India tightens guidelines on adverse events following COVID-19 vaccination, studies ongoing to monitor safety

The Union government has updated the National Adverse Effects Following Immunization (AEFI) guidelines, originally established in 2005 and previously revised in 2010 and 2015. This latest revision in 2024 follows concerns about deaths linked to COVID-19 vaccines in the UK.

The Serum Institute of India’s Covishield, an adenovector-based vaccine, has been associated with serious side effects such as Thrombotic Thrombocytopenia Syndrome (TTS) and Thrombocytopenia in some recipients.

According to the revised guidelines, serious adverse events like TTS (large blood clots combined with low platelet counts) occur at a rate of less than 1 in 100,000 individuals vaccinated with adenovector-based COVID-19 vaccines in India. To improve the reporting of all side effects, including minor ones, the revised guidelines recommend the use of digital vaccination recording software.

The guidelines emphasize the need to strengthen the adverse effects surveillance system for both routine immunization and emergency use authorization of new vaccines.

The National AEFI Committee and other health authorities have confirmed that studies are underway to monitor the risks associated with COVID-19 vaccines. These studies aim to assess the incidence of specific adverse events, including myocarditis, pericarditis, encephalitis, myelitis, seizures, idiopathic thrombocytopenia, Guillain-Barré Syndrome, TTS, and other forms of thrombosis. Despite these concerns, the current evidence indicates that COVID-19 vaccines maintain a favorable benefit-to-risk ratio.