Health experts have written to the Centre demanding an “urgent investigation” into the deaths and serious adverse events following the administration of Covid-19 vaccine. They also raised concerns over the possibility of blood clots among beneficiaries post the inoculation.
“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”, experts said in their letter to the central government.
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, said the letter.
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,
Explaining what could have led to the death of people after vaccination, experts said in the letter, 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 postvaccination. The government has not met these obligations