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To: freeandfreezing; blueplum; Pollard; Prince of Space; metmom; kiryandil
Per the FDA in June 2020, the FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated.

This is where words become REALLY important. In the US, the basis of approval EUA and the only "approved" Vaccine, was for PREVENTION...NOT for decreased severity. Indeed, look at the actual FDA and Pfizer-BioNTech info.

Per the FDA's website,

On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.(emphasis added)

Per the Comernity Insert,

--------------------------- INDICATIONS AND USAGE----------------------------
COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. (1)(emphasis added>

Per the Summary Basis for Regulatory Action, under "Indication"

Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. (Emphasis added)

Clearly, the vaccine is for PREVENTION. Nothing else. All of the clinical trials (limited as they were) and statistical confidence intervals were focused on VE with regard to PREVENTION...not hospitalization, not ER visits, not fatalies, and not symptoms. Accordingly, THAT is the basis upon which approval and Efficacy should be based.

So let's examine the time-series of VE for these shots since authorization, keeping in mind the FDA benchmark of 50%. Remember, VE = the percentage reduction in infection rate in the test vs control groups.

Without making this a massive post, I'll concede that published VEs in various studies in 2021 were above 50%. At the same time, VE declined over time. In and of itself, this isn't too problematic - few things last forever. BUT, the rate of decay in VE didn't get much airtime. Indeed, by the end of July I did some modeling and it looked like VE would fall below 50% just 6 months after the second shot and become totally ineffective by 10 months. Further research in August showed VE during Delta falling to 66%.

Ruh roh.

As an important side note, all of this research is based on statistical analyses of data. They are NOT clinical trials. That is an important distinction, because 1) none of these shots underwent legitimate trials that examined long-term impacts that other approved vaccines underwent and 2) vaccines fail trials 59% of the time and take a median of 9 years. Therefore, we should have VERY LITTLE TOLERANCE for declining VE for these shots.

And now, with Omicron, we are seeing VE being zero in Norway and Denmark.

Pleae note, at no point in this post have I declared that these shots have nanotechnology in them, make you glow, have the Mark of the Beast, or are part of some conspiracy. I'm playing the game of "science."

Therefore, if VE is now not only below 50% but at zero, and the benchmark was 50%, the EUAs and approvals should be yanked. Even if these elixirs lower symptoms, that's not the basis of approval...rules are there for a reason.

Finally, these "approved" shots have caused familial and societal strife, vective, unrest, unemployment, and have brought us to a Constitutional "crisis" where SCOTUS will decide if OSHA can enact a mandate without congressional approval. If they don't not have VE above 50%, then they absolutely deserve ridicule and revocation.

/rant.

71 posted on 01/01/2022 8:16:22 AM PST by DoodleBob (Gravity's waiting period is about 9.8 m/s^2)
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To: DoodleBob; freeandfreezing; blueplum; Pollard; Prince of Space; metmom
Finally, these "approved" shots have caused familial and societal strife, vective, unrest, unemployment, and have brought us to a Constitutional "crisis" where SCOTUS will decide if OSHA can enact a mandate without congressional approval. If they don't not have VE above 50%, then they absolutely deserve ridicule and revocation.

This is an awesome point.

78 posted on 01/01/2022 12:54:53 PM PST by kiryandil (China Joe and Paycheck Hunter - the Chink in America's defenses)
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To: DoodleBob
Yes, your post #71 is a GREAT rant!  ROFL face
79 posted on 01/01/2022 12:56:28 PM PST by kiryandil (China Joe and Paycheck Hunter - the Chink in America's defenses)
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