Amid the global outrage over the ‘rare’ side effects of Covishield — AstraZeneca’s Covid vaccine produced in India by the Serum Institute of India (SII) — and the slew of lawsuits filed against AstraZeneca abroad and against SII in India by those who had lost their near and dear ones post-Covishield vaccination, The Pioneer’s Tanisha Saxena examines the legal implications surrounding vaccine-related fatalities. For, about 90 per cent of Indians vaccinated in the country against Covid-19 are believed to have taken Covishield jabs. In a legal submission, AstraZeneca admitted that their vaccine could lead to Thrombosis with Thrombocytopenia Syndrome (TTS) — a condition characterised by blood clot formation and low platelet count. The company’s submission is believed to be a gross understatement, considering that nationwide there have been several unexplained deaths of people who had taken Covishield jabs. It is a different matter that AstraZeneca has since announced a global withdrawal of its COVID-19 vaccine, developed in collaboration with Oxford University.
On the whole, this case of a vaccine going haywire reflects the questionable haste with which the makers of the vaccine pushed it into the market. It also mirrors the irresponsible manner in which government authorities in various nations, including India, mandated jabs (including Covishield) during the peak of Covid-19 pandemic and later. All told, the case underscores the necessity for a thorough examination and fixing of accountability within an appropriate legal framework governing vaccine safety. The complexities involved in navigating consumer protection laws, medical negligence claims, and public health regulations have compounded the challenges faced by individuals seeking justice for vaccine-related adverse events.
The parents of a woman who tragically passed away after receiving the Covishield vaccine have proceeded legally against SII. AstraZeneca too is currently embroiled in a class-action lawsuit over allegations linking their vaccine to fatalities and serious injuries, notably TTS, which manifests as blood clots and a low platelet count. The responsibility for these deaths caused by vaccination raises questions about why there was a lack of sufficient cautionary information about potential side effects, despite the widespread acclaim of the vaccine’s efficacy. Amidst the narrative of the vaccine marvel, the grim reality of deaths attributed to Covishield remains unresolved, demanding closer scrutiny and accountability.
Addressing vaccine-related deaths in India
Samridhi Arora, Advocate on Record (AOR), Supreme Court of India, elaborates, “In 2021, the legal dimension of the COVID vaccine was scrutinised in the case of Jacob Puliyel v. UOI, where the Central government asserted that out of 180 crore doses administered, only 0.004% reported adverse effects. From a legal standpoint, the focus lies on whether the vaccine approval process adhered to prescribed protocols.
The Supreme Court ruled that the government cannot mandate vaccination, offering individuals the liberty to choose. Additionally, Covishield provided a fact sheet detailing common, uncommon, and rare symptoms. Valid medical evidence demonstrating that any adverse effects exclusively resulted from the Covid vaccine is imperative if making any claim.”
In a significant legal development in 2022, the Bombay High Court issued notices to SII and Microsoft co-founder Bill Gates in response to a petition filed by Dilip Lunawat. Lunawat alleged that his daughter, a doctor and senior lecturer, had died due to the purported side effects of the Covishield vaccine. This tragic incident prompted renewed scrutiny over vaccine safety assurances, particularly given the partnership between SII and the Bill and Melinda Gates Foundation to expedite Covishield production.
However, amidst these concerns, a contrasting narrative emerged from a 2023 study conducted by the Indian Council of Medical Research (ICMR). This study, aimed at understanding sudden deaths among young adults in India, concluded that the Covid-19 vaccination was not the cause of unexplained fatalities in this demographic. Instead, the study pointed to other factors such as a history of severe Covid-19 infection, binge drinking, and recreational drug use as potential contributors to sudden deaths. These divergent accounts underscored the intricate landscape of public health discourse and the need for a proper understanding of vaccine safety within broader health considerations.
Advocate Manan Aggarwal recalls: “On June 24, 2023, the parents of two young women who tragically passed away after receiving the Covid-19 vaccine filed a rejoinder in the Supreme Court, challenging the government’s response to their petition. Rachana Gangu from Hyderabad and Venugopalan Govindan from Tamil Nadu, who had lost their daughters aged 19 and 20, respectively, alleged that the government had engaged in “mass deception” by promoting vaccines as the sole solution to combat the pandemic without adequate evidence. They refuted the government’s claim of not enforcing vaccination and accused authorities of downplaying adverse events. The petitioners sought compensation and the formation of an independent medical board to investigate their daughters’ deaths. This development shed light on the contentious debate surrounding vaccine safety and accountability.”
As the world continues to grapple with the aftermath of mass Covid-19 vaccination campaigns, a haunting reality persists: the loss of lives allegedly linked to vaccination. As families mourn the untimely passing of their loved ones, In the aftermath of vaccination efforts, the question lingers: who can these grieving families turn to for solace and justice? In their quest for answers, it is imperative that their voices are heard with empathy and urgency.What does the law say?
