Even though the devastating Ebola outbreak in West Africa has ended, U.S. officials and top pharmas aren't letting up on their vaccine development efforts against the virus. Now, the U.S. government is committing millions of dollars in support for leading vaccine programs at Merck & Co. and Johnson & Johnson.
BARDA, a unit of the U.S. Department of Health and Human Services, pledged $44 million to support a Janssen vaccine and $39 million for a Merck vaccine, the agency announced Friday. The money will help with late-stage development and potential licensure and purchasing of the vaccines for stockpiling. Merck's shot is a single-dose regimen while the vaccine from J&J's Janssen drug unit is a two-dose option.
BARDA's announcement includes stockpiling options of up to 1.13 million doses, according to the agency. Janssen has partnered with Bavarian Nordic on its program and Merck licensed its shot from NewLink Genetics.
The BARDA funding will additionally help Janssen optimize and fully validate the manufacturing process on its candidate, the company's global Head of Vaccines Johan Van Hoof told FiercePharma.
Ebola took the world by storm in 2014 and claimed more than 11,000 lives in West Africa by the end 2016. Vaccine developers, health officials and others scrambled to address the emergency but as promising programs reached late-stage testing, the outbreak came to an end. Janssen's Van Hoof said that was "good news for the world," but a "challenge for development."
After the outbreak ended, experts voiced concerns that Ebola vaccine work might go unfinished. Now, though, officials are hoping to avoid that fate with continued funding and work on top programs.
Licensing vaccines against emerging diseases like Ebola requires an "enormous upfront investment," Van Hoof said in an interview, making public/private partnerships an important strategy in development. He added that there's a "huge uncertainty on the way that vaccine will ever be used," making the commercial prospects for such vaccines unknown.
Of course, after the Ebola outbreak ended attention wound soon shift to the Zika emergency that exploded in Brazil and spread to many countries around the world. The reactive nature of emerging disease vaccine R&D recently led governments, nonprofits and pharma to join together to form the Coalition for Epidemic Preparedness Innovations, which is designed to be an "insurance policy against epidemics.” With hundreds of millions of dollars in financing, the group is focusing on programs for MERS-CoV, Lassa and Nipah viruses to start.
After recording positive phase 3 results, Merck has said it will submit its Ebola shot for FDA approval by the end of the year.
BARDA has supported both programs before. In 2015, it awarded a contract worth up to $69 million to J&J. The agency also signed off on a Merck deal last October worth up to $76 million.
In a separate announcement on Monday, Baltimore's Profectus Biosciences said it won a contract worth up to $22.25 million to support work on a vaccine designed to protect against Zaire ebolavirus, Sudan ebolavirus, Marburgvirus, and Lassa viruses.