Having seen Zika’s devastating effects reach Florida residents, a group of lawmakers in the state is urging the Army to pump the brakes on its exclusive vaccine license to Sanofi.
In letters to acting Army Secretary Robert Speer, nine members of the House of Representatives from the state and Sen. Bill Nelson have castigated the proposed vaccine license, questioning why the partners can’t include a fair pricing assurance. The House members are requesting that the license be delayed until officials can hold a public hearing on the plan.
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For his part, Sen. Nelson noted that more than 1,400 cases of Zika have been documented in Florida. He wrote (PDF) that a “failure to limit the vaccine’s market price could make it inaccessible to thousands of Floridians who need it.” Nonprofit Knowledge Ecology International (KEI) posted the letters on its website Wednesday.
The Army and reportedly Sanofi itself have rejected calls for pricing assurances on the planned license, first announced late last year. Their refusal has angered politicians and public watchdog groups who have pointed out that the vaccine was developed with funds from U.S. taxpayers.
In response to the requests, the Army said it simply can’t enforce future vaccine prices. Sanofi has said that the terms of the license are still under negotiation.
KEI was among the first to protest the proposed license, kicking off a campaign that’s gained a great deal of steam in recent months. Sen. Bernie Sanders wrote a New York Times op-ed requesting the Trump administration call the deal off, and Sanofi R&D head Elias Zerhouni defended his company in the same newspaper.
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Zerhouni pointed out that Sanofi wouldn’t be getting something for nothing in the deal and that the drugmaker would have to pay “significant” milestone and royalty payments if the partners are able to develop a successful vaccine. Before the Florida lawmakers wrote to protest the deal, a separate group of 11 Democrats urged against the license back in February.
On Wednesday, KEI’s counsel for policy and legal affairs, Andrew Goldman, said in a written statement that the new letters “highlight the absurdity of paying for virtually all of the R&D for the vaccine, giving a French company a monopoly until 2036, and not having any conditions on the price before signing the license.”
The U.S. government is also partnered with GlaxoSmithKline and Takeda on different Zika vaccine approaches, and the proposed license to Sanofi would not prohibit other companies from bringing vaccines to market and competing on price.
"Whether or not the agreement with WRAIR is exclusive or non-exclusive, the license does not prevent other companies from pursuing vaccine candidates based on alternative technologies which have the potential to be more viable than this one," a Sanofi spokesperson said on Wednesday. "There is a very strong likelihood there will be a competitive Zika vaccine marketplace with 32 Zika vaccines in early development. Many of these other companies are also receiving funding from the U.S. government."
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Further, it’s in the "public-health interest for Sanofi to price this and other vaccines in a way that will facilitate access to and usage of a preventative vaccine," she said.
The Army is set to decide on the license by the fall, according to the Miami Herald. Its press office didn’t immediately respond to a