio vaccine was not a true vaccine, as no cow pox was involved. Definitions are modernized as technology advances, slick. It’s not a conspiracy.

          2. Yeah. Just a coincidence that it changed just as mRNA tech was set to make billions selling to states.
            I’m sure that you think that a woman is “an adult who lives and identifies as female though they may have been said to have a different sex at birth”

            Again, you one of the worst propagandist hacks ever to stain the internet.

          3. Of course it’s not a coincidence that the definition was expanded just when new methods for inducing an immune response were developed.

            Just like it wasn’t a colncidence when the definition was expanded when “vaccines” were developed for diseases other than small pox.

            You seem to think this is some decisive debating point.

          4. They had to change the definition to make way for mRNA. They also changed the definition of pandemic.

          5. Linda:

            You are correct. They expanded the formal dictionary definition of “vaccine” when new methods of inducing an immune response were developed. They brought it in line with how the term was now being used in practice by the medical profession, which is how a dictionary is supposed to work.

            I guess for someone steeped in conspiracy theories, this is deeply critical and revealing. For everyone else, it’s just common sense.

    1. Lots of people get myocarditis from the jab, so some moron posits that the vax reduces chances of getting myocarditis.
      The stupid, it burns!

      1. It does require following a chain of thought, so I didn’t have high hopes for you.

        1. I have to give it to ya Killer you just don’t want to realize as people get “smarter” principals and ethics just get in the way.
          Smart people used to have a backbone, and deserved some credit.
          Not so much anymore.

          1. Which principals [sic] and ethics are you referring to?

            I don’t know of any vaccine that doesn’t entail risk. All vaccines are a trade off between benefits and downsides. The question is always “Does this vaccine do more good than harm?”.

    2. You are ignoring the fact that said benefit was only seen in the elderly, not healthy young men who were at near zero risk of ending up in the ICU from the virus. Furthermore the dubious benefit in the elderly (results strongly criticized by many experts) was already in doubt even for the elderly once the alpha variant had passed through the population and absolutely so once omicron arrived. Furthermore, the incidence of myocarditis and pericarditis has been shown to be grossly underreported than the oft quoted 30/million doses and saying the cases were mild and without long term effects is also wrong as we simply don’t know.

      I can’t be sure that the pharmaceutical manufacturers deliberately decided to cover up the myocarditis issue. However the fact that anyone under 14 days post vaccination (21 in BC and Alberta) was classified as unvaccinated, certainly had the effect of hiding post vaccination myocarditis and shifting the count over to virus caused myocarditis.

      A recent study from Denmark, Finland, Norway, and Sweden that did not play the nasty little 14 day game (21 in Sask and BC) shows rates of myocarditis in young people within 28 days of vaccination was increased.

      “Adjusted IRRs in homologously vaccinated males aged 16 to 24 were 5.31 (95% CI, 3.68 to 7.68) after a second dose of Pfizer and 13.83 (95% CI, 8.08 to 23.68) for Moderna. An estimated 5.55 (95% CI, 3.70 to 7.39) excess myocarditis cases per 100,000 vaccinees occurred after the second dose of Pfizer, compared with 18.39 (95% CI, 9.05 to 27.72) after Moderna. Pericarditis rates were similar.”

      It could debatably be said that the risk of myocarditis is greater with the virus and therefore the benefit of the vaccine outweighs the risk but due to that pesky 14 day rules a lot of the myocarditis classified as occurring from the virus may actually have been caused by the vaccine since myocarditis most commonly occurs in the first seven days after the second vaccine during the time cases were automatically reclassfied as myocarditis in an unvaccinated cohort in Canada.

      I found it interesting that the Denmark, Finland, Norway, and Sweden study made the obligatory benefits outweigh the risks but did not address the risk of the virus in those who had not had the vaccine. They did point out that the risk of myocarditis was higher in those who had BOTH the vaccines and the virus which would seem to indicate any exposure to spike either by the virus or the vaccine caused increased risk for myocarditis. Therefore if we leave healthy young people alone instead of jabbing them they will be less likely to develop heart damage.

      1. Yes, there was very little scientific evidence to support giving the covid shots to healthy young people. As noted, the 14 day classification as unvaccinated after the shots intentionally obscured the safety signals. There certainly was no attempt at informed consent to let young men and teenage boys know the myocarditis risk they faced from the shots. In fact, if they refused the shots they were kicked out of post secondary school and employment. Both of my sons in that age group were forced out of college in Sask for refusing the covid shots (later rescinded but there was no way to catch up on lost class and lab time).

        The violation of every citizen’s medical rights and human rights was vile. These actions by government, public health officials, school administrators and employers should not be forgotten nor forgiven until legislation to protect basic rights are passed.

        1. From Kate’s link:

          Sen. Ron Johnson just released subpoenaed records exposing a damning timeline of what officials knew and when.

          Pfizer and Moderna got insider updates from the government while those warning the public got censored.

          • Feb. 28, 2021: Israeli health officials alerted the CDC to “large reports of myocarditis, particularly in young people,” after Pfizer shots—just 2.5 months after EUA.

