key: cord-0008440-1fka66ul
authors: nan
title: Corrections
date: 2015-05-17
journal: Lancet Infect Dis
DOI: 10.1016/s1473-3099(15)00028-6
sha: 2d743c8bc9667a1c17e0fbfa63b10a085749c7a2
doc_id: 8440
cord_uid: 1fka66ul

nan

estimates of vaccine effectiveness in post-licensure settings. Further discussion of this topic by experts is warranted.

A key feature common to all of these approval provisions is that the established standards for the demonstration of safety and effectiveness are maintained. From our perspective, if needed, any of these pathways to licensure could provide an alternative science-based approach to the demonstration of vaccine effectiveness against Ebola virus disease.

The rapid evolution of the Ebola outbreak will need continued regulatory flexibility and adjustment to approaches used for product development and approval. By fostering a high level of communication both together and with our stakeholders, the FDA, EMA, and Health Canada will continue to employ their science-based regulatory approaches to expedite Ebola vaccine licensure and thus facilitate the availability of one or more effective Ebola vaccines. 

Code of Federal Regulations (CFR) title 21

Guidance document-submission and Information requirements for extraordinary use new drugs (EUNDs)

Immunology of protection from Ebola virus infection