Even so, the government needs to front-foot efforts to train healthcare personnel, especially at the grassroots, on adverse event monitoring, so that reporting can be accurate and immediate.
The Centre’s directive to states to set up at least one adverse event following immunisation (AEFI) monitoring centre in each block is crucial to sustaining public trust in vaccines in the fight against Covid-19. The move comes against the backdrop of two cases of severe allergic reactions and one of a relatively milder onset of allergic reaction in recipients being reported for the Pfizer vaccine in the UK, following which the country has advised all people with a history of anaphylaxis (severe allergic reaction) to any food, drug or vaccine not to opt for the Pfizer shot.
While Pfizer has clarified that people with a history of severe allergic reactions to other vaccines or those allergic to its vaccine candidate’s key ingredients were excluded from the late-stage trials, the vaccine’s trial reports from the US show that 0.63% in the vaccine arm and 0.51% in the control arm reported possible allergic reactions, which, experts say, is a very small number. Given the Pfizer trials had not reported any severe allergic reactions, and these were reported only post roll-out, the importance of post-marketing surveillance can’t be stressed enough, as public health expert Dr K Srinath Reddy had told The Financial Express in a recent interview.
More so, when conventional data requirements are eased for candidates under what is understood as ‘emergency use authorisation’. The proposal to include private sector healthcare facilities as AEFI reporting centres is rare foresight on the part of the government, given the conventional approach in India has been one of scepticism towards private players rather than collaboration. Linking every session site to the AEFI monitoring centre—likely through Co-WIN, the digital platform that has been designed to track vaccine recipients, among other things—could prove a game-changer.
Even so, the government needs to front-foot efforts to train healthcare personnel, especially at the grassroots, on adverse event monitoring, so that reporting can be accurate and immediate. The other, more crucial part of this would be to generate widespread awareness on AEFI so that recipients know what needs to be reported to the healthcare personnel. Against the backdrop of the Chennai incident—where a trial participant for a vaccine manufactured by the Serum Institute of India (SII) initiated litigatory action against SII for what he believed to be vaccine-related adverse events, a claim that was later rejected by experts and health authorities—this will ensure that AEFI claims that can’t be substantiated don’t choke AEFI reporting and, in the process, undermine trust in the vaccine.
Though Covid-19 vaccine hesitancy has fallen—as per surveys by LocalCircles, a social media company, the proportion of Indian respondents who replied that they wouldn’t rush to take the vaccine has come down from 61% in late-October to 59% in early-December—it remains a significant concern. Dr VK Paul, the co-chair of the National Expert Group of Vaccine Administration, had exhorted the masses to trust the authorities on vaccine-related information and data; awareness about AEFI will help nurture such trust.