U.S. immunity against legal claims given to developers of Ebola treatments
Health and Human Services Secretary Sylvia M. Burwell has announced a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to facilitate the development and availability of experimental Ebola vaccines. This declaration is intended to assist in the global community's effort to help combat the current epidemic in West Africa and help prevent future outbreaks there.
The declaration provides immunity under U.S. law against legal claims related to the manufacturing, testing, development, distribution and administration of three vaccines for Ebola virus disease. It does not, generally, provide immunity for a claim brought in a court outside the U.S.
For many years, the U.S. has encouraged vaccine development by managing liability and compensation, starting with the National Childhood Vaccine Injury Act of 1986. The PREP Act was designed to facilitate the development of medical countermeasures to respond to urgent public health needs, including the development of critical vaccines like those to prevent the spread of Ebola. This U.S. declaration under the PREP act is part of a global dialogue to address these issues in the U.S., and other countries where the vaccine is being developed, manufactured and potentially used.
"My strong hope in issuing this PREP Act declaration in the U.S. is that other nations also will enact appropriate liability protection and compensation legislation," said Burwell. "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."
The PREP Act declaration is expected to strengthen the incentive to conduct research and spur development, manufacturing and the potential use of the vaccines in large scale vaccination campaigns in West Africa. The PREP Act declaration provides legal protection under U.S. law for three vaccine candidates:
- GlaxoSmithKline's Recombinant Replication Deficient Chimpanzee Adenovirus Type 3-Vectored Ebola Zaire Vaccine known as ChAd3-EBO-Z;
- the BPSC1001 vaccine, known as rVSV-ZEBOV-GP, made by BioProtection Services, a subsidiary of Newlink Genetics; and
- the Ad26.ZEBOV/MVA-BN-Filo vaccine manufactured by Janssen, a subsidiary of Johnson & Johnson/Bavarian Nordic.
Similar PREP Act declarations have been issued, revised or renewed 14 times since the act was signed in 2005. Past declarations have covered vaccines used in H5N1 pandemic influenza clinical trials in 2008, products related to the H1N1 influenza pandemic in 2009 and the development and manufacturing of antitoxins to treat botulism in 2008.