Burwell moves to encourage Ebola vaccine development, use

The drugmakers of three potential vaccines in development against the Ebola virus will be immune from legal liability related to their production, testing or distribution, federal officials announced Tuesday.

HHS Secretary Sylvia Burwell issued a declaration (PDF) under the Public Readiness and Emergency Preparedness Act (PREP) to encourage development, production and potential use of the vaccines in West Africa.

“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 released statement. “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.”

Vaccine candidates being developed by the pharmaceutical firm GlaxoSmithKline, as well subsidiary companies of Iowa-based, Newlink Genetics and Johnson & Johnson will be granted legal protection in the U.S., but that does not provide immunity against claims made in courts of other countries.

All three vaccines are currently in Phase 1 of clinical trials where they are being administered to healthy adult volunteers to test for safety and their ability to stimulate a response within the immune system, according to HHS. If shown to be effective, additional trials would begin in January with volunteers from West Africa.

Similar declarations under the PREP Act have been implemented 14 times since it was signed in 2005 to facilitate medical development during public health emergencies. Past declarations include the development of vaccines and products during influenza pandemics in 2008 and 2009.

The latest figures from the World Health Organization indicate more than 17,000 people have been infected and more than 6,000 have died from the disease as of Nov. 30.

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