At least 26 cases of bleeding and clotting events have increased following the Covid-19 vaccine injection in India. These are identified as "minuscule" and in line with the expected number of diagnoses of these conditions in the country, says a report submitted by a panel of the National AEFI (Adverse Event Following Immunization) Committee to the Ministry of Health & Family Welfare.
The panel stated that it has studied 498 of 700 serious events and found that 26 had been reported as "potential thromboembolic events". This is referred to as a potentially deadly form of a blood clot that could break loose and be carried by the bloodstream to block another vessel.
Some countries were cautioned about the events on post-vaccination, particularly with the AstraZeneca-Oxford vaccine (Covishield in India). Right after a decision to conduct an urgent strong analysis of the adverse events in India after the global concerns were raised.
The National AEFI committee noted that as of 3 April 2021, 75,435,381 vaccine doses had been administered (Covishield – 68,650,819; Covaxin – 6,784,562). Of these, 65,944,106 were first doses and 9,491,275 second doses. Since the COVID-19 vaccination drive was initiated – more than 23,000 adverse events were reported through the CO-WIN platform reported from 684 of the 753 districts of the country. Of these, only 700 cases (@ 9.3 cases /million doses administered) were reported to be serious and severe.
Covishield vaccine is linked to clotting issues by some studies which have been reported in as less than 0.61 cases per million doses administered, the panel added. Whereas were no potential thromboembolic events reported following administration of the Covaxin vaccine.
"It is important to know that thromboembolic events keep occurring in the general population... background and scientific literature suggest this risk is almost 70 per cent less in persons of South and South-East Asian descent in comparison to those of European descent," the panel said.
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The ministry has advised people to be aware of the suspected thromboembolic events. Symptoms that need to be watched for are 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.
Covishield vaccine continues to have a positive benefit-risk profile with huge potential to prevent infections and reduce deaths due to COVID-19 across the world and in India, said a statement by the Health Ministry.
More than 13.4 crore doses of the Covishield vaccine have been given as of 27 April 2021 in India, the ministry said, adding that it is constantly monitoring the safety of all COVID-19 vaccines and is promoting reporting of suspected adverse events.
AstraZeneca had earlier said that a possible link to rare blood clotting issues in adult recipients after vaccination was reported in several countries like Denmark, Indonesia. The firm said though the vaccine is safe and effective, the link to clotting disorder cannot be ruled out.
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However, scientists in Denmark and Norway published a study in the British Medical Journal earlier this month, which have discovered insignificantly increased vein blood clots including in the brain. Yet stressing on the point that theirs was a purely observational study, scientists said the cause could not be established.