The story that @BharatBiotech's US partner Ocugen has decided to hold its application to the US FDA (Food and Drugs Administration) for an Emergency Use License and file later for a full license has been widely reported. reuters.com/business/healt…
But what is an Emergency Use Authorization (#EUA) and what does a company need to to satisfy @US_FDA? here's a video explaining it:
But, in essence, it is a provision to make availabile and permit the "use of medical countermeasures (MCMs)" in a public health emergency. 
But that doesn't mean open season. The emergency may justify some risk-taking but the process seeks to mitigate it as much as possible and strike a balance between benefit and harm. A classic public policy dilemma. Actually the process is quite ONEROUS. re an #EUA for a vaccine
There are 10 steps before @US_FDA writes that all-important letter informing a vaccine manufacturer that its product has been granted Emergency Use Authorisation. In addition to the summary flow chart above, here is an excellent explainer: fda.gov/vaccines-blood…
Applying the same detailed process to the #Covaxin case it seems to be the company tried to go from Step 3 - conduct the trial (on Jan 3 2021 the Phase-3 trial was still recruiting) to EUA )
As of now, the US FDA has granted EUA to only 3 vaccines: fda.gov/emergency-prep…
These 3 vaccines are:
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