Posts by Keith Wilson

We’ve already broken down which metrics are primary (symptoms) and which are secondary (antibody titers). From a health standpoint, symptoms clearly take precedence, but unfortunately, they overlap heavily with other illnesses—especially in kids.
Trying to validate vaccine efficacy against COVID-19 based solely on primary metrics is a joke. It’s an approach that clearly works for Pfizer (I've quoted them before), which is just sad.
Secondary measures are labeled "less important" by definition, but they're the only way to actually confirm if we're dealing with COVID-19 or something else entirely.

Megan Green72 said:The study could be wrapped up way sooner than that.

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

Megan Green72 said: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.

Maybe because of this...
In evaluable Phase 2/3 participants at selected dose level in each age group, Average antibody levels of SARS-CoV-2 neutralizing titers with no serological or virological evidence of past SARS-CoV-2 infection [ Time Frame: At baseline, and at 1, 6, 12(participants who originally received BNT162b2) and 24 months(participants who originally received BNT162b2) after dose 2 ]
As measured at the central laboratory

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

Looking at the details for NCT04816643 Recruitment status... It’s an interventional study, specifically a Study Type : Interventional ( Clinical Trial. The focus seems to be on the Primary Outcome Measures regarding how people respond to the vaccine. The setup is an Allocation : Non-Randomized Intervention model : Parallel Assignment Masking : None ( open Label ) Primary Purpose : Prevention official Title. They're looking at an Estimated Enrollment that's quite significant. Regarding the timeline, the Estimated Primary Completion date is March 4, with the Estimated Study Completion date set for September 1. Most clinical Studies have One primary outcome measure, though you have to watch for those specific cases for clinical Studies with more Than One primary outcome measure with different completion dates... just standard procedure. Everything is tracked under the ClinicalTrials.gov Identifier. Just keeping an eye on the progress...
This link is actually great.

Just learned that a clinical study actually uses Primary Outcome Measures and Secondary Outcome Measures...

The Primary Outcome Measures look like this: "Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as reported via electronic diaries for participants aged 2 to Could be vaccine side effects... or just standard COVID symptoms in kids, if not the flu...

The Secondary Outcome Measures—which the protocol defines as "planned outcome measures that aren't quite as critical as the primary ones for gauging an intervention's effect, but are still worth tracking"—are looking specifically at Geometric mean Titers of SARS-CoV-2...

So, which two were actually used by the FDA to confirm its effectiveness?

I think this is meant for the under-12 group, though we were discussing the 12-16 age bracket... and that's what the media seems to be focusing on anyway...

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.

rustywalker82 said:Yeah, if that's the case, then absolutely.
Studies claim vaccines protect kids 100% from infection. I just don't think it's right to leave our kids vulnerable to some modified virus cooked up in a lab during a GoF experiment.

Small correction. According to the Pfizer website, it hasn't been established that they prevent infection—just that they didn't show symptoms.

It would be nice if our morning, evening, and local news outlets actually bothered to report the facts regarding the push for childhood vaccinations:

1. The need for this vaccine in children is being driven by the manufacturer, not your country's Department of Health based on independent studies
2. The manufacturer submits its application to a regulatory agency that relies on clinical trial data conducted by the manufacturer itself (specifically in the USA, rather than the EU)
3. The manufacturer's clinical trial measures vaccine efficacy like this:
"The study showed that the immune response to Comirnaty in this group was comparable to the immune response in the 16 to 25 age group (measured by SARS-CoV-2 antibody levels). Vaccine efficacy was calculated in approximately 2,000 children aged 12 to 15 who had no prior symptomatic COVID-19 infection. Half of the subjects received the vaccine, while the other half received a placebo. None of the 1,005 people who received the vaccine developed symptomatic COVID-19, compared to 16 out of 978 subjects who received the placebo. This means the vaccine demonstrated 100% efficacy in preventing COVID-19 disease in the trial (though the actual rate could be between 75% and 100%)."

First, they claim efficacy was measured via antibody levels. Then, they select a sample of kids who haven't shown symptoms before (shouldn't they have measured antibodies before the shot too?), only to ultimately determine efficacy based on whether symptoms appeared—not through PCR testing—and those symptoms are basically just a common cold in kids...

Morgan Peterson, please... any thoughts on point 3?

From the Mayo Clinic website (

"Vaccine efficacy was tested in 2,260 individuals aged 12 to 15, following a pediatric investigation plan (PIP) approved by the American Academy of Pediatrics at the FDA."

So, based on this, it’s unclear if those 2,000 kids were actually tested here in the US or if they just repackaged FDA data. Anyone know someone in the States whose kid was part of this trial?

"The study showed that the immune response to the Pfizer-BioNTech vaccine in this group was comparable to the immune response in the 16 to 25 age group (measured by SARS-CoV-2 antibody levels). Efficacy was calculated in approximately 2,000 children aged 12 to 15 who had no prior symptoms of COVID-19 infection. Half of the participants received the vaccine, while the other half received a placebo. None of the 1,005 people who received the vaccine developed COVID-19 symptoms, compared to 16 out of 978 participants who received the placebo. This means the vaccine demonstrated an efficacy of 100% in preventing COVID-19 disease (though the actual rate could be between 75% and 100%)."

First, they claim efficacy was measured via antibody levels, then they say they selected a sample of those without symptoms—shouldn't they have measured antibodies before the shot too?—only to conclude efficacy based on symptoms that, in kids, feel just like a common cold...

If that's not how it works, why aren't they being more precise? Are we just supposed to assume we're too dim to grasp scientific research, so they give us these oversimplified versions...

Quick question if anyone knows how this actually works. Did the folks over at Sony Music run any actual tests on small American groups—like what kind of sample size or methodology were they using? Or did they just shuffle some paperwork around, mix a few test tubes together, and decide it was good enough to pass?
Thanks.

I only collect skulls... As for bleaching, I assume people use peroxide, though I personally avoid it because it makes them look fake and too bright. If I find an uncleaned skull, I boil it (fair warning: it smells disgusting—do this outside or in the garage), clear out the tissue, and let it sit in the sun for a few weeks.
Anyway, you can find tons of stuff on eBay, but I prefer scavenging in nature. Just make sure you aren't buying endangered species.
Go for it.

test

Try picking up two books on the same topic, even if they take different angles...

Zaj...'s guide on surviving family life—Oliver James
EPIDEMIJA POPUSTLJIVOG ODGOJA by Robert Shaw

You might find some answers, or you might just end up more confused ;-)