A health worker prepares a dose of the AstraZeneca COVID-19, London, February 18, 2021. Photo: Reuters/Henry Nicholls/File Photo.
New Delhi: A group of independent experts penned a letter dated March 16 to senior members in the government in charge of India’s pandemic response asking for an “urgent investigation of deaths and serious adverse events following administration of COVID-19 vaccine” (sic).
The group of 29 is mostly composed of health professionals but also includes a journalist, two advocates and notable voices like virologist T. Jacob John, public health doctor Sylvia Karpagam, Indian Journal of Medical Ethics editor Amar Jesani and health activist Malini Aisola. The letter is addressed to:
- Union health minister Harsh Vardhan
- Drug Controller General of India V.G. Somani
- NITI Aayog member V.K. Paul
- Department of Biotechnology secretary Renu Swarup
- National Task Force on COVID-19 member N.K. Arora
Most members of the same group had earlier written a similar letter addressed to the same people in government in January 2021, asking the government to investigate “deaths of 11 healthcare and frontline workers following administration of COVID-19 vaccine” (sic).
The March 16 letter states, “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.”
AEFI stands for ‘adverse events following immunisation’, and denotes significant ill health that could be attributed to receiving a vaccine.
The AstraZeneca vaccine candidate for COVID-19, called AZD1222 and ‘Covishield’ in India, has been in the news of late thanks to a small number of reports of recipients in Europe developing unusual blood clots.
Both the WHO and the European Medicines Agency, which is Europe’s drug-controller body, have recommended that health bodies and the people continue to use the vaccine even as they investigate the reports.
Thus far, scientists have been yet to ascertain a causal link between an AZD1222 shot and the blood clots. However, according to Science, even though scientists are scratching their heads, “vaccine safety officials say they did not take the decision lightly, and that symptoms seen in at least 13 patients, all between ages 20 and 50 and previously healthy, in at least five countries are more frequent than would be expected by chance.”
Reports in the Indian media last week indicated India’s COVID-19 task force, of which N.K. Arora is a member, was considering post-vaccination data of Covishield as well – even as Arora said the number of cases of concern in India remains “very, very low”.
The group writes in the March 16 letter: “Media reports indicate that many deaths post vaccination with Covishield … occurred due to cardiac arrest, cerebral venous thrombosis and stroke.”
The experts among the group also offer one potential explanation.
The novel coronavirus hijacks a cell in the body by using its spike protein to bind with an enzyme associated with the cell, called an ACE2 receptor. Once hijacked, the virus uses the latter’s biological machinery to manufacture, among other things, its spike protein. The spike protein will later bind with the ACE2 receptors of other cells to hijack them as well, and so on.
when these spikes are displayed on a cell’s surface, according to the experts, the ACE2 receptors of other cells could mistake the cell for the virus itself. This misidentification could set off a “cascade” of events leading up to blood clots. “We suggest that there is a possibility of this being enacted by some vaccines,” they write.
The letter’s authors also call into question the government’s refusal to share AEFI data after February 26 and poor local follow-ups: “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 full letter is available to read below, together with the references. (Emphases in the original.)
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 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 use of the vaccines in persons such as those with allergies, who are immunocompromised or using immunosuppressants, or using blood thinners/anti-coagulants.
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