BENGALURU: The Ministry of Health & Family Welfare’s Adverse Events Following Immunisation (AEFI) causality assessment reports on analyses into the 10 post-vaccination deaths occurring in Karnataka between January 16 and November, 2021, have concluded that none of these fatalities were due to the vaccine.
Yet, about one of the deaths, the reports mention “lack of evidence” due to “missing crucial information”, while about another, it mentions existing “plausibility” for the vaccine causing an acute stroke with severe thrombocytopenia -- a condition in which a fall in blood platelets causes bleeding -- but still classified it as “temporal relationship is consistent but there is insufficient definitive evidence for vaccine causing the event”.
About a third death, the reports marked it as “indeterminate”, referring to reactions occurring soon after taking the vaccination but without definitive evidence in current literature/clinical trial data that it could have been caused due to the vaccine.
The seven other deaths were marked as coincidental, placing them under a category of “underlying or emerging condition or conditions caused by exposure to something other than the vaccine”, like a 43-year-old man from Ballari, who took the vaccine on January 16, 2021.
His death was marked as coincidental, and the justification by the National AEFI Committee read: “Acute myocardial infarction with underlying comorbidities -- diabetes mellitus and hypertension with probable chronic lung infection.”
These 10 deaths (eight men and two women) were part of a total of 38 AEFI cases (34 due to Covishield, four due to Covaxin) reported across the state in the studied period. The remaining 28 patients had been hospitalised, treated and discharged on recovery.
The causality assessment reports -- which TNIE has in its possession -- were discussed and approved by the National AEFI Committee, but experts have raised questions about the system of observation, data reporting on AEFI cases and lack of concrete evidence in deciding whether or not vaccines had caused the deaths.
Eminent virologist Dr T Jacob John said the quality of diagnosis of deaths is questionable in India and hence, diagnosis of AEFI cannot be believed as well.
“The system is not good enough to detect vaccine-related AEFIs. Ideally, the centre that is vaccinating people must be told that the beneficiary must be under their watch for the next 30 days. People do not know where to go if they develop reactions within this period. They go to a known doctor or hospital, where no diagnosis is done to find any link with the vaccine. They don’t check for blood clotting or other disease known to occur post taking the Covid-19 vaccine.”
He said no postmortem is done in cases of death, and inadequate information is sent from the states to the National AEFI Committee.
The committee comes to conclusions based on what is sent to them, making it difficult to assign any causality to the vaccines.
Proper diagnosis at the time of AEFI can help prevent death, Dr John said, adding that there is a bias in India to look for evidence not related to the vaccine.
AEFI CASES AND DEATHS IN KARNATAKA
28 Patients hospitalised and recovered
28 CASES DISCHARGED
Of the remaining 28 cases which were treated and discharged on recovery, six reported vaccine product related reactions, including allergy, fever with fainting and anaphylaxis, and six others reported immunisation anxiety-related reactions
The 28 include four AEFI cases post taking Covaxin, wherein three cases with comorbidities were marked as coincidental