Over $80 million in funding will support late-stage development, with possible approval and purchase of product for US stockpiles.
The Ebola outbreak in 2014 in West Africa created recognition that a vaccine for this deadly virus was needed. By the time the outbreak was over at the end of 2016, the virus killed more than 11,000 people. Many major pharmaceutical companies and emerging biotech firms initiated Ebola vaccine development programs during the outbreak.
While there were concerns that efforts would dwindle once the emergency was over, that has not been the case. Recently announced funding from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services will provide development support to Ebola programs at Merck & Co. and the Janssen business of Johnson & Johnson (J&J).
Merck will receive $39 million to support the development of its single-dose regimen Ebola vaccine, while Janssen will get $44 million for its two-dose Ebola vaccine. According to BARDA, the funds are intended to support late-stage development and commercialization, including efforts to obtain FDA approval. The agency has also included the option to stockpile up to 1.13 million doses.
Janssen is developing its Ebola vaccine in collaboration with Bavarian Nordic. The BARDA money will fund efforts to optimize and fully validate the manufacturing process, according to Johan Van Hoof, Janssen’s Global Head of Vaccines. J&J previously received a contract from BARDA worth up to $69 in 2015.
Merck licensed its shot from NewLink Genetics. The company achieved positive Phase III results for its vaccine and has indicated that it will submit the product for FDA approval by the end of 2017. Merck has also received previous funding from BARDA, signing a deal with the agency in October 2016 valued at up to $76 million.
Funding for vaccine development for potential future outbreaks of specific diseases such as that provided by BARDA is often necessary given the large upfront investment required by vaccine manufacturers contrasted against the uncertainty as to whether the vaccines will ever be used.
The Coalition for Epidemic Preparedness Innovations, recently formed by various governments, nonprofits and pharmaceutical companies, is another approach. This organization has hundreds of millions of dollars in financing and was designed to be an "insurance policy against epidemics.” The first viruses targeted by the group for vaccine development include MERS-CoV, Lassa and Nipah.