Pandemic Vaccines Probably Can’t Use Accelerated Approval – US FDA Chief Scientist
That’s not because the agency doesn’t want to get products cleared as fast as possible, Luciana Borio says; it’s because the pathway remains elusive for many pandemic treatments in the absence of surrogates due to largely undeveloped science.
You may also be interested in...
Chief Scientist At US FDA Is Hinton As Borio Moves To White House
Luciana Borio is detailed to National Security Council; FDA promotes Denise Hinton to acting chief scientist.
Zika Vaccines Might Be Approved By 2020
Nothing's even in Phase II yet, but sponsors and US government researchers remain optimistic.
Zika Vaccine Trials Could Test Multiple Candidates Vs. Common Control Group
FDA and NIH officials propose three strategies for clinical trials, saying it will be challenging to identify the most promising candidates; Sanofi and Walter Reed researchers note challenges in vaccine development, including manufacturing scale up.