In a significant development, British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca has acknowledged that its COVID vaccine, Covishield, can cause a rare side effect known as Thrombosis with Thrombocytopenia Syndrome (TTS). This admission comes amidst a class action lawsuit in the UK, with 51 cases filed against the company, alleging that its vaccine caused deaths.
Covishield, developed by AstraZeneca and produced by the Serum Institute of India, was one of the widely administered COVID vaccines in India. The vaccine has been at the center of controversy, with several health experts questioning its rare side effects.
What is TTS?
Thrombosis with thrombocytopenia syndrome (TTS) is a rare but serious condition characterized by blood clot formation (thrombosis) coupled with low platelet counts (thrombocytopenia). TTS typically manifests with symptoms such as severe headaches, abdominal pain, leg swelling, shortness of breath, and neurological deficits. Diagnosis involves blood tests to assess platelet levels and imaging studies to detect blood clots.
Treatment for TTS involves a multidisciplinary approach, including hospitalization, anticoagulation therapy to prevent further clotting, and supportive care. Intravenous immunoglobulin (IVIG) and plasma exchange may also be utilized to stabilize platelet levels and manage immune-mediated reactions. Healthcare providers closely monitor patients with TTS due to the potential for severe complications, including organ damage and death. Prompt recognition and management are essential for improving outcomes in individuals affected by this rare but critical syndrome.
AstraZeneca’s Admission
In court papers, AstraZeneca has admitted that Covishield can “in very rare cases, cause TTS.” This admission has sparked concerns about the safety of the vaccine, with many questioning the company’s transparency in disclosing potential side effects.
Expert Insights
Medical expert Dr. Rajeev Jayadevan explained that TTS is a known rare side effect of certain vaccines, including adenovirus vector vaccines like Covishield. “Although COVID vaccines have prevented numerous deaths, reports of these extremely rare but potentially serious immune-mediated events have also been published in reputed journals,” Dr. Jayadevan added.
WHO’s Stance
In 2023, the World Health Organisation (WHO) reported that TTS emerged as a new adverse event following immunization in individuals vaccinated with COVID-19 non-replicant adenovirus vector-based vaccines, including the AstraZeneca COVID-19 ChAdOx-1 vaccine and the Johnson & Johnson (J&J) Janssen COVID-19 Ad26.COV2-S vaccines.
AstraZeneca’s Response
AstraZeneca has reaffirmed the safety of its vaccine, stating that patient safety is its highest priority. “Our sympathy goes out to anyone who has lost loved ones or reported health problems. Regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines,” an AstraZeneca spokesperson said.
The company emphasized that the benefits of the COVID-19 vaccine far outweigh the risks of extremely rare potential side effects. “From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile,” the statement said. “Regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects,” it added.
The COVID-19 Pandemic
The COVID-19 pandemic, caused by the novel coronavirus SARS-CoV-2, emerged in late 2019, triggering a global health crisis. The virus spreads primarily through respiratory droplets, leading to a range of symptoms from mild respiratory illness to severe pneumonia and death, particularly in vulnerable populations. Governments worldwide implemented various measures such as lockdowns, mask mandates, and vaccination campaigns to curb transmission.
As the pandemic continues to evolve, the importance of vaccine safety and transparency cannot be overstated. AstraZeneca’s admission of the rare side effect of its COVID vaccine, Covishield, serves as a reminder of the need for continued vigilance and monitoring of vaccine safety.