Makers of 3 Ebola vaccines granted US liability protection
This article was originally published in SRA
The companies involved in making the three lead Ebola vaccines have gained liability protection in the US by a declaration from the Obama administration acting under the Public Readiness and Emergency Preparedness (PREP) Act of 20051.
The vaccines covered by the US declaration are ChAd3, being developed by the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline; Ad26.ZEBOV/MVA-BN-Filo, being developed Johnson & Johnson subsidiary Janssen and Bavarian Nordic; and rVSV-ZEBOV, initially developed by the Canadian government, which licensed the product to BioProtection Systems, a subsidiary of NewLink Genetics, which late last month inked a licensing deal with Merck.
The declaration became effective on 3 December.
Reduced liability spurs R&D
Department of Health and Human Services Secretary Sylvia Burwell said it was her "strong hope" that issuing the PREP Act declaration would spur other nations to also enact similar liability protection and compensation legislation for the Ebola vaccine manufacturers2.
"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," she said.
Jim Greenwood, president and CEO of the Biotechnology Industry Organization, noted that managing risks related to product liability is "always a top concern" when developing an experimental drug or vaccine3.
Reducing the liability for the three Ebola vaccines, he said, "is an important step forward" in facilitating the development of products intended to protect against the disease.
The PREP Act was specifically 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.
PREP Act declarations provide immunity from liability – except for willful misconduct – to entities and individuals involved in the development, manufacture, testing, distribution, administration and the use of medical countermeasures against claims of loss related to the administration or use of those therapies.
The PREP Act, however, does not generally provide immunity for claims brought in courts outside the US.
Injury compensation
Many vaccines already are covered under the National Childhood Vaccine Injury Act of 1986, which created the National Vaccine Injury Compensation Program (VICP), a no-fault compensation program intended to protect vaccine makers against large judgments that could put companies out of business, while providing compensation to those who are injured from vaccines.
Under the VICP, manufacturers enjoy significant tort liability protections. The law provides that a party alleging a vaccine-related injury may file a petition for compensation in the court of federal claims, naming the HHS secretary as the respondent.
The vaccine court must resolve the case by a specified deadline. The claimant can then decide whether to accept the court's judgment or reject it and seek tort relief from the vaccine manufacturer.
The PREP Act created a similar injury compensation fund for medical countermeasures.
Under the PREP Act, the liability immunity for the administration or use of certain countermeasures applies to "covered persons" – meaning manufacturers, distributors, program planners and qualified persons and their officials, agents, and employees and the US government.
The law considers a manufacturer to include its contractors and subcontractors; suppliers or licensers 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 medical countermeasure; and any or all of the parents, subsidiaries, affiliates, successors and assigns of a manufacturer.
The PREP Act declaration for the Ebola vaccines, the HHS said, is expected to strengthen the incentive for companies to conduct research and spur development, manufacturing and the potential use of the products in large scale vaccination campaigns in West Africa.
The HHS noted that PREP Act declarations have been issued, revised or renewed 14 times in the law's lifetime, including in 2009 for the vaccine against the H1N1 flu pandemic.
Vaccines in the pipeline
The NIAID and GSK on 26 November reported successful safety results of a Phase I trial testing the ChAd3 vaccine. A Swiss university testing rVSV also reported on 2 December safety of that product looked good so far.
Those vaccines are slated to enter a Phase II/III trial in Liberia if all goes according to plan.
Further behind is J&J's and Bavarian Nordic's Ad26.ZEBOV/MVA-BN-Filo vaccine, which is expected to enter human safety trials in January.
There are at least four other vaccines in the works, but those were not included in the current PREP Act declaration.
The HHS Secretary, however, may amend any portion of the declaration through publication in the Federal Register.
References
- HHS, Notice of Declaration under the Public Readiness and Emergency Preparedness Act, Federal Register, 10 December 2014, www.gpo.gov/fdsys/pkg/FR-2014-12-10/pdf/2014-28856.pd f
- HHS press release, 9 December 2014, www.hhs.gov/news/press/2014pres/12/20141209a.html
- BIO press release, 9 December 2014, www.businesswire.com/news/home/20141209006625/en/BIO-Secretary-Burwell%E2%80%99s-PREP-Act-Declaration-Advance