According to The Telegraph, the vaccine’s manufacturer claimed in court filings that there was a chance the shot may occasionally cause thrombosis with thrombocytopenia syndrome (TTS), a condition that causes blood clots and a low platelet count.
For the first time, the multinational pharmaceutical company AstraZeneca has formally admitted that the COVID-19 vaccine it sells under the trade names Covishield and Vaxzevria may cause an uncommonly serious health complication.
According to The Telegraph, the vaccine’s manufacturer claimed in court filings that there was a chance the shot may occasionally cause thrombosis with thrombocytopenia syndrome (TTS), a condition that causes blood clots and a low platelet count. The company is presently dealing with a class action lawsuit in the UK due to claims that AstraZeneca’s vaccine resulted in fatalities and serious injuries.
The University of Oxford and AstraZeneca worked together to create the vaccine. Under a license from AstraZeneca, the Serum Institute of India (SII) produces Covishield in India. In India, SII has made this vaccination widely available. On the FAQ section of their website, SII, however, has mentioned possible side effects of Covishield. These vary from extremely frequent adverse effects, such as exhaustion and nausea, to extremely uncommon ones, such as significant blood clotting combined with low platelet count, which affect less than one in every 100,000 vaccinated people.
What does India stand to gain from the development?
According to Statista, a worldwide statistics and business intelligence website, over 174 crore doses of the AstraZeneca vaccine will have been given by October 2023, making it a crucial tool in India’s fight against Covid-19. Given how heavily Covishield is used in India’s immunization campaign, this legal change will have a big impact on the nation.
Regarding possible consequences, medico-legal specialists say that a successful resolution for the plaintiffs might spark a wave of such cases not only in the UK but across the globe. The decision may potentially have an effect on the global vaccination campaign by making people more skeptical and hesitant. These events could have a major effect on public trust in the vaccine, especially in India, where Covishield was licensed for emergency use in early 2021 and the drug regulator waived the vaccine’s trial mode.
Desai & Diwanji’s partner, Alpana Srivastava, voiced reservations regarding the state of affairs in India. “Due to emergency authorization, India accelerated Covishield, the AstraZeneca vaccine from Serum Institute of India, without completing comprehensive clinical trials. Even a small number of possible side effects could undermine public confidence in the vaccine, according to Srivastava.
As a result of claims connecting TTS to Covishield, Srivastava issued a warning about possible lawsuits taken by impacted parties against AstraZeneca. She clarified, citing the Consumer Protection Act, 2019 as a legal avenue, “If many in India experience TTS post-Covishield and hold AstraZeneca accountable, a class action lawsuit could seek compensation for medical expenses and suffering.”
In addition, Srivastava raised the prospect of filing a Public Interest Litigation (PIL) challenging the clearance of Covishield in light of new TTS concerns, directed at India’s pharma regulator. She continued, “AstraZeneca may be liable under the CDSCO, the Drugs and Cosmetics Act, and DCGI policy.” Many regulatory bodies across the world continue to hold the view that the advantages of the AstraZeneca vaccination currently exceed the drawbacks.
What is TTS?
Vaccine-induced immune thrombotic thrombocytopenia (VITT) is the term used to describe blood clots that are associated with a lowered platelet count. Because platelets are essential for the production of clots and the control of excessive bleeding, this disease may obstruct blood flow in the vascular injury. VITT is thought to be a subtype of TTS, and researchers have linked the AstraZeneca vaccination to it. Nevertheless, it doesn’t seem that AstraZeneca makes this distinction in their court filings.
TTS is an uncommon adverse reaction to COVID vaccines based on mRNA. Venous or arterial thrombosis, particularly at atypical sites such as cerebral sinus venous thrombosis (CSVT) or splanchnic thrombosis, is its characteristic. According to Dr. Tushar Tayal, Lead Consultant, Department of Internal Medicine, CK Birla Hospital, Gurugram, “Symptoms usually appear 4 to 42 days after COVID-19 vaccination and include intense headache, abdominal pain, back pain, nausea, vomiting, vision changes, shortness of breath, leg pain, swelling, and bleeding.” The frequency could reach up to 10 per million vaccinated people. Low platelet counts and high d-dimer levels—which suggest the possibility of blood clot formation or thrombosis in the body—are frequently found in blood tests. TTS is a medical emergency that needs immediate medical intervention because of its high mortality rate, the doctor stated.
This official admission by the business highlights the possible dangers connected to vaccination and is an important step forward in the continuing legal dispute. Jamie Scott, the original plaintiff in the lawsuit, suffered irreversible brain injury after being vaccinated against AstraZeneca in April 2021.
Furthermore, the legal admission could lead to significant compensation payouts in the event that AstraZeneca recognizes the claim of vaccine-induced injuries or fatalities in particular cases. AstraZeneca disputes claims of widespread vaccination flaws or exaggerated efficacy, notwithstanding the acknowledgement. The Indian government hasn’t released a formal comment in reaction to AstraZeneca’s admission yet.