<p>Finally, on January 16, India started its vaccination against Covid-19 with two indigenously produced vaccines under `Emergency Use Authorisation’. It targeted the health staff and frontline workers followed by elderly citizens. With a slow start of 1.9 lakh doses per day for a month and then briskly shooting up to 14.1 lakh doses per day by March 15, we have now administered 7.48 crore doses as on April 3. As per the Cowin website data, only 8% of total doses administered have been Covaxin and the rest Covishield. </p>.<p>An exercise of this magnitude must have utmost safety checks apart from operational efficiency. People rely on a responsible and responsive government to safeguard them against any vaccine-induced harm including an unfortunate death. That is why, scientific community has established safety norms and mechanisms for monitoring adverse events while introducing new vaccines. Pharmaceutical industry in the past responded to evidence generated on potential harm including death due to new drugs or vaccines by re-modelling the product to a better one and if still not successful, discarded it for a newer product.</p>.<p>When the government purchases a vaccine and uses it for the public, it should also ensure the vaccine’s efficacy and safety. Any lapse in safety or efficacy must be quickly acknowledged and corrected. There should be no denial of truth or delay in action on the reports of adverse events, especially death. The manufacturer is responsible and liable for the damage. If there is denial and refusal to share the details or action taken to prevent further harm, people will doubt connivance of government with the manufacturer.</p>.<p>Surprisingly in India till now, although more than 70 deaths have taken place following vaccination, no case of serious adverse event following immunisation (AEFI) including death has been attributed to Covid vaccine. “No link to vaccination” is the repeated quick response even before the systematic investigation as per WHO-AEFI protocol. This hurried declaration of a verdict -"Not related to Vaccination" - without even completing an autopsy and a histopathological examination to establish diffused thromboembolic phenomena and infarcts of heart, lungs, and brain, is our main concern. </p>.<p>Dr N K Arora, Advisor, National AEFI Committee, and member of Covid National Task Force, said that “in 38 out of 71 post-mortem reports received so far, a causal link to vaccine has been not been established. All the events so far are coincidental.”</p>.<p> What type of post-mortem did they conduct? Was there any histopathological examination done apart from examining gross anatomical changes of organs like heart, brain and lungs? Only histopathological examination can establish the diffused thromboembolic phenomena and multiple infarcts of the heart, lungs, and brain. It also differentiates a suddenly developing diffused thromboembolic phenomena as seen in Sepsis and immune reaction like in Covid either virus or vaccine-induced spike protein stimulated from a slow evolving thrombus of myocardial infarction.</p>.<p>Media reports indicate that many deaths post-vaccination (Covishield) occurred due to cardiac arrest, cerebral venous thrombosis and stroke. Deaths in Germany and Norway were due to clots or thrombus formation after Covishield vaccination. Ireland, Denmark, Iceland and Italy etc suspended vaccination.</p>.<p>Autopsy findings with histopathological examination must be made mandatory to confirm or revise the clinical diagnosis in post-vaccination deaths. Our issue is whether vaccine-induced pathological changes have occurred in the body or not. That can be established only through inspection of gross anatomical and histopathological changes in the internal organs.</p>.<p class="CrossHead">Verbal autopsy</p>.<p>Verbal autopsy is not at all a satisfactory alternative for post-mortem. Like in maternal or infant death audit, it can only throw light on the socio-economic and logistic problems leading to or aggravating the medical cause of death. At the maximum, it can put on record the version from immediate family members (either s/he was perfectly healthy before vaccination or s/he had an underlying cardiac disease or haematological disorder). Local-level authorities are often eager to project that everything has gone well under their watch rather than investigate and understand the real causality. Sometimes, even the protocols are flouted.</p>.<p> Post-mortems can be badly conducted by inexperienced junior doctors, especially if there is interest or pressure to quickly dispose of the matter. It must be at medical colleges or major hospitals where a pathologist and police surgeon or forensic expert are available. In a controversial death after vaccination, getting post-mortem organised must be made the responsibility of district administration and chief medical officer. </p>.<p>Another hurdle in getting to the truth is refusal of permission for autopsy by the family members, which is understandable. If they take an informed decision against it, we cannot force an autopsy. It is the duty of the vaccination officials to convince them that both the family and society stand to gain to know whether the vaccine has caused the death. It is also required for a claim of higher financial compensation from the government or insurance.</p>.<p>There are gaps in AEFI investigations at the local level affecting the quality of evidence submitted to State and National AEFI Committees which depend on these findings for making causality assessments. If the causality assessment report is made public, any lapses in the process by the various AEFI committees can be pointed out by alert and competent citizens. Whether the WHO guidelines for investigation of AEFI occurring as cluster have been strictly followed or not must be made public to allay fears.</p>.<p>If no diagnosable specific cause is found, the death must provisionally be attributed to the vaccine. The government must ensure prompt, complete, time-bound and transparent investigation of all deaths and other serious adverse events following vaccination. Make these findings on few deaths versus the benefit of protection from lakhs of Covid deaths public. Let the person standing in the queue for vaccination decide.</p>.<p><span class="italic"><em>(The writer is a paediatrician and public health consultant based in Kochi) </em></span></p>
