HHS Shelters Three Ebola Vaccine Makers from Liability

Ebola vaccine manufacturers Janssen, GlaxoSmithKline and NewLink Genetics will be sheltered from legal liability under a law that protects companies that produce treatments to combat public health emergencies, HHS said.

None of the three companies can be sued for any claim of loss caused during the manufacture, testing, development, distribution, administration or use of the vaccines, unless it is attributed to willful misconduct on the part of any of the drugmakers, HHS said in a Dec. 9 Federal Register notice.

The companies’ immunity kicked in Dec. 3, under the 2005 Public Readiness and Emergency Preparedness Act, and lasts for one year without geographic limitation, HHS says.

GlaxoSmithKline’s vaccine, developed jointly with the National Institutes of Health, is the furthest along on the development path, with positive results of a Phase I trial announced recently. NewLink Genetics began Phase I trials of its vaccine in September. And Janssen said it anticipates starting trials in the middle of 2015.

View the Federal Register notice at www.fdanews.com/12-09-14-Ebolavaccines.pdf.—Lena Freund

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.