[rarestia]

Excuse me? How do you suppose people are receiving vaccines, since no drug can be dispensed without FDA approval? The FDA has, in fact, issued Emergency Use Authorizations for all three of the vaccines now being distributed.

The devil is in the details. An EUA is NOT an approval.

What is an Emergency Use Authorization (EUA)? An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

Once submitted, FDA will evaluate an EUA request and determine whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.

The bold sections are mine.

These are not approved, they have approval to disburse, but they are not tested to the same stringent guidelines to which other medicines are held.

[nagant]

**These are not approved, they have approval to disburse, but they are not tested to the same stringent guidelines to which other medicines are held.**

Right. Testing 150 million people and counting isn’t cautious enough.