Wednesday, December 10, 2014

HHS Secretary Burwell Invokes PREP Act Immunity For Ebola Vaccine Makers -- Merck Included

While the HHS press release of yesterday only mentions NewLink Genetics, the PREP Act itself makes clear that those companies in Merck's shoes in this sort of a situation become "Covered Persons" -- under the Act's immunity provisions.

The Act's products liability immunity applies to “Covered Persons” -- with respect to administration or use of a "Covered Countermeasure". Covered Persons include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States. The PREP Act goes on to define the terms “Manufacturer” and “Distributor”, thus: a "Manufacturer" includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all of the parents, subsidiaries, affiliates, successors, and assigns of a Manufacturer. A "Distributor" means a person or entity engaged in the distribution of drug, biologics, or devices, including but not limited to: Manufacturers; repackers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies. Both of these definitions would clearly apply to Merck's role in rVSV-ZEBOV candidate efficacy trials, ultimate vaccine conjugate manufacture and finished vaccine distribution.

And that makes sense. Here's the Secretary's press release of yesterday -- and a bit:

. . . .The PREP Act was designed to facilitate the development of medical countermeasures to respond to urgent public health needs, including the development of critical vaccines like those to prevent the spread of Ebola. This U.S. declaration under the PREP act is part of a global dialogue to address these issues in the U.S., and other countries where the vaccine is being developed, manufactured and potentially used.

“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 Secretary 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.”

The PREP Act declaration is expected to strengthen the incentive to conduct research and spur development, manufacturing, and the potential use of the vaccines in large scale vaccination campaigns in West Africa. The PREP Act declaration provides legal protection under U.S. law for three vaccine candidates:

• GlaxoSmithKline’s Recombinant Replication Deficient Chimpanzee Adenovirus Type 3-Vectored Ebola Zaire Vaccine known as ChAd3-EBO-Z;

• the BPSC1001 vaccine, known as rVSV-ZEBOV-GP, made by BioProtection Services Corporation, a subsidiary of Newlink Genetics; and

• the Ad26.ZEBOV/MVA-BN-Filo vaccine manufactured by Janssen Corporation, subsidiary of Johnson & Johnson/Bavarian Nordic. . . .

This is a truly sound public policy decision, in my experienced view. Next up -- the first clinical efficacy head to head results will start trickling in, perhaps by mid-February 2015.

1 comment:

Birdman said...

It appears that Secretary Burwell has not included the ChAd3-EBOL/MVA-mBN226B heterologous prime boost regimen in her indemnity declaration.

I have not yet seen the ChAd3-EBOL/MVA-mBN226B mentioned as one of the regimens to be used in the West Africa Field study that is supposed to start in early 2015.