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naraburns  nihil supernum  1yr ago (text post)   31623 thread views

Culture War Roundup for the week of January 9, 2023

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if Pfizer or Moderna could actually distribute an FDA approved and LABELLED as approved "Comirnaty" or "Spikevax" vial of vaccine

Isn't this what they are already doing, or are you engaging in legal hair-splitting of the type about "the FDA issued approval labels for the original vaccine but the boosters are only recommended"? So if they're only "recommended" or "authorised" but not "approved" this means they're dangerous? There's a whole article about the difference between "approved" and "authorised" here.

If EUA is essentially the same process, only faster, what’s the benefit of the full FDA approval process?

It’s not really an “apples-to-apples” comparison.

In public health emergencies, the development process may be a little different. The world experienced—and is still experiencing—a global pandemic, which means there was an outpouring of resources and energy on one goal: developing vaccines and treatments against COVID-19.

To that end, early on the FDA provided clear communication to the pharmaceutical industry about the scientific data and information needed to ensure the timely development of vaccines. And among other efforts, the government developed a coordinated strategy involving its own agencies, academia, nonprofit organizations, and pharmaceutical companies to prioritize the development of the most promising vaccines.

That focus—and the resources applied to it—isn’t typically available for every vaccine or medical product, especially those that fall outside of a public health emergency.

Also, the processes are not designed to be nimble. They’re designed to give people confidence—and peace of mind—that products receiving FDA approval continue to be viewed as the gold standard of scientific rigor.

You may have a point somewhere buried beneath all the scare-mongering, but it's hard to discern. Maybe less "The vaccine has been proven to cause strokes!" when no such thing has been established would make your case better.

The irony here is that people have been complaining the full FDA approval process takes too long and a modified version (say, where drugs are trialled for a shorter period and the FDA approves them but you take them at your own risk, or that drugs legal in the EU shouldn't have to go through the same process in the USA for approval) would be better to get drugs to market and treating patients faster.

You can't please everyone!

Your response didn't address the crux of FDA and EUA labelling. The entire power structure of our country, legal recourse and all, rests along these lines. Sorry to bring Foucault into the mix, but he's the ultimate nightmare of a public health pandemicist.

https://www.comirnaty.com/

There are no data available on the interchangeability of COMIRNATY with COVID-19 vaccines from other manufacturers to complete the vaccination primary series. Individuals who have received 1 dose of COMIRNATY should receive a second dose of COMIRNATY to complete the vaccination series.

Is this not VERY different from the medical advice given to people getting the EUA? Mix and match the first vial you can even get your hands on?

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