A group of people working in public health, ethics, medicine, law, and journalism, has written to the Health Minister Dr Harsh Vardhan asking for urgent investigation into reports of deaths and serious adverse effects following COVID-19 vaccination in the country. The letter is also addressed to Drug Controller General of India Dr VG Somani, Chair of the National Expert Group on Vaccine Administration for COVID-19 VK Paul, Department of Biotechnology Dr Renu Swarup, and Advisor to National AEFI (adverse effects following immunisation) Committee, Dr NK Arora. Dr Arora is also a member of the National Task Force on COVID-19.
The writers note that at least 65 deaths have been reported to have occurred after COVID-19 vaccination since January 16, 2021 when vaccination drive began in India. â€śHowever, the National AEFI Committeeâ€™s investigation findings of only two of these deaths have been made public. Till now, no case of serious AEFI including death has been attributed to the vaccine,â€ť the letter says.
It cited procedures laid down by the World Health Organisation for investigating AEFIs, and said that these reports should be made available in the public domain to build trust and transparency. â€śThis is especially important for new vaccines such as the COVID-19 vaccines currently being rolled out across the country under emergency use authorisation, targeted to millions of people,â€ť the authors have said.
They further note that â€śDenmark, Iceland, Norway, Italy, France, Bulgaria, Germany, Luxembourg, Estonia, Lithuania, Latvia and Ireland have paused immunisation with the AstraZeneca vaccine pending investigation of a small number of post-vaccination deaths from intravascular clotting/ thromboembolic events, while Austria has suspended the use of certain batches.â€ť However, no such action has been taken in India.
The experts note that many deaths post vaccination with Covishield, Oxford and AstraZeneca's vaccine being manufactured by Pune based Serum Institute of India here, have occurred due to cardiac arrest, cerebral venous thrombosis and stroke.
â€śWe believe that due to the possible linkages of vaccination and blood clotting, all these deaths and adverse events should be reviewed together for a possible causal relationship with the vaccine,â€ť the letter says. It raises the possibility that for the ACE 2 receptors found in the human body, â€śhuman cells bearing SARS-CoV-2 spikes displayed on the surfaceâ€ť may appear like the virus itself. â€śThe event cascade leading to clotting is a part of the pathogenesis of the virus-human interactions. We suggest that there is a possibility of this being enacted by some vaccines,â€ť the letter says. ACE 2 is a protein on the surface of many kinds of cells. The SARS-CoV-2 virus uses the spike-like protein on its surface to bind to ACE 2, making the latter like a â€ścellular doorwayâ€ť for the virus behind COVID-19.
The authors also urge the government to investigate other serious AEFIs including neurological symptoms, hemiplegia (condition caused by brain damage or spinal cord injury that leads to paralysis on a side of the body. It can result in weakness, challenges with muscle control, and muscle stiffness) and Guillain-Barre syndrome (where the bodyâ€™s immune system attacks its nerves).
The letter argues that it is all the more important to investigate these cases, because vaccination has now opened to people above 60 as well as those above 45 with comorbidities to ascertain if they could be predisposed to aggravation of their basic conditions.
â€śWe note with concern that critical updates to the fact sheets recommended by the CDSCOâ€™s Subject Expert Committee have not been issued, even though they are meant to provide additional guidance and clarify use of the vaccines in persons such as those with allergies, who are immunocompromised or using immunosuppressants, or using blood thinners/anticoagulants,â€ť the letter adds.
In the earlier letter written to all others except Dr NK Arora, the public health experts had asked the government to look into deaths of 11 health and frontline workers between January 16 to 30, 2021, following administration of the COVID-19 vaccine. These had occurred in Uttar Pradesh, Karnataka, Andhra Pradesh, Rajasthan, Telangana, Gurugram, Odisha, and Kerala. The beneficiaries were between 42 and 56 years of age, except one who was 23, and their deaths were ascribed to cardiovascular problems or brain stroke. All of them had taken Covishield. While the district and state officials denied any connection with the vaccine, the assessment of the deaths and other serious AEFIs was not released.
The letter also quoted WHOâ€™s global manual for surveillance of adverse events following immunization, which says, â€śAEFIs must be investigated urgently in order to issue warnings to people who should not take it due to contraindications, to correct errors, to reassure the public, as well as to identify potential serious problems in the vaccine. The algorithm for cluster AEFI investigation can rule out errors in manufacturing or administration, anxiety clusters, and coincidental events, to identify signals for further investigation.â€ť
The signatories to the letter dated March 16 say that they received no response from the government to their January letter. Now, they have asked for the following to be made available in the public domain.
1. For each of the vaccines rolled out, details of all serious AEFIs as of March 16, 2021, and the status of investigation.
2. Findings of all completed serious AEFI investigations, including:
a. cause of death by clinical diagnosis;
b. autopsy findings when possible, or verbal autopsy, to confirm or revise the clinical diagnosis;
c. causality assessment and the reasoning behind that assessment;
d. aetiology; if no aetiology is found, the death must provisionally be attributed to the vaccine, and
e. the process undertaken by the various AEFI committees, including whether the WHO guidelines for investigation of AEFI occurring as cluster have been strictly followed,
f. cause of other AEFIs, and the causality assessments by the various committees.
The letter is signed by 30 persons, including activists, doctors, researchers, journalists, professors associated with the field of public health.