The Indian government has acknowledged the occurrence of serious side effects associated with the Covishield vaccine, a key component of India’s COVID-19 vaccination program. Specifically, the revised guidelines on vaccine-related adverse effects have confirmed the presence of Thrombotic Thrombocytopenia Syndrome (TTS) and Thrombocytopenia among recipients of the adenovirus-based vaccine, manufactured by the Serum Institute of India.
According to the revised guidelines, TTS, characterized by the formation of large blood clots in conjunction with low platelet counts, has been observed in less than one in 100,000 individuals who received Covishield. This acknowledgment comes amidst ongoing concerns about vaccine-related deaths in the United Kingdom.
The revision of the National Adverse Effects Following Immunization (AEFI) guidelines, last updated in 2015, underscores the importance of ongoing monitoring and data collection. The guidelines recommend the implementation of digital vaccination recording software to enhance the reporting of all adverse events, including those of a minor nature. This digital approach is intended to strengthen the surveillance system for both routine and emergency use authorization vaccines.
The health ministry guidelines, developed collaboratively by the National AEFI Committee and other stakeholders, emphasize the ongoing research efforts aimed at evaluating the potential risks associated with COVID-19 vaccines. These studies are investigating the potential connection between various events, including myocarditis, pericarditis, encephalitis, myelitis, seizures, idiopathic thrombocytopenia, Guillain-Barré Syndrome, and thrombosis, with the administration of COVID-19 vaccines.
Despite the acknowledgement of these serious adverse events, the guidelines emphasize that the available evidence suggests a favorable benefit-to-risk ratio for COVID-19 vaccines in India. Common minor side effects reported following the administration of COVID-19 vaccines in the country include fever, injection site pain, swelling and redness, headache, dizziness, vomiting, fatigue, and hypersensitivity.
