The Drugs Controller General of India has issued a new set of guidelines for coronavirus vaccine facilities, on the lines of the World Health Organization and the United States Food and Drug Administration, the Hindustan Times reported on Wednesday.
According to the guidelines, a Covid-19 vaccine candidate should have at least 50% efficacy in the Phase-3 clinical trial for it to be widely used. The pharmaceutical companies developing the vaccines must provide data informing the users about the potential risk of vaccine-associated Enhanced Respiratory Disease.
The drug controller has also asked pharmaceutical companies to consider the situation of pregnant women and women of childbearing potential while developing vaccines. “For respiratory viruses, we never get 100% efficacy,” Indian Council of Medical Research Director General Balram Bhargava had said earlier this…
