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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With seven COVID-19 treatment/prophylactic candidates lined up, India's Zydus Cadila is unleashing all it can to combat the disease. Meanwhile, the firm has also offered an update on the state of its injectables and transdermals business in the US, which is contingent on resolving deficiencies at its Moraiya plant.
Pfizer is unlikely to tie up with Indian companies soon for manufacture of its COVID-19 vaccine as it has built capacity for the first phase. However, as discussions to supply to the COVAX facility and developing countries progress, it could evaluate such opportunities later.