Posts by Megan Green72

Keith Wilson said:Not happening... unless they skip their own planned steps (those secondary measures mentioned above) or just decide to scrap the whole damn thing entirely.

Let's see what these Secondary outcome measures actually are

Secondary outcome measures Quote : in a clinical study's protocol are planned results that aren't quite as big as the primary goal for testing an intervention, but they’re still worth looking at. Most clinical trials track more than one of these.

Keith Wilson said:Great, so we’re basically stuck waiting until September 1, 2023, before we can decide on vaccinating kids.
Could be.

The study could be wrapped up way sooner than that.

Keith Wilson said:Morgan Peterson, thanks for the link. It makes things a bit clearer...
Since everything is written in the future tense, I'm curious about some of these dates and statuses listed below (specifically, what "Recruitment status: Recruiting" and "Estimated Primary Completion date: March 4" actually imply):

"ClinicalTrials.gov Identifier: NCT04816643
Recruitment status : Recruiting
First Posted : March 25, 2021
Last update Posted : June 1, 2021"

The info link says: "Recruiting: The study is currently recruiting participants."

"Study design
Go to sections
Study Type : Interventional ( Clinical Trial)
Estimated Enrollment : 4644 participants
Allocation : Non-Randomized Intervention model : Parallel Assignment Masking : None ( open Label ) Primary Purpose : Prevention official Title
Allocation : Non-Randomized Intervention model : Parallel Assignment Masking : None ( open Label ) Primary Purpose : Prevention official Title
Masking : None (Open Label)
Primary Purpose : Prevention
Official Title : Evaluate The Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate against COVID-19 in Healthy Children < 12 Years of age
Actual Study Start Date : March 24, 2021
Estimated Primary Completion date : March 4
Estimated Study Completion date : September 1, 2023"

Thanks.

Estimated Primary Completion date = The projected date for finishing the main part of the study

If you click the term, you get this:

The date on which The Last participant in a clinical study was examined or received an Intervention / treatment to collect Final data for The primary outcome measures. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical Studies with more Than One primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.

I don't see why things wouldn't wrap up earlier than that date.

Matthew Jackson2 said:Look, certain long-term—or even mid-term—consequences can be caught during those extra rounds of testing typically performed before a standard Marketing Authorization, whereas with a CMA, they happen after the fact.

Naturally, it’s impossible to catch absolutely everything, especially those issues that take ages to actually manifest, but this process definitely bumps up the safety profile of the drug. Comparing this to drugs that went through a standard MA just isn't an apples-to-apples comparison, which is exactly why I felt the need to speak up.

Must have been a bad cup of coffee...

Look, I reacted to a specific entry that stated a very specific thing. If you feel the need to argue about something I never even mentioned, that’s your own problem.
And just so you know—all the primary endpoints were cleared in Phase III before they even asked for approval. ☕

nimblesurfer17 said:Honestly. 🤦🤦

And apparently, before Phase IV even starts, they make sure to check if the weather is nice during the experiment too.

Since you decided to pull Wikipedia as your primary source—using that exact same link, by the way—let's look at what it actually says:

"Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Phase III trials of chronic conditions or diseases often have a short follow-up period for evaluation, relative to the period of time the intervention might be used in practice.[10] This is sometimes called the "pre-marketing phase" because it actually measures consumer response to the drug."

"While not required in all cases, it is typically expected that there be at least two successful Phase III trials, demonstrating a drug's safety and efficacy, in order to obtain approval from the appropriate" regulatory agencies such as FDA (US), or the EMA (European Union)."

"The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials."

Anyway. 🤦🤦
Yeah, Phase IV is really just about monitoring side effects. 🤦

People kept droning on about long-term consequences—talking about 5+ years and all that. That’s what Phase 4 is for. Every single drug and vaccine goes through this. If you're gonna nitpick these vaccines based on that, then you gotta apply that logic to every other medicine out there too. ☕

Matthew Jackson2 said:Look, a CMA is granted for a drug or vaccine when the full suite of data required for a standard Marketing Authorization simply isn't available yet. You can play around with the definitions of different phases all you want, but the blunt reality remains: for the COVID-19 vaccines, we lack the exact data sets typically demanded for a standard MA. Because of that, they aren't even in the same category as those other drugs that hold a standard MA, even if both groups share the commonality of ongoing monitoring for rare side effects.

Same goes for you—you were talking about 5+ years and long-term stuff. That's Phase 4. ☕

Rachel Barrett8 said:Everything I'm saying comes from the information available to us. And since we are discussing kids, I’m going to stick to my guns.
There is a specific amount of time required to monitor side effects, right? You can't just shorten that window, can you?
Side effects don't always show up immediately. That’s why vaccines undergo testing for at least five years. It’s only after all that data is collected that they can be declared relatively safe for humans—not "100% safe," despite what the media claims.
Am I making things up? Did I use a "cliché" or something?

Unlike Fata, it looks like you're dealing with a severe case of dementia. Let me refresh your memory regarding the last two pandemic panics, which weren't even that long ago—about ten years back.

