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+--- Thread: Vaccinated People Spread The Delta Variant, CDC Says (/showthread.php?tid=22374)
RE: Vaccinated People Spread The Delta Variant, CDC Says - randomq - 09-15-2021
(09-15-2021, 09:11 PM)kander Wrote:(09-15-2021, 06:59 PM)randomq Wrote: Kander,Re authorization of the EUA is not "full approval" as you have been told by fox news.
Do you not know that Pfizer has full FDA approval?
And why do you say it has questionable efficacy, when it's obviously effective?
Also, do you really believe there could be such a broad uptick in side effects without scientists or the media taking note of it? J&J was in the news for far less than all that.
No, it is FDA Approved for 16+.
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine#main-content
On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-biontech-covid-19-vaccine-comirnatyr-receives-full
PFIZER-BIONTECH COVID-19 VACCINE COMIRNATY® RECEIVES FULL U.S. FDA APPROVAL FOR INDIVIDUALS 16 YEARS AND OLDER
RE: Vaccinated People Spread The Delta Variant, CDC Says - kander - 09-15-2021
(09-15-2021, 09:25 PM)kalakoa Wrote: It really cant be any more clear. Its right there in the authorization letter.They approved the BioNTech Manufacturing GmbH for COMIRNATY. They extended the EUA for Pfizer. with a footnote that says.
Read carefully: FDA granted full approval for individuals 16 years of age and older, while also leaving the EUA in place for ages 12-15 and extending the EUA to allow a third (booster) shot.
Disclaimer: I do not work for Fox News.
8 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.
Somewhere the, "and certain differences" though "the same formulation" make all the difference in pfizer not getting their BLA. Two different entities two vaccines, one approved one not. It is interesting to note that the BLA authorization on the German product requires long term studies until 2027.
It further supports the emergency authorization of Phizer in footnote 9.
9 Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years
of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at
the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in
individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised
population described in this EUA.
Re issuance of an EUA is not full approval. Clearly the fda is trying to cya with this non approval approval letter. And had anyone actually looked up Section 564 of the code like anyone(news, media etc) would realize that when they say authorized pursuant to. It is Emergency Use Authorization.
https://astho.org/Programs/Preparedness/Public-Health-Emergency-Law/Emergency-Use-Authorization-Toolkit/Section-564-of-the-Federal-Food,-Drug,-and-Cosmetic-Act-Fact-Sheet/
Its still black and white even if its bait and switch. The best part is an EUA protects Pfizer from liability. Why would Pfizer want to give up that sweet deal. they dont.
RE: Vaccinated People Spread The Delta Variant, CDC Says - randomq - 09-15-2021
https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUSL1N2PY0OL
News reports did not mislead the public that the Pfizer-BioNTech COVID-19 vaccine was approved by the U.S. Food and Drug Administration (FDA), despite contrary claims on social media.
RE: Vaccinated People Spread The Delta Variant, CDC Says - Durian Fiend - 09-16-2021
(09-15-2021, 10:47 PM)randomq Wrote: https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUSL1N2PY0OLIt makes no difference to those who are inclined to doubt the process. If you can show the FDA did in fact approve it, they will say it was done in error, unduly rushed, only because of pressure from politicians or big pharma, and so on. Go ahead, throw a dart.
News reports did not mislead the public that the Pfizer-BioNTech COVID-19 vaccine was approved by the U.S. Food and Drug Administration (FDA), despite contrary claims on social media.
RE: Vaccinated People Spread The Delta Variant, CDC Says - kalakoa - 09-16-2021
Yes, let's have an indefinite argument about whether the vaccine is approved or merely authorized, because that's clearly the problem.
RE: Vaccinated People Spread The Delta Variant, CDC Says - HereOnThePrimalEdge - 09-16-2021
... approved or merely authorized, because that's clearly the problem.
On par with the deep philosophical discussions from some decades ago:
Tastes great!
Less filling!
RE: Vaccinated People Spread The Delta Variant, CDC Says - TomK - 09-16-2021
(09-15-2021, 04:19 PM)Or1on Wrote: I have been reading over this thread for awhile and decided to finally comment:
You simply cannot force someone to inject something into their body that they don't want to. Or eat a pill they don't want to. Or say something they don't want to. Or worship a deity they don't want to.
I got the vaccine. It was my choice. No matter how much some of you berate those that choose not to get it, that doesn't make your point of view correct. Yes, the world we live in is different now. Some would even say its f#*#-ed. People are losing loved ones. Sadness and sorrow runs deep. Still you cannot force people to get vaccinated. Should our government go fully "big-brother" and try to make it a mandate to be vaccinated, it would get really ugly. Much worse than it is now with all the people that would rise up in resistance.
I'm not in favor of forcing vaccinations on anyone either. I agree it would end up becoming ugly if that happens. On the other hand, I am in favor of pointing out the idiocy of not getting vaccinated and the ridiculous arguments anti-vaxxers use in order to justify their attempts to mislead others about vaccinations.
(09-15-2021, 04:27 PM)kander Wrote: Now, i wont take it because the people I talk to and ask, (because from the horses mouth right?) Nurses, Doctors have seen upticks in brain bleeds, melanomas, spontaneous abortions, heart attacks, kidney failures, early signs of creutzfeld jacobs manifesting in people in their 20's, that coincide with them haven taken the vaccine in the last 6 months. These are just the people I know and not all in the same hospital. Im NOT talking about all the other people more vocal about it, and that are immediately attacked for stepping forward about saying "hey, there seems to be a problem here". These medical professionals are low key for fear of reprisals if they were to speak out. Think about that for a minute.
Frankly, I don't believe a word you're saying. Sorry if that's harsh, but I've seen too many credulous people over the years make similar claims to yours about all sorts of stuff and they never back it up, and I doubt you will either.
(09-15-2021, 07:04 PM)Justin Wrote: Making a requirement to be vaccinated in order to fly, enter a restaurant, attend a concert, etc., is not "forcing" someone to get vaccinated. It is giving them a choice - to be part of a healthy society, or to be a nomad. There is a choice there. In my own house I can walk around naked, smoke all day, and be drunk as a skunk. No one can take that freedom away from me. But I can't walk the streets naked, smoke in a restaurant, or drive drunk - those are requirements that society has agreed upon as being for the greater good.
Exactly. And very well said.
RE: Vaccinated People Spread The Delta Variant, CDC Says - AaronM - 09-16-2021
You can attempt to ostracize people from society all you want and yet they will still walk among you, unvaccinated.
Government will not be able to confine people to their homes and will not be able to ban people from every corner of public life.
At some point, you will have to accept that you can't get everyone to board the group think train.
RE: Vaccinated People Spread The Delta Variant, CDC Says - kander - 09-16-2021
(09-16-2021, 09:03 AM)TomK Wrote: Frankly, I don't believe a word you're saying. Sorry if that's harsh, but I've seen too many credulous people over the years make similar claims to yours about all sorts of stuff and they never back it up, and I doubt you will either.Nope, Its not harsh. In time, one of us will get to say, "I told you so."
RE: Vaccinated People Spread The Delta Variant, CDC Says - AaronM - 09-16-2021
Tom doesn't believe everyone about everything. Duly noted.