Legal Immunity Offered to Makers of Ebola Vaccines in the US

December 11, 2014
BioPharm International Editors

US Department of Health and Human Services announced a declaration to provide immunity to legal claims made in the US in relation to three investigational Ebola vaccines.

On December 9, 2014, US Department of Health and Human Services (HHS) announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to protect drug makers in the development of Ebola vaccines. Fujifilm, GSK, Tekmira, and recently, Merck and Newlink, have entered into the race for approvals of investigational Ebola vaccines in response to the recent outbreak in West Africa.

According to the most recent updates from the CDC, there have been almost 18,000 total cases and over 6300 deaths related to the 2014 outbreak. The largest outbreak of Ebola in history has caused companies to push investigational drugs to gain agency approvals and begin distributing vaccines worldwide, especially in the most affected areas. With reduced testing, development, and approval periods, HHS announced that the PREP Act will protect three vaccine candidates from legal claims made in relation to manufacturing, testing, development, distribution, and administration. GSK’s ChAd3-EBO-Z, NewLink’s rVsV-ZEBOV-GP, and Janssen’s Ad26.ZEBOV/MVA-BN-Filo vaccines will be protected under this declaration, with the hopes that there will be incentives to continue research and development of vaccines for use against Ebola.

“My strong hope in issuing this PREP Act declaration in the United States is that other nations will also enact appropriate liability protection and compensation legislation. As a global community, we must ensure that legitimate concerns about liability do not hold back the possibility of developing an Ebola vaccine, an essential strategy in our global response to the Ebola epidemic in West Africa,” said Health and Human Services Secretary Sylvia M. Burwell, in a press release.

The PREP Act protects from liability, except in the case of willful misconduct. In the past, the PREP Act has been used to protect H5N1 and H1N1 vaccines, and anthrax, botulism, and smallpox countermeasures.

Sources:
HHSPHE