India confirms one death due to adverse reaction to COVID-19 vaccine

The Indian government appointed panel which was looking into Serious Adverse Events Following Immunization (AEFI) has confirmed the death of a man following vaccination for the COVID-19 infection. A June 4 report by the Ministry of Health and Family Welfare (MoHFW) said that a 68-year-old man died due to anaphylaxis, after taking the COVID-19 vaccine on March 8. Anaphylaxis is a severe allergic reaction that can occur within seconds and can be fatal if not treated immediately.

The panel looked at 31 cases (28 passed away, while 3 people recovered), which took place between January and March. Of which, 3 cases including the death of the 68-year-old man were classified as vaccine related. Two other individuals who had anaphylaxis recovered after hospitalisation. The 68-year-old man had been administered Covishiled vaccine, while among the two others, one got Covaxin and the other Covishield.

Eighteen were classified as having inconsistent causal association to vaccination (coincidental - not linked to vaccination), 7 were classified as indeterminate and 2 cases were found to be unclassifiable. Indeterminate  reactions are reactions which have occurred soon after vaccination but there is no definitive evidence in current literature or clinical trial data that this event could have been caused due to the vaccine, with further studies required. Unclassifiable is defined as events which have been investigated but there is not enough evidence for assigning a diagnosis due to missing crucial information. However unclassifiable events may be reconsidered for assessment when information becomes available.

The two unclassifiable events include that of a 43-year-old man who died after taking the vaccine on January 18, and a 55-year-old man who died after being vaccinated on February 5. Their deaths have been listed as unexplained.

“Mere reporting of deaths and hospitalizations 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,” the report says.

India has till now given nearly 26 crore doses of vaccine (first and second doses included).