FRIDAY, SEPTEMBER 30, 2016

HHS chief's legal-immunity order aims to further Ebola vaccine efforts

Health and Human Services Secretary Sylvia Burwell issues a PREP Act order to protect Ebola vaccine efforts from legal claims. | Courtesy www.hhs.gov

Health and Human Services Secretary Sylvia Burwell has taken the initiative to facilitate the development and availability of experimental Ebola vaccines.

Burwell made the declaration under the Public Readiness and Emergency Preparedness (PREP) Act, intended to assist in worldwide efforts to help battle the current Ebola epidemic in West Africa and to stop future outbreaks in that region.

The HHS is the federal agency used for protecting the health of all Americans and providing essential human services.

“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,” Burwell said. “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 declaration provides immunity under United States law against legal claims related to the manufacture, testing, development, distribution and administration of three vaccines for Ebola virus disease (GlaxoSmithKline 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 Corporation, a subsidiary of Newlink Genetics; and the Ad26.ZEBOV/MVA-BN-Filo vaccine manufactured by Janssen Corp., a subsidiary of Johnson & Johnson/Bavarian Nordic).

The declaration does not provide immunity for a claim brought in a court outside of the U.S.

Similar PREP Act declarations have been issued, revised or renewed 14 times since the act was signed in 2005, including those that covered the H5N1 pandemic influenza clinical trials in 2008, the H1N1 influenza pandemic in 2009 and the creation of antitoxins to treat botulism, also in 2008.

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