Pune-based Serum Institute of India (SII), the manufacturer of Covishield, finds itself potentially entangled in legal troubles as the parents of a 21-year-old woman, who allegedly died ten days after receiving the vaccine in 2021, are contemplating suing both the company and UK-based AstraZeneca, the developer of the jab.

The British pharmaceutical giant is already under legal scrutiny in the UK, facing claims in at least 51 cases alleging that its vaccine caused deaths and severe injuries. AstraZeneca recently admitted that its vaccine can, in very rare cases, lead to Thrombosis with Thrombocytopenia Syndrome (TTS).Covishield, derived from the AstraZeneca COVID-19 vaccine, was extensively administered in India. However, SII, based in Pune, has not yet responded to reports of impending legal action. Interestingly, the Union Health Ministry too has chosen to remain silent despite mounting criticism and concerns among Covishield recipients on social media. The Opposition parties like those from Congress, Samajwadi party and AAP have also criticized the Government following AstraZeneca’s admission in a 100 million pound class action lawsuit.

Venugopalan Govindan, who tragically lost his daughter, Karunya, expressed dissatisfaction with AstraZeneca’s belated admission, stating that it came after numerous lives had already been lost. He criticized SII for not halting vaccine supply after 15 European countries restricted its usage due to reported deaths from blood clots in March 2021. Despite their efforts to seek justice, grieving parents have struggled to get a hearing in various courts.

“The manufacturer SII, the government who advertised these vaccines throughout the nation at huge expense to exchequer as ‘safe and effective’ without sufficient data (and when data emerged about the adverse events from around the world, they chose not to stop the rollout or at least sensitise people and medical fraternity about it), the regulatory bodies that approved it and subsequently didn’t intervene to stop it when data emerged about the dangers, are all culpable in the death of my daughter and countless others who have died after taking this so called vaccine,” read Govindan’s post which has gone viral since AstraZeneca submission that its Covid jab can cause blood clotting.

Venugopalan Govindan initiated a petition titled ‘Post-vaccination side effects - Blood clots, MIS-A etc. Awareness required’ soon after his daughter’s demise in 2021. In his post, he held SII, the government, regulatory bodies, and others responsible for his daughter’s death and those of others who died after receiving the vaccine.

The national committee formed by the government concluded that there was insufficient evidence to link her death to the vaccine. India’s vaccination campaign began on January 13, 2021, administering Covaxin and Covishield. Covishield received approval for use in 49 other countries. As of April 29, 2024, India has administered 1,749,417,978 doses of Covishield, making it the world’s largest vaccination program.

Symptoms of TTS, a rare condition associated with Covishield, include severe headaches, abdominal pain, leg swelling, or shortness of breath, usually appearing two weeks post-vaccination. Timely identification and intervention are crucial in mitigating severe consequences.

India’s vaccine arsenal during the pandemic included Covaxin, Covishield, Sputnik-V, Covovax, Corbevax, ZyCoV-D, among others. Soon after the UK vaccine manufacturer’s jab which is being sold as Covishield in India came under legal tangle, Bharat Biotech, based in Hyderabad, emphasized Covaxin’s safety. It issued statement that it’s vaccine underwent meticulous evaluation and demonstrated an excellent safety record during its licensure process

The vaccine maker also said that Covaxin was the only Covid-19 vaccine in the government’s Covid-19 immunisation programme to have conducted efficacy trials in India.

“Covaxin was evaluated in more than 27,000 subjects as part of its licensure process. It was licensed under restricted use in clinical trial mode, where detailed safety reporting was carried out for several hundred thousand subjects,” Bharat Biotech said.