Coronavirus: Bleeding and clotting events following a vaccine injection in India are “miniscule” and “in line with the expected number of diagnoses of these conditions”, a panel on AEFI (adverse events following immunisation) told the Health Ministry

India has approved three Covid vaccines – Covishield, Covaxin and Sputnik V (File)
New Delhi: The number of bleeding and clotting events following a Covid vaccine injection in India – of which 26 have been identified – are “miniscule” and “in line with the expected number of diagnoses”, a panel on AEFI (adverse events following immunisation) told the Union Health Ministry Monday afternoon.
The panel said it had studied 498 (of 700) “serious and severe events” and found that 26 had been reported as “potential thromboembolic events”, referring to the potentially fatal formation of a blood clot that could break loose and be carried by the blood stream to block another vessel.
The panel further said Covishield – the AstraZeneca-Oxford University vaccine linked by some studies to clotting issues – reported fewer than 0.61 cases per million doses administered.
It was noted that this figure was far below the four cases per million doses reported by the United Kingdom’s health regulator, and the 10 cases per million doses reported by Germany.
The panel also said Covaxin – the vaccine developed by Bharat Biotech – reported “no potential thromboembolic events” following administering of the drug.
“It is important to know that thromboembolic events keep occurring in the general population… background and scientific literature suggests this risk is almost 70 per cent less in persons of South and South East Asian descent in comparison to those from European descent,” the panel said.
National AEFI (Adverse Event Following Immunization) Committee submits report to @MoHFW_INDIA
Bleeding and clotting cases following COVID vaccination in India are minuscule and in line with the expected number of diagnoses of these conditions
PIB India (@PIB_India) May 17, 2021
Nevertheless, the ministry has advised people to be aware of suspected thromboembolic events.
Symptoms to watch out for include breathlessness, pain in the chest or limbs, pinhead-sized red spots or bruising of skin in areas other than the injection site and persistent abdominal pain.
The AEFI report is the result of a government review ordered in early April, after reports of increased thrombosis risk associated with the AstraZeneca vaccine. That was after the European drug regulator said it had found a possible link to rare blood clotting issues in adult recipients.
In March several countries, starting with Denmark and including Venezuela and Indonesia, paused use of the vaccine over adverse events and, in some cases, deaths, linked to a rare clotting disorder.
Following an investigation the European Medicines Agency said “this is a safe and effective vaccine”, but said it “cannot definitively rule out” a link to the rare clotting disorder. The World Health Organization also backed the drug, saying that it was better to take the vaccine than not.
However, a study by scientists in Denmark and Norway, published in the British Medical Journal earlier this month, found slightly increased rates of vein blood clots, including in the brain. But the scientists also also stressed that theirs was a purely observational study, and so cause could not be established.
The AstraZeneca vaccine, or Covishield, as it is known in India, is one of the cheapest shots available today and is widely seen as a key weapon in the fight against COVID-19, particularly for poor nations.
With input from AFP, Reuters