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.
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.