          • April 2021: CDC officials reviewed heart inflammation signals using DoD and Israeli data—but issued no warning.

          • By late April: VAERS recorded 2,926 deaths, nearly half within 3 days of injection. Johnson said, “Somebody ought to be looking at it.”

          The governmnent health officials and politicians knew and yet continued to not just recommend but force shots without informed consent. Then they used a bizarre data collection trick that counted a person as unvaccinated until 14 days after the shots, knowing that most of the heart conditions would appear within the 14 day period.

          1. Someone did look at it. There were numerous early papers on the vaccines and myocarditis. Johnson is trying to make it look this was a cover up, but it was anything but. This paper reviewed many of the early studies:

            https://pmc.ncbi.nlm.nih.gov/articles/PMC10203748/

            The risk of mycarditis was stated on the official label for the Pfizer mRNA vaccine. Here’s the label from October 2021:

            https://www.fda.gov.ph/wp-content/uploads/2021/11/Pfizer-BioNTech-and-Comirnaty-Product-Information-for-vaccine-recipients.pdf

            Later labels expanded on this warning.

          2. If that information was “known” by April/May 2021then I assume medical professionals were informing people, especially young people, of the myocarditis risk and the covid shots package inserts also made this warning clear. If not, and the risks of vaccine induced heart disorders were known…then people were denied informed consent.

            If people were also being coerced (a form of force) after April/May 2021 to take the shots by being threatened with being fired, kicked out of school, etc…then they were also denied free, informed consent.

            I remember the media calling anyone who talked about any adverse affects from the vaccine being labeled as conspiracy theorists about 2 years. The mantra was first “safe and effective” then later ‘the benefit outweighs the risk”, without clearly detailing those risks. Now we know that politicians and health officials knew of the link between myocarditis and the covid shots, particularly for young men and teenage boys. They had the information and then denied all of us free, informed consent. This was a gross violation of rights and medical ethics.

          3. LC Bennett:

            Every vaccine has risks and adverse effects. This is because vaccines work indirectly through the immune system, and everyone’s immune system reacts a little differently. There can be no guarantees.

            The points you bring up have little to do specifically with myocarditis and COVID vaccines (which was a rare adverse effect, and usually mild), but with all adverse effects for all vaccines. What is the medical profession’s duties in regards to informed consent, and precisely how should it be done?

        2. “they were not zero.”
          They were very close to zero for healthy young people. COVID was not more dangerous than the vaccines. Viruses become less virulent as time passes. Eventually Omicron was not much worse than a cold. The figures on lives saved by the vaccines has been debunked. And we are still seeing people suffering from vaccine damage.

        3. Notice how carefully you did not address the issue of widespread misclassification of who was vaccinated and who was unvaccinated.

          Now let me add in a false positive rate of 58% for infectivity in the PCR testing.

          Most of the data published on the topic is crap because of misclassification.

          1. No, I’m not going to address every single point everyone makes. Live with it.

          2. It is very convenient to ignore the key point I made which is the data is unreliable die to the 14 day rule (21 in BC and Sask) as well as ignoring the 58% false negative rates for testing of the infectivity state of the person tested and then turn around and quote studies that ignore that issue.

    3. “GIven that the vaccines both reduced the odds of getting COVID, and reduced the severity of symptoms if you did get COVID.”. Absolutely no proof of this. I think you are desperately hanging on to a dead horse.

    4. Are you aware of any studies containing BROBDINGNAGIAN RODENT PHALLI?

      Honestly, my thesaurus is getting a workout with you.

      You might want to ask yourself why there are no studies comparing myocarditis rates in the vaccinated vs unvaccinated, but that would require wrongthink.

    5. I have the scars and loss of full heart function from the damage of myocarditis from Covid, pre vaccine.

      Increasing the risk of that damage by taking a vaccine that offered no benefit to me, as I had naturally acquired immunity following that exposure, would not be of benefit. However our health officials touting ‘science’ demanded I take that risk using coercive force.

      The protective effect of the vaccines waned quickly, meaning that everyone that took a vaccine was compounding their risk of myocarditis, with risk both from the vaccine and then again from the infection which they were bound to get anyway.

      It is a slight of hand to claim that the vaccines ‘prevented’ the risk one would get from the getting sick with the virus. Because the vaccine did not prevent spread, and because the vaccine waned and the virus mutated we were all going to get Covid eventually, even despite being previously vaccinated. The risk is happening each time, no matter.

      Your statement that the risk of myocarditis from Covid was greater than from the vaccines is disputed, has been refuted by scientists, as in science people DO get to disagree, and it should at least be presented that it is age dependent.

      “Misconception 1: Coronavirus Infections Cause More Myocarditis Than COVID-19 Vaccinations”

      https://cardiovascular-research-and-innovation.reseaprojournals.com/Articles/myocarditis-after-sars-cov-2-infection-and-covid-19-vaccination-epidemiology-outcomes-and-new-perspectives

      1. 1. One of the authors is Peter McCullough, the biggest anti-vaxx grifter on the planet.

        2. This paper is in the International Journal of Cardiovascular Research & Innovation, whose Editor-In-Chief is… Peter McCullough. This reeks of conflict of interest.

