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 AstraZeneca Acknowledges Covishield Vaccine’s Potential Side Effects

Context:

AstraZeneca, the manufacturer of the Covishield vaccine for the Covid-19 pandemic, has admitted that the inoculation carries potential side effects. This admission was made in a legal document presented before the High Court of Justice in London. The document conveys that the Covid vaccine can, in extremely rare cases, induce Thrombosis with Thrombocytopenia Syndrome (TTS).

Relevance:

GS II: Health

Dimensions of the Article:

  1. AstraZeneca’s Position on Thrombosis with Thrombocytopenia Syndrome (TTS)
  2. Covishield: An Overview
  3. Thrombosis with Thrombocytopenia Syndrome (TTS)

AstraZeneca’s Position on Thrombosis with Thrombocytopenia Syndrome (TTS)

  • AstraZeneca’s statements regarding Thrombosis with Thrombocytopenia Syndrome (TTS) were made in court documents filed in the United Kingdom in response to a lawsuit against the company. Here’s a summary of their remarks:
    • AstraZeneca is facing legal action over health claims related to the vaccine it developed with the University of Oxford during the Covid-19 pandemic in 2020.
    • In the court documents, AstraZeneca denied that TTS is caused by the vaccine on a broad scale.
    • However, the company acknowledged the possibility of TTS occurring as a result of its vaccination, albeit in “very rare cases.”

Covishield: An Overview

Development and Production

  • Developed by AstraZeneca in collaboration with the University of Oxford.
  • In India, marketed under the brand name Covishield, manufactured by the Serum Institute of India (SII) in Pune.

Administration in India

  • Vaccination commenced in India on January 16, 2021.
  • Notable observations:
    • Indian government issued a caution regarding its administration in individuals with thrombocytopenia.
    • Thromboembolic events reported at a rate of 0.61 cases per million doses.
    • Covishield continues to have a positive benefit-risk profile according to the Union Health Ministry.

International Concerns and WHO Observations

  • European countries temporarily paused the use of AstraZeneca vaccine due to reported cases of blood clotting.
  • World Health Organization (WHO) noted cases of Thrombosis with Thrombocytopenia Syndrome (TTS) post-Covishield vaccinations.
  • WHO stated that while TTS risk with Covishield vaccines appears low based on available data.

Thrombosis with Thrombocytopenia Syndrome (TTS)

Definition and Characteristics

  • Rare condition characterized by blood clot formation (thrombosis) and low platelet counts (thrombocytopenia).
  • Associated with certain COVID-19 vaccines, particularly those using adenovirus vectors like Covishield.
    • Adenovirus vectors are non-enveloped, double-stranded DNA Virus that are commonly used for gene therapy, vaccination, and cancer gene therapy. 
    • They are considered the most efficient gene delivery vehicles due to their safety profile and expression.

Mechanism and Hypotheses

  • Mechanism not fully understood but hypothesized to involve vaccine-triggered immune response leading to platelet activation and clot formation.
  • Resembles autoimmune heparin-induced thrombocytopenia, involving heparin-triggered immune response.

Symptoms and Complications

  • Symptoms include breathlessness, chest or limb pain, skin bruising beyond the injection site, headaches, numbness, etc.
  • Complications depend on clot location, including stroke, heart attack, and respiratory issues.

Risk Factors

  • Factors predisposing individuals to TTS include age, gender (more common in younger women), and potentially genetic factors.

-Source: Indian Express, The Hindu


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