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More From the BEST Initiative on CV-19 Vax Safety

By February 1, 2024Commentary

I believe I have said this 100 times or more.  I don’t think the CV-19 vax were particularly effective at preventing infection, they were a little better for a somewhat longer period of time at preventing serious disease leading to hospitalization or death.  The CV-19 vax have this modest effect in common with almost every respiratory virus vaccine.  At this point I see little reason for anyone to get further vaccinations, almost everyone has some form of immunity already from infection and/or vax.  The majority of the population has been both vaxed and infected.  It is possible that repeated vaccinations may actually hinder the immune response to attempted new infections.  At the same time, I see absolutely no evidence to suggest that the CV-19 vax have serious widespread side effects and I tire of the vax safety nuts making wild conspiratorial claims with zero evidence.

The very best, near real-time monitoring of vaccine safety comes from the FDA’s long-standing BEST Initiative, used for many years for drug and vaccine safety monitoring.  This uses large health plan claims databases and large EHR databases to identify potential associations between vaccination and adverse events.  Outside epidemiological experts work with FDA staff to create and run the algorithms against the data sets and report the results to FDA.  The basic methodology is pretty simple–you create baseline rates of certain events and then see if there is a change in those rates following vaccination.  There is no better data source; this is constant actual information on the receipt of health care.    The vax safety nuts almost never refer to BEST, because they know it is the most accurate source of data and it doesn’t support their farcical claims of millions of deaths and other serious adverse events.  In fact it appears there are almost no vaccine-related deaths.

When they do refer to BEST studies, it is to try to twist them to say what they don’t say.  So it is with the most recent best study, assessing the safety of updated boosters.  In regard to populations of children and adults, the study looked at a large number of potential adverse events which either have been linked generally to administration of any vaccine or have been suggested as associated with the CV-19 vaccine.  The result is either no signal of a potential safety issue or a signal.  If there is a signal, further research would be needed to establish that the events were caused by the vaccine.  This can be done by doing more in-depth adjustment for potential confounding factors or by examination of the clinical course of the patient.  (Medrxiv Paper)

For this particular study, four administrative claims databases, including Medicare’s, were used and anyone over the age of 6 months was included who received a vax during the study period of August 2022 to July 2023.  Twenty potential events were examined for children from 6 months to about 5 years of age, twenty-one for those aged 5 to 17 and eighteen for those persons 18 and over.  Both Moderna and Pfizer vaccines were covered.  Almost 14 million people received a vax and were included in the study databases.

Only one database showed any safety signals.  One was for anaphylaxis in persons aged 18-64 for both vaccines and one was for heart inflammation for the Pfizer vaccine in persons aged 18 to 35.  There were no safety signals in children under the age of 18.  Anaphylaxis is a reaction common to most vaccines.  A significant portion of people in the data set received a flu vaccine at the same time as the CV-19 one, so it isn’t clear which vaccine led to the anaphylaxis.  The absolute number of events was low.  Heart inflammation is a fairly well confirmed adverse event following CV-19 vaccine, particularly in younger males.  Neither of these adverse events typically have serious clinical consequences and clear up relatively quickly.

The fact that the absolute numbers of these events was very low and that the signal only appeared in one database suggests that any association is quite weak.  So nothing here to suggest any significant safety issues with the mRNA CV-19 vaccines.

Join the discussion 3 Comments

  • Larry Fitz says:

    I don’t think this recent study you reference really validates the safety of the CV vaccines, because it only covers the 2.0 version bivalent vaccines used after August 2022. There is no equivalent safety data for the original three 1.0 version CV vaccines used in early 2021 thru early 2022. Thus, the recent study on bivalent vaccines does not refute arguments attributing significant deaths and adverse reactions to the initial round of CV vaccines used in 2021. It would be premature for you to state: “…absolutely no evidence to suggest that the CV-19 vax have serious widespread side effects and I tire of the vax safety nuts making wild conspiratorial claims with zero evidence.”

    In addition, the recent advice from the Florida State Surgeon General to suspend use of mRNA CV vaccines due to contamination of viral promoter elements used in their manufacture until studied further is wise, since the manufacturing protocols for at least the Pfizer vaccine in the initial 2020 human trials used a different manufacturing process (smaller scale lab synthesis) compared to the later commercial production process.

    When you look at excess deaths in different countries, then Australia and Sweden are interesting examples….3% excess deaths in Sweden with vaccination and no lockdowns…..10% excess deaths in Australia with vaccines + lockdowns. This suggests that there remains a significant number of excess deaths that possibly are associated with vaccine use.

    • Kevin Roche says:

      I have posted multiple times on these safety studies on the vax since inception, it is untrue that there were no similar studies on the vax from the start. I just posted on a study indicating that the nonsense about contaminated vax is just that, nonsense. The excess death stuff is similarly garbage, no properly done study shows any excess death linkage to vaccines.

  • joethenonclimatescientist says:

    Interesting testimony from Dr Wyner, the statistician, in the Mann v Simberg/Steyn trial. He stated that Mann had not used any professional statisticians in the MBH98 or mbh 99, and that one of the major problems was the uncertainty range was far too narrow thus having too high confidence level in the quality of the HS study. He also indicated that most of the multitude of other climate reconstructions had not employed professional statisticians.

    Wyner also had a very short statement when he testified that similar problems were common in the medical studies due to the failure to use statisticians to be involved in analysizing the data. Whereby the effectiveness of a treatment (or the effectiveness of a drug ) was often greatly overstated. He may have limited that testimony to drug studies. (fwiw – I am in agreement with kevin on the vax safety).

    Kevin – thoughts on the data analysis and or lack of statisticians in medical/drug studies?

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