The concerned professionals got no response to an earlier letter to the Centre seeking details of adverse events that occurred after vaccination for COVID-19 in India. They say in their letter that other countries have halted vaccination despite far fewer reports of adverse reactions. India, 65 reported deaths, has recorded no serious adverse event attributed to the vaccine, HAMZA LAKDAWALA writes from Mumbai.
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ON 16 March 2021, a group of social workers, lawyers, doctors, journalists, and other influential individuals working in public health wrote to senior officials of the central government who are leading India’s pandemic response. They are asking for an “urgent investigation of deaths and serious adverse events following administration of COVID-19 vaccine.”
This is a follow-up to a previous letter written to the government, where the group had asked the central government to express their “concerns regarding the lack of information on the investigations of deaths following COVID-19 vaccination in India.”
The letter highlights that countries such as Denmark, Iceland, Norway, Italy, France, Germany, Ireland, and a few others, have paused immunisation with the AstraZeneca vaccine, and are investigating a small number of post-vaccination deaths caused due to intravascular clotting/thromboembolic events.
The letter is addressed to
- Union Health Minister Dr. Harsh Vardhan
- Drug Controller General of India VG Somani
- NITI Aayog member VK Paul
- Secretary, Department of Biotechnology, Renu Swarup
- Member of the National Task Force on COVID-19, NK Arora
The group writing the letter consists of numerous health professionals including Dr. Babu KV. Dr Mira Shiva, Dr. Ramani Akturi, virologist T Jacob John, public health doctor Sylvia Karpagam, and many others. It also has been signed by notable figures from various fields who are working towards public health.
Some of them are Senior Advocate Anand Grover, who was the United Nations Special Rapporteur on the Right to Health, Brinelle Dsouza, who is co-convenor of the Jan Swasthya Abhiyan and a professor at TISS Mumbai, journalist Laxmi Murthy, Indian Journal of Medical Ethics editor Amar Jesani, and health activist Malini Aisola.
The letter states, “The government is responsible for ensuring the safety of all vaccines and particularly those administered through a government programme. This includes monitoring and surveillance of adverse events following immunisation (AEFIs). AEFIs are to be investigated through well-defined procedures for vaccine pharmacovigilance and the reports made available in the public domain, for trust-building and transparency. This 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.”
It further says, “We understand that at least 65 deaths have occurred following vaccination for COVID-19 since the vaccination campaign started on January 16. However, the National AEFI Committee’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.”
The group had written to the authorities on 31 January, asking for details of all investigations into deaths and other serious AEFIs, as well as other details related to vaccine rollout. However, the state is yet to respond to that letter.
The authors of the letter have also questioned the government’s refusal to share AEFI data after February 26. “There are gaps in AEFI investigations at the local level, affecting the quality of evidence submitted to State and National AEFI Committees who depend on these findings for making causality assessments.”
The coronavirus pandemic hit India in March 2020 and has so far infected over 11 million people and has resulted in approximately 1.5 lakh deaths. India launched its vaccination drive on 16 January. Initially, the drive was limited to healthcare workers and frontline staff. The government has since expanded the program to cover people over 60 years, as well as people with co-morbidities. India has so far administered 36.4 million shots of the Covid-19 vaccine to its people.
The unedited text of the letter is reproduced below for the benefit of our readers:
Date: 16 March 2021
1. Hon’ble Dr. Harsh Vardhan
Union Minister
Ministry of Health and Family Welfare
New Delhi
Email: [email protected]
2. Dr VG Somani
Drugs Controller General of India
New Delhi
Email: [email protected]
3. Dr VK Paul
Member, NITI Aayog
Chair, National Expert Group on Vaccine Administration
For COVID-19
Email: [email protected]; [email protected]
4. Dr Renu Swarup
Secretary, Department of Biotechnology
Chair, NTAGI
Email: [email protected]
5. Dr NK Arora
Member, National Task Force on COVID-19 Advisor, National AEFI Committee, Delhi
Email: [email protected]; [email protected]
Urgent investigation of deaths and serious adverse events following administration of COVID-19 vaccine
We are writing to you as people working in public health, ethics, medicine, law, and journalism, and as members of the public who support the immunisation programme. We wrote to you earlier on 31 January 2021 expressing our concerns regarding the lack of information on the investigations of deaths following COVID-19 vaccination in India. We are disappointed at the government’s silence on our letter while further reports of deaths following administration of COVID-19 vaccine are appearing in the media.
The government is responsible for ensuring the safety of all vaccines and particularly those administered through a government programme. This includes monitoring and surveillance of adverse events following immunisation (AEFIs). AEFIs are to be investigated through well-defined procedures for vaccine pharmacovigilance and the reports made available in the public domain, for trust-building and transparency. This 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.
We understand that at least 65 deaths have occurred following vaccination for COVID-19 since the vaccination campaign started on January 16. However, the National AEFI Committee’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.
Denmark, Iceland, Norway, Italy, France, Bulgaria, Germany, Luxembourg, Estonia, Lithuania, Latvia and Ireland have paused immunisation with the Astra Zeneca 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.
Media reports indicate that many deaths post-vaccination with Covishield, AstraZeneca’s vaccine which is being manufactured in India by the Serum Institute of India, occurred due to cardiac arrest, cerebral venous thrombosis, and stroke.
We 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. We raise one possibility: human cells bearing SARS-CoV-2 spikes displayed on the surface, are, for the ACE 2 receptors, like the virus itself. The 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.
Reports of other serious AEFIs including neurological symptoms, hemiplegia and Guillain-Barre syndrome also need to be investigated.
As the vaccination drive has been expanded to include persons over 60 years and persons above 45 years with specified morbidities, it is all the more important to investigate any possibilities of the COVID-19 vaccines triggering serious AEFI in people with certain medical conditions, who are the very people in need of vaccination. Could they be ‘predisposed’ to aggravation of their basic condition?
