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)
The only FDA EUAs are for
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…
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.

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More from @GorwayGlobal

11 Jun
@jyotiyadaav @sujakrao, @CDDEP director Ramanan Laxminarayan, and me on a Panel discussion on #Covid in India arranged by @archanacramesh of @oxfordind…
Some fascinating insights from @jyotiyadaav from rural India. She describes one location where you have to travel 20 kilometers (or is it miles) just to be able to send or receive a whatsapp message? And we complain of slow 4G!!
Her account of vaccine hesitancy (VH) in villages have changed my perspective. Yes there is vaccine hesitancy everywhere but at least thus far in India VH is NOT the rate limiting factor but that may be bec we have not yet taken it out to the villages
Read 5 tweets
11 Jun
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.…
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.
Read 8 tweets
10 Jun
Please don't embarrass yourself and your Institution, @NITIAayog, with this statistically naive, low level spin. The numbers you are reeling off are "Free-Floating Numerators" and mean zilch unless expressed as a %age of the denominator population of 850 million 18+ adults.
I refer you sir to my column on this subject of absolute numbers vs percentage covered. See…
The Prime Minister understood the concept of population "coverage", when, in his 7 June TV Address he referred to #Mission #IndraDhanush which aimed to raise vaccine coverage (this is the general immunisation programme, not Covid) to 90%.
Read 5 tweets
9 Jun
My #sanghified, #Bhakt-riddled NRI doctors group is an amusing place. In response to my columns on India's vaccine policy reversals some one posted this message aboput how Western Media are always negative aboput India:
I put the group right by doing a quick search. I posted a CNN story…
Read 5 tweets
9 Jun
You may have missed this bit of genius:
Under the heading,
Conflict of Interest:, the ICMR/Bharat Biotech team wrote:
"Authors do not have a conflict of interest among themselves."
I comment on this in…
This is like the story:
6 year old, "Mummy, what is sex?"
Mum (all flustered), "you'll have to ask your dad... why do you want to know?"
6 yr old, "We got this form to fill out and after Name, and Date of Birth ( I can write my name and I know my birthday) it says,
I am taking a screenshot before they twig to it and amend it. Also to defend myself against any accusation that I am making it up. This is from the pdf file here:…
Read 4 tweets
9 Jun
Time line of #Covaxin phase 3 trial
Nov 16. 2020 Phase 3 trial start announced. 26,000 subjects planned to be recruited…
Dec 22, 2020. Half-way mark, 13,000 subjects recruited.…
Jan 02, 2021. 23,000 subjects enrolled. This press rlease also announces " 5 publications, 4 of which have been accepted by international peer reviewed journals and will be published soon."…
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