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A good discussion on vaccines, with several viewpoints, but Dr Jacob John makes a couple of statements from 44 min onwards which are rebutting, because they explain why he has dismissed all opposition to Covaxin's approval as "muddle-headed"
He says that "it is clear" what "clinical trial mode" is. According to him: if Covaxin is given to an individual due to perceived risk of severe disease, that individual's name will be added to the Phase 3 trial list of people given the vaccine
He says: they will not be part of safety and efficacy analysis but their "names will be maintained in vaccine trial list".
Response: This is *no different* from safety surveillance which SII has to do in India, and Pfizer and Moderna have to do after their vaccine launch under EUA in USA. *After* Phase 3 trials.
Contd response: What does adding their names to Phase 3 list mean? If they are not compared with another similar randomised controlled group, then they are a different group, and NOT COMPARABLE with anyone in Phase 3.
Contd response: The whole idea of randomisation is to create two groups among whom human bias has not introduced unknown confounders. So, if you are giving the vaccine to people at greater risk of disease, that can't simply be *added* to Phase 3 data.
Contd response: In any case, Bharat Biotech has given conflicting responses of what it thinks Phase 3 is. At one point, Krishna Ella said he doesn't know, at onother point, he said its an uncontrolled trial. If Ella doesn't know, it is certainly not "clear" to anyone.
Contd response: Also, another speaker in this discussion uses the term EUA, and says it is different from regular approval. Yes, there is such a thing as "accelerated approval" in Second Schedule of New Drugs and CT Rules 2019 https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/NewDrugs_CTRules_2019.pdf
Contd response: But most importantly, this accelerated approval clause has never been used to revoke approval if safety/efficacy is not demonstrated at later stage. Look at itolizumab an favipiravir, which were approved on poor-quality trials, but never asked to do larger ones.
Contd response: The Indian legal clause for accelerated approval is used very differently from American EUA. Please don't conflate them. The USA revoked EUA for hydroxychloroquine. India has *never* revoked any accelerated approval.
Next, Dr John says that Covaxin trial participants were aged 18-95, which is a wide age range (and that seems to give him comfort). And says that if 24000 people have received one shot of vaccine, assuming half of them got placebo...
...and this half saw no adverse reactions (going by Krishna Ella's claim that no paracetamol was given to participants after vaccine shot, and reactogenicity was very low), Dr thinks the reactogenicity and safety "is more or less reasonably, sure"
Response: Of course not! Reactogenicity is immediate adverse effects after vaccine administrations. Dr John himself has raised questions about the relatedness of the adverse event to the SII vaccine ten days after it was administered!
Contd response: There is a chance that fairly frequent adverse effects will be discovered in the Phase 3 (even after second dose is administered). It happens! That's why Phase 3 is being done. Reactogenicity is a subset of safety, not all of safety.
Finally, he refers to the dilemma faced by the SEC while approving a "British vaccine". Emotionally, he argues, SEC felt that they had to give the Indian vaccine a "respectful acceptance".
Response: This is really a silly argument. The SEC doesn't exist to bypass the DCGI's guidelines (which require efficacy data prior to approval for COVID vaccines) & give a "respectful acceptance" to Indian vaccines. They are supposed to be a scientific body, not RSS.
Contd response: And even if it was jingoism that led to this approval, it's dangerous. Not something that should be accepted because the SEC faced a "dilemma". the only person facing such a "dilemma" should be Subramaniam Swamy. Certainly not a body of scientists.
