After India’s regulatory head ruled out an emergency use authorization for COVID-19 vaccines, the country issued draft guidelines on clinical development and evaluation and licensure for vaccines, with a special focus on SARS-CoV2 vaccines.
India’s Draft Guidelines For COVID-19 Vaccines Follow WHO, US Lead
Primary Endpoint Efficacy 50%, Secondary Up To 30%
India has rolled out draft guidelines for development of vaccines with special focus on COVID-19 vaccines, drawing from those of other regulatory bodies and the WHO. Experts suggest the primary efficacy endpoint of minimum 50% is acceptable given that vaccines against respiratory diseases are difficult to develop though not necessarily enough to snuff out a pandemic.
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