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HHS issues declaration to support Ebola vaccine development

Companies manufacturing three Ebola vaccine candidates were granted a level of immunity Dec. 9 against future legal claims by the U.S. Department of Health and Human Services via a declaration known as the PREP Act. Health and Human Services Secretary Sylvia M. Burwell announced a declaration under the Public Readiness and Emergency Preparedness Act to facilitate the development and availability of experimental Ebola vaccines. 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, according to a news release. It does not, generally, provide immunity for a claim brought in a court outside the U.S.

“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 in a news release. “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 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, according to the release. The declaration is expected to strengthen the incentive to conduct research and development of potential vaccines.

The PREP Act declaration provides legal protection under U.S. law for three vaccine candidates:

• The 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 Corporation, a subsidiary of Newlink Genetics

• The Ad26.ZEBOV/MVA-BN-Filo vaccine manufactured by Janssen Corporation, subsidiary of Johnson & Johnson/Bavarian Nordic

Past PREP Act 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.

For more information about the PREP Act, visit http://www.phe.gov/preparedness/legal/prepact/pages/default.aspx.

By | 2014-12-15T00:00:00-05:00 December 15th, 2014|Categories: National|0 Comments

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