If one of the experimental coronavirus vaccines gets emergency use authorization (EUA) from the US Food and Drug Administration, clinical trials examining the safety and efficacy of that vaccine will continue as planned, a senior FDA official said Thursday.
The FDA has said it would consider EUA for coronavirus vaccines in the works – a quicker route to getting one distributed than full approval would be. But that would mean beginning vaccination of the populace before clinical trials have finished. Some people have worried that would mean the clinical trials would end before all the data was collected.
Dr. Doran Fink, deputy director of the FDA’s division of vaccines and related products applications, said that won’t happen. Companies still will have to continue their formal clinical trials to get full licensing approval, Fink told a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
"Continuation of placebo-controlled follow up after emergency use authorization will be important, and may actually be critical to ensure that additional safety and effectiveness data are accrued to support submission of a licensure application as soon as possible following an emergency use authorization," Fink said.
The FDA's Center for Biologics Evaluation and Research does not consider the authorization of a vaccine as reason to "unblind" ongoing trials and offer the vaccine to volunteers who received a placebo, Fink said.
“CBER does not consider issuance of an EUA for a Covid-19 vaccine, in and of itself, as grounds to unblind ongoing clinical trials and offer vaccine to placebo recipients,” Fink said.