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U.S. Health Agency Offers Legal Immunity to Ebola Vaccine Makers

Declaration seen as important step in effort to develop Ebola vaccines

Department of Health and Human Services (HHS) 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.

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, however, provide immunity for a claim brought in a court outside the U.S.

The three vaccine candidates are:

  • GlaxoSmithKline’s recombinant replication-deficient chimpanzee adenovirus type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z)
  • BioProtection Services Corporation’s BPSC1001 vaccine, known as rVSV-ZEBOV-GP
  • Janssen Corporation’s Ad26.ZEBOV/MVA-BN-Filo vaccine

According to the HHS, 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 such as those to prevent the spread of the Ebola virus.

“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,” said Secretary 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 to spur development, manufacturing, and the potential use of the vaccines in large-scale vaccination campaigns in West Africa.

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.

Drug companies and scientists are racing to develop an effective vaccine to help fight the worst Ebola outbreak on record, which has killed approximately 6,300 people in the three worst-hit countries in West Africa, and they are collaborating to find the best approach.

Earlier this month, scientists at Oxford University in the U.K. started the first clinical trials of ChAd3-EBO-Z on behalf of GlaxoSmithKline and the National Institutes of Health.

Other vaccine developers include Johnson & Johnson, Merck and NewLink Genetics Corp., and Denmark’s Bavarian Nordic, which is developing a booster shot to help improve the effectiveness of some of the vaccines.

Sources: HHS; December 9, 2014; and Reuters; December 9, 2014.

 

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