Party of Science: Anthony Fauci Says Vaccines Lacking Full FDA Approval Merely a ‘Technical Issue’

[mystery-ak]

Party of Science: Anthony Fauci Says Vaccines Lacking Full FDA Approval Merely a ‘Technical Issue’

Hannah Bleau 12 Jul 2021

Dr. Anthony Fauci, chief medical adviser to President Joe Biden, dismissed the fact that the Food and Drug Administration (FDA) has not yet approved vaccines for the Chinese coronavirus as merely a “technical issue.”

For months, Fauci has branded himself, quite literally, the voice of science. The National Institute of Allergy and Infectious Diseases chief has routinely dismissed critiques against him as attacks on science itself.

“It is essential as a scientist that you evolve your opinion and your recommendations based on the data as it evolves,” he said during a June appearance on the podcast Sway.

“And that’s the reason why I say people who then criticize me about that are actually criticizing science,” he added, attributing his continual pivots — such as dismissing drug store masks as “not really effective” to becoming a leading voice pushing their use — to being consistent with science.

Now, Fauci is backing the Biden administration’s efforts to convince unvaccinated Americans to get the jab, flatly dismissing concerns over the FDA’s lack of approval, a factor the Biden administration has routinely ignored.

While Fauci said it is “understandable” that some may want the FDA’s full approval before getting the shot, he dismissed it as nothing more than a ” technical issue.”

“It’s the FDA dotting the I’s and crossing the T’s,” he said during an appearance on ABC’s This Week. “But there’s no doubt in my mind that these vaccines are going to get full approval because of the extraordinary amount of positive data.”

more
https://www.breitbart.com/science/2021/07/12/party-science-anthony-fauci-says-vaccines-lacking-full-fda-approval-merely-technical-issue/

[Wingnut]

I'll get my shot in, oh lets say in maybe 5 years.  You know like after the human trials are over.    Which will prolly coincide with this and the other Covid 19 variants ( like Omega Theta Pi thru Delta Tai Chi) dying out like all previous flu stains since the dawn of man.

[PeteS in CA]

Here's the FDA testing and approval process, including Emergency Use Authorization, which is only used in declared emergencies:

Phase 1 test - usually less than 100 participants; tests for safety and effectiveness at two or more dosing levels;

Phase 2 test - often less than 1000 participants; further testing for safety and effectiveness with a fuller demographic range than in Phase 1;

Phase 3 test - With the Covid vaccines, done with 30,000-60,000 participants; further testing for safety and effectiveness as full a demographic range as practical (e.g., not many Tibetans or Uyghurs);

Emergency Use Authorization - Only used in declared emergencies; based mainly or entirely on data from Phase 3 testing; with the Covid vaccines the FDA required at least 2 months of data from the last participant injected (with the second dose, in the cases of Pfizer and Moderna);

Biologics License - Full approval.

Calling "Emergency Use Authorization" a "technical issue" is as imprecise and potentially misleading as saying the Covid vaccines authorized by the FDA under Emergency Use Authorization are "experimental" (the favorite word of anti-vaxxers, anti-Covid-vaxxers, and some Covid-vax skeptics). None of the three Covid vaccines authorized for use by the FDA currently have a Biologics License (= full FDA approval). I do not know how long the process will take, but Pfizer began the process of obtaining a Biologics License on May 7th, https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics , and Moderna began that process on June 1st, https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-initiation-rolling-submission-biologics . J&J received EUA later than P and M, and thus would not begin the Biologics License Application process until later.

Based on what I've seen from anti-vaxxers and anti-Covid-vaxxers elsewhere, when, as seems likely, Pfizer and Moderna do receive a Biologics License (= full FDA approval), I do not expect many anti-vaxxers and anti-Covid-vaxxers to be honest enough to drop the "experimental vaccine" meme/narrative.

[mountaineer]

In other technical issues:

Disclose.tv  @disclosetv
JUST IN - FDA expected to announce that the Johnson & Johnson vaccine has been linked to a serious but rare side effect called Guillain-Barré syndrome, in which your body's immune system attacks your nerves (WSJ)
1:46 PM · Jul 12, 2021·