FDA promised very extensive surveillance for adverse effects of Covid vaccines–presentation to FDA VRBPAC Advisory Committee, October 22, 2020

https://www.fda.gov/media/143557/download

It should be apparent that FDA was aware by October 22, 2020 of many of the side effects of Covid vaccines that the public only learned about later.  It should also be apparent that FDA (and CDC has access to even more methods for surveillance) has many databases to learn about vaccine safety–whose data are being hidden from the public.  The EUA statute requires that known benefits and risks be provided to potential vaccine recipients.  That is not happening.

The first slide below, “Slide 17” at the URL above, would suggest that FDA was well aware, presumably from the clinical trials, of all the severe adverse events that have subsequently been publicized.  But if FDA knew about these 9 months ago, it has been slow to tell the public.  For instance, we only just learned about Guillain Barre syndrome last week being a known adverse effect.

 

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7 Comments

  1. The listed "possible adverse event outcomes" are so dangerous and debilitating that it is bewildering how anyone would agree to play Russian Roulette with these experimental gene therapies. The brainwashing has been very effective.

  2. The coroner's report finally came out on that x-ray tech California who died 4 days after his second Pfizer shot. The results: he "died of hypertensive and atherosclerotic heart disease with severe cardiomegaly and heart failure." Mind you, his symptoms started within hours of getting the vaccine, with abdominal pain and shortness of breath. He had a history of hypertension, but it was well-controlled with medication.

    So how does a guy who has no history of an enlarged heart, has controlled hypertension, suddenly dies of "severe cardiomegaly and heart failure?" Can we say Myocarditis??? Am I wrong?

  3. Below, all data, directly from the United States Centers for Disease Control and Prevention, Vaccine Adverse Event Reporting System, VAERS.

    This compares the total number of adverse events reported to VAERS:
    1] from 1990-2020 for all vaccines spanning 31 years,
    compared with
    2] 2021 and covid-vax

    Total deaths reported to VAERS after vax
    8,680: 1990-2020 all vax
    10,991: 2021 covid vax

    Total hospitalized after vax reported to VAERS
    15,952: 1990-2020 all vax
    59,347: 2021 covid vax

    Put another way, 8,680 deaths over 31 years = 280 per year average.
    In six months, or half a year, this = 140 deaths per half-year average.

    In six months of after covid vax = 10,991 deaths in half a year.

    10,991 is 79.5 times more deaths after covid vax compared to historical average.

    Or 7,950% more.

    15,952 after vax hospitalizations in 31 years = 514.6 average per year.

    This is six-month average = 257.3.

    Six months of after covid-vax hospitalizations = 59,347.

    This is 230.7 times more hospitalizations.

    Or 23,662% more hospitalizations after covid-vax.

    The total number of adverse events reported is six-month average of 49,294, 1990-2020.

    Total adverse events in 2021 from covid-vax in six months = 2,053,959.

    This is 41.7 times greater after covid vax, or 4,167% higher.

    Total permanent disability after vax reported to VAERS 1990-2020 is six-month average of 304.9.

    Total permanent disability after covid vax reported to VAERS in 2021 in six months is 30,781.

    This is 101 times greater than 31 year historical average.

    Or 10,095% greater.

    Total Emergency Room [ER] after vax reported to VAERS
    15,952: 1990-2020 [all vax combined]
    59,347: 2021 [covid vax]

    Put another way, 15,952 ER over 31 years = 514.6 per year average.
    In six months, or half a year, this = 257.3 ER per half-year average.

    In six months of after covid vax = 59,347 ER in half a year.

    59,347 is 230.7 times more ER visits, after covid vax compared to historical average.

    Or 23,065% more ER reported to VAERs, from after covid vax, compared to 31 year historical vax average for all vax combined.

    This is not a comparison from after covid vax, to any single other vaccine type.

    This is comparison of ALL COMBINED, historical average of 31 years of all of the others.

    Any covid vax to any particular type of vax are astronomically more adverse events, i.e., viz. death, hospitalization, permanent disability, etc.

    From 1990 through first six months of this year, VAERS reports of:
    1,849 spontaneous abortions [fetal death at <20 weeks of gestation].

    810 of these reported after covid vax since January of this year.

    From 1990-2020
    1,034 miscarriages after vax [zero covid vax in this total]

    1,034 over 31 years
    = 33.4 per year, average or
    = 16.7 per half-year average.

    This is 48.6 times more miscarriages < 20 weeks reported to VAERS with after covid vax, compared to all other vax' combined.

    Or 4,857% more.

    Government continues to hide the V-SAFE data, allegedly set up by the CDC to closely monitor adverse effects during pregnancy.

    -30-

  4. Yes, they did promise to monitor AEs, separately from VAERS, using data sources from claims and electronic health records, and where is the reporting on that monitoring? Why is NO media asking for updates on the FDA's own tracking of AEs?
    Also: In slides 4 + 5 that you posted, listing their proposed data sources, notice the very small print in the lower left corner – data lags of up to 12 months.

  7. Re: the term "experimental gene therapies"

    These synthetic gene products (injectable products intended to prevent or reduce the severity of COVID-19) should not be called therapies. They have absolutely no therapeutic effect, and are not even intended to be therapeutic.

    I understand the impulse to refuse to call them vaccines. However, replacing the word "vaccine/s" with "therapy/ies" simply replaces one fallacy with another – because therapy implies a remedial benefit.

    Please, find another word if you just can't live with the word vaccine for these synthetic gene products.

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