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Govt  panel  to  review vaccine  side effects

Written by eveningindia

NEW DELHI :
Indian experts are investigating if there are any domestic cases of blood clotting—even mild ones —as a side effect of the two covid-19 vaccines being administered in India, two people aware of the development said.

At over 83 million, AstraZeneca’s Covishield vaccine accounts for 90% of the doses administered in India so far. The remaining 8.1 million doses are of Bharat Biotech International’s Covaxin.

The move by the national committee on adverse effects following immunization (AEFI) came a day after European and UK regulators spoke of a possible link between the AstraZeneca vaccine and some rare occurrences of blood clots.

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“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 people said, adding that a report on it is likely to be ready by next week.

The European Medicines Agency (EMA) on Wednesday said that its vaccine safety committee concluded that the unusual blood clots caused by the AstraZeneca vaccine should be considered as a “very rare” side effect.

In the UK, the Joint Committee on Vaccination and Immunisation advised that people below 30 years of age with no other condition should be offered an alternative to the AstraZeneca vaccine.

The EMA’s safety committee carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis—blood clot in the brain—and 24 cases of splanchnic vein thrombosis—blood clot in the abdomen—reported in the European Union drug safety database as of 22 March.

Of these cases, 18 were fatal. The cases were reported from the European Economic Area and the UK. Most of the cases reported have occurred in women under 60 years of age within two weeks of vaccination.

Both the EU and UK have together administered vaccines to around 34 million people as of 4 April, while in India over 91.1 million doses have been given.

However, India’s AEFI committee has so far given final reviews for only 13 cases of severe adverse side effects, while the EMA’s panel had reviewed over 200 cases of blood clots alone as of 4 April.

The EMA panel’s review also included five people in India under the age of 70 who had died due to heart attack after vaccination. However, the government determined that the deaths “were not related to the vaccine”.

“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.”

Davinder Gill, a vaccine expert based in Massachusetts, US, said that India should take immediate steps without waiting for the AEFI panel’s report.

“One possible move is to review global data without waiting for Indian data, and if they see a link, they can restrict the use of Covishield in people below the age of 60 years until there is clarity on the issue from Indian data.”

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eveningindia