Regulatory professionals and product developers, scientists and investors are all wondering, how does/will the urgent need for a COVID vaccine affect the CMC regulatory landscape, are rules changing, are standards changing, what does ‘acceleration’ mean? Today FDA released the Final Guidance for Industry: Development and Licensure of Vaccines to Prevent COVID-19.
One virus therapy and two gene therapies have been approved by FDA in the last 10 years. The FDA website contains public information on the CMC review discussions, information requests, manufacturing inspections, and the advisory committee discussions.
Over the last decade structure based protein platforms have been viewed as a potential catalyst for vaccine development. To this end, computer aided vaccine engineering has been applied for the design of recently licensed vaccines for meningitis and shingles prophylaxis and for a Phase 1 vaccine candidate for Respiratory Syncytial Virus (RSV). Recently the team of Walls et al. published results in the journal Cell demonstrating promising immune responses in animals injected with a vaccine candidate generated by computer modeling of the COVID-19 and associated proteins.