ICMR's criticism seems quite lame, prima faci. Instead of looking at the researcher's definition of risk from a "do no harm" perspective, they seem to be just focused on defending the vaccine. I will take their criticism one by one:
1. They chose to highlight the absence of a control arm - when the population level prevalence of adverse events is already well established and can be used to compare the levels of such events among research subjects. This criticism seems quite deliberate nitpicking at best.
2. ICMR mentions that it was not clear how frequently adverse events were reported. Yet, that information can easily be sought from researchers before using it as criticism.
3. The study tool was not consistent with the definition of “adverse events of special interest” that is globally accepted - This is highlighted as a critical issue without specifying why the tool is worse than the globally accepted definition. In any case, this does not imply that the definition was not reasonable.
4. Four, the responses of the participants were recorded one year after immunization without verification of any clinical records or physician examination - There is no reason to believe that anyone reporting their own adverse event experience will be biased, especially when that person already took the jab, which was a sign of faith in the narrative about vaccine efficacy. This criticism also seems like nitpicking.
Most importantly, ICMR has significant conflicts of interest as they jointly developed COVAXIN along with Bharat Biotech. An ethical firm would immediately look to work with researchers that highlighted risks and work with them to do confirmatory studies/deeper studies instead of using whatever they can to just discredit researchers. BHU is by no measure a lame institution and their research should be analysed without conflicts of interests, and in the interest of citizen without biases.
Yes, ICMR's conflict of interest and political control are big red flags. Some of the criticism is also not powerful. The only serious concern to me seems to be this, somewhat badly phrased "
Two, it does not mention how frequently these adverse events were reported by the sample population to establish that they were associated with vaccination".
I don't see anywhere that BHU reported the frequency of occurrence in general population historically, e.g. "new skin or under-skin disorders" for adolescents, that they are saying were 10.5% in the vaccinated population as reported. If general population has a similar rate over the last 50 years, vaccine is obviously blameless. Maybe BHU did report the occurrence in general population, and the news reports chose to not include it in their articles, I'm not sure. The paper is apparently not in public domain.
Lack of control, is not a big deal, I agree, but for a different reason. The people who chose to not get vaccinated in the biggest calamity in living memory are not "normal" by any stretch of imagination. Either they have a known allergy, or their weird thinking exposes them to stimuli that makes them bad controls anyway.
The study tool was not consistent with the definition of “adverse events of special interest” that is globally accepted - This is highlighted as a critical issue without specifying why the tool is worse than the globally accepted definition. In any case, this does not imply that the definition was not reasonable.
This matters, but not in saying anything about the efficacy or safety of covaxin. It matters because if BHU used a unique definition that's not globally accepted, , news report's running away with the terminology "adverse events of special interest" is misleading.
The patterns of AESIs developing after BBV152 differed from those reported with other COVID-19 vaccines
Thanks for the link to the paper.
If BHU compared the events with other Covid vaccines, ICMR's criticism about controls is absolute nonsense.
The
link in NIH is just a preview. I had read such a preview from another source. The abstract and preview, both don't answer the questions :
1. What is BHU's statement on prevalence of the reported effects in general population e.g. skin, menstrual issues, 0.1% strokes musculoskeletal disorders etc.? Us checking the prevalence separately won't make sense because the definition and methodology of the effects needs to be consistent.
2. How did the comparison fare between Covaxin and other vaccines, that BHU claims to have studied?
I lost access to the research material that I had due to my institute and job earlier. In the absence of the full paper, I can only say some questions raised by ICMR are very valid.
