U.S. Grants Legal Immunity to Drugmakers for Ebola Vaccines

December 11, 2014

The U.S. Department of Health and Human Services this week offered liability protections to drugmakers rushing to develop Ebola vaccines and urged other countries to follow suit.

Health and Human Services (HHS) Secretary Sylvia Burwell made the announcement as part of the Public Readiness and Emergency Preparedness (PREP) Act in a move aimed at encouraging 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 the Ebola virus. However, it does not provide immunity for a claim brought in a court outside the United States.

The United States has for many years offered similar protections to vaccine makers to encourage the development of childhood vaccines.

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HHS said the declaration is part of global efforts to address issues in the United States and in other countries where such vaccines are being developed, made and potentially used.

Burwell urged other countries to follow suit by enacting similar liability protections.

“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,” she said in a statement.

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Drug companies and scientists are racing to develop an effective vaccine to help fight the worst Ebola outbreak on record, which has killed some 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 started the first clinical trials of an experimental Ebola vaccine being developed by GlaxoSmithKline and the U.S. 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.

(Reporting by Julie Steenhuysen; Editing by Jonathan Oatis)

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