        3. The journal claims to be peer reviewed, but the time between submission and acceptance of this paper was 29 days. That’s not impossible, but it’s extraordinary difficult. It virtually guarantees that the “peer review” process was perfunctory at best.

        4. There is no description of the peer-review process.

        5. The journal is two years old.

        6. In the journal’s short history, many of the same authors appear again and again (e.g., Mahotra).

        These are all red flags, strongly suggesting this journal is not scientific, but rather a vehicle for advancing a specific anti-vaxx agenda under the guise of science.

        1. You have not refuted the information presented. You have offered an ad hominem attack of ‘grifting’, instead. What you are relating is that you simply dismiss the opinions of professionals and scientists that you disagree with not on the merit of their ideas, but on ‘who you think they are’ = gossip promoted by others like yourself.

          It is obvious from JUST that action that you are not looking at this topic from a scientific viewpoint, but from one of advocacy.

          This is one of the authors you are deliberately slandering and it is this type of attack which you have undertaken that discredits you.

          Dr. Peter McCullough, Career Timeline

          1984: Graduated from Baylor University with a Bachelor in Science
          1988: Graduated with a medical degree from the University of Texas Southwestern Medical School
          1991: Completed his residency at University of Washington School of Medicine
          1991: Dr. McCullough begins his period as a medical attending at Mercy Hospital
          1993: Studies his Masters degree in Public Health at the University of Michigan School of Public Health
          1994: Begins his fellowship in cardiovascular diseases at the William Beaumont Hospital
          1997: Joins the Henry Ford Heart and Vascular Institute
          2000: Appointed to serve as Section Chief of Cardiology of the University of Missouri-Kansas City School of Medicine, Truman Medical Center
          2002: Made a Consultant Cardiologist and Division Chief of Nutrition and Preventive Medicine at the William Beaumont Hospital
          2010: Serves as the Chief Academic and Scientific officer of the St. John Providence Health System
          Current: Joined Baylor University Medical Center as Vice Chief of Internal Medicine and Chief of Cardiovascular Research of the Baylor Heart and Vascular Institute

          https://www.radcliffecardiology.com/authors/peter-mccullough?language_content_entity=en

          1. The ad hominem is thoroughly deserved. Somewhere in his distinguished career, McCullough abandoned professionalism, common sense, and scientific integrity, and went loony. In January, the American Board of Internal Medicine revoked his certification.

            Here’s Retraction Watch’s results when you search for author McCullough with COVID in the title. Little wonder the guy had to start his own journal to get published. His record is abysmal.

            https://retractiondatabase.org/RetractionSearch.aspx?AspxAutoDetectCookieSupport=1#?AspxAutoDetectCookieSupport%3d1%26auth%3dMcCullough

            McCullough is also the chief scientist of The Wellness Company, which sells fringe “remedies”, including some to detoxify you of COVID vaccines. He’s hardly a disinterested party.

            https://www.twc.health/

        2. So you refute by slander. How convenient.

          Oh and retractions of his work were ordered by senior editors over the objections of the reviewers and the journal editors. I’m sure the fact that Pfizer was a major funder of the journal had nothing to do with it.

          1. Libel, actually, as it’s in print.

            But it’s only libel when it’s untrue. McCullough is verifiably cuckoo for Cocoa Puffs. See my post directly above.

          2. Nothing so impressive as the searing scepticism of the gullible dunce who suddenly isn’t hearing what he wants hear.

  3. The list of side effects from the clot shots will require a six cube box, in ten years how many healthy kids will get turbo cancers from that poison?

    1. So we’re going ten years out now? Dolores Cahill said that anyone over 70 who got a mRNA vaccine would die in two or three years.

  4. Leg cramps are just a touch of polio because even though you have been vaccinated against polio, it doesn’t mean you don’t get polio, you still get it, but the symptoms are a little less. Talk to your doctor.

    1. “LIST OF ADVERSE EFFECTS OF SPECIAL INTEREST” is not a list of adverse effects from COVID vaccines. Rather it’s a list of adverse effects that vaccine manufacturers must be on the look-out for.

      This has been explained thousands of times, but anti-vaxxers keep repeating the falsehood. I suspect they’re not interested in getting it right.

  5. Studies now coming out, Pfizer’s injection alone killed a half million Americans, and I think those numbers are low.
    Doesn’t include J&J and Moderna.

  6. This is turning into a PR disaster for the pharmaceutical industry, no matter which way you try and spin it. Side effects would never have been this big of an issue had the authorities not tied vaccination to employment, travel, public event attendance and so on.

  7. My wife and I both got Covid at the same time, her double vax, me none, she was also very sick for 4 days from the side effects of her second jab , we almost went to the emergency.
    When we both got Covid at the same time, it hit her harder than me and I recovered faster even though I am 5 1/2 years older and not vaxed.
    So am I to believe my lying eyes or the vax pushers.

    1. Your story is not unusual. I know so many people whose health has deteriorated significantly since the vaccine. Some have died from heart issues or turbo cancers. We know the vaccines were never adequately tested and that side effects were minimized. The health profession has lost a lot of credibility on this one. They are still denying.

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