A new set of guidelines, focusing on safety, immunogenicity, and efficacy for pharmaceutical giants developing COVID-19 vaccines, has been issued by the Drugs Controller General of India (DCGI).
The DCGI said that in the Phase III clinical trial, a COVID-19 vaccine candidate should have at least 50 percent efficacy to be widely deployed and adequate information on the possible danger of vaccine-related Enhanced Respiratory Disease (ERD) needs to be produced.
To ensure that vaccines are well characterized and continually manufactured, the comprehensive draught regulatory guidelines for the development of a vaccine with special consideration for the COVID-19 vaccine guide the vaccine developers.
Given the urgent need for a safe and effective vaccine for the prevention of COVID-19, the guidance reads that clinical development programs for the COVID-19 vaccine may need an adaptive and seamless approach including data to inform the potential risk of vaccine-related ERD.
The document highlighted that the use of COVID-19 preventive vaccines is an important consideration for vaccination programs in pregnancy and women with childbearing potential.
For a vaccine, there are three things: security, immunogenicity, and efficacy. WHO also says that an accepted vaccine is an accepted vaccine if we can obtain more than 50 percent efficacy. We never get 100 percent effectiveness for respiratory viruses.
Furthermore, the draft guidelines indicate that the pharmaceutical companies finalized a quantitative final evaluation strategy before closing the trial database and treatment assignments. This should include any interim scheduled analysis that should be addressed properly in terms of its purpose, timing, and any statistical tools adjustments.