As many as 14 healthcare workers have died within 24 hours to 11 days after receiving the shot. JYOTI SHELAR reporting from Mumbai finds that experts are saying that there must be more information available and there has to be better transparency.
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ON January 31, nearly 71,000 frontliners and healthcare workers were vaccinated against Covid-19 in Gujarat. Thirty-year-old Jignesh Solanki, a sanitation worker attached to the Vadodara Municipal Corporation was one of them. Two hours after receiving the shot, Solanki began feeling dizzy and then fell unconscious. His breathing had stopped before an ambulance could reach and rush him to a hospital.
Solanki is among the 14 healthcare and frontline workers who have died within a few hours or days after being vaccinated under the world's largest immunisation programme in India.
On Monday, a panel of doctors conducted a post mortem and video recorded the entire procedure. "Preliminary findings did not show any link of vaccination with his (Solanki's) death," Dr. Devesh Patel, a medical officer of health in Vadodara told The Leaflet. "He had a serious heart ailment for which he was hospitalised in 2016. It seems to be the primary cause. His viscera has been sent for forensic analysis based on which further investigations will be carried out".
Hours after Solanki's death, civic and state officials had told the media that the death had no likely connection with the vaccination. The promptness at which local authorities have denied this link has become a major cause of concern.
“The 14 deceased had received the Oxford-AstraZeneca's Covishield vaccine manufactured by the Serum Institute of India.
"How can local authorities deny any link on the same day the death occurred," questioned Dr. Amar Jesani, editor of the Indian Journal of Medical Ethics. "The right procedure should be for the state and national level Adverse Event Following Immunisation (AEFI) committees to probe and determine the cause of death. Till then, such deaths are under investigation".
The 14 deceased had received the Oxford-AstraZeneca's Covishield vaccine manufactured by the Serum Institute of India. All deaths have been linked to cardiovascular events. While the deaths are scattered across ten states in the country, the common elements cannot be ignored.
These deaths should be investigated as AEFI clusters, say health experts.
"It may not be a geographical cluster. But when you have consistency in the health events leading to the deaths and one type of vaccine, it definitely is a vaccine cluster," said Dr. Jesani, who is based in Mumbai.
The World Health Organization defines an AEFI cluster as two or more cases of the same adverse event related to time, place or vaccine administered.
“"AEFIs 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 potentially serious problems in the vaccine," the letter states.
Emphasizing this definition, a group of 23 experts including Dr. Jesani has written to the health minister Dr. Harsh Vardhan, Drugs Controller General of India Dr. VG Somani, NITI Aayog member Dr. VK Paul, and secretary of Department of Biotechnology Dr. Renu Swarup. "AEFIs 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 potentially serious problems in the vaccine," the letter states. "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."
The letter from the experts also demands that the complete information on all deaths, severe and serious AEFI in the Covid-19 vaccine rollout, and their investigation, should be put up in the public domain. "This information should include the numbers, date of vaccination, details of the AEFI, place, investigation status and results," the letter said.
"There is not much transparency about the investigations into these deaths," said Malini Aisola, a Delhi based public health researcher and one of the signatories to the letter. "The deaths have been quickly declared as 'unrelated to vaccination' or 'linked to comorbidities' of the deceased. No one knows how exactly the causality was determined."
“Currently, history of chronic diseases and morbidities such as cardiac, neurological, pulmonary, metabolic, renal, malignancies are not listed as contraindications for the Covid-19 vaccine.
Aisola said that the information about the process of investigating these deaths, the findings of the committees, and causality reports should be put up in the public domain. "Not just the deaths, but all the serious adverse events that have led to hospitalisations should be in the public domain. This is critical for building public confidence in vaccination and to quell misinformation and rumours. The assessments are also important for fine-tuning guidance for certain groups of people, such as those with preexisting conditions, and for reviewing the list of contraindications," said Aisola, who is also the co-convenor of All India Drug Action Network (AIDAN).
Currently, history of chronic diseases and morbidities such as cardiac, neurological, pulmonary, metabolic, renal, malignancies are not listed as contraindications for the Covid-19 vaccine. The list of contraindications include people who have had an anaphylactic or allergic reaction to a previous dose of Covid-19 vaccine, immediate or delayed onset of anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products or food items, etc, women who are pregnant or not sure of their pregnancy, and lactating women.
Timeline
Jan 17: Nagaraju (43), a worker of a government hospital in Ballari, Karnataka reportedly died of a heart attack. He was vaccinated on Jan 16.
Jan 17: Mahipal Singh, a 52-year-old ward boy of a hospital in Moradabad, Uttar Pradesh, died a day after receiving the Covid-19 vaccine. He was vaccinated on Jan 16 and complained of chest pain and breathlessness.
