THROMBOCYTOPENIA SYNDROME (TTS)

2. AstraZeneca's Statements on Thrombosis with Thrombocytopenia Syndrome (TTS)

• AstraZeneca, in response to a lawsuit filed against the company in the United Kingdom over its COVID-19 vaccine developed in collaboration with the University of Oxford, addressed the issue of Thrombosis with Thrombocytopenia Syndrome (TTS) in court documents.
• The report highlighted that a total of fifty-one cases have been filed in the UK High Court, with affected individuals and their families seeking damages amounting to an estimated £100 million.
• In court documents dated February, AstraZeneca stated that it does not believe TTS is caused by the vaccine at a generic level. However, the pharmaceutical giant acknowledged the potential for TTS to occur as a result of its vaccination, albeit in "very rare cases".

Thrombosis with Thrombocytopenia Syndrome (TTS) is associated with a variety of symptoms, including:

1. Breathlessness
2. Chest or limb pain
3. Pinhead-size red spots or bruising of the skin beyond the injection site
4. Headaches
5. Numbness in body parts

TTS can result in a restriction of blood flow due to clotting, leading to various complications depending on the location of the thrombosis.  Thrombosis can block blood flow in both veins and arteries, with serious complications including stroke, heart attack, and severe breathing problems.

4. Emergence of Concerns Regarding TTS and AstraZeneca Vaccines

• The concerns surrounding Thrombosis with Thrombocytopenia Syndrome (TTS) and its potential link to AstraZeneca's vaccines have been present for some time but have garnered significant attention recently due to AstraZeneca's confirmation of the association.
• Before the rollout of COVID-19 vaccines in India, the Indian government issued a fact sheet in January 2021 cautioning against administering Covishield, the Indian variant of AstraZeneca's vaccine, to individuals with thrombocytopenia, a condition characterized by low platelet counts.
• In March 2021, several European countries, including France, Germany, Italy, and others, temporarily suspended the use of the AstraZeneca vaccine following reports of blood clotting in some individuals.
• Subsequently, the World Health Organization (WHO) acknowledged the occurrence of TTS in a few cases following vaccinations with Covishield and Vaxzevria, another trade name for AstraZeneca's vaccine.
• However, the WHO emphasized that the risk of TTS associated with these vaccines appears to be very low, with approximately four cases per million adults in the UK and an estimated rate of around 1 per 100,000 in the European Union (EU).

• In May 2021, the Indian government disclosed that 26 potential thromboembolic events, involving the formation of blood clots in blood vessels, had been reported following the administration of Covishield.
• Considering the initiation of vaccine administration on January 16, 2021, and the total number of doses administered up to that point, the incidence rate of potential thromboembolic events was calculated at 0.61 cases per million doses or a percentage of 0.000061.
•  More recent data from the government's committee on Adverse Events Following Immunization (AEFI) revealed that at least 36 cases of Thrombosis with Thrombocytopenia Syndrome (TTS) were vetted and confirmed to be associated with Covishield. Of these cases, 18 resulted in fatalities. These TTS incidents primarily occurred in 2021, the inaugural year of COVID-19 vaccination in India.
• The Union Health Ministry characterized the possibility of TTS associated with Covishield as "minuscule," affirming the vaccine's positive benefit-risk profile.
• It emphasized Covishield's efficacy in preventing COVID-19 infections and reducing related mortality rates.
• Additionally, the Ministry noted the absence of reported thromboembolic events associated with Covaxin, India's indigenous vaccine produced by Bharat Biotech.
• Furthermore, it highlighted scientific literature suggesting a lower risk of blood clotting in individuals of South and Southeast Asian descent compared to those of European descent.
• In 2023, the World Health Organization (WHO) included vaccine-induced immune thrombotic thrombocytopenia (VITT) within its classification of Thrombosis with Thrombocytopenia Syndrome (TTS), acknowledging the potential link between specific vaccines and this rare adverse event.