'Delay in WHO Nod for Covaxin Suggests Problems Exist; This Is Serious Setback to Indian Science'

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In a 27-minute interview with Karan Thapar for The Wire, Dr Sabyasachi Chatterjee agreed that another indication the World Health Organization has concerns about Covaxin’s Phase 3 data and is thus delaying granting Emergency Use Authorization emerges when you compare how Covaxin has been treated with Pfizer, Moderna and AstraZeneca. Six weeks after Pfizer published its Phase 3 results the WHO granted Emergency Use Authorization. In the case of Moderna and AstraZeneca that happened roughly nine weeks after they published their Phase 3 results. In the case of Covaxin, 12 weeks have elapsed since its Phase 3 results were published on 3rd July and not only has EUA not been granted but there’s no sense of when it will be granted. Dr Chatterjee says: “Yes, this suggests that this delay is because of something inadequate”. He said if clearance is taking much longer than it took for other vaccines that is a sign there are concerns and problems.

Going into the details and specifics of his concerns with Covaxin’s Phase 3 trial results, Dr Chatterjee made a point of emphasizing that he was relying entirely on what Bharat Biotech has published in a preprint on the 3rd of July. It’s possible – though rather unlikely – that Bharat Biotech has made more and better data available to the WHO which has so far not been released to the public through a preprint. However, Dr Chatterjee added, given “the scientific community finds (the data) extremely inadequate” he finds it hard to believe the company has more or better details that have not been released to the public.



Dr Chatterjee first expressed concern about how the preprint handles deaths and adverse effects during the Phase 3 trials. He said 15 deaths have been acknowledged but no explanation is given of what caused them beyond a general statement that they are not a result of vaccination. He says further details are necessary and required.



Speaking about adverse effects, he says the preprint accepts there were 39 in the vaccinated category and 60 in the unvaccinated but does not break up and differentiate between minor, semi-serious and serious adverse effects. Again, this is necessary.



However, Dr Chatterjee’s greatest concern is that the efficacy figure given for the above 60 age group, which is the most vulnerable section of the population, is said to be 67.8% but the confidence interval bands within which it’s located stretch from 8% to 90%. He believes that’s an incredibly wide range which makes the 67.8% figure almost meaningless.

Dr Chatterjee also agreed that there are two further Covaxin Phase 3 efficacy results where the confidence intervals are worryingly wide. The 65.2% efficacy against the Delta variant has a confidence interval stretching from 33.1% to 83%. The confidence interval for 93.4% efficacy against severe Covid stretches from 57.1% to 99.8%.

“Efficacy is very important”, Dr Chatterjee said. “If it stretches between 8 and 90% then that clearly means the 67.8 figure is not reliable.”

Asked whether these are merely technical concerns or serious concerns, Dr Chatterjee said “they are serious concerns”. He said the scientific community finds (this data) “extremely inadequate”.

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