by Casey Harper
The U.S. Food and Drug Administration gave full approval Monday to the Pfizer COVID-19 vaccine, a major step that will likely have significant implications for vaccination mandates nationwide. The Moderna and Johnson & Johnson vaccines have not yet received full FDA authorization.
The Pfizer vaccine previously received FDA authorization, which allowed its emergency use but did not give the full approval. Pfizer is the first company to receive full approval in the U.S.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
Many Americans have held off receiving a COVID-19 vaccine, arguing the FDA had not yet given full approval. Several companies and institutions had also held back implementing vaccine mandates, citing the same concern.
Now that the Pfizer vaccine has full FDA approval, many companies will likely put in place those mandates, though it’s unclear how they would manage any mandates with Pfizer and Johnson & Johnson vaccines not full approved.
“This is a crucial milestone that will empower many more employers to mandate vaccination,” Leana Wen, a medical doctor and visiting professor at George Washington University, wrote on Twitter. “It will help people understand this vaccine as they do all others: safe, effective & life-saving.”
Woodcock said the full FDA approval should increase vaccination rates in the U.S.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” she added. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Moderna and Johnson & Johnson are still waiting for the FDA seal of approval.
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities. We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
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Casey Harper is a Senior Reporter for the Washington, D.C. Bureau.
Photo “Philippines: COVID-19 Vaccine” by Asian Development Bank. CC BY-NC-ND 2.0.
Pfizer still experimental. Full approval to a vax not yet produced. Read the letter.
Read the approval letter.
.gov is letting Pfizer off the hook with all of the previously manufactured vaccine under the EUA. The “approved” Pfizer must have new name label Comirnaty. It is legally the only one that can be “mandated”. Those millions of doses sitting on the shelf are still Emergency use only and cannot be mandated.
“page 2 last line, footnote: here FDA quietly admits that the licened Pfizer vaccine and the authorized Pfizer vaccine are identical w.r.t. safety and efficacy, but they are “legally distinct.” That’s code for one has manufacturer liability, while the other doesn’t. It is also code for “we don’t want to impose a mandate on the EUA product ’cause it is illegal, but we can probably get away with a mandate on the licensed product.”page 12 AA. This tells you that yes, we licensed the vaccine, but…there is a lot of the old vaccine out there, actually “a significant amount” and this amount will be considered an EUA vaccine and will continue to be used. Maybe for a very long time.
Now, why would they do that? Why specify that identical versions of the product will be legally different? Because they need the license to impose the mandates. But they need the EUA to evade liability.”
https://anthraxvaccine.blogspot(dot)com/2021/08/i-explain-my-theory-of-comirnaty.html?
The FDA just got rich off that little back alley transaction. Talk about global warming, Hell sure is heating up these days.
FDA = Fraudulent Drug Administration
CDC = Center Dictating Control
Nothing but alphabet agencies of a illegitimate federal government. I trust the homeless 10 times more for medical advice than these political shams.
A very timely announcement cued by Biden to deflect from his disastrous surrender in Afghanistan.
I don’t think so. We will soon be showing same results as Israel. 75% of ICU are vaxxed. We have hidden the vaxxed infected since May 1. Their window is very short to start forcing before it is irrefutable that the vaxxed create variant, spread it, and kill each other.
It’s not hard to find a list of FDA drugs that were once approved, that have yanked from the market at a later date. Chantix was one of recent. Just sayin’. Eat Organic, Drink Water, Exercise Vigorously, and you wont need any drugs. Just say no to drugs! It has been my professional experience, after 22 years at bedside, that a person can get more mileage out of a personal trainer and a good nutritionist than they ever could out of an American trained medical doctor. Planet fitness is only $10 a month in a little bit of sweat equity. The key is to stay healthy and out of the system. America needs an organic sound money revolution and an escape from under Rockefeller Medicine.