The new draft guidelines say that COVID-19 vaccine candidate should have at least 50 per cent of efficacy in the Phase-III clinical trial
New Delhi: The Drugs Controller General of India has issued new guidelines for pharma manufacturing company to develop COVID-19 vaccine. The new guidelines have special attention on safety, immunogenicity and efficacy parameters.
The new draft guidelines say that COVID-19 vaccine candidate should have at least 50
per cent 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.
The draft regulator guideline for the development of a vaccine with special consideration for the COVID-19 vaccine provides guidance to the vaccine developers to ensure that vaccines are well-characterised and manufactured consistently.
The guidelines underlines
urgency for vaccine prevention of COVID-19 and states that clinical development
programs of the COVID-19 vaccine may proceed through an adaptive and seamless
approach including data to inform the potential risk of vaccine-associated ERD will
Three important aspects of new guidelines COVID19 vaccine are safety’ ‘immunogenicity, and the efficacy. Even, WHO says that if we can get more than 50 per cent efficacy that is an accepted vaccine.