Posted on 09/16/2021 9:47:37 PM PDT by SeekAndFind
The FDA just released its briefing book for Pfizer’s request for a third dose of Comirnaty (or is that BNT162b2? No matter! It’s approved either way, sorta).
It is every bit the mess we all expected.
Let’s go to the highlights:
Pfizer basically hasn’t bothered to test the booster AT ALL in the people actually at risk - it conducted a single “Phase 1” trial that covered 12 people over 65. The main Phase 2/3 booster trial (beware efforts to cover multiple “phases” of drug research at once, you want it bad you get it bad) included no one over 55.
No one.
As in NONE.
Which makes total sense - why test the booster in people who actually need it because they’re at high risk from the ro? Nothing good can come of that.
So that’s our trial design.
Now safety:
Of the 300 people who received the booster, one had a heart attack two months later. No worries, Pfizer concluded it wasn’t related. Yay!
Five percent of recipients had enlarged lymph nodes.
How about effectiveness?
Well, we don’t have enough data - or any data, really - telling us how well the booster will work.
But the FDA made Pfizer go back and review its data from the pivotal clinical trial from last year. Pfizer compared people who received the vaccine with those who received the placebo and THEN the vaccine (the best we can do at this point, since Pfizer blew up the trial by giving placebo subjects the vaccine, double-yay!)
Pfizer concluded that your annual risk of getting Covid-19 IF YOU ARE VACCINATED is about 7 percent.
Further:
“An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2 at the start of the analysis period.”
Oh.
But don’t worry, Uncle Joe already told you you can get your booster on September 20. If it’s good enough for our fearless leader, it should be good enough for the FDA, amirite?
SCIENCE!
SOURCE: https://www.fda.gov/media/152176/download
Seems like they have given up even pretending to do real science and are just trying to move product.
$cience!
Perhaps the author forgets we are dealing with living, breathing human beings in these trials, not mice, as well as how trials in general work.
\Phase 1 clinical trials involve only a small number of people to determine if a drug or treatment is safe and to determine the best dose of a drug and how it should be given
Since phase 1 trials are the first studies to be tested on humans, and thus carry the greatest risks, people enrolled in the study are usually monitored very closely by the study investigators.
If a treatment appears safe at the end of a phase 1 clinical trial, it may then move forward to a phase 2 clinical trial, a study done to see if a treatment is effective. If a drug or treatment is deemed safe in a phase 1 trial and effective in a phase 2 trial, it will then enter a phase 3 clinical trial. Phase 3 clinical trials have much larger study popualtions and are done to see if a treatment is not only safe and effective but works better or has fewer side effects than treatments currently available.
I read most of the study will do more tomorrow.
Fortunately non of the observed side effects from the 28 black african americans in the study were consistent with getting shot
Instead of two tests a week, Joe style, how about one Covid antibody effectiveness test?
And those who don’t get an A or B can get a jab, if they choose to do so.
This was never about health, and always about control AND terrorism (and it didn’t stop with the BLM/ANTIFA riots). I saw an article about how gaslighted sheeple even mistreat those who can’t hear, “Deaf Woman Terrorized by Mask-Obsessed Store Clerks After Asking to Read Their Lips”, and you can give that a look at PJmedia. As someone with a relative who can’t hear...I *know* there are legal exemptions for covid in my state and I bet they have them in hers too. And Pfizer is just putting on a show, they don’t care as long as they profit.
From the virus actually travelling 30 meters (about 99 feet) instead of 6, to cloth being magical in the case of ONE virus the left continues to prove their claim to ‘love the science’ is BS. They are DNA and Sun deniers too.
They are looking at daily shots or pills now. This will never end unless we collectively say NO!
Pfuk Pfizer.
This is the intersection of covid and climate change. Saving the planet by reducing the population.
Sounds good enough for the FDA to approve.
And this isn’t a phase 1 trial with few people. It should be phase 3 for approval, which should include large numbers of participants.. Suspect you know this already and are trying to confuse the issue.
Phase I studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects. Although the treatment has been tested in lab and animal studies, the side effects in people can’t be known for sure. These studies also help to decide on the best way to give the new treatment
Larger numbers of patients get the treatment in phase II trials, so less common side effects may be seen. If enough patients benefit from the treatment, and the side effects aren’t too bad, phase III clinical trials are begun.
Phase III clinical trials: Is it better than what’s already available?
Treatments that have been shown to work in phase II clinical trials must succeed in one more phase before they’re approved for general use. Phase III clinical trials compare the safety and effectiveness of the new treatment against the current standard treatment.
Because doctors do not yet know which treatment is better, study participants are often picked at random (called randomized) to get either the standard treatment or the new treatment. When possible, neither the doctor nor the patient knows which of the treatments the patient is getting. This type of study is called a double-blind study. Randomization and blinding are discussed in more detail later.
Key points of phase III clinical trials
Most phase III clinical trials include a large number of patients, at least several hundred.
These studies are often done in many places across the country (or even around the world) at the same time.
Phase III clinical trials are more likely to be offered in local community hospitals and doctor’s offices.
These studies tend to last longer than phase I and II studies.
Placebos may be used in some phase III studies, but they’re never used alone if there’s a treatment available that works. Sometimes, a patient who is randomly assigned to the placebo for part of the study will at some point be offered the standard treatment as well.
As with other trials, patients in phase III clinical trials are watched closely for side effects, and treatment is stopped if they’re too hard to manage.
Pfizer ran Phases 1/2/3 as one phase the first time as two parts. Part 1 to choose participants, part 2 as phase 2/3 is actual trial; https://clinicaltrials.gov/ct2/show/study/NCT04368728
Completion date(s). Primary Purpose: Prevention (FAIL)
People will be on their 5th shot before they finish this first trial
So they are injecting what into you? !!
They only care about the $$ money they are getting and not your health.
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