Shravan Patel Kanagandhula Patel, a high court lawyer in Hyderabad, explains that In India, the legal system regarding complaints related to deaths allegedly caused by vaccination is primarily governed by:
1. Consumer protection laws: The Consumer Protection Act, 2019 provides avenues for consumers to seek compensation for damages caused by defective products, including vaccines. The National Consumer Disputes Redressal Commission (NCDRC) and the State Consumer Disputes Redressal Commissions adjudicate such cases.
2. Medical negligence laws: Claims of medical negligence can be pursued under tort law. The Indian judiciary recognises the principle of ‘res ipsa loquitur’, meaning ‘the thing speaks for itself’, where negligence can be inferred from the circumstances surrounding the incident.
3. Public health regulations: Public health authorities regulate vaccine safety and efficacy. The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, provide the regulatory framework for the manufacturing, distribution, and sale of vaccines in India.
4. Civil and criminal liability: Depending on the nature of the case, both civil and criminal liability may arise. Civil suits seek compensation for damages, while criminal complaints may result in prosecution and punishment for negligence or misconduct.
5. Government guidelines and policies: The government may issue guidelines and policies regarding vaccination-related complaints, including reporting mechanisms and compensation schemes for vaccine-related adverse events.
Shedding light on the legal framework, Rouble Chhabra, a lawyer, states, “Holding the state responsible is a lost cause. The manufacturers can be held responsible, and a class-action suit can be urged where all the victims have similar variables and similar results backed by proof that the vaccine resulted in such harm. The vaccine came with its terms and conditions; if they are all abided by, and still there has been a finding backed by medical evidence of reactions, the victim can sue the company under the Consumer Act or Criminal Act.”
Adding to the discourse, Abhishek Rastogi, founder of Rastogi Chambers, says, “A medical malpractice claim related to the Covid-19 vaccine would be feasible if based on improper administration or storage. For example, if the health care provider gave the wrong dosage or reused a syringe, a patient might have a viable malpractice claim. But potential malpractice claims covered under CICP would likely be preempted by the federal government. Victims can pursue the matter as a class-action lawsuit under the Consumer and Criminal Act on the grounds of a similar adverse reaction to the dosage, keeping all other parameters of the pre- and post-conditions the same.”
Overall, individuals seeking to address complaints of deaths allegedly caused by vaccination in India should navigate these legal avenues with the assistance of legal counsel and adhere to the due process outlined by relevant laws and regulations.
Research outlines
A research report published in February 2022, titled ‘Death after the Administration of Covid-19 Vaccines Approved by EMA: Has a Causal Relationship Been Demonstrated?’ analysed 55 reported cases. It found that in 17 cases, a causal relationship between vaccination and death was excluded. However, in the remaining cases, the causal link was either unspecified, deemed possible, probable, or demonstrated. The causes of death varied and included vaccine-induced immune thrombotic thrombocytopenia (VITT), myocarditis, acute disseminated encephalomyelitis (ADEM), myocardial infarction, and rhabdomyolysis. The study emphasises the imperative of further investigation, particularly through post-mortem examinations, to comprehend the potential pathophysiological mechanisms of fatal vaccine side effects. Despite these findings, the study underscores that the benefits of vaccination outweigh the risks, highlighting the importance of vaccination in containing the spread of Covid-19.
Doctor Praveen Kumar Kulkarni, Senior Consultant, Internal Medicine Specialist at KIMS Hospitals, Secunderabad, referred to a study, stating, “The results of the causality assessment for 254 reported serious Adverse Events Following Immunisation (AEFI) cases following Covid-19 vaccination, approved by the National AEFI Committee on May 3, 2022, have been thoroughly reviewed and deliberated upon by medical specialists, including cardiologists, neurologists, pulmonary medicine specialists, and obstetrician-gynecologists, who form the causality assessment sub-committee at the national level. A special group had been established to conduct a causality assessment of AEFIs following the Covid-19 vaccination. The results of the causality assessment conducted by this special group were discussed in the national AEFI committee meeting and finally approved.”
Out of the 254 cases assessed, 78 were found to have a consistent causal association with vaccination. Among these, 31 cases were attributed to vaccine product-related reactions, including 2 deaths, while 47 cases were related to immunization anxiety. In all, 122 cases showed an inconsistent causal association with immunization (coincidental – not linked to vaccination), including 83 deaths. A total of 33 cases fell into the indeterminate category, including 1 death, and there were 21 cases in the unclassifiable category, all resulting in death.
