In its first, the Centre confirmed 1 death following COVID-19 vaccine. Further, the Centre also claimed that the benefits of the vaccine are greater than risk. The first claimed death following vaccine is of a 68-year-old man who died on March 31. The man was completely vaccinated and his death is labelled as ‘vaccine product related reaction’.
As the second wave of COVID-19 recedes, and states ramp up its health infrastructural facilities to face the possible third wave, a new development emerged with Centre claiming the first and only death following immunization. The report came from the AEFI (Adverse Effect Following Immunization) panel of the Indian government.
According to a AEFI review, 3 people from the 60 million people who received the COVID-19 jabs between Feb 5, 2021 and March 25, 31 developed a case of anaphylaxis post the vaccine. ‘Anaphylaxis’ is an immediate and acute allergic reaction to a new antigen that’s injected in the body.
As per the review, only 1 death can be linked to the vaccine, and thus, the notion of fatalities post vaccination being rare is strengthened. According to the data, a total of 28 patients died after getting a COVID-19 vaccine dose during the study period. However, these appear not to be linked to the vaccine. In at least 9 off the 28 patients, cause of death could not be determined.
Only small number got severe reaction: AEFI Chairperson
Dr. N.K. Arora, the chairperson of the AEFI Committee said-
“This is the first death where causality has been established, with vaccine resulting in an anaphylaxis reaction. But if you look at the overall numbers (crores of doses administered), and there is only this small number that got a severe reaction.”
Dr. Arora further said that there were 31 cases of death after vaccination that that were investigated. Among anaphylaxis (acute allergic reaction due to antigen) cases, only 2 were product related and most of these cases were managed.
The story of the 21-year-old & 22-year-old girl
Among the two cases that the AEFI committee investigated, one of was a 21-year-old woman. The other case was that of a 22-year-old man. Both the persons received their vaccine jabs on January 19 & January 16 respectively. After anaphylaxis, both the patients were saved after hospital treatment.
The committee report said-
“Of the 31 causally assessed cases, 18 were classified as having inconsistent causal association to vaccination (coincidental – not linked to vaccination), 7 were classified as indeterminate, 3 cases were found to be vaccine-product related, 1 was anxiety-related reaction, and 2 cases were found to be unclassifiable.”
In the report, the AEFI also explained how vaccine-related reactions are expected ones. These reactions can be attributed to several factors based nonscientific evidences. The report also put a label to those cases. These labels include, indeterminate reactions, unclassified events & coincidental events.
Indeterminate Reactions, Unclassified Events, Coincidental Events
An indeterminate reaction occurs soon after receiving vaccine but for which there is no prior clinical data or any scientific evidences. In such cases, analysis, observations and research is required to connect a link.
Unclassifiable events are the ones where the investigation is done, but there aren’t enough scientific evidences to conclude a diagnosis. Upon assessing relevant information, the case can then be considered to come under casualty assessment.
Finally, coincidental events are those ones which are reported after vaccination, but where a clear reason for an adverse reaction is found after investigation.
Benefits overwhelmingly greater than risk
According to the experts in the report-
“Mere reporting of deaths and hospitalisations as serious adverse events does not automatically imply that the events were caused due to vaccines. Only properly conducted investigations and causality assessments can help in understanding if any causal relationship exists between the event and the vaccine. For causality assessments, priority has been given to death cases.”
In its report, the Centre run AEFI also claimed how-
“Overall, the benefits of vaccination are overwhelmingly greater than the small risk of harm.”