Covishield’s Alleged Health Concerns: Legal Implications and Historical Context

Historical Context: The COVID-19 pandemic, which began in late 2019, led to a global race to develop effective vaccines. AstraZeneca, in collaboration with the University of Oxford, developed one of the earliest vaccines, known as Covishield in India. The Serum Institute of India (SII), the world’s largest vaccine manufacturer, produced this vaccine under license. The rapid development and deployment of vaccines were crucial in combating the pandemic, but they also raised concerns about potential side effects and legal liabilities.

Legal Concerns and Recent Developments: In May, AstraZeneca admitted in a UK court that its COVID-19 vaccine could potentially cause a rare side effect known as Thrombosis with Thrombocytopenia Syndrome (TTS). This admission came after more than 50 individuals claimed that the vaccine led to deaths and serious injuries due to TTS.

Following this revelation, a lawsuit was filed in India against the Serum Institute of India by the parents of Karunya, who died after receiving the vaccine in 2021. Additionally, a public interest litigation was filed in the Supreme Court of India, seeking the establishment of a medical board to investigate the vaccine’s adverse health effects.

Potential Legal Actions: According to Himanshu Vidhani, a partner at Chandiok & Mahajan’s dispute resolution practice, there are several legal avenues available for victims and concerned parties:

1. Product Liability Class Action: Victims can file a class action under the Consumer Protection Act, 2019, seeking damages for the defective vaccine.
2. Complaints under the Drugs and Cosmetics Act: Complaints can be made against the manufacturer and approving authority.
3. Public Interest Litigation: This can be filed to seek an investigation into the vaccine’s health effects and to establish a compensation mechanism for those severely affected.

Challenges in Proving Cases: Vidhani cautions that an admission in a UK court is not sufficient evidence in Indian courts. Complainants must provide concrete evidence linking the vaccine to health effects or death. The standard for criminal charges is even higher, requiring proof of criminal intent and disclosure of pre-market test results.

Defenses by AstraZeneca and SII: AstraZeneca and SII are likely to defend their actions on two main grounds:

1. Medical Necessity: The vaccine’s urgent need during the pandemic outweighed potential adverse effects on a small number of individuals.
2. Rarity of TTS: The incidence of TTS is extremely rare, as admitted by AstraZeneca in the UK court.

SII may also argue that it was not informed of potential adverse impacts, raising questions about the need for independent analysis of the vaccine.

Summary:

• Historical Context: Rapid vaccine development during the COVID-19 pandemic.
• Legal Concerns: AstraZeneca’s admission of potential TTS side effects.
• Lawsuits in India: Filed against SII and public interest litigation in the Supreme Court.
• Legal Actions: Product liability class action, complaints under the Drugs and Cosmetics Act, and public interest litigation.
• Challenges: Need for concrete evidence and high standards for criminal charges.
• Defenses: Medical necessity and rarity of TTS, with potential arguments about independent analysis by SII.

This summary provides a comprehensive overview of the legal implications and historical context surrounding Covishield’s alleged health concerns, aiding students in understanding the complexities of vaccine-related litigation.