The first was bird flu, when DOJ specialists were trekking through rural towns telling farmers to cull their chickens and poultry. Based on what, exactly?
The second was swine flu, which turned out to be one of the biggest scandals in modern medical history, confirmed by countless investigations. Do you need me to dig up links to prestigious medical journals, immunologists, or even the Council of Europe?
Back then, people were being jabbed in a rush, too. Then, more than two years later, there was an explosion of autoimmune issues like ALS. Remember that social media challenge where celebrities dumped ice water on themselves to raise awareness for ALS? That was the connection.

Fear-mongering is the common thread in all three of these pandemic scares. Even worse? The total loss of trust in Big Pharma.

Google is your friend, too. No need to lecture me.🙂

Exactly. That's the famous Phase IV—it's always doneafter a drug or vaccine gets the green light.

https://en.wikipedia.org/wiki/Phases...nical_research

Phase IV - Post marketing surveillance in public - Monitor long-term effects

So, what's the deal—do you have this same problem with every single medication and vaccine, or are you still being selective just with these ones?

vividjackal89 said:My car goes through more technical inspections than these COVID-19 vaccines ever did.

Even some cheap plastic toys from overseas that cost pennies to make undergo stricter testing.

Side note: actual drugs take 5 to 10 years to test.

None of this is even remotely accurate.

Amanda Kim2 said:So, what’s the deal with self-isolation now—is it still 10 days? A family member just tested positive, but honestly, nothing was said about anyone needing to isolate or track down contacts... feels like they aren't even active about it anymore? If not, does that 10-day count start from the actual day the test comes back positive?

The CDC epidemiologist called me personally—they tracked down all the contacts and told me exactly how long everyone in the house had to isolate.

coastaltiger7 said:I guess every epidemiologist handles things differently.
I know plenty of cases where family members stayed in isolation starting from the day the sick person recovered.
The epidemiologist in my city tells us you can still be contagious on the very last day of the primary patient's illness, so because of that, everyone else's isolation period starts from that final day.
And honestly, that makes sense to me.

Exactly—that’s what they told me and everyone else I know. That’s why my wife was stuck in isolation for 10 days starting after my last day.
I guess Morgan Peterson just got lucky since she gets out of isolation right after her test, which is probably why those other folks only had to deal with 9 days.

Morgan Peterson said:Either this was written incorrectly, or it's simply imprecise.
My household members were required to be in self-isolation from the very day I received my positive test result. As far as I was concerned, my isolation period began when symptoms first appeared, but since I wasn't even tested until nearly ten days later, I was technically only in isolation for one single day; meanwhile, they had to remain in isolation for another nine days following my lead.

That’s what they told me too. 7 days if you can physically separate from her, 10 days if you can't. Starting from whenever my own isolation ends.

Grace Rogers3 said:My wife just tested positive for COVID. We share the same house—so, how many days am I stuck in isolation?

As far as I can remember, it’s 10 days from when her isolation period ends if you can't actually separate—you know, different rooms, bathrooms, kitchen, etc. Honestly, though, just have her call the local health department. They'll call her back, ask a few questions, and then you'll have your answer.

bluerider63 said:It’s honestly a bit wild to me how fast people just rolled over to this whole system of being tracked, labeled, and scanned for "safety," all while lying to themselves that it’s nothing more than a temporary fix.

What do you mean "in such a short time"? They've been tracking our every move for decades.
Nothing new here. Nothing revolutionary. And nothing happened without us giving them the green light.

Charles Chase4 said:By that logic, we could just construct a worst-case scenario where 20,000 people die on American highways in 2021, and then use that specific projection to justify banning motor vehicles entirely.

That scenario is perfectly valid and theoretically possible, and any measures resulting from it would guarantee—and I mean absolutely guarantee—that at least a few lives are saved. No cars on the road means no traffic accidents and no fatalities. It’s a simple matter of cause and effect.

I really don't understand why this is being contested. 🤷

And fine, I know what comes next. You'll argue that the virus was an unknown variable, that it was unpredictable, and that even the most brilliant scientists in the world couldn't have foreseen how this completely novel respiratory virus would behave compared to anything ever recorded in history. Fine. Theoretically, that scenario was just as plausible as my highway example above.

However. If it has since become clear that such a scenario was off by several orders of magnitude, is it actually controversial to point out that we are still implementing policies based on it? Or that after a full year, the perceived danger is still being communicated through the lens of that flawed model? Is there perhaps some merit to questioning that? 🤷

Look, traffic laws exist because of decades of data. And that data has drastically cut down those "worst-case" disasters.

Fine, I get it—you’ll say the virus was a total mystery, that even the top scientists at the CDC couldn't predict how this brand-new respiratory bug would act since it was unlike anything ever recorded. Fine. Theoretically, that scenario is just as possible as my car example above.

The virus was new, sure, but it shared enough traits with other viruses that we weren't flying blind—plus, the response measures weren't exactly revolutionary or unheard of in history. 😉

But here's the thing: if it turns out that scenario was totally off base—like, orders of magnitude wrong—isn't it still sketchy that they're still making rules based on it? That they're still telling us there's a massive danger using that busted model? Isn't that at least worth debating? 🤷

I don't have an answer for that. Since the mandates are already in place, how can we actually know if the worst-case didn't happen? Or if we just barely missed it?

