Background
Global pharmaceutical giant AstraZeneca has admitted that its AZD1222 vaccine, commonly known as the Covishield vaccine. which is produced under license in India, leads to low platelet counts and the formation of blood clots in very rare cases. This includes a link between the vaccine and thrombosis with Thrombocytopenia Syndrome (TTS), a medical condition that leads to abnormally low platelet levels and the development of blood clots.
AstraZeneca’s Vaccine Formula
The AZD1222 vaccine formula was licensed to the Pune-based Serum Institute of India (SII) during the peak of the coronavirus pandemic on 1 January 2021 by the Drug Controller General of India (DCGI) for the production of vaccine under the local trade name “Covishield” which has since seen over 175 crore doses conducted in India.
AstraZeneca’s Statement
In court documents from February, AstraZeneca denied a direct link between TTS and its covishield vaccine but conceded the possibility of TTS occurrence in “very rare cases.”.
Symptoms and Risks of TTS
Symptoms related to TTS (Thrombocytopenia Syndrome) include breathlessness, chest or limb pain, pinhead-sized red spots or bruising beyond the injection site, headaches, and numbness in body parts. TTS can lead to blood flow restriction due to clotting, potentially resulting in serious complications like stroke, heart attack, or respiratory problems.
Symptoms of TTS (Thrombocytopenia Syndrome)
- Symptoms of TTS may include
- Severe or persistent headaches
- blurred vision
- Shortness of breath
- Chest pain
- Leg swelling
- and persistent abdominal pain
- Easy bruising or tiny blood spots under the skin beyond the injection site
Legal Proceedings and Admission
Since there are multiple lawsuits filed against AstraZeneca and its COVISHIELD continuing side effects faced by people at England. This admission by AstraZeneca comes as a result of legal proceedings in the United Kingdom, where the pharmaceutical giant is facing a lawsuit over multiple health claims associated with its vaccine, developed in collaboration with the University of Oxford during the Covid-19 pandemic.
Court Case Details
The case, brought forward by Jamie Scott from UK, a father of two who suffered a permanent brain injury after receiving the vaccine in April 2021, highlighted a series of similar claims. The Telegraph reported that fifty-one cases have been filed in the UK’s High Court, with claimants and their families seeking damages estimated to be worth up to £100 million.
Early Concerns and WHO Acknowledgment
The concerns regarding TTS surfaced much earlier, though it’s the first time AstraZeneca has confirmed the link between TTS and its vaccines. Before the rollout of Covid-19 vaccines in India, the government issued a fact sheet in January 2021, urging caution for individuals with low platelet counts when administering Covishield.
European countries like Denmark, Norway,, and Iceland suspended the use of the AstraZeneca vaccine in March 2021 due to reported cases of blood clotting, prompting the World Health Organization (WHO) to accept TTS cases associated with both Covishield and Vaxzevria (another trade name for AstraZeneca’s vaccine). Despite this, the WHO emphasized a very low risk, estimating around four cases per million adults who receive the vaccine.
Situation in India and Covaxin is better than Covishield vaccine
In India, by May 2021, 26 potential thromboembolic events had been reported since the Covishield usage, translating to 0.61 cases per million doses. However, recent data from the government’s records, on Adverse Events Following Immunization (AEFI) confirms at least 36 TTS cases linked to Covishield, with 18 deaths reported. The Union Health Ministry described the risk as “minuscule,” stating Covishield’s significant benefits in preventing Covid-19 infections and reducing deaths.
Unlike the Covishield vaccine, India’s Bharat Biotech’s indigenous vaccine, Covaxin has not reported any potential thromboembolic events. The Health Ministry also pointed out a lower risk of blood clotting among individuals of South and Southeast Asian descent compared to those of European descent. In 2023, the WHO incorporated vaccine-induced immune thrombotic thrombocytopenia (VITT) into its classification of TTS.
