New COVID-19 Vaccines May Be Accelerated By Using Existing Manufacturing Platforms, US FDA's Marks Says
Executive Summary
FDA's CBER director says the development of new COVID-19 vaccines can be accelerated by using manufacturing platforms developed for other types of vaccines, thereby reducing the need for product-specific data.
You may also be interested in...
The Good, The Bad And The Ugly Of COVID-19 Vaccine Manufacturing Technology Platforms
Not all technology platforms provide the expected benefit of filling in CMC review gaps and speeding coronavirus vaccine approvals.
India’s Draft Guidelines For COVID-19 Vaccines Follow WHO, US Lead
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.
COVID-19 Vaccination: Gaps In Pediatric Data Make Adult Uptake More Vital, Surgeon General Says
US lawmakers press the Surgeon General and NIH Director on how to instill vaccine confidence in an increasingly wary American public.