Gerald Gomez2 said:Honestly, I think those janitors would provide much more realistic assessments than these "experts" who seem to specialize in nothing but wasting everyone's time researching ore.

I’ll go ahead and point out one of the supposed masterminds here; perhaps you could enlighten us as to which specific, relevant skills he possesses that justify calling him a scientist within the context of our discussion.

https://www.rainbowbuilders.org/d/team/otto-kolbl-d

How about you give me an official list of the people who actually worked on that Robert Koch report?

Nathan Evans78 said:There’s just no way you can claim it's impossible to quantify how successful those measures actually were. 😁

Your comment has zero to do with mine.

Tyler Garcia69 said:Let's stop splitting hairs here. The bottom line is that Seehofer was being crystal clear when he demanded his experts cook up some absolute worst-case scenarios just so they’d have an excuse to roll out those heavy-handed, repressive restrictions. We're talking about actual surveillance—basically tracking citizens via their location data. It looks like that whole document was just a roadmap to bring those old-school FBI tactics straight to our doorstep under the guise of a "emergency" (total Corona-dictatorship vibes). Even if you ignore everything else, this is a textbook case of weaponizing a crisis for political gain.
And honestly, the fact that the original article was "manipulated" by the author of this piece? That's the least of our worries right now.

So what, you'd rather have "experts" design policy based on a best-case scenario? 🤔
Of course you ask for the worst-case scenario to plan your response. I don't see what the big deal is.

Gerald Gomez2 said:Just a small correction here.

We aren't even talking about actual scientists. If you look at those involved, you won't find a single epidemiologist, infectious disease specialist, immunologist, virologist, or any medical expert whatsoever. These individuals have essentially just repackaged this apocalyptic propaganda piece:

https://tomaspueyo.medium.com/corona...e-be9337092b56

👎

Yeah, I heard those analyses were done by some low-level hacks from the Robert Koch Institute too.

nimblesurfer17 said:Don't try to twist this.
There is a massive difference between being prepared for bad outcomes and what happened here. Look at this:

"The American Secretary of Homeland Security, Donald Trump engaged scientists specifically to ramp up public fear regarding the COVID-19 pandemic, essentially aiming to manipulate citizen attitudes to ensure compliance with radical epidemiological mandates and forced lockdowns"

"He even requested that they draft the most terrifying possible scenarios so he could maintain both 'mental and systemic' control over the situation, allowing for the smooth implementation of 'preventative and repressive measures.'".

"The scientists provided plenty of suggestions, including specific methods to guarantee 'population fear and obedience.'"

Yeah, totally normal stuff. Nothing suspicious there at all.

That sounds like nothing more than some journalist's conclusion trying to be sensationalist. Unless we have an actual quote from a specific email explicitly mentioning ramping up fear? 🤔

bluerider63 said:We can sit here all day playing semantics with "could be" versus "will be" and trying to guess exactly what Merkelica meant or intended, but the point is that we finally have a look under the hood at the scare tactics they're using just to keep these kinds of restrictions in place.

It's pathetic how you guys turn everything into "it might be" or "it could be"—it's just semantics to cover up your own mental gymnastics.

Basically, the absolute worst-case scenario didn't even happen—probably thanks to the lockdowns—but they were making calls before anyone actually knew what was going on with COVID-19. And then someone had the genius idea to build their entire strategy around that nightmare scenario.
I don't know, isn't that just bad math? You're supposed to plan for the best-case scenario, right?

Linda Lee4 said:Just a quick question for the survivalist crowd here. If having a little bit of bourbon and some whiskey is fine, does that really violate any safety protocols? I mean, if people can hang out in a crowded hospital during a pandemic, surely we can manage a few drinks without breaking the world. ☕

Who's claiming it breaks the rules? 🤔

Joseph Taylor3 said:So this is exactly the kind of crowd I’m out here arguing with. You've got someone acting all high and mighty, making absolute claims without a shred of evidence, leaving zero room for the possibility—God forbid!—that they might actually be wrong. They insist that you needed a visa for the USA back before 2013. Then, the second someone jumps in with actual personal experience saying, "Actually, I didn't need one," the person just goes, "Oh, my bad." 🤣 🤣

I honestly have to wonder how people like this even function in everyday life. Like, seriously, do they even have friends?

She admitted she was wrong. I don't see her claiming her info was set in stone or 100% gospel.
Man, most people on this board would rather die than admit a mistake, and here you are attacking someone for being honest enough to own up to it.
It's people like you who make everyone else too stubborn to admit when they're wrong. You got any friends?

wearypilot34 said:Of course it's true. Poor nutrition, chronic stress, increased alcohol consumption, and the various other side effects of poverty all trigger illnesses that lead to premature death. There are millions of scientific papers on this exact subject. In the US, the life expectancy gap between the top 1% and the bottom 1% is a staggering 14 years.

So basically, our lives get shorter—we aren't just dropping dead tomorrow. But let's be real, we're cutting our lives short with shitty lifestyle choices anyway, crisis or no crisis.