EMA establishes expedited review framework for Ebola vaccines
- The European Medicines Agency (EMA) has put a rolling review system in place to expedite the Ebola vaccine review process.
- As part of this effort, the EMA has convened a group of infectious disease specialists who are knowledgeable about vaccines. Some of them are Ebola experts.
- Although the review process will still weigh the risks versus the benefits of any submitted treatments, the process will be more lenient, reflecting an appropriate response to the largest and most complex outbreak of Ebola that has ever occurred.
The Ebola outbreak, which started in West Africa in March, is the type of public health threat that has elicited an all-hands-on-deck approach to drug development and approval to address the growing epidemic.
In light of the appearance of infected patients in several West African countries, Spain, Texas, and now New York City, the WHO, the FDA, and the EMA are all on the same page as they support pharmaceutical development efforts. Available support includes accelerated scientific advice, including advice on clinical trial design, as well as support with manufacturing-related questions and post-approval safety monitoring.
- European Medicines Agency EMA ready to start assessment of Ebola vaccines and treatments as soon as data are made available