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Bleeding and clotting events following COVID-19 vaccination 'minuscule', says govt panel

The National AEFI Committee found that till April 3, 26 incidents of potential thromboembolic cases (blood clotting) following the administration of the Covishield vaccine were reported in India, with a reporting rate of 0.61 cases/ million doses.

May 17, 2021 / 06:38 PM IST
A vial of the Oxford University-AstraZeneca COVID-19 vaccine, which is produced in India and marketed as Covishield (Image: Reuters/Gleb Garanich)

A vial of the Oxford University-AstraZeneca COVID-19 vaccine, which is produced in India and marketed as Covishield (Image: Reuters/Gleb Garanich)

The National Committee on Adverse Events Following Immunization (AEFI) informed the Union Ministry of Health and Family Welfare that very few cases of blood clotting associated with COVID-19 vaccination have been reported in India.

In a report submitted on May 17, the National AEFI committee said that “bleeding and clotting cases following COVID-19 vaccination in India are minuscule and in line with the expected number of diagnoses of these conditions in the country”.

The National AEFI committee noted that, as of April 3, 75,435,381 coronavirus vaccine doses had been administered in India -- 68,650,819 doses of Covishield and 6,784,562 doses of Covaxin. Of these, 65,944,106 were first doses and 9,491,275 were second doses.

Since the COVID-19 vaccination drive started in India on January 16, over 23,000 adverse events have been reported through the CO-WIN platform. Of these, only 700 cases -- or 9.3 cases /million doses administered -- were found to be serious and severe.

An in-depth review of 498 of these serious and severe events was conducted by the national AEFI Committee. They found that there were 26 incidents of potential thromboembolic cases (blood clotting) following the administration of the Covishield vaccine, with a reporting rate of 0.61 cases/ million doses. However, there were no potential thromboembolic events reported following the administration of Bharat Biotech’s Covaxin coronavirus vaccine.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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As per AEFI data, India showed a very minuscule but definitive risk of thromboembolic events with a reporting rate of around 0.61/million doses, as against 4 cases/million reported by United Kingdom’s regulator Medical and Health Regulatory Authority (MHRA). Germany has reported 10 events per million doses.

The report was prepared by the AEFI committee after alerts were raised in some countries on post-vaccination “embolic and thrombotic events” on March 11, 2021, particularly with regard to the AstraZeneca-Oxford vaccine.

The Union Health Ministry will separately issue advisories to Healthcare Workers and Vaccine Beneficiaries to raise awareness on suspected thromboembolic symptoms occurring within 20 days after receiving any COVID-19 vaccine (particularly Covishield).

Here are some of the symptoms to watch out for:

Breathlessness

Chest Pain

Pain in limbs/pain on pressing limbs or swelling in 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 headache with or without vomiting (in the absence of previous history of migraine or chronic headache)

Weakness/paralysis of limbs or any side or part of the body (including face)

Persistent vomiting without any obvious reason

Blurred vision or pain in eyes or having double vision

Change in mental status or having confusion or depressed level of consciousness

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

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Moneycontrol News
first published: May 17, 2021 03:25 pm

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