Safe and Effective®

Safe and Effective 34 Comments

International Journal of Risk & Safety in Medicine- Pharmaceutical product recall and educated hesitancy towards new drugs and novel vaccines

Parallels with past drug withdrawals and gene-based vaccines include distortion of clinical trial data, with critical adverse event data absent from high-impact journal publications. Delayed regulatory action on pharmacovigilance data to trigger market withdrawal occurred with Vioxx (rofecoxib) and is apparent with the gene-based COVID-19 vaccines.

34 Replies to “Safe and Effective®”

  1. All of us had the choice to not take the experimental juice and to research the reality of what Covid was, to counter the Official Narrative according tot he corrupt media, corrupt health ‘officials’ and corrupt, inept government.
    The weak and the coerced took it.

    1. Exactly – some quick research when this first broke; confirmed this vaxx wasn’t formally tested.
      Not effect nor safe.

      3 deaths (at home, after vax) in my family; unexplained to us; gov put them down to covid. No autopsies were done.

      So glad we didn’t bend to their lies & BS, and I’m not getting any ‘shots’ they push.

  2. This is based on the VAERS dataset, which explicitly says it is not designed to draw conclusions from. The problem is that reporting is voluntary, there is no checking for accuracy, there are no controls, and there is no way to determine cause and effect.

    https://www.cdc.gov/vaccine-safety-systems/vaers/index.html

    Suppose we were to give a supposed vaccine — but in reality just harmless saline — to a million people, chosen randomly. How many would die in a month?

    The answer is about 1000.

    This demonstrates the problem with using the VAERS dataset. If 1000 people die of causes having nothing to do with the vaccine, how do we know that 20 were caused by the vaccine, as reported by this paper? The signal is swamped by the noise. The results will be far more of an indication of people’s willingness to report deaths to VAERS than the actual danger of the vaccine.

    This is why VAERS states that it is meant only to suggest where to proper controlled studies may be needed, not to draw final conclusions from.

    1. The numbers I saw suggested a total 8 in 1000 worldwide as opposed to your 1 in 1000 after vaccination. But death from a reaction to a vaccine is not the same as a death by a car accident on the way home from the clinic. the VAERS is a report of deaths that are very likely attributed to taking the vaccine. They do check for accuracy but do not check every death, more a statistical review of a subset of the reported deaths. The onus is on the medical professional that reports the death to determine some plausible cause. Given the backing by most medical professionals, to getting the jab, are now saying that they then went out of their way to attribute the deaths to the vaccine that they promoted?

      1. The paper that Campbell is discussing reports 19 deaths per MILLION COVID-vaccine doses administered, not per thousand.

        I can’t see how one could determine that from the VAERS dataset even in principle. It’s the wrong tool for the job. It’d be like trying to extract a tooth using a pile driver.

        1. Given about 680 million doses given in the USA, that comes to almost 13,000 deaths…compare that to the number of deaths which caused other drugs to be taken from the market. You do know that the mRNA shots work by the individual strands penetrating a cell and cause it to start producing the spike protein. After enough (or the maximum it can) are produced, the cell ruptures releasing the spike proteins in to the surrounding tissue/blood stream. Now there are about 1×10-13 strands (1 followed by 13 zeros) in a single dose of the vaccine. If a large enough group of strands settles on some critical area of the body..say the pericardium for example…they can enter a large number of cells and after finishing their task become somewhat disruptive to the operation of the organ as the cells die.

          1. The point is that there’s no way we can determine if the 19 number is accurate. Given the methodology, it might be entirely spurious, an artifact of using the VAERS database rather than performing a large-scale controlled study.

    2. I’m all for controlled studies, but Pfizer and Moderna unblinded their controls and dosed that group with the magic juice after a few months.

      That said, maybe you and the other clot-shot advocates could volunteer for some long-term studies with continuous boosting – see what happens? Oh, and create the mRNA batches using plasmids with SV40 enhancer and promoter sequences.

      “In Cohort 1, 4.7% of COVID-19 infected children without vaccination developed new-onset asthma, versus 2.0% in their non-COVID-19 counterparts within a year (HR = 2.26; 95% CI = 2.158–2.367). For Cohort 2, COVID-19 infected children with vaccination showed an 8.3% incidence of new-onset asthma, higher than the 3.1% in those not infected (HR = 2.745; 95% CI = 2.521–2.99). ”

      Those are some vaccines.
      https://link.springer.com/article/10.1007/s15010-024-02329-3

      1. At this point, the initial studies are pretty much moot. There have been hundreds of independent studies from around the world since then studying the safety and effectiveness of the vaccines, and they have generally found the vaccines to be reasonably safe and effective. Here’s a meta-analysis of 122 articles that studied the safety of COVID mRNA vaccines:

        https://pubmed.ncbi.nlm.nih.gov/37376508/

        1. You are gas-lighting the readers. This paper deals with AEFIs (headaches, pain at injection site, allergic reactions observed for a short – up to 48 hours – after injection), not the whole new crop of AESIs that were never recorded for vaccines until they started showing up for the Covid-19 genetic therapeutics.

