The death of nine health workers following the Covid-19 vaccine rollout has become a serious concern of the nation and the government haven’t disclosed the details of the investigations and any of the actions taken.
The deaths were reported from Uttar Pradesh, Karnataka, Andhra Pradesh, Rajasthan, Telengana, Gurugram and Odisha. These deaths took place between 24 hours and five days of taking the vaccines and all have been ascribed to cardiovascular problems or “brain stroke”. The vaccine taken in each case was Covishield.
In each case, the government has stated that the death was not due to the vaccine but has not revealed who made that determination and the details of the investigation.
Scroll reported on the massive clinical trail and the Adverse Events Following Immunisation (AEFI) investigations. The Scroll piece said that the government must immediately disclose all details of the investigations into these serious Adverse Events Following Immunisation and any action taken.
Coronavirus antibodies in India have been endorsed for confined use in a crisis, based on restricted information showing that the likely advantages of the immunization are more prominent than the dangers. Almost 20 Lakh health workers have been administered in less than two weeks and it is said to cover over 3 crore in the first phase of vaccine.
As a senior clinical pharmacologist noticed, this monstrous rollout is in actuality an exceptionally enormous clinical preliminary and requires a solid reconnaissance component. This group of genuine Adverse Events Following Immunization – eight AEFI related with same antibody, during a similar mission, and with a similar reason for death – would not have been recognized in clinical preliminaries of two or three huge number of individuals, and of only a couple months. This group of AEFI in the Covishield immunization should be completely and earnestly explored, and the discoveries made known
The government’s operational guidelines for Covid-19 vaccines describe the protocol for reporting and investigation of severe (such as anaphylactic shock) and serious AEFI (such as long-term disability, hospitalisation or death). The guidelines emphasise the importance of identifying cluster AEFI for urgent investigation.
These guidelines require immediate reporting of serious and severe AEFI; chain of investigation to ensure centralised analysis of AEFI. The guidelines require that severe and serious AEFI are treated as a medical emergency and reported immediately to the District Immunisation Officer, along with all available details including medical reports and in the case of death, the findings of the postmortem examination or verbal autopsy.
These processes are meant to ensure prompt and thorough investigation of all severe and serious AEFI, as well as note any patterns in their occurrence. to identify potential safety concerns with the vaccine, its quality, or its administration, in order to take prompt remedial action.
Flaws in protocol
While the guidelines require that severe and serious AEFI investigation be timebound, they do not specify the timeline. Though cluster AEFIs are of particular concern in the rollout of a new vaccine, the operational guidelines for Covid-19 vaccines do not give details of how a cluster AEFI investigation should be conducted. This is a major lacuna in the rollout of a new vaccine with limited safety data. There is a need of urgent investigation to be informed to the public to avoid the fear.
The health workers who died had taken the vaccine with the confidence that it would protect them from a serious disease. They are owed some respect, and at least a prompt, thorough and transparent investigation of their deaths, and action based on that investigation.