Novavax aims to recruit 10,000 subjects in the UK, and will include a flu vaccination co-administration for some participants.

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.

Pink Sheet reporters and editor discuss the pandemic’s effects on non-coronavirus-related product manufacturing, US FDA efforts to ensure vaccine sponsors maintain placebo controls once a product is available, and precedents that burden the agency.

Plus: Valneva confirms supply deal with the UK government for its inactivated vaccine candidate; Humanigen expands manufacturing ahead of Phase III data.