The committee said there has been a drastic drop in reporting levels by states. States must tell vaccinators to report all events of concern that occur within 28 days of Covid-19 vaccination, committee chair NK Arora he said, adding that reports need to be uploaded to the CoWin platform.
Due to the low reports, India may be overlooking rare adverse events that could be of relevance to the community, Indian regulators and other countries, as some vaccines here are also implemented globally, he said.
Malini Aisola, co-convener of the All India Drug Action Network, said the current reporting system is extremely weak and unresponsive. “Many people have faced difficulties in reporting AEFI, let alone obtaining medical support from the vaccination program, even though there is a provision for medical management in the protocols,” he said. He said that the quality of the evidence when probing AEFI locally is very poor and that many events are dismissed as unrelated to vaccination even before the evidence has been collected. The slowness of the reporting doesn’t serve the purpose either, as only 91 AEFI investigations were completed as of May 27. Recently, the AEFI committee approved a report of 60 serious adverse events, ruling 55 of them, most of which required hospitalization. were associated with vaccination based on causation assessment. The remaining five cases, including the death of a 57-year-old man in February after a Covishield jab, were scored “coincidental” and were not directly related to vaccination.