Jan 20: A 42-year-old male health care worker from the Nirmal district in Telangana died within 24 hours of being vaccinated. He was vaccinated on Jan 19. He developed a chest and had to be rushed to a hospital where he was declared brought dead.
Jan 20: Dr. Jayaprakash TA attached to the medical college in Shivamogga, Karnataka passed away after complaining of chest pain. He was vaccinated on Jan 18.
Jan 21: Suresh Chandra Sharma, an assistant administrative officer in Chittorgarh district of Rajasthan passed away. He was vaccinated on Jan 16.
Jan 22: Lajwanti Singh, a 56-year-old nurse from Gurugram, Haryana passed away due to a sudden cardiac arrest. She was vaccinated on Jan 16. Her husband Lal Singh has filed a police complaint.
Jan 24: B Vijayalakshmi, a 42-year-old ASHA worker from Guntur, Andhra Pradesh died at a government hospital. She was vaccinated on Jan 19. Chief Minister YS Jagan Mohan Reddy announced Rs 50 lakh ex-gratia to her kin. Her family member has also been promised a job.
Jan 24: G Vanitha, a 48-year-old anganwadi worker from Warangal, Telangana died five days after receiving the Covid-19 vaccine. She had received the vaccine on Jan 19.
Jan 26: A 27-year-old security guard working at a district hospital in Odisha died after complaining of discomfort. He was vaccinated on Jan 23.
Jan 28: A 55-year-old class IV nutrition worker Pratap Ram in Pilibhit, Uttar Pradesh died hours after he was vaccinated. He had a history of cardiac ailment.
Jan 29: Suja, a 52-year-old nurse from Kollam in Kerala died after complaining of discomfort post-vaccination. She had taken the shot on Jan 28.
Jan 30: Susheela, a 55-year-old female health worker in the Mancherial district of Telangana was vaccinated on Jan 19. On Jan 29, she complained of shortness of breath and dizziness and had to be hospitalised. She was later shifted to a higher center. She succumbed on Jan 30. A media release from the Telangana's officer of Director of Public Health and Family Welfare stated that "death is clearly indicative of underlying morbidities and not due to Covid vaccination".
Jan 31: Jignesh Solanki (30), a sanitation worker at the Vadodara Municipal Corporation in Gujarat was vaccinated on the morning of Jan 31. He reportedly fainted a few hours later and was rushed to a hospital where he was declared dead. He had a history of heart disease.
Jan 31: A 61-year old radiologist Dr. Tulsio Gawalani (61) passed away at Ulhasnagar. He had received the Covid-19 vaccine on Jan 20. His kin said that he had no discomfort and that his death was natural.
(Compiled from media reports)
Health experts in their letter have questioned whether the programme will be amended based on deaths, serious AEFIs investigation findings. "Will the programme be re-assessed and amended, with warnings, informed consent, etc., prior to the completion of the rollout of the first dose and prior to the commencement of the rollout of the second dose of the vaccine?"
More than 39.50 lakh people have been vaccinated in India since the drive was launched on January 16. In addition to Covishield, India has also approved Bharat Biotech's Covaxin on a clinical trial mode as its phase III trials are currently ongoing.
Prime Minister Narendra Modi has hailed the vaccination drive as not only the world's biggest but also the fastest.
“"Vaccines don't kill. We all know that. But is there something more happening that needs to be investigated thoroughly?"
"With such a large scale vaccination drive, it is the sacred responsibility of the government and the DCGI to maintain the trust of the people," said Vellore based eminent virologist Dr. T Jacob John. "Vaccines don't kill. We all know that. But is there something more happening that needs to be investigated thoroughly?" (See Box)
According to Dr. John, deaths are a serious matter and the families of the deceased need answers and justice. "When the first death occurred, I was okay. But the second death and the deaths thereafter made me anxious. Something doesn't seem right to me," said Dr. John. "Transparency and public knowledge is a national necessity," he said.
Health experts and activists have also demanded clarity about whether the kin of the deceased is eligible for a no-fault compensation. While Covishield and Covaxin both have been granted emergency use approval with limited data, the latter has a clause of compensation for its recipients as it is being administered on a clinical trial mode.
There is no such clause for the recipients of Covishield. "While the CM in Andhra Pradesh has announced an ex-gratia award of Rs 50 lakh to the family of the ASHA worker who died and jobs have been offered to family members of the deceased in other cases, these grants are not by way of compensation," said Aisola. "The government is yet to put in place a mechanism to compensate individuals who suffer unexpected injury or death post-vaccination."
The Serum Institute of India declined to comment on the query sent by The Leaflet.
(Jyoti Shelar is an independent journalist based in Mumbai. She writes on health, gender, and related topics.)