FDA Commissioner Dr. Stephen Hahn
FDA Commissioner Dr. Stephen Hahn used a virtual conference appearance today to repeat that a COVID-19 vaccine approval will be up to the agency’s scientists — not political pressure.
“We want to make sure that any vaccine we approve is safe and effective according to our criteria,” Hahn said during The Virtual Medtech Conference held by medtech trade group AdvaMed.
As for when the process would result in an approval, Hahn repeated a phrase he used when cancer patients asked him about eventual outcomes: “I don’t have a crystal ball.”
FDA’s Center for Biologics Evaluation and Research will receive applications only when a vaccine maker and the independent data safety monitoring board for the Phase 3 trial decide that the safety and effectiveness data is mature enough — and that there is also reliable data to back up the chemistry, manufacturing and controls to produce the vaccine, Hahn said.
Once an application is received, there will be biologics advisory committee hearings that FDA will mostly open up to the public. “Our intention is for us to have an open process that everyone will see,” Hahn said.
Hahn’s comments came only hours before a New York Times report in which people familiar with the vaccine approval process said that White House officials have blocked strict new vaccine approval guidelines. Experts on the outside advisory committee, however, could still enforce the guidelines.
Just days before, Pfizer CEO Albert Bourla told employees in an open letter that the pharma giant will “never succumb to political pressure.”
“Our independence is a precious asset. .. Our priority is the development of a safe and effective vaccine to end this pandemic,” Bourla said.
There are presently five COVID-19 vaccine candidates in Phase 3 clinical trials. President Donald Trump has been calling on government scientists to quickly approve a vaccine — and criticizing vaccine trial guidelines.
Filed Under: clinical trials, Drug Discovery, Infectious Disease
