Posted on 09/07/2021 8:22:02 PM PDT by Meah
Last week, Children’s Health Defense (CHD) filed suit in Tennessee federal court against the U.S. Food and Drug Administration (FDA) and its acting director Janet Woodcock for their deceptive, rushed licensure of Pfizer’s Comirnaty vaccine. CHD argues that the licensure was a classic “bait and switch,” allowing Pfizer, the Administration, the military and employers to exhort people to take “licensed” vaccines when in fact the vaccines available continue to be the Pfizer-BioNTech Emergency Use Authorization (EUA) vaccines.
The lawsuit alleges that the FDA’s actions are arbitrary and capricious. Under federal law, if the FDA licenses a product for the same precise purpose as an existing emergency use authorization product, it must withdraw the EUA. Yet here, the FDA is allowing Pfizer to have “interchangeable” vaccines, Comirnaty and Pfizer-BioNTech, on the market at the same time for the same indication of people aged 16 and up, while suggesting that the vaccines are “legally distinct.” CHD asserts that the FDA has violated the law.
CHD is following up on the Citizen Petition that Robert F. Kennedy, Jr. and Meryl Nass, M.D. submitted on behalf of CHD on May 16, 2021, which garnered over 30,000 public comments. On August 23, 2021, the same day that it licensed the Pfizer Comirnaty vaccine, the FDA responded to CHD’s petition. This licensure and FDA response cleared the administrative path for CHD to file suit. Attorneys Robert F. Barnes and Derek Jordan of Barnes Law are the lead attorneys along with Robert F. Kennedy, Jr. and other counsel for CHD.
“The FDA must justify its actions in open court,” said Mary Holland, CHD President and General Counsel. “The language of its licensure is nearly incomprehensible, and the result of licensed and unlicensed vaccines for the same indication is arbitrary.”
(Excerpt) Read more at yahoo.com ...
Ping.
Any chance the press is going to be honest that the actual pfizer vaccine in use didn’t get full FDA approval?
Did the journalists not even read the relevant documents at all, or are they just hyper corrupt or bought out?
Where are the retractions and corrections? Anyone?
great...now all they need is an honest judge not paid off by china or big pharma
Fat chance.
yeah, slim and none
This sounds like it might be delicious!
The way I read it is that the Pfizer EUA is still in effect for the 12-15 y/o age group, “FDA approved” for those 16+ with the normal 2 doses and still EUA for a 3rd “booster” shot for immunocompromised. 3 distinct classes/no overlap.
Prevent COVID-19 in persons aged 12-15 years
Provide a third dose (i.e., additional dose) to persons aged ≥12 years with certain kinds of immunocompromising conditions
On August 30, 2021, the Advisory Committee on Immunization Practices (ACIP) met and reviewed data for the Pfizer-BioNTech COVID-19 vaccine using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach and the Evidence to Recommendation Framework. The following proposed recommendation was presented to ACIP: the Pfizer-BioNTech COVID-19 vaccine is recommended for people aged ≥16 years under FDA’s Biologics License Application (BLA). After a public comment period, the recommendation was unanimously approved by the voting ACIP members.
The following interim recommendations previously issued by ACIP under EUA for Pfizer-BioNTech COVID-19 vaccine remain in place:
Use of Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12–15 years to prevent COVID-19
Use of an additional dose of Pfizer-BioNTech COVID-19 vaccine (for persons aged ≥12 years) or Moderna COVID-19 vaccine (for persons aged ≥18 years) after an initial 2-dose primary mRNA COVID-19 vaccine series for moderately to severely immunocompromised people.”
Oh, I can guarantee you it will be delicious. It will be delicious all the way up to where a bought-and-paid-for leftist judge says, “Nope you can’t have any.”
Two different drugs. The first one is the one approved but not available. The second one is the one people have been getting for months under the EUA.
Same ingredients...just has a “brand name” (bad one) now that it is approved:
https://heavy.com/news/comirnaty-vs-pfizer-vaccine-legally-distinct/
Eventually they’ll pay to avoid further court.....however there is something to be said for exposure.
Unless it is labeled “Comirnaty” it is being administered under an EUA, regardless of the age of the patient or whether it’s the first, second, or third jab.
The Pfizer-BioNTech Covid-19 Vaccine — that is, the vax that is currently administered in the US — is still only EUA-authorized.
Pfizer’s label states that its product has the same formulation as Comirnaty and can be used interchangeably. By keeping EUA status Pfizer continues to avoid all liability from its vaccine.
"The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangably to provide the COVID-19 vaccination series." [emphasis added]
Many years ago that was a valid and positive point of view, however, it has expired long ago.
Wake up man, and smell the roses.
* * *
Same vaccine, 3 different approval classes of use...still EUA for 12-15 year olds...FDA approved for 16+, and 3rd shot “Boosters” still EUA (for immunocompromised).
Not really “conforming” to anything...making my own choices (not vaxxed yet due to very low exposure risk (retired/not in “public groups”)...but if I was still doing a “public-facing” job would be getting Moderna (or Novavax when avail.). Moderna worked fine for my 83 y.o Mom, so “genetic tendency” wise should be fine for me also. “Many, many years ago” we didn’t have the Internet and click-based ad revenue streams...just think if the Internet was around for the introduction of Antibiotics and the Smallpox vaccine: “Dangerous! Unproven! “Will kill you”, etc., etc.. I see myself taking more of the “Occam’s Razor w/data “ approach...still valid today especially with Internet clickbait shenanigans.
Is it apple flavored?
Later use
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