Opinion: STAT+: How PDUFA VII can catalyze ‘lightspeed’ vaccine and drug development

I’ve had a front-row seat watching how the Covid-19 pandemic has transformed the stately process of drug development into a far more nimble one. It’s a transition the pharmaceutical industry and the FDA must pay attention to.
It took just 17 months from the time Covid-19 was declared a global pandemic for Pfizer, the company I work for, and our partner BioNTech to develop and receive full approval from the FDA for Comirnaty, the first Covid-19 vaccine to reach that goal. On a similarly accelerated path, Pfizer designed, developed, and recently received FDA emergency use authorization for Paxlovid , an oral antiviral treatment for Covid-19. Continue to STAT+ to read the full story…