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Pfizer is FDA approved

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I wonder how convincing this will be to people who already don't trust the federal government, and don't trust the FDA in particular.

Just put yourself in their shoes. Imagine, for example, Trump's EPA formally declared that Climate Change wasn't happening. You already don't trust Scott Pruitt, and you already believe CC is real, so why would that change your position?
 
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Were you or a loved one harmed by (insert FDA approved drug), you may be entitled to compensation. Contact Joe Blow law firm and see if you qualify today.
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I’m still not sure. They pushed this through too fast. It’s all about control. I’m going to wait to do more research. Actually, the vaccine is failing. If you look at Israel ....

I ain't letting no dumb democrats inject their nano chips in me. Let the sheep get their control shots.
 
It honestly shouldn't be too much of a shock at how quickly FDA approved Pfizer.

A few of the key elements in "full approval" are the Quality System, Manufacturing etc (ISO 13485 controls/internal auditing)

Pfizer has been making pharmaceuticals for decades, and many of the documents FDA would need to review/audit would already be familiar to them. Especially if the mRNA vaccine is being manufactured in the same facilities other vaccines or drugs are being made.

Moderna may take a little longer, simply because those facilities are "new" and this is the first product they are releasing.

These reviews aren't merely looking at the clinical data - it is all-encompassing, and much of Pfizer's documentation is already familiar to FDA here.

EDIT: Also, part of the full approval is having robust/comprehensive followup studies/evaluation for any problems with the vaccine OR manufacturing issues. Pfizer, AGAIN, already has most all of this in place from all the OTHER stuff they do. Moderna is building these systems from scratch, because their vaccine is their first product to market.
 
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It honestly shouldn't be too much of a shock at how quickly FDA approved Pfizer.

A few of the key elements in "full approval" are the Quality System, Manufacturing etc (ISO 13485 controls/internal auditing)

Pfizer has been making pharmaceuticals for decades, and many of the documents FDA would need to review/audit would already be familiar to them. Especially if the mRNA vaccine is being manufactured in the same facilities other vaccines or drugs are being made.

Moderna may take a little longer, simply because those facilities are "new" and this is the first product they are releasing.

These reviews aren't merely looking at the clinical data - it is all-encompassing, and much of Pfizer's documentation is already familiar to FDA here.
Makes sense.
 
"A number of universities and hospitals, the Defense Department and at least one major city, San Francisco, are expected to mandate inoculation once a vaccine is fully approved. Final approval could also help mute misinformation about the safety of vaccines and clarify legal issues about mandates. "

 
I just wonder how many other companies had their filings delayed due to FDA pushing a huge amount of their resources to the Pfizer and Moderna applications....
 
How can the FDA approve this for ANYONE with 6 months of safety data and few (if any) well-done randomized control trials, and no long-term data?

It's absurd.

ALSO, because in the entire history of vaccines, EVERY side effect has been identified within 2 MONTHS of the final vaccination dose.

Now, certainly absolute RATES of those side effects can take longer, but they've been observed in FAR LESS THAN 6 MONTHS.
 
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