NEW DELHI: The health ministry has said “consistent causal association” to vaccination has been found in six out of 13 serious adverse events following anti-Covid-19 shots though there is not enough evidence to show that the vaccine itself caused these events or even death in 10 of these cases.
The health ministry report follows detailed deliberation and assessment of the adverse events following Covid vaccination at multiple levels. In earlier statements, government experts had said there is no causal link but also pointed out that the number of adverse events, including deaths, were within the anticipated range. They also said deaths and other adverse events had to be considered in the light of 60 plus and 45-60 with co-morbidities age brackets having health conditions.
While around 79 deaths were reported till mid March of individuals who received the Covid vaccine, 13 serious adverse events have been assessed by different committees at district, state and national levels. A special committee on adverse events following immunisation has also deliberated and assessed the reports. The other cases are at different levels of the three-stage evaluation process.
According to two separate assessment reports (one with eight cases of adverse events and another with five) — released by the immunisation department of the health ministry — in six cases “consistent causal association” to vaccination has been found, whereas in another six cases “inconsistent causal association to vaccination (coincidental)” were found. One case was found “unclassifiable”.
“None have been found to be due to the vaccine,” says the latest causality assessment results released by the immunisation division.
The “consistent causal association” to vaccination indicates a possibility of a causal link as the adverse event happened soon after receiving the jab in three cases. Officials reiterated that the Covid vaccines are safe and concerns about adverse events following immunisation are unfounded and negligible.
“India has a robust system for surveillance and management of adverse events. Even anxiety or hysteria after vaccination are recorded as AEFI and still if you look at the number of AEFIs, they are insignificant,” a senior official said.
Of the total vaccinations, only 0.027% of AEFIs have been reported so far. Of the eight deaths analysed recently, two each were reported from Maharashtra and Karnataka, and one each from UP, Bihar, Telangana, and MP. The age group of the deceased was between 36 and 61 years; three of them were women.
Of the total 10 deaths assessed by the committee, three deaths were placed in B1 category, which indicates “temporal relationship is consistent but there is insufficient definitive evidence for vaccine causing event”, while six are in coincidental category described as “underlying or emerging condition(s), or conditions caused by exposure to something other than the vaccine”.
While in one of the three B1 cases where a 61-year old patient died of a cardiac arrest 11 days after vaccination, it was found that he was a known case of hypertension on medication. However, a 38-year old patient without any cardiac risk factors died. He was infected two months back.