Posted on 08/27/2021 2:26:26 PM PDT by rxsid
Sen. Ron Johnson: 5 Questions for FDA About Pfizer Vaccine Approval
Sen. Ron Johnson (R-Wis.) on Thursday sent a letter to Dr. Janet Woodruff, acting commissioner of the U.S. Food and Drug Administration (FDA), demanding answers to five questions pertaining to the FDA’s approval of the Pfizer Comirnaty COVID vaccine.
The FDA on Aug. 23 granted full approval to Pfizer’s vaccine, over the objections of some scientists who pointed out that full approval was based on only six months’ worth of data — despite clinical trials designed for two years — and that there was no public discussion of the data.
In his Aug. 26 letter, Johnson asked questions similar to those raised earlier this week by Children’s Health Defense Chairman Robert F. Kennedy, Jr. and Dr. Meryl Nass about the legal distinction between the Pfizer-BioNTech vaccine being administered under Emergency Use Authorization, and Pfizer’s Comirnaty vaccine, which was granted full licensure.
In his letter, Johnson asks these five questions:
1. Why didn’t the FDA grant full licensure for the Pfizer-BioNTech vaccine that is in use and available in the U.S.?
2. How are the Comirnaty and Pfizer-BioNTech COVID-19 vaccines “legally distinct” and what are the “certain differences”?
3. There is no doubt that the FDA’s action will lead to more vaccine mandates and increased pressure on those currently choosing not to get vaccinated. Your letter to Pfizer suggests that “there is not sufficient approved vaccine available for distribution.” Is there sufficient supply in the U.S. of the Comirnaty vaccine to ensure that those being vaccinated under mandates will be receiving the FDA-approved version? Or is it more likely (or certain) that they will be vaccinated using the vaccine administered under the reissued EUA?
4. If there is insufficient supply of Comirnaty vaccines for those succumbing to the coercion of mandates, isn’t the FDA de facto endorsing vaccine mandates utilizing EUA vaccines?
5. Will individuals who receive either vaccine be afforded the same legal protections if they are injured by the vaccine? If not, why not?
They are REQUIRING them to conduct several multi-year studies on what THEY, the FDA are saying are "known serious risks of myocarditis and pericarditis"
FDA "Approval" of Pfizer Injection COMIRNATY States There Were No Concerns Or Controversial Issues - Yet - Pfizer Is Required To Conduct Several Long Term Studies
https://freerepublic.com/focus/f-news/3988135/posts
The decision to grant (or not) a Biologics License Application for Pfizer's injection was due by January 2022.
Moderna's is around that timeframe as well.
Janssens expect to file for the BLA sometime later this year making any decision due by later in 2022.
https://www.fdanews.com/articles/203794-fda-reassigns-staff-to-accelerate-full-approval-for-pfizers-covid-19-vaccine
Why, with all the clear signs out there....and admission (booster shot needed) that the injection efficacy was falling....did they feel the need to rush the "approval," while also admitting they don't know the "serious" long term affects?
This was ALL about political science (i.e. politics) and NOT about science.[1][2]
Sen. Ron Johnson: 5 Questions for FDA About Pfizer Vaccine Approval
FDA to Senator Johnson .....
... crickets
Pfizer is changing the labels to say Comirnaty as fast as they can.
Isn’t naty what hunter called the niece he was abusing?
Leftist have no idea or are willfully ignorant the FDA ‘approval’ is for a jab not available or scarce in America.
I have some too.....
6. When will the FDA PULL the EAU for alternate manufacturers (like Maderna, J&J, etc) now that an APPROVED vaccine is available? (EAU is only lawful when other approved drugs are NOT available)
7. Is the Pfizer still experimental??? When was the last time a drug was EVER FULLY approved while it was still in an experimental phase???
8. Does Pfizer still enjoy full immunity from adverse side effects or death? If so, why?
They are counting on the MSM to cover for them and obfuscate what’s going on. 99% of Americans will think “FDA approval of the Pfizer vaccine! That’s great news!” They will not have a clue the FDA did not approve the inoculation people have been getting or that the Comirnaty vaccine is a completely different product.
This subterfuge stinks to high heaven. But it IS the Biden administration.
Yes, #6 is an excellent question that also needs to be addressed.
Available at the time of approval.
When they were approved there weren’t any approved alternatives and there’s no provision that revokes the EUA when alternatives emerge.
>>> there’s no provision that revokes the EUA when alternatives emerge.
Funny how we have not heard any complaints from Maderna, J&J, others about their seemingly unequal treatment or lack of consideration for their “full approval” as well.
Add asking about adjuvants to the list.
So, some of the early commenters have been proven absolutely correct when they said that Pfizer’s shot wasn’t approved and they only had the EUA extended. Interesting.
And that’s exactly what will happen.
FDA...”Hey Fauci, some Senator is asking quetions”.
Fauci...ignore him. All he might do is draft a strongly worded and stern letter demanding the information. Ignore that, too.
Not funny at all. They submitted their respective applications and paperwork to the FDA later than Pfizer did and they know it.
Don’t worry. Both will get BLAs.
9. Did the fact that Pfizer now employs, Dr Scott Gottleib, as a Board Member/Expert/Special Partner, was formerly the Commissioner of the Food and Drug Administration, who had worked at the agency for 16 years, play a role in the approval process?
_____________________________________________________________
https://www.pfizer.com/people/leadership/board-of-directors
https://www.pfizer.com/people/leadership/board-of-directors/scott_gottlieb-md
Special Partner, New Enterprise Associations, Inc.’s healthcare investment team and Resident Fellow of the American Enterprise Institute. Dr. Gottlieb served as the 23rd Commissioner of the U.S. Food and Drug Administration (FDA) from 2017 to 2019.
Prior to serving as Commissioner, Dr. Gottlieb held several roles in the public and private sectors including serving as Managing Director, T.R. Winston & Company from 2013 to 2017. Dr. Gottlieb was previously the FDA’s Deputy Commissioner for Medical and Scientific Affairs from 2005 to 2007, as well as the senior advisor to the FDA Commissioner from 2003 to 2004
Nothing to see here, move along.
I also read somewhere that the NIH is the entity that actually does the testing and then sends the recommendations to the FDA. A senior member of the NIH is none other than Mrs Fauci. Wondering if anyone can confirm that the NIH does do the testing.
5 questions are not enough
ridiculous approval needs congressional investigation not letter writing
9. How does the FDA know about the supply numbers of either Pfizer version at this time enough to make their assessment? What are those supply levels?
Not true, when "approved" alternatives are available.
Section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act (PDF, 142 KB) (21 USC 360bbb-3)
Moderna's "Criteria for Issuance of Authorization" -
I have concluded that the emergency use of Moderna COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:...
C. There is no adequate, approved, and available alternative to the emergency use of Moderna COVID-19 Vaccine to prevent COVID-19.
Jannsen's "Criteria for Issuance of Authorization" -
I have concluded that the emergency use of the Janssen COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because:...
3. There is no adequate, approved, and available alternative to the emergency use of the Janssen COVID‑19 Vaccine to prevent COVID-19.
Emergency Use Authorization of Medical Products and Related Authorities - "FDA may revise or revoke an EUA if the circumstances justifying its issuance (under section 564(b)(1)) no longer exist (See "C" for Maderna & "3" for Janssen above), the criteria for its issuance are no longer met, or other circumstances make a revision or revocation appropriate to protect the public health or safety."
Now, if the rest of our "elected" "representatives" would get off their backsides and actual DO something about this...we might get some answers/action.
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