The study referred to by doctor Kulkarni highlights, “Vaccine product-related reactions are expected reactions that can be attributed to vaccination based on current scientific evidence, such as allergic reactions and anaphylaxis. Indeterminate reactions are those that have occurred soon after vaccination, but there is no definitive evidence in the current literature or clinical trial data to suggest they were caused by the vaccine. Further observations, analysis, and studies are required. Unclassifiable events are those that have been investigated but lack sufficient evidence for assigning a diagnosis due to missing crucial information. Coincidental events are those reported following immunisation but for which a clear cause other than vaccination is found upon investigation.”
Medical professionals’ perspectives
Doctor Tarun Sahni, Senior Consultant, Internal Medicine, Indraprastha Apollo Hospitals, accentuates, “Traditional vaccine development processes typically follow a well-established pathway, involving preclinical studies, phased clinical trials, regulatory review, and post-market surveillance. This approach ensures a thorough assessment of safety, efficacy, and quality before vaccines are approved for public use. For instance, vaccines like those for measles or polio underwent years of development and testing before widespread implementation. However, the urgency of the Covid-19 pandemic necessitated an expedited timeline for vaccine development. Covishield, developed by AstraZeneca and the University of Oxford, followed a similar process but with accelerated timelines and simultaneous phases. Clinical trials were conducted swiftly, involving tens of thousands of participants across multiple countries. While regulatory approval was expedited in some regions, it still underwent rigorous evaluation.”
The evolving nature of scientific understanding, coupled with the rapid dissemination of information through media and social channels, has further fueled the debate. Conflicting reports, varying interpretations of data, and differing regulatory responses across regions have contributed to the complexity of the discussion.
AstraZeneca has responded to legal proceedings in the United Kingdom by discussing TTS in court filings. The lawsuit against the pharmaceutical giant revolves around claims concerning the health implications associated with the Covid-19 vaccine it co-developed with the University of Oxford during the 2020 pandemic.
Dr. Prasang Bhardwaj, Sri Siddhartha Medical College and Hospital (SSMC), explains, “Thrombotic Thrombocytopenia Syndrome (TTS) is a rare but serious condition characterised by the simultaneous occurrence of blood clots and low platelet levels. It primarily affects individuals who have received certain Covid-19 vaccines, particularly non-replicating viral vector vaccines like Covishield. Symptoms can range from severe headaches and abdominal pain to difficulty in breathing and chest pain. TTS is most commonly observed in younger individuals, particularly women under 60, and typically manifests within 4 to 42 days after vaccination. While the risk of TTS is low, individuals who have received Covishield should remain vigilant for symptoms and seek prompt medical attention if any concerns arise.”
He stresses that, despite the rare occurrence of TTS, the benefits of vaccination in preventing Covid-19 far outweigh the risks associated with this condition. Covishield and similar vaccines have been deemed effective in reducing the severity of illness and preventing hospitalisations. It is essential for individuals to stay informed about potential side effects, communicate with healthcare providers, and adhere to guidelines from health authorities. Continued monitoring and evaluation of vaccine safety profiles are crucial to ensuring public health while managing potential risks associated with vaccination.
Enhanced information accessibility for scrutiny
The recent acknowledgement by AstraZeneca regarding the potential side effects of Covishield has triggered speculation and scrutiny over vaccination certificates in India. Concerns arose when users noticed Prime Minister Modi’s photo missing from some certificates, attributed to the Model Code of Conduct during the ongoing elections. While officials cite procedural reasons, speculation persists, highlighting how digital age discourse fuels conjecture and analysis of every change, underscoring the need for clarity amidst evolving narratives.
Recently, actor Shreyas Talpade suggested his heart attack last year may be linked to the Covishield vaccine, citing fatigue and tiredness post-vaccination. Talpade, 47, experienced a major heart attack in December 2022 and speculates on the vaccine’s possible role amid emerging concerns over side effects. Despite his recovery and return to filming, Talpade raises questions about vaccine safety amidst growing uncertainties.
Gauri Nandan from Indiranagar, Hyderabad, shares her harrowing experience after getting the Covishield vaccine, “Reflecting on those days is horrifying. I opted for the Covishield vaccine, hoping to protect my family. But after the jab, I developed a fever, which I was told was normal. My condition worsened over the days, with a high fever persisting. My husband faced the same. Then came the night when breathing became a struggle. We felt isolated, unable to seek help. Eventually, we improved, but learning about potentially fatal side effects left us shaken. Better information before vaccination could have prevented our ordeal.”
In the midst of legal battles, medical investigations, and public discourse surrounding vaccine-related fatalities, one crucial aspect emerges: the necessity for transparent and accessible information dissemination. The complexities of vaccine safety, coupled with evolving scientific understanding and media scrutiny, underscore the importance of clear communication channels. Proper dissemination of information not only empowers individuals to make informed decisions but also fosters trust in public health measures. As families seek solace and justice for their losses, ensuring transparency in communication could have provided clarity and perhaps mitigated some of the uncertainties surrounding vaccine side effects.
