ARTICLE | Regulation
Expanding access to COVID-19 vaccines
Imminent release of interim data will force FDA to make tough decisions about pre-approval access to COVID-19 vaccines
October 31, 2020 3:35 AM UTC
As lightning-quick vaccine development comes close to catching up with a runaway pandemic, FDA must quickly decide how it will respond to the first clear signs that a vaccine candidate may be effective.
Former senior agency officials are advocating that FDA respond to favorable interim data from COVID-19 trials by allowing expanded access rather than by issuing emergency use authorizations. The goal is to gain more control over the launch of the first COVID-19 vaccines. ...