Posted on 08/30/2021 3:01:48 PM PDT by Meah
On Aug. 23, the U.S. Food and Drug Administration (FDA) issued its approval (also known as a license) for Pfizer’s Comirnaty COVID vaccine.
The FDA documents related to the vaccine’s approval are as difficult to understand as the new brand name is to pronounce.
According to the FDA, although Pfizer’s Comirnaty vaccine is now approved, considerable amounts of the vaccine will remain under Emergency Use Authorization (EUA).
Also, the approval of the Comirnaty vaccine was limited to adults over age 16 receiving their first two doses.
Vaccination with the EUA Pfizer-BioNTech or the Comirnaty vaccine in the 12- to 15-year age group, or providing a third booster dose of either, are still considered an unapproved use — however, those uses remain authorized under EUA.
FDA made some clear but cagey statements about the differences between the Comirnaty vaccine and the Pfizer-BioNTech EUA vaccine.
For example:
“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”
What does that statement mean? What, specifically, are the “certain differences” that make the two vaccines “legally distinct?”…
(Excerpt) Read more at childrenshealthdefense.org ...
Can you point out once where I have ever said it is NOT a personal choice (Hint you cannot). I simply choose to set lies and half truths correct. You posted a very liberal and notoriously antivaxx source. Own it
And you have no idea what gaslighting means — typical of people who try to limit conversation. Throw out a psychobabble term and hope for the best
When you attack, you will be attacked.
Treat others as you would want to be treated.
The Golden Rule.
I have been attacked all day long — pinged to a post to be called Mengele without so much as a statement. Sorry. The attacking comes from the other side.
Why is it that groups who support vaxxing refer to “the science is settled” with no arguments whereas those that question vaxxing always have the arguments why you shouldn’t. It’s like evolutionists saying “well, it’s evolution” so just accept it.
So, would you care to explain why the Pfizer vaccine receiving approval is not the Pfizer vaccine currently in widespread use?
To me, it sure makes it look like a clear case of bait and switch. I have already had people tell me that the “Pfizer vaccine” is now not under EUA. What gives?
“The state of the art currently is monoclonals for treatment that actually work, and vaccination for prevention of disease”
So which covid vaccination actually prevents covid ?
I receive RFK, Jr.’s daily email on vaccines and other related information and I find it to be informative and something I can pass on to friends.
I’ve never been a “Kennedy” fan/supporter, but I stand with him on this issue regarding vaccines.
Well, now that he doesn’t have a committee any more, maybe he will be better able to get-to-the-bottom-of-what-happened than he was when he DID have a committee...
Sure thing.
What, specifically, are the “certain differences” that make the two vaccines “legally distinct?”
Or is any question dismissible if posed by a group you disdain?
DU is Vax Nazi Central.
You would be at home there.
Everyone there will take your advice.
No, I support freedom. You cherry pick. If a PRIVATE employer decides to mandate vaccinations — that is his prerogative. I laugh and note you FAILED to present that I said I CHOOSE NOT TO MANDATE VACCINATION for my employees.
You want everyone to conform to you — you dont believe in at will employment or an employers rights. YOU are the fascist (and spell it right — the tedious reference to Pfizer is a talking point of the moronic and idiotic).
So, what say you now that you are exposed for telling a half truth?
All of them prevent a large percentage of disease and the breakthrough cases are not critically ill.
RFK Jr — he is quite comfortable at DU, nice try
Do you know ALL of what is in each of these jabs? Or do you even care, just shove it into everyone?
AGREE with you algore. Dr. Gas please tell us uninformed people exactly WHICH “vaccine” PREVENTS COVID-19 !! From what I’ve seen, the vaccinated are in the hospital seriously ill with COVID-19 and not just the un-vaxxed. The key word here is PREVENTS. Which one ??
I don’t believe an employer should not have the right to impose unproven potentially dangerous medical experiments on their employees as a condition of employment—unless the employee consented at the time of initial employment.
You know what is going on out there—you know how people are being pressured with propaganda, employer intimidation etc to take vaccines they do not want to take.
That is Pfascism.
If you support liberty you would be fighting it tooth and nail.
It’s just a couple question? Sure they lace it with some headliner juice and mix in some carrot juice to focus but I think the Qs are good ones. What’s the difference between the two shots? Why is under 16 not yet approved, what are the resonings behind the specific approval labels of each category?
Boosters not approved yet either cept under EAu.
Why?
CNN says the breakthrough rate is less than one percent, while CBS News reports that 99.7 percent of new COVID cases involve unvaccinated people. The Hill, meanwhile, agrees that CDC data show less than one percent of fully vaccinated people get COVID.
How does this data mesh with anecdotal evidence that suggests many vaccinated people are contracting COVID? To be sure, it’s not just Major League Baseball teams who are seeing spikes of COVID cases among vaccinated individuals.
A recent outbreak in Provincetown, Massachusetts, for example found that the vast majority of COVID cases involved vaccinated individuals.
“Overwhelmingly, the affected individuals have been fully vaccinated for COVID-19,” Town Manager Alex Morse told NBC.
The outbreak, attributed to the rise of the Delta variant, was serious enough to prompt the CDC—which published a report on the outbreak—to reverse its recommendation that vaccinated individuals needn’t wear masks indoors.
But that wasn’t all. The CDC’s study also found, the Washington Post noted, individuals “carried as much virus in their noses as unvaccinated individuals.”
“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus,” Walensky said.
All of this data suggests two important things.
First, COVID cases among vaccinated individuals appear to be higher than the “less than 1 percent” many claim. Two, vaccinated individuals appear quite capable of transmitting the virus to others, as Walensky states. Indeed, viral loads in nasal passages suggest they could transmit the virus at rates similar to unvaccinated carriers.
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