What is Covishield Controversy? (GS Paper 3, Science & Technology)
Context
- Recently, the British pharmaceutical company AstraZeneca has acknowledged in court documents submitted to the High Court in London that its COVID-19 vaccine, developed in collaboration with the University of Oxford, can cause Thrombosis with Thrombocytopenia Syndrome (TTS) in very rare cases.
- This admission comes as AstraZeneca faces a class-action lawsuit in the UK, with claimants alleging that the vaccine has caused fatalities and severe injuries.
About Thrombosis with Thrombocytopenia Syndrome (TTS)
- TTS is a rare condition characterized by the formation of blood clots (thrombosis) accompanied by low platelet count (thrombocytopenia).
- Symptoms of TTS may include breathlessness, chest pain, pinhead-sized red spots or bruising on the skin, headaches, and numbness in body parts.
- TTS can lead to serious complications such as stroke, heart attack, and severe breathing problems, depending on the location of the blood clot.
AstraZeneca’s Admission and Lawsuit
- In court documents, AstraZeneca stated that the vaccine “can, in very rare cases, cause TTS,” but the causal mechanism is unknown.
- The company is facing a class-action lawsuit in the UK, with 51 cases lodged in the High Court, and victims and grieving relatives seeking damages estimated to be worth up to £100 million.
- AstraZeneca maintains that patient safety is its highest priority and that regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines.
Previous Concerns and Regulatory Responses
- Concerns about the potential link between AstraZeneca’s vaccine and TTS have been raised in the past, with several European countries temporarily pausing the use of the vaccine in March 2021.
- The World Health Organization (WHO) and regulatory authorities have acknowledged the risk of TTS but have stated that the benefits of vaccination outweigh the risks of extremely rare potential side effects.
- In India, where AstraZeneca’s vaccine is manufactured and sold under the brand name Covishield by the Serum Institute of India, the product information includes a warning about the risk of TTS.
Impact and Perspective from Doctors
- Doctors in India have stated that the information about the potential risk of TTS is not new and that they have been aware of the warning since the vaccine’s introduction.
- They emphasize that any adverse events associated with the vaccine would have occurred within 21 days to a month of the first dose and that the vaccine has protected millions of people from severe COVID-19.
- Doctors also highlight that COVID-19 itself is known to increase the risk of clotting, heart attacks, and stroke, both during and after recovery.
