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The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.
Vaccination providers must complete and submit reports to VAERS online at vaers.hhs.gov... For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.
Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at vaers.hhs.gov... by calling 1-800-822-7967. The reports should include the words "Pfizer-BioNTech COVID-19 Vaccine EUA" in the description section of the report.
originally posted by: lordcomac
my local grocery store has a sign outside.
free vaccine!
today's flavor was moderna.
least week or was something else.... haven't seen j n j offered for free yet.
considering it doesn't prevent infection and doesn't prevent spreading infection,
they are are pushing it hard.
originally posted by: Tempter
I earn a really good salary that I think anyone would be happy to earn in America, in any location. But I've already come to terms with this in that I'm willing to forfeit my role if I'm mandated to take it.
If these "vaccines" are FDA-approved, they can be mandated by employers, right?
originally posted by: Vasa Croe
Ok....so Moderna applied yesterday. Of note, they left out the Pfizer statement that it has not been approved.
Also of note is this quote:
Vaccination providers must complete and submit reports to VAERS online at vaers.hhs.gov... For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.
There has been a LOT of back and forth about the data integrity of VAERS....the simple fact Moderna specifically recommends using VAERS to report should dispel any doubt.
Moderna Press
originally posted by: 1947boomer
originally posted by: Vasa Croe
Ok....so Moderna applied yesterday. Of note, they left out the Pfizer statement that it has not been approved.
Also of note is this quote:
Vaccination providers must complete and submit reports to VAERS online at vaers.hhs.gov... For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Moderna COVID-19 Vaccine EUA” in the description section of the report.
There has been a LOT of back and forth about the data integrity of VAERS....the simple fact Moderna specifically recommends using VAERS to report should dispel any doubt.
Moderna Press
You're right. The VAERS system is highly suspect.
By the way, who SHOULD people report adverse effects to?
I'm thinking maybe the Cyber Ninjas.
originally posted by: bahnsai
I’ll have to look & see if I can locate the video I saw (I watch so much #), but I seem to recall an FDA member very adamantly stating that they have no plans to circumvent their normal process & requirements for a full approval. Obviously, anything is possible. However, I found it encouraging.
That means that the earliest that anyone would be given approval would be in 2023 after the clinical trial period wraps up. They’ll still need to analyze all the data though. I don’t know...the entire thing is sus.
reply to: Vasa Croe
originally posted by: Xtrozero
The vaccines have had about the same testing as any other drug, so what more do people want? Drugs go through 3 phases of clinical trials and after that it is mainly paperwork. The vaccines went through the three phases so I'm not sure what everyone is looking for.
Patients might think the US Food and Drug Administration’s stamp of approval means that a product is the last word on safety, but about a third of the drugs the FDA approved between 2001 and 2010 were involved in some kind of safety event after reaching the market, according to a study published Tuesday in the Journal of the American Medical Association.
Debate in the United States about the optimal amount of time required by the Food and Drug Administration for adequate testing of new drugs has raged since 1962, when Congress established formal criteria for proving drug safety and effectiveness. Through much of the past decade the FDA has been accused of delaying drug approvals: now it is accused of acting too hastily in approving drugs that have later had to be withdrawn. The height of the initial criticism came in 1995, with the election of a Republican majority in Congress that favoured full privatisation of all healthcare matters. The Republican speaker of the House of Representatives, Newt Gingrich, referred to the FDA as “job killers”: its excessive reviews, he claimed, delayed the launch of new drugs and thereby forestalled growth for the pharmaceutical industry.1