A notice in the Federal Register on Tuesday from HHS Secretary Sylvia Burwell states that the declaration will provide liability protection for activities related to Ebola Virus Disease Vaccines
Under the Public Readiness and Emergency Preparedness Act (PREP Act), Secretary Burwell can issue a declaration to provide “liability immunity to certain individuals and entities…against any claim of loss caused by, arising out of, relating to, or resulting from the administration or use of medical countermeasures,” of which Ebola is now one.
Vaccines from GlaxoSmithKline, NewLink Genetics and J&J are all listed as covered under the declaration.
As the Ebola vaccine trials begin ramping up in the UK, Switzerland and Mali, the legal immunity offers another layer of protection for those covered, which not only includes manufacturers (and contractors or subcontractors of manufacturers), but distributors, program planners, and qualified persons, and their officials, agents, and employees, as well as the US as a whole.
“Thus, it is the Secretary's interpretation that, when a declaration is in effect, the Act precludes, for example, liability claims alleging negligence by a manufacturer in creating a vaccine, or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct,” according to the notice.
In addition, the PREP Act specifies that liability immunity is afforded to manufacturers and distributors regardless of whether the Ebola vaccine is used by or administered to individuals in other geographic areas.
Obama and Ebola
The legal liability immunity declaration comes just a couple of days after President Barack visited NIH labs and called on Congress to pass his $6.2bn (€5bn) emergency funding request for Ebola programs before Congress goes on holiday.
The funding request includes $4.64bn to help combat the epidemics that have ravaged West Africa, to bolster the public health response in the US, speed development of new treatments and vaccines, and to improve the public health capabilities in other vulnerable nations.
In a blog post, NIH head Francis Collins revealed that the Ebola treatment Zmapp may soon be easier to manufacture. He noted that “researchers speculated that it might be possible to eliminate one [antibody] from the ZMapp cocktail, which may make the drug less expensive and easier to manufacture.”
Researchers at Scripps are collaborating with Mapp Biopharmaceutical to image more than 20 antibodies to determine if they can develop a more effective cocktail than ZMapp, Collins added. “The Scripps team is also planning to image antibodies in the bloodstreams of people who’ve survived Ebola without taking ZMapp or other drugs, to learn more about how their immune systems defeated the virus,” he said.