Even as AEFI deaths are reported daily, causality assessment by the AEFI committee appears to be lagging with information about just 10 deaths in the public domain. Many of the AEFIs and deaths reported in India bear striking similarities to those recorded in the European Union and the UK, on the basis of which European Medicines Agency (EMA) has warned “healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination”.
Public health activists who have been tracking adverse events following immunisation (AEFI) in the ongoing covid vaccination effort have repeatedly sought greater transparency in AEFI investigations and more rapid causality assessments to help inform vaccination policy.
‘AEFI panel needs to work faster for proper causality assessment’
After initial denial, the European Union and the UK medicine regulators, following detailed investigation, have concluded that there is a possible link between some blood clotting events with low platelets and the Oxford-Astra Zeneca vaccine and have asked for these to be listed as “extremely rare potential side-effects”. However, they have asked for the vaccination to continue as benefits still outweigh risks.
The presentation to National AEFI Committee on March 31, showed that over 90% of AEFI hospitalisations (276/305), more than 87% of cases of severe AEFI (55/63) and 93 out of 124 deaths happened within three days of the vaccination. “The majority of reported AEFIs occurring soon after doing may also represent a reporting bias as events happening after the initial few days could be getting missed out,” said Malini Aisola, a public health activist.
Since the start of the vaccination drive on January 16, according to the health ministry press briefings, there were 9 deaths recorded by January 27, 46 by February 26 and 89 by March 16. “As expected, with the pace of vaccination picked up and the categories of those eligible for vaccination expanded, the number of deaths reported went up. Between March 16 and 29 there were 91 deaths,” pointed out Siddarth Das, who has been tracking AEFI events reported from across the country. He added that with so many cases, the committee would have to work much faster to do proper causality assessment.