India – COVID-19 vaccine guidelines in India

India’s Central Drugs Standard Control Organization (CDSCO) has published draft guidelines about the development of COVID-19 vaccines, falling in line other regulatory agencies by setting the bar for vaccine efficacy at a 50% reduction in infections, for example.
Several COVID-19 vaccines are in clinical development in India, including candidates from AstraZeneca, Bharat Biotech and Zydus Cadila (RELATED: COVID-19 vaccine tracker, Regulatory Focus 17 Sept. 2020). CDSCO is supporting the programs through the release of guidelines that detail what is expected of COVID-19 vaccine developers as they navigate preclinical, manufacturing, clinical trials and postmarketing.
The requirements are in line with those imposed by organizations including the US Food and Drug Administration (FDA) in some key areas. Like FDA, CDSCO wants sponsors to use the prevention of infection as the primary endpoint, rather than let them show an effect on biomarkers or the rate of hospitalization.
CDSCO copied FDA’s guidance on statistical considerations verbatim, as it did in other areas of its text. However, the Indian agency diverged from its US counterpart in some areas. CDSCO will decide on the size of the required preapproval safety database on a case-by-case basis. Developers of shots featuring components not previously used in approved vaccines will need to collect enough data to detect adverse events that affect between one in 100 and one in 1,000 people…