The U.S. Army's decision to transfer a Zika vaccine candidate's license to development partner Sanofi has prompted protest from a nonprofit worried about the legality of the plan and the product's future pricing.
Developed by Army scientists, the Zika purified inactivated virus vaccine is currently in phase 1 testing at the Walter Reed Army Institute of Research and the National Institutes of Health. Under a development agreement with Sanofi, the pharma is to prep for larger-scale development and manufacturing.
But Knowledge Ecology International has some concerns about the Army’s plan to transfer the vaccine license to the company. It's worried, for one, “about how the price of the vaccine may affect access.” The Army disclosed its plan Dec. 9 in a Federal Register post.
Additionally, KEI believes the license would “not be legal” because it isn’t necessary to motivate the pharma company to develop the vaccine through to the market; so far, the candidate has been supported by “extensive government subsidies,” KEI argues.
If the vaccine were to earn approval, Sanofi would win a priority review voucher from the FDA, KEI says. Those vouchers have been growing in value in recent years. One sold for $350 million in August 2015. According to a draft KEI statement, that is a “valuable incentive in itself.”
A Sanofi spokesperson said the company is "sharing inherent risks" by partnering with the government on Zika, adding that, even with tax-funded support, the drug giant is "still assuming financial and opportunity risks by devoting human and other resources to this project that otherwise would be working on other projects."
"We have been informed of the objections and welcome the opportunity to respond," according to the spokesperson.
Sanofi says it has "modeled various scenarios" for the virus and its prevalence, adding that the "nature of the epidemiology and spread of the virus will impact the degree of profitability." Sanofi said it's "way too early" to talk about pricing or when the vaccine candidate might be available.
In seeking to learn more about the plan, KEI requested information about the vaccine's related intellectual property, the licensing agreement and the amount of government funding the project has received. The Army declined, KEI says, and the nonprofit is objecting to the “lack of transparency” in the process. After hearing from KEI, the Army extended the comment period about its plan to Jan. 23, a KEI representative said.
Sanofi partnered with the U.S. Army on the technology in July 2016 and later won a $43 million government grant to support the work. That money covers development through phase 2, and Sanofi said it might ask for phase 3 or other support "if all goes well" with the program. With many service members deployed in endemic areas, work on the vaccine is part of the Army's response to Zika.
The tie-up is one of several inked by government agencies in response to the Zika outbreak. Shortly after Sanofi signed on with the Army, GlaxoSmithKline partnered with the NIH to tackle Zika with technology called self-amplifying mRNA, or SAM. Takeda later entered the vaccine hunt with a $312 million deal with the U.S. government's Biomedical Advanced Research and Development Authority (BARDA).
An R&D path spanning government and industry is not uncommon, as many top drugs start out in tax-funded labs and eventually make their way to biopharma companies for further development.
Industry-watchers have said a Zika vaccine could be a lucrative prospect even outside countries where the disease is endemic, thanks to international travelers' ability to pay a high price for protection. In addition, campaigns in endemic areas might target girls to protect against the virus and its associated birth defects.
The Army didn't immediately respond to a request for comment.
According to its website, the nonprofit KEI "searches for better outcomes, including new solutions, to the management of knowledge resources."