HHS Issues New PREP Act Immunity to Marburgvirus Countermeas

HHS Issues New PREP Act Immunity to Marburgvirus Countermeasures | Faegre Drinker Biddle & Reath LLP


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On December 9, 2020, the Department of Health and Human Services (HHS) Secretary Alex Azar issued a new notice of declaration under the Public Readiness and Emergency Preparedness (PREP) Act (the Declaration) to provide limited immunity for activities related to countermeasures against marburgvirus and/or Marburg Disease. 85 FR 79198-01. The Declaration is effective as of November 25, 2020.
The Declaration notes that Marburg Disease is a severe and often fatal illness in humans caused by marburgviruses, which are in the same family as the Ebola virus. Marburg Disease is highly infectious, can cause hemorrhagic fever, and has a fatality rate of approximately 88%. Person-to-person transmission can occur via direct contact with droplets of body fluids from infected persons or contact with equipment and other objects contaminated with infectious blood or tissues. Similar to Ebola virus outbreaks, marburgvirus has been determined to have the potential to be a threat to U.S. public health security. There have been previous Marburg outbreaks, most recently in 2014 and 2017, and the U.S. government has been focused on the development of relevant countermeasures over the past decade.

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