AstraZeneca has acknowledged that its vaccine may lead to clotting, but there’s no need for panic among Covishield vaccine recipients in India.

AstraZeneca has acknowledged that its vaccine may lead to clotting, but there’s no need for panic among Covishield vaccine recipients in India.

AstraZeneca, a leading global pharmaceutical firm, has acknowledged a rare side effect associated with its Covid-19 vaccine, which was developed in collaboration with researchers from Oxford University. This side effect involves blood clotting and low platelet count following immunization. In India, the same vaccine, known as Covishield and produced by the Serum Institute in Pune, has been widely administered, totaling 175 crore doses. Understandably, this revelation prompts concerns about the safety of the vaccine that many of us have received.

The acknowledgment of this side effect, termed Thrombosis with Thrombocytopenia Syndrome (TTS), came during a legal proceeding where AstraZeneca is facing a lawsuit alleging severe harm and fatalities linked to the vaccine, as reported by The Daily Telegraph. While this may mark the company’s first formal admission in court, instances of TTS have been extensively documented and recognized in scientific literature. Reports of TTS emerged shortly after vaccination campaigns began in Europe, prompting some countries to temporarily halt the use of the AstraZeneca vaccine.

The implications of the case for Covishield users in India are significant.

The Government committee on Adverse Events Following Immunisation (AEFI) reviewed approximately 36 cases of TTS and confirmed 18 deaths attributed to it in 2021, marking the inaugural year of Covid-19 vaccination in the nation. However, Indian individuals affected by this condition are unlikely to participate in the British petition due to legal complexities, including differing regulatory approvals and the fact that the vaccine is produced by an Indian company, thus falling under Indian jurisdiction and laws.

Why is there no cause for alarm?

According to experts, while TTS was early on reported by European nations during the pandemic, its occurrence in India remained exceptionally rare. A senior health ministry official involved in the vaccination campaign discussions stated, “TTS is an extremely rare side effect, even rarer among Indians and South Asians compared to Europeans. Nonetheless, there is substantial evidence indicating that vaccination has been instrumental in saving lives—its benefits far outweigh the associated risks.”

Furthermore, the likelihood of encountering the risk is not only uncommon but primarily elevated within the initial weeks following the first vaccination. According to Dr. Gagandeep Kang, Director of Global Health at the Bill and Melinda Gates Foundation and a member of the WHO safety advisory committee for COVID-19 vaccines, “It’s crucial to emphasize that the risk of TTS is most prevalent shortly after vaccination. Given that most individuals have already received three doses and a significant amount of time has elapsed, we are well beyond the vaccination phase.”

Dr. Anurag Agarwal, Dean of Biosciences and Health Research at the Trivedi School of Biosciences of Ashoka University, notes the current reaction as surprising. He emphasizes that the rare side effect had been thoroughly documented and scientifically acknowledged during the vaccination campaigns. At the peak of the pandemic, the benefits of vaccination were deemed to outweigh the associated risks.

Moreover, the package insert accompanying Covishield consistently includes a cautionary note regarding a rare condition. It states, “A very rare and serious (side effect) … has been observed following vaccination with ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) during post-authorisation use… Cases have occurred in patients with a previous history of thrombosis, as well as in patients with autoimmune disorders. The benefits and risks of vaccination should be considered in these patients.”

According to a study published in Lancet Global Health in 2022, AstraZeneca reported rates of 8.1 TTS cases per million for the first dose and 2.3 TTS cases per million for the second dose. Additionally, the study revealed geographical disparities in TTS reporting, with Nordic countries reporting the highest incidence (17.6 per million doses) and Asian countries reporting the lowest (0.2 per million doses).

Dr. Agarwal advises against immediate vaccination for the majority of individuals presently. He emphasizes that the antibody levels among the Indian population are currently elevated despite the circulation of the virus. Consequently, vaccination is deemed unnecessary unless an individual is severely immunocompromised. In such cases, Dr. Agarwal suggests opting for newer vaccines capable of safeguarding against emerging COVID-19 variants like Omicron. Additionally, he suggests considering alternative vaccines for younger women who face lower risks of severe illness at this time.

AstraZeneca’s Covishield vaccine has been associated with a rare blood clot disorder known as Vaccine-induced Thrombotic Thrombocytopenia (VITT).

TTS, or vaccine-induced immune thrombotic thrombocytopenia (VITT), is a medical condition characterized by the simultaneous occurrence of blood clots (thrombosis) and a low count of blood platelets (thrombocytopenia). Thrombosis refers to the formation of a clot within a blood vessel, which can potentially impede blood flow. Thrombocytopenia indicates a shortage of platelets in the blood, which are essential for proper blood clotting and preventing excessive bleeding.

TTS often manifests with atypical blood clotting, particularly in critical areas such as the brain (cerebral venous sinus thrombosis) or abdomen. Symptoms of TTS can be serious and include severe or persistent headaches, blurred vision, chest pain, shortness of breath, leg swelling, or continual abdominal discomfort. Furthermore, individuals should be vigilant for signs such as easy bruising or small blood spots beneath the skin, extending beyond the injection site, which could indicate the presence of TTS.

In 2023, the World Health Organization (WHO) underscored TTS as a significant adverse outcome subsequent to the administration of Covid-19 vaccines utilizing non-replicating adenovirus vectors. These vaccines encompass the AstraZeneca Covid-19 ChAdOx-1 vaccine and the Johnson & Johnson (J&J) Janssen Covid-19 Ad26.COV2-S vaccines.

The emergence of this situation began with a class action lawsuit in the UK targeting AstraZeneca, alleging that its vaccine was linked to multiple fatalities and serious injuries. According to The Telegraph, legal proceedings highlighted claims that the AstraZeneca Covid-19 vaccine had adverse effects, impacting several families.

The inaugural case was documented in 2023 by Jamie Scott, who had been administered the vaccine in April 2021. Following his inoculation with AstraZeneca’s vaccine, Scott asserted that he suffered a lasting brain injury due to the formation of a blood clot and cerebral hemorrhage, which left him incapable of working. Kate, Scott’s spouse, stated, “The medical community has long recognized that vaccine-induced immune thrombocytopenia and thrombosis [VITT] were triggered by the vaccine.” However, AstraZeneca conveyed to Scott’s legal representatives in May 2023 that they do not universally acknowledge TTS as being caused by the vaccine. Despite AstraZeneca disputing the claims, it has conceded that its Covid vaccine “can, in very rare instances, lead to TTS”.

Scott’s wife has firmly requested an apology and fair reparation for their family and others impacted. She expressed that it took three years for any acknowledgment to come forth. “We stand with truth, and we won’t relent,” she asserted.

Regarding the litigation against AstraZeneca concerning its Covid vaccine, the latest report indicates that 51 cases have been brought to the High Court by affected individuals and their families. They are seeking compensation estimated to reach as high as £100 million.

In a legal submission made in February, AstraZeneca informed the court that its vaccine could, in rare cases, result in TTS (thrombosis with thrombocytopenia syndrome). However, the pharmaceutical company acknowledged that the exact causal mechanism behind this occurrence remains unknown.

refer: ndtv.com/india-news/parents-plan-to-sue-vaccine-maker-after-astrazeneca-admits-side-effects