Thread by @GorwayGlobal

India's far-Right Internet warriors are so quick to jump on the desi v Amreeka bandwagon. This @Twitter exchange is being shared on Whatsapp groups with comments s/as: "Typical mentality that keeps us enslaved psychologically".

The US FDA's action might seem arbitrary, and Pfizer's demands may well seem arrogant, but to link the two in some kind of #Bharat as #Vishwaguru v America as Foreign #Angrez #Gora bad guy is silly, unhelpful, and won't get us anywhere. There are two questions that are relevant

Q1. Is the @US_FDA singling out @BharatBiotech's Covaxin for discriminatory treatment because it is a #desi #vaccine?. BTW, that is not my descriptive term it was used by @blsanthosh.
A. No. Not if you consider that so far ONLY 3 vaccines have had #EUA from the FDA.

Among the list of vaccines that are in widespread use around the world and that are on the WHO-approved list for smaller countries to use, BUT DO NOT have EUA
Oxford AstraZeneca (Covishield)
Sinovac
Sputnik
The only FDA EUAs are for
Pfizer
Moderna, and
Johnson & Johnson

Q2. Did @US_FDA turn down @Ocugen's (@BharatBiotech's US partner) application for an #EuA?
Ans: NO. There was never an application made in the first place. The process of asking for an #EUA starts long before the actual submission of an application. see fda.gov/media/142749/d…

Specifically, the law requires 4 criteria to be met for an EUA to be considered.

For a vaccine, "issuance of an EUA would require a determination by FDA that the vaccine’s benefits outweigh its risks based on data from at least one well-designed Phase 3 clinical trial that
demonstrates the vaccine’s safety and efficacy in a clear, compelling manner"

@BharatBiotech and @Ocugen's position is made difficult, if not impossible, by the absence of data from their Phase-3 trial. Besides my understanding is that with 2 vaccines (Pfizer and Moderna) already in widespread use and a 3rd available - albeit all are under an EUA

it can hardly be argued that the 4th criterion - that there should not be an "adequate, approved, and available alternative to the product.." - is met.
Yes, there is an ongoing public health emergency, but vaccines are available and effective.

Therefore far from rejecting @bharatbiotech's EUA application. what FDA did was advise the company's US partner Ocugen to submit a Biologics Licence Application (a BLA) - eff a full license. Indeed getting an EUA is not the end of the road for a company.

The EUA comes with a requirement that the company continues to monitor the subjects in their Phase 3 trial without unblinding, and collect data on both efficacy and longer-term side-effects, and submit all that information for a full license.

Indeed Pfizer (on May 7), and Moderna (a month later on June 1) announced that they would seek a Biologics License. What's the difference? what would a BL do for these 2 companies that they could not do under a #EUA? Two things:

1. Their vaccines would continue to be available for use after the public health emergency is declared ended.
2. They can advertise their vaccines direct to the consumer. (this is a dreadful thing but that is how US healthcare works, sadly)

So what is the take away from all this for @BharatBiotech and all the Bhakts getting into a lather and their knickers in a twist?
1. Get your act together. Don't cry foul because you messed up Phase-3
2. If you want a piece of the US market then you've got to play by US rules.