The Drugs Controller General Of India (DCGI) has issued a new set of guidelines for COVID-19 vaccine candidates, focussing on safety, immunogenicity and efficacy parameters.The DCGI has said that a COVID-19 vaccine candidate should have at least 50 percent of efficacy in the Phase-III clinical trial for it to be widely deployed and adequate data informing the potential risk of vaccine-associated Enhanced Respiratory Disease (ERD) needs to be generated.
DCGI has also asked the pharma companies to keep pregnant women and women of childbearing potential in mind while developing the vaccines, reports Xinhua.
Last week India’s health ministry said about 30 COVID-19 vaccines were under various stages of development in the country. According to the ministry, of the 30 vaccines, three were in the advanced stage.
India is in the grip of an ongoing COVID-19 pandemic.