        3. KM, a major point you overlook in all your jabbering is that not one person who got the clot shot gave his informed consent, and that was because there was no relevant information to give. It was just arbitrarily deemed safe and effective by evil governments and complicit medical authorities, not to mention the stupid regime media.

  3. A customer told me on Thursday that she could not pick up her parcel because she was getting the jab. Today she phoned saying I can’t pick up I am having a reaction from the jab. What else do you have to know if this doesn’t cause concern?

    1. Lots of people feel a bit flu-ish the day after vaccination. It’s normal, not just for COVID but influenza and many other diseases. It means your body is reacting to the vaccine, which is the entire point.

      1. “Flu-ish”? Reacting to the Covid jab only means someone is feeling “flu-ish”? A bit presumptive on your part, KM, or do you believe that’s the only adverse effect? Ever hear of Jack Last, age 27?

        1. Actually, the most common reaction is a sore shoulder for a few days. But yes, flu-like systems are also common. I never said that these were only the possible adverse reactions, so don’t put words in my mouth.

          1. I know this is running the risk of being accused by an overweight rodent of making “personal remarks”, but you “put words in” your own mouth, with your evasive answers and cherry-picking of the literature.

          2. Cherry pick the literature? The anti-vaxx crowd scours the internet for scientific papers that seem to support their cause, no matter how dodgy those papers are. They never cite papers that run counter to their beliefs, despite the fact that those papers dominate the literature by a huge margin.

          6. Interesting report. A few notes.

            1. Out of 14 million doses, that there were only 5646 non-serious adverse effects reported. It beggars belief that this is all there were. A plausible explanation is that people expected non-serious effects, and didn’t bother reporting them.

            2. There were 485 serious effects reported, or about .003%. Again this seems low, but how low?

            3. There were 20 deaths reported. The link says it cannot reliably blame the vaccine for them, as most people had serious existing conditions.

            This report runs into the same problem as the VAERS dataset relied on in Campbell’s paper. If 14 millions doses were administered, we expect about 14 thousand deaths within a month of vaccination just in the natural course of things, having nothing to do with the vaccine. And yet only 20 deaths were reported. Presumably the deaths didn’t appear to the physicians to be related to the vaccine. It really is impossible to draw reliable conclusions from this. This is why large-scale controlled studies are pretty much the only way to measure the safety of vaccines.

          7. KM you’re a bad faith actor. Put words in your mouth? Explain how I did that? YOU said the person had a “Flu-ish” reaction. No other possibility was given. It wasn’t “just an assumption” based on some universal post jab reaction. You inserted an unsubstantiated fact to control narrative. You backtrack now when light is shined on your gaslighting attempt. It’s ok KM – everyone here saw thru it. Just more of your nefarious pro-jab bs.

          8. Martin B.:

            You’re the one acting in bad faith. But you forgot that my original comment is above for all to read.

            I said many people have flu-like symptoms after vaccination. I never stated that this was for-sure the case in this particular instance. My point, which was obvious, was that someone saying that they can’t pick up a parcel the day after vaccination is NOT something to be overly concerned about.

          9. No problems making unsubstantiated assumptions yet again, KM? You know nothing specific to what the person’s adverse reaction was but portray it as minor because that fits your “Safe Effective” narrative. The bad faith is all yours.

          11. Gawd. The autistic anti-vax conspiracy spurges on 4Chan are less irritating than you are, Fat Rodent. First you say the vaccines are safe and effective, then you acknowledge they killed people.
            Let me spell it out for you. Those 485 AESIs from the BC CDC report all required hospitalization and often frantic emergency medical intervention to save those injured by the clot shots from dying. Without that, Bonnie Henry could have been looking at 485 deaths instead of 485 vaccine-injured survivors of AESIs. I know you would be happier with 14,000 dead, but I guess those are your standards that we just can’t live up to…

            Here’s one of those AESIs – the case of Shaun Muldoon:

            Video actually starts at 7:40:

            https://rumble.com/v4b6ur8-shaun-mulldoon-may-04-2023-vancouver-british-columbia.html

          12. “First you say the vaccines are safe and effective, then you acknowledge they killed people.”

            I said nothing of the sort. I said figuring out the number of deaths due to the vaccine is impossible using a simple reporting system, as the number of natural deaths that have nothing to do with the vaccination will overwhelm any signal.

            But then you probably knew that. It’s obvious you’re trolling, pretending to be dense. This is your idea of “debating”.

  4. The shots are killing and injuring people and the terminally stupid are still taking them and the evil are pushing them, yes everyone that pushes those shots are evil.

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