We note with concern that critical updates to the fact sheets recommended by the CDSCO’s Subject Expert Committee have not been issued, even though they are meant to provide additional guidance and clarify the use of the vaccines in persons such as those with allergies, who are immunocompromised or using immunosuppressants or using blood thinners/anticoagulants.
There are gaps in AEFI investigations at the local level, affecting the quality of evidence submitted to State and National AEFI Committees who depend on these findings for making causality assessments. The National AEFI Committee also has a critical role in assessing cases that present as a cluster and to explore potential common pathways.
In our letter dated January 31, 2021, we asked for details of all investigations into deaths and other serious AEFIs, as well as the minutes of AEFI monitoring committees, and details of all AEFI committee members and other experts overseeing the vaccine rollout. We have not received any response. We also note that the government has stopped sharing any details of AEFIs after February 26, 2021.
Lakhs of people in India are being administered the COVID-19 vaccines every day in the confidence that the vaccine will protect them against severe disease and death.
The vaccine programme owes them complete information on the vaccines, a vaccination protocol that minimises the risk of harm, and an assurance of thorough and transparent investigation of injuries and death following immunisation. They are also owed medical care, and compensation for harm suffered post-vaccination. The government has not met these obligations.
The government must immediately undertake complete, time-bound and transparent investigation of all deaths and other serious adverse events following vaccination with the COVID-19 vaccine. The following must be put 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. Based on the findings of investigations the vaccination protocols should be modified with screening procedures that decrease the probability of serious adverse events following immunisation, if found necessary.
Awaiting a response,
Thanking you,
Sincerely,
Ms Sandhya Srinivasan, Consulting Editor, Indian Journal of Medical Ethics,
Mumbai
Dr Amar Jesani, Editor, Indian Journal of Medical Ethics, Mumbai
Adv Veena Johari, Advocate, Courtyard Attorneys, Mumbai
Adv Anand Grover, Senior Advocate, Former UN Special Rapporteur on the Right to Health (2008-14), Director, Lawyers Collective, Mumbai/Delhi
Dr Babu KV, Public Health Activist, Kannur
Ms Brinelle Dsouza, Co-convenor, Jan Swasthya Abhiyan, Mumbai, and faculty member, School of Social Work, Tata Institute of Social Sciences, Mumbai
Dr Chayanika Shah, Independent Researcher and Retired College Teacher, Mumbai
Dr George Thomas, Orthopaedic Surgeon, Chennai
Dr Imrana Qadeer, Former Professor, Centre of Social Medicine and Community Health, JNU, New Delhi
Dr KR Antony, Paediatrician and Public Health Consultant, Kochi
Ms Laxmi Murthy, Journalist, Bengaluru
Ms Malini Aisola, Public Health Professional, New Delhi
Dr Mira Shiva, Public Health Physician, Delhi
Dr Mohan Rao, Independent Public Health Researcher, Bengaluru, and former Professor, Centre of Social Medicine and Community Health, JNU, New Delhi
Dr Prabir Chatterjee, Independent Public Health Consultant, Kolkata
Dr Ramani Akturi, Public Health Physician, Bhopal
Dr Ravi Dsouza, Community Health Physician, Bhopal
Dr Sanjay A Pai, Pathologist, Bangalore
Dr Sanjay Nagral, Director, Department of Surgical Gastroenterology, Jaslok Hospital and Research Centre, and Head, Department of Surgery, K B Bhabha General Hospital, Mumbai
Ms Sarojini N, Public Health Researcher, New Delhi
Dr Sejal Tambat, Family Medicine Practitioner, Mumbai
Mr S Srinivasan, LOCOST, Vadodara
Dr SP Kalantri, Physician, Sewagram
Dr Siddhartha Das, Theoretical Physicist, Purnea, Bihar
Sunita Bandewar, PhD, Independent Researcher in Health and Bioethics, Pune
Dr Sylvia Karpagam, Public Health Doctor and Researcher, Bengaluru
Dr T Jacob John, Retired Professor and Head, Department of Clinical Virology, Christian Medical College, Vellore
Dr Vandana Prasad, Public Health Professional, Delhi
Dr Yogesh Jain, Public Health Physician, Chhattisgarh
References
1. Global manual on surveillance of adverse events following immunization. Geneva: World Health Organization; 2014 (Revised March 2016). Available here.
2. Covid-19 vaccines: safety surveillance manual. Geneva: World Health Organization; 2020. Available here.
Cc:
1. Mr Rajesh Bhushan, Secretary, MOHFW, Co-Chair National Expert Group on Vaccine Administration for COVID-19: email: [email protected]
2. Dr S Eswara Reddy, Joint Drugs Controller: email: [email protected]
3. Dr P B N Prasad, Joint Drugs Controller: email: [email protected]
4. Dr Balram Bhargava, Director General ICMR, & Vice Chair NTAGI: email: [email protected]
5. Dr Pradeep Haldar, Deputy Commissioner (Immunisation): email: [email protected]
6. Dr M K Aggarwal, Deputy Commissioner (UIP): email: [email protected]
7. Mr A K Pradhan, DDC(I), CDSCO: email: [email protected]
8. Dr Roderico Ofrin, Regional Emergencies Director, Office of the WHO Representative India: email: [email protected]
9. Dr J N Shrivastava, Executive Director, NHSRC, Chairman National Quality Assurance Committee for AEFI Surveillance Program; email: [email protected]
10. Mr P K Mishra, Principal Secretary, PMO: email: [email protected]
(Hamza Lakdawala is a researcher and writer who is keenly interested in constitutional law, Indian history, and legal journalism. The views expressed are personal.)
