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India confirmed the first death related to Covid-19 vaccination in the report on causality assessment of adverse events following immunisation (AEFI).

The death of a 68-year old man who received a Covishield shot on March 8 and died due to anaphylaxis (severe allergic reaction) was classified as ‘vaccine product-related reaction’ by the National AEFI Committee.

In a report released on June 4, the health ministry said of the 31 causally assessed cases, 18 were classified as having inconsistent causal association to vaccination (coincidental — not linked to vaccination), seven were classified as indeterminate, three cases were found to be vaccine product-related, one was anxiety-related reaction and two cases were found to be unclassifiable.

Adverse Events Following Immunization (AEFI)

As vaccine-preventable infectious diseases continue to decline, people have become increasingly concerned about the risks associated with vaccines. Furthermore, technological advances and continuously increased knowledge about vaccines have led to investigations focused on the safety of existing vaccines which have sometimes created a climate of concern.

Adverse event following immunization is any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. If not rapidly and effectively dealt with, can undermine confidence in a vaccine and ultimately have dramatic consequences for immunization coverage and disease incidence.

Alternatively, vaccine-associated adverse events may affect healthy individuals and should be promptly identified to allow additional research and appropriate action to take place. In order to respond promptly, efficiently, and with scientific rigour to vaccine safety issues, WHO has established a Global Advisory Committee on Vaccine Safety.

Key points

There is no such thing as a "perfect" vaccine which protects everyone who receives it AND is entirely safe for everyone.

Effective vaccines (i.e. vaccines inducing protective immunity) may produce some undesirable side effects which are mostly mild and clear up quickly.

The majority of events thought to be related to the administration of a vaccine are actually not due to the vaccine itself - many are simply coincidental events, others (particularly in developing countries) are due to human, or programme, error.

It is not possible to predict every individual who might have a mild or serious reaction to a vaccine, although there are a few contraindications to some vaccines. By following contraindications the risk of serious adverse effects can be minimized.

AEFI President - Dr. N. K. Arora

India's Revised AEFI Guidelines