Maharashtra: Adverse events reporting by states ‘not satisfactory’ | Mumbai News

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Pune: The national Adverse Effects Following Immunisation (AEFI) committee has urged states to ensure all side-effects after Covid jabs are reported on the CoWIN portal. The committee said there has been a drastic drop in reporting levels by states.
Dr NK Arora, who heads the committee, said states should tell vaccinators to report all events of concern occurring within 28 days of vaccination. The reports should be uploaded on the CoWIN platform, he said. Dr Arora added that due to low reporting, the country may be missing rare adverse events, which could be of relevance to the community, Indian regulators and other countries as some vaccines here are also deployed globally.
The co-convenor of the All India Drug Action Network, Malini Aisola, termed the current reporting system weak and unresponsive. “Many people have faced difficulties while reporting AEFI, let alone securing medical support, though there is a provision for medical management in the protocols,” she said. She added the quality of evidence while investigating AEFI at the local level is very poor with many events being brushed aside as unrelated to vaccination, even before the evidence has been collected. “It reveals poor awareness and training among district-level authorities and committees,” Aisola said.
The pace of reporting poses another problem with only 91 AEFI investigations completed till May 27. She said it’s also unlikely families of those affected were informed. “So there is little being done to instill confidence in a system that’s meant to protect patient safety,” she added.
Recently, the AEFI committee approved a report of 60 serious adverse events, ruling that 55 of them (most of which needed hospitalisation), were associated with vaccination. The rest of the five cases, including that of a 57-year-old male who died in February after a Covishield jab, were ruled as “coincidental”, not directly linked to vaccination. The report said 36 of the 60 were anxiety-related reactions, while 18 were vaccine product-related reactions. One was classified as both vaccine product-related and anxiety-related reaction.
The first national report on causality assessment, which had 31 serious AEFI cases, was released in June. That report recorded India’s first Covid vaccine-related death since the start of the vaccination drive.