AstraZeneca’s Covishield and Bharat Biotech International’s Covaxin have come under serious scrutiny, a day after European and UK regulators hinted at a possible link between the vaccine and some recent incidents of blood clots.
AEFI Panel Reviews Possible Covid-19 Side Effects
Indian experts are presently investigating domestic cases of blood clotting including mild ones for all Covid-19 vaccine cases in India, according to unspecified sources aware of this development.
As the Mint reports, around 90% of the Covishield vaccine doses are presently being administered in India while the rest of the 8.1 million doses are of Covaxin.
The government organised national committee of Adverse Effects Following Immunisation (AEFI) panel are currently investigating the case of unusual blood clots as a side effect of the two vaccines being administered in India.
“We are looking at side-effects of blood clots that have been seen in people who received Covishield and Covaxin, even if it was a mild case,” one of the two unidentified sources said, citing that a report on it will be ready by next week.
EMA Touts Side Effects of Covishield as “Very Rare”
Meanwhile, the European Medicines Agency (EMA) has emphasised that the AstraZeneca vaccine induced blood clots should be treated as a “very rare” side effect, as verified by its expert committee on vaccine safety.
People aged under 30 years in the UK with no other condition, are advised by the Joint Committee on Vaccination and Immunisation to administer an alternative to Covishield vaccine.
An in-depth review conducted by the EMA’s safety committee, has revealed 62 cases of cerebral venous sinus thrombosis (blood clot in the brain) and 24 cases of splanchnic vein thrombosis (blot clot in the abdomen) as reported in the European Union Drug Safety database dated 22 March.
Several of these cases are linked to women aged under 60 within a fortnight of getting vaccinated while 18 of them were reportedly fatal.
EMA vs AEFI: Highly-Contrasting Review Sample Numbers
Out of the 91.1 million doses of these vaccines administered in India, only 13 cases of adverse side effects have been reported by the AEFI panel during its final reviews. In contrast, EMA had reported over 200 cases of blood clots since 4th April.
Around five people in India aged under 70, had died due to heart attack following the vaccination, the EMA panel’s review confirmed. Nevertheless, the government has denied all such claims, suggesting the vaccine had nothing to do with these deaths.
“There is a huge backlog that the national AEFI committee is sitting on. This is seen by the fact that final reports have been issued for only 13 serious side effects and deaths, which is a fraction of over 200 cases (in India) that we have a count of,” said Malini Aisola, co-convenor of All India Drug Action Network.
“This is when India has administered more Covishield doses than the EU and UK have together given of AstraZeneca’s vaccine. Also, there is a big gap in the data that is collected at the ground level from the district administration and hospitals as there are no post-mortems conducted in many cases. We need to have robust information gathering at the ground level to have a strong AEFI review.”
Meanwhile, Devinder Gill, a vaccine expert based in Massachusetts (US), has cautioned India to take necessary steps instead of awaiting AEFI panel’s report. “They can restrict the use of Covishield in people below the age of 60 years until there is clarity on the issue from India data,” he added.