Covid vaccines still not licensed nor approved by the FDA

originally posted by: Vasa Croe

originally posted by: OccamsRazor04
a reply to: Vasa Croe

None of them will be until 2022 at the earliest. The process usually takes years after application, and in this case the FDA has made them a 'priority review' which will take ~6 months. So why would a few months be 'concerning'?

Phase 4 doesn't usually take years. It is usually around 6 weeks. I'd have to look them all up, but I believe this is the longest phase 4 wait for any vaccine.

Phase IV generally, the drug is already FDA approved and Phase IV monitors AE's to an expanded patient pool.

originally posted by: Vasa Croe
So....from another thread I posted on. This is the full list of FDA licensed vaccines. Of note is the absence of any covid vaccines.

FDA Licensed Vaccine List

Now Pfizer applied for it May 7. It has still not gotten any approval or licensing for the manufacturer. This is why they are not allowed to advertise for it and why we haven't seen any vaccine manufacturer made commercials.

Here is the Pfizer announcement from May 7.

Pfizer presser

The important part:

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older.

Bold is mine.

So.....not on the list and still not approved nor licensed....seems there is some need for concern in my mind.

I believe Moderna finally applied as well, but also has not been approved or licensed.

FDA is known as a joke outside of the USA, especially in the UK, EU and rest of Europe. There are nearly a thousand drugs on sale in the USA and approved by the FDA that are banned in Europe.

The Pfizer vaccine is approved by the European medicines regulator, which has a far better stamp of approval than the FDA ever will.