FDA set to authorize updated COVID-19 booster shots for newer Omicron strains without completed human tests: Agency will assess new jabs based on mice research and older vaccines

UK Daily Mail ^ | 08/28/2022 | ANDREA CAVALLIER and AP

[DFG]

New COVID-19 booster shots are set to be authorized this week by the Food and Drug Administration (FDA) and will be available to most Americans before human testing has even been completed.

The shots have been modified to target the latest Omicron variant, but won't have finished testing in humans when the FDA makes the decision. Instead, the FDA is relying on data from other sources - like research in mice and older vaccines, the Wall Street Journal reported.

'Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,' FDA Commissioner Robert Califf said in a tweet last week.

[butlerweave]

Just say NO

[rovenstinez]

Yeah, they need to hasten the day we will all be overcome, sick in dire need and on ventilators. HURRAY now and get the booster.. Let’s make sure everyone is double jabbed. The fact it doesn’t work is beside the point. Faucci Science at work.

[roving]

I could name a few on this board who will be first in line

[Oscar in Batangas]

Here we go again.
And again.
And again.

[SaveFerris]

(before human testing has even been completed)

Sounds

safe AND effective

[Mark]

Still immune from civil lawsuits?

[SaveFerris]

Trust the science!!

💉💉💉💉💉💉💉💉💉

[TexasGator]

Flu shots are updated every year without human trials.

[Gene Eric]

For those who normally get flu shots, be aware of what you’re actually getting.

[CJ Wolf]

I don’t think I would give my dog an untested on dogs shot, let alone my kid. Do people have no common sense anymore?

[RetiredTexasVet]

Insanity: Doing the same thing over and over and expecting different results.

Welcome to the Big Pharma Insane Asylum.

[cgbg]

“Flu shots are updated every year without human trials.”

My understanding is that the Aussies are the human trials for each new season.

[Jane Long]

What.....could possibly.....go WRONG?

🙃

[Pollard]

New COVID-19 booster shots are set to be authorized this week by the Food and Drug Administration (FDA) and will be available to most Americans before human testing has even been completed.

Well technically, trials are ongoing for the original jabs so - "what difference at this point does it make"

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Pfizer's COVID-19 Clinical Trial Phase 1/2/3 in clinicaltrials.gov https://clinicaltrials.gov/ct2/show/study/NCT04368728

Trial start date April 29, 2020. Estimated completion date February 8, 2024

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Moderna's COVID-19 Clinical Trial Phase 3 in clinicaltrials.gov https://clinicaltrials.gov/ct2/show/study/NCT04470427

Trial start date July 27, 2020. Estimated completion date December 29, 2022

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Normal for Phase 1/2/3 to be run concurrently? Doubt it. Normally, there is a Phase 4 which is when a portion of the public starts getting it and it's monitored.

Welcome to the first annual Hunger Games and may the odds be ever in your favor.

[aMorePerfectUnion]

—> but won’t have finished testing in humans when the FDA makes the decision

[FReepers begin lining up so they can eat endlessly at cruise buffets!]

[Equine1952]

Is it looking like “NEW AND IMPROVED”? I hope whoever gets my dose gets it shove in their azz.

[FamiliarFace]

Is it still an emergency? Doesn’t seem like we’re in an emergency anymore.

[Varsity Flight]

.....current mRNA .....

[OHPatriot]

Fully approved or EUA?