WASHINGTON, DC–The federal government has extended liability protection to Johnson & Johnson’s (J&J's) Janssen subsidiary, which is developing an Ebola vaccine candidate with its Danish partner Bavarian Nordic.
The December 9 announcement granting immunity was made by U.S. Department of Health and Human Services (HHS) Secretary Sylvia M. Burwell, in accordance with the Public Readiness and Emergency Preparedness (PREP) Act of 2005.
J&J is investing about $200 million to study and make the vaccine, which must be combined with the Bavarian Nordic Vaccine. J&J has said that it expects to begin January testing in up to 600 human volunteers in Europe and Africa.
The global pharmaceutical giant will help Bavarian Nordic build a facility to make its part of the combination.
The United States has granted immunity against legal claims related to the manufacture, testing, development, distribution, and administration of three vaccines for Ebola virus, said Burwell.
The immunity was issued under the provisions of the PREP Act, a 2005 law that aims to make possible the development of medical countermeasures to urgent public health needs, including: chemical, biological, radiological, nuclear agents of terrorism, and epidemics or pandemics.
However, the PREP Act provides immunity only for claims brought before a U.S. court. In most cases, it does not protect against claims made abroad.
“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 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.”
On October 22, J&J CEO Alex Gorsky discussed the company's Ebola vaccine on the Fox Business Network, calling the combination of both vaccines a "one-two punch."
"It is very exciting news and we think this is a very important step in the fight against Ebola," said Gorsky. "At Johnson & Johnson we've been working on a vaccine for Ebola for some years, but recently, in fact just yesterday, we announced this agreement that we have with a company called Bavarian Nordic."
"We still have a lot of testing to do, but we are very hopefull and we think this a very important step," said Gorsky.