FDA Approvals: Lessons Learned from COVID-19
Summary: Prior to 2020, the average vaccine took ten years or longer to develop, test and bring to market. The COVID-19 pandemic changed all of that. In less than a year after the World Health Organization declared the spread of the novel coronavirus as a pandemic, several COVID-19 vaccines emerged and were ready to roll out across the world. In an industry where regulatory hurdles, financial barriers and clinical trial enrollment challenges all present obstacles for biopharma, how could COVID-19 vaccines reach patients so quickly? And is it possible to leverage the practices that soared vaccines through FDA emergency use and approvals processes once the pandemic is over?
The rapid pace of development that led to not one but three vaccines in the U.S. is nothing short of a sea change for pharma. The story also holds critical lessons for emerging biotech companies that aspire to succeed in the post-pandemic world. The pandemic sent everyone scrambling—especially biopharma companies. But as the dust settles, biotechs are fast realizing novel strategies that can speed up drug discovery, streamline clinical trials and secure the green light from regulators such as the FDA.