Ebola Vaccines Get Legal Immunity

In an effort to speed development of promising Ebola vaccines, US Health and Human Services Secretary Sylvia Burwell today invoked the Public Readiness and Emergency Preparedness (PREP) Act. The law protects drug developers from legal claims related to the manufacture, testing, development, distribution and administration of 3 vaccine candidates.

That protection applies only in the US, and Burwell expressed “strong hope” that other nations would also enact similar measures. “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,” Burwell said.

The three vaccines are:

• GlaxoSmithKline’s Recombinant Replication Deficient Chimpanzee Adenovirus Type 3-Vectored Ebola Zaire Vaccine known as ChAd3-EBO-Z. It will be tested at the University of Maryland.
• BPSC1001 vaccine, known as rVSV-ZEBOV-GP, made by BioProtection Services Corporation, a subsidiary of Newlink Genetics. Merck has acquired the rights to that vaccine in a $50 million deal that will allow Newlink to get royalties on the drug if it works and is approved. The product was developed with the Public Health Agency of Canada.
• Ad26.ZEBOV/MVA-BN-Filo vaccine manufactured by Janssen Corporation, subsidiary of Johnson & Johnson/Bavarian Nordic.

The PREP Act, which took effect in 2005, was used in 2008 to cover vaccines used in H5N1 flu trials, in 2009 to spur development of products related to the H1N1 flu, and in 2008 to aid in the development and manufacture of botulism antitoxins.

Though Ebola has not caused widespread infections in the US, the West African outbreak has overwhelmed the public health systems in Guinea, Liberia and Sierra Leon, according to a report from the World Health Organization.

On Monday WHO reported that there have been 17,800 Ebola cases including 6,331 deaths since the outbreak began early this year.