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Mrunal Manmay Dash

Bhubaneswar: The Odisha Health and Family Welfare Department on Wednesday issued advisory for the physicians and beneficiaries to report suspected Thrombosis after Covishield vaccine administration.

The State government's AEFI (Adverse Events Following Immunisation) advisory came after Centre wrote to all the states in this regard on May 17.

In a letter to all the District Collectors, the Odisha Health Department stated, “An in-depth analysis of AEFI cases by the National AEFI Committee for Thrombosis & Thrombocytopenic Syndrome (TTS) following COVID-19 vaccination revealed that, there is a miniscule but definite risk of thromboembolic events following the administration of Covishield vaccine.”

“The reporting rate of such event in India is around 0.61/million doses and there are no potential thromboembolic events reported following Covaxin. Although, the incidence of such events is less than expected rate, it is essential for early management and timely reporting of suspected adverse events for investigation and casualty assessment,” the letter said.

The national AEFI Committee has prepared an advisory to vaccine beneficiaries encourage reporting of such events to the Health system, be aware of TTS and seek medical help.

Advisory:

Reports of rare cases of thrombosis (blood clotting) associated with thrombocytopensa (low platelet counts) - Thrombosis and Thrombocytopenla Syndrome (TTS) have been reported globally from some countries following the use of some COVID19 vaccines particularly AstraZeneca vaccine (Covishield In India) and Johnson & Johnson's vaccine, The World Health Organization (WHO) and drug regulators of EU, UK and USA are investigating these reports. A causal relationship between these rare events has not been established at this time though it is considered to be plausible by WHO.

In India, a review of reported 4913 serious and severe AEFI cases by National AEFI Committee shows only a few cases clinically compatible with the diagnosis of TTS have been identified and published in scientific literature shows that thromboembolic phenomenon is almost 70% less in South East Asian population compared to those of European descent.

Information for vaccine beneficiaries

A vaccine beneficiary vaccinated with any of the COVID19 vaccines, particularly Covishield and having one or more of the symptoms mentioned below should be suspected to have Thrombosis and Thrombocytopenia Syndrome.

Symptoms occurring within 20 days after receiving any COVID 19 vaccine (Recipient should report to the health facility where vaccine was administered)

• Shortness of breath

• Chest Pain

• Pain in limbs/pain on pressing the limbs or swelling in the limbs (arm or calf)

• Multiple, pinhead size red spots or bruising of skin in an area beyond the injection site

• Persistent abdominal pain with or without vomiting

• Seizures in the absence of previous history of seizures with or without vomiting

• Severe and persistent headaches with or without vomiting (in the absence of previous history of migraine or chronic headache)

• Weakness/paralysis of limbs or any particular side or part of the body (includes cranial nerve involvements)

• Persistent vomiting without any obvious reason

• Blurred vision/ pain in eyes/Diplopia

• Mental status change/encephalopathy/ depressed level of consciousness

• Any other symptom or health condition which is of concern to the recipient or the family

Contraindications for the administration of Covishield In the context of TTS

Past history of major venous and arterial thrombosis occurring with thrombocytopenia.

“The Ministry of Health and Family Welfare will continue to monitor the safety of all COVID19 vaccines and promote reporting, investigation and monitoring of suspected adverse events. Covishield, the COVID19 vaccine continues to have a definite positive benefit-risk profile, with tremendous potential to mitigate the severity of infection and reduce death due to COVID19 across the world in India. Over 15.3 Crore of doses of Covishield vaccine have been administered as of May 8, 2021,” the Union government said in the advisory

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