U.S. declares 2019-nCoV a public health emergency
HHS Secretary Alex Azar Friday declared that 2019 Novel Coronavirus (2019-nCoV) poses a public health emergency.
The declaration of a public health emergency, which came a day after WHO declared the coronavirus outbreak a Public Health Emergency of International Concern, gives HHS authority to make grants and enter into contracts for medical countermeasures and to access funds that Congress has set aside for public health emergencies (see “WHO Declares Coronavirus Public Health Emergency”).
The move does not give FDA power to issue Emergency Use Authorizations (EUAs). To trigger FDA’s authority to issue EUAs, the HHS secretary must issue a separate declaration that circumstances exist justifying an EUA.
EUAs allow the use of unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions in an emergency.
EUA declarations are usually issued for specific categories of products, such as diagnostics, antiviral drugs or vaccines.
EUAs are most often used to allow the use of unapproved diagnostics. For example, in 2014-15, FDA issued 12 EUAs for Ebola diagnostics, and in 2016-17 the agency issued 20 EUAs for Zika diagnostics.
Multiple companies have begun vaccine or therapeutic programs against the virus in the past few weeks (see “The Race is On to Develop Therapies and Vaccines for the Coronavirus Outbreak”).