<p>Finally, on January 16, India started its vaccination against Covid-19 with two indigenously produced vaccines under `Emergency Use Authorisation’. It targeted the health staff and frontline workers followed by elderly citizens. With a slow start of 1.9 lakh doses per day for a month and then briskly shooting up to 14.1 lakh doses per day by March 15, we have now administered 7.48 crore doses as on April 3. As per the Cowin website data, only 8% of total doses administered have been Covaxin and the rest Covishield. </p>.<p>An exercise of this magnitude must have utmost safety checks apart from operational efficiency. People rely on a responsible and responsive government to safeguard them against any vaccine-induced harm including an unfortunate death. That is why, scientific community has established safety norms and mechanisms for monitoring adverse events while introducing new vaccines. Pharmaceutical industry in the past responded to evidence generated on potential harm including death due to new drugs or vaccines by re-modelling the product to a better one and if still not successful, discarded it for a newer product.</p>.<p>When the government purchases a vaccine and uses it for the public, it should also ensure the vaccine’s efficacy and safety. Any lapse in safety or efficacy must be quickly acknowledged and corrected. There should be no denial of truth or delay in action on the reports of adverse events, especially death. The manufacturer is responsible and liable for the damage. If there is denial and refusal to share the details or action taken to prevent further harm, people will doubt connivance of government with the manufacturer.</p>.<p>Surprisingly in India till now, although more than 70 deaths have taken place following vaccination, no case of serious adverse event following immunisation (AEFI) including death has been attributed to Covid vaccine. “No link to vaccination” is the repeated quick response even before the systematic investigation as per WHO-AEFI protocol. This hurried declaration of a verdict -"Not related to Vaccination" - without even completing an autopsy and a histopathological examination to establish diffused thromboembolic phenomena and infarcts of heart, lungs, and brain, is our main concern. </p>.<p>Dr N K Arora, Advisor, National AEFI Committee, and member of Covid National Task Force, said that “in 38 out of 71 post-mortem reports received so far, a causal link to vaccine has been not been established. All the events so far are coincidental.”</p>.<p> What type of post-mortem did they conduct? Was there any histopathological examination done apart from examining gross anatomical changes of organs like heart, brain and lungs? Only histopathological examination can establish the diffused thromboembolic phenomena and multiple infarcts of the heart, lungs, and brain. It also differentiates a suddenly developing diffused thromboembolic phenomena as seen in Sepsis and immune reaction like in Covid either virus or vaccine-induced spike protein stimulated from a slow evolving thrombus of myocardial infarction.</p>.<p>Media reports indicate that many deaths post-vaccination (Covishield) occurred due to cardiac arrest, cerebral venous thrombosis and stroke. Deaths in Germany and Norway were due to clots or thrombus formation after Covishield vaccination. Ireland, Denmark, Iceland and Italy etc suspended vaccination.</p>.<p>Autopsy findings with histopathological examination must be made mandatory to confirm or revise the clinical diagnosis in post-vaccination deaths. Our issue is whether vaccine-induced pathological changes have occurred in the body or not. That can be established only through inspection of gross anatomical and histopathological changes in the internal organs.</p>.<p class="CrossHead">Verbal autopsy</p>.<p>Verbal autopsy is not at all a satisfactory alternative for post-mortem. Like in maternal or infant death audit, it can only throw light on the socio-economic and logistic problems leading to or aggravating the medical cause of death. At the maximum, it can put on record the version from immediate family members (either s/he was perfectly healthy before vaccination or s/he had an underlying cardiac disease or haematological disorder). Local-level authorities are often eager to project that everything has gone well under their watch rather than investigate and understand the real causality. Sometimes, even the protocols are flouted.</p>.<p> Post-mortems can be badly conducted by inexperienced junior doctors, especially if there is interest or pressure to quickly dispose of the matter. It must be at medical colleges or major hospitals where a pathologist and police surgeon or forensic expert are available. In a controversial death after vaccination, getting post-mortem organised must be made the responsibility of district administration and chief medical officer. </p>.<p>Another hurdle in getting to the truth is refusal of permission for autopsy by the family members, which is understandable. If they take an informed decision against it, we cannot force an autopsy. It is the duty of the vaccination officials to convince them that both the family and society stand to gain to know whether the vaccine has caused the death. It is also required for a claim of higher financial compensation from the government or insurance.</p>.<p>There are gaps in AEFI investigations at the local level affecting the quality of evidence submitted to State and National AEFI Committees which depend on these findings for making causality assessments. If the causality assessment report is made public, any lapses in the process by the various AEFI committees can be pointed out by alert and competent citizens. Whether the WHO guidelines for investigation of AEFI occurring as cluster have been strictly followed or not must be made public to allay fears.</p>.<p>If no diagnosable specific cause is found, the death must provisionally be attributed to the vaccine. The government must ensure prompt, complete, time-bound and transparent investigation of all deaths and other serious adverse events following vaccination. Make these findings on few deaths versus the benefit of protection from lakhs of Covid deaths public. Let the person standing in the queue for vaccination decide.</p>.<p><span class="italic"><em>(The writer is a paediatrician and public health consultant based in Kochi) </em></span></p>