Ebola vaccine makers Merck, GSK, J&J get legal protections in U.S. thanks to HHS declaration
|Ebolavirus under an electron microscope--Courtesy of CDC|
Ebola vaccine developers now have a little less to worry about thanks to a Tuesday announcement from the U.S. Department of Health and Human Services (HHS). The department will provide liability protections for the companies scrambling to develop Ebola vaccines in response to the current outbreak in West Africa, it said.
This immunity was declared under the Public Readiness and Emergency Preparedness (PREP) Act, and it protects drugmakers against legal claims related to the manufacturing, testing, development, distribution and administration of three Ebola vaccines, the department said in a statement. It is a protection the U.S. has used before to fast-track vaccine development.
The three covered vaccines are GlaxoSmithKline ($GSK) and the NIH's candidate, NewLink ($NLNK) and Merck's ($MRK) prospect and an investigational shot from Johnson & Johnson's ($JNJ) Janssen subsidiary and Bavarian Nordic.
The declaration only protects vaccinemakers within U.S. borders and does not provide protection for a claim brought in a court overseas. HHS is encouraging other countries to follow suit. If they do, that's good news for Merck and NewLink, as their jab has already been tested in the U.S., Canada, Germany and Gabon, and for GSK and the NIH, which are conducting tests in England, the U.S., Mali and Switzerland. J&J expects to start trials in January.
|HHS Secretary Sylvia Burwell|
"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," HHS Secretary Sylvia Burwell said in a 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."
PREP Act declarations have been issued, revised or renewed 14 times since the act's implementation in 2005. Previous declarations have covered vaccines used in H5N1 clinical trials and the development and manufacturing of antitoxins to treat botulism in 2008.
- here's the release
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