Covishield Risks Ignite Legal Challenges

For the first time, pharmaceutical giant AstraZeneca has admitted that its COVID-19 vaccine may cause a rare health condition, legally known as Covishield and Vaxzevria worldwide. The Telegraph reported that this immunization could sometimes result in thrombosis with thrombocytopenia syndrome (TTS), a disease-causing blood clots and low platelets, according to the manufacturer in court documents. There is currently a class action lawsuit against the UK company over claims of death and serious injury caused by its vaccines.

The University of Oxford partnered with AstraZeneca to create this vaccine. The Serum Institute of India (SII) manufactures Covishield under a license from AstraZeneca and distributes it widely throughout India. Nonetheless, on its website’s FAQs, SII listed potential side effects for Covishield, ranging from very common fatigue or nausea to rarer instances of major blood clottings and a low platelet count seen in fewer than one out of every hundred thousand people vaccinated.

What does this mean for India?

According to Statista, an international data and business intelligence platform, over 1.74 billion doses have been administered in India alone as of October 2023, making AstraZeneca vital to the fight against COVID-19. With such heavy reliance on Covishields within its vaccination drive, this legal development could have serious ramifications for the country.

Medico-legal experts suggest that if claimants win, not only in the UK but also globally, there will be an avalanche of similar lawsuits following suit. This might also instill fear among the masses, thereby affecting global immunization campaigns. This is especially true in nations like ours, where the drug regulator waived off even trial mode early on in 2021, so these events can seriously undermine public confidence.

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Alpana Srivastava, a partner at the Desai & Diwanji law firm, expressed her worry over such a scenario taking place in India, saying, “India expedited Covishield from the Serum Institute of India, an AstraZeneca vaccine, without full clinical trials due to emergency authorization. Any news of potential side effects, even if rare, could damage public trust in the vaccine.”

Srivastava also highlighted that those affected by it might sue AstraZeneca on the grounds of the Consumer Protection Act 2019 for compensation towards medical expenses incurred as well as suffering undergone during this period through a class action lawsuit; moreover, there is always a possibility for PIL against our drug regulator questioning approval given recent TTS concerns with Covishield itself. She added: “AstraZeneca may face liabilities as per CDSCO/Drugs and Cosmetics Act/DCGI policy.” Nevertheless, many regulators worldwide still hold the view that the benefits outweigh the risks when using AstraZeneca vaccines.

What is TTS?

TTS stands for Vaccine-Induced Immune Thrombotic Thrombocytopenia, which refers to blood clots along with low platelet count. In the vessel affected, this condition can impair blood flow since clot formation is important while preventing excessive bleeding requires platelets. Researchers have linked VITT (Vaccine-induced immune thrombotic thrombocytopenia) as a subset under TTS caused specifically by AstraZeneca’s vaccine, although nothing seems to distinguish them according to court papers filed recently.

“TTS is a rare side effect of mRNA-based COVID vaccines. It typically involves venous or arterial thrombosis in uncommon sites such as cerebral sinus venous thrombosis (CSVT) or splanchnic thrombosis,” said Dr Tushar Tayal, Lead Consultant, Department of Internal Medicine, CK Birla Hospital, Gurugram. “Symptoms may occur within 4 to 42 days after COVID-19 vaccination and can include severe headache, abdominal pain, backache, nausea, vomiting, vision changes, shortness of breath, leg pain, swelling or bruising under the skin elsewhere than the injection site.”

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“This admission by the company is a significant development in this ongoing lawsuit and highlights potential risks involved with vaccinations,” said Jamie Scott, who sustained permanent brain damage following receipt of the AstraZeneca vaccine in April 2021.

If AstraZeneca accepts that vaccines caused injury or death on certain occasions, then legally accepting liability could lead to substantial compensation payouts. Even though they now acknowledge it, they continue to deny any claims of widespread flaws or exaggerated claims of vaccine efficacy; as of yet, the Indian Government has not made an official response to this issue in light of what AstraZeneca said.

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