FYI, per a trusted Doctor, they had not been able to EVER get these past the animal testing phase (look it up. It’s 100%true) The only way you could test it on humans was Emergency Use Authorization (EAU). It’s basicallly “Right to try” as in “ the medicine might kill you but if you take it, you have a chance to survive”. I’m seeing people who are not sick or dying willingly line up to be lab rats! Imagine that!
pfizer and moderna went through clinical trials before receiving EUA. So it was tested on humans without the EUA. The EUA is not some trick it was a way to speed up delivery after Phase 3 human trials were completed and reviewed.
pfizer clinical trials started April 29, 2020
phase 1 results: Jul 1, 2020
phase 2 results: Aug 20, 2020 (reported in Nature as phase 1/2 results)
phase 3 results: Dec 10, 2021
EUA for Pfizer issued Dec 11, 2021
About 7-8 months of clinical trial use preceded the issuance of the EUA
Every drug/vaccine may have problems when moving from phase 3 trials to widespread distribution. COX-2 inhibitors are the perfect example. They are great for arthritis pain but one was taken off the market after it was noticed that people taking COX-2 inhibitors had a higher rate of cardiovascular disease and heart attacks.
Since 2005 Celebrex carries a black box warning, (Merck took their drug Viox off the market):
https://www.fdanews.com/articles/75244-black-box-warning-added-to-celebrex-labeling
Both drugs were FDA approved after usual review of clinical trials. Celebrex completed favorable phase 3 trials around 11/13/1998. It received FDA approval under a priority review on 12/31/1998. Black Box warning added in 2005.
The point is no drug or vaccine is 100% safe. In medicine there is always a tradeoff. There can always be unwanted long term effects even with drugs approved by the FDA.
The EUA process is being used for COVID-19 (in all products targeted at the virus) because an emergency was declared. Companies that take advantage of the EUA will likely apply for "de novo" approval so that when the emergency declaration is lifted they can market their vaccine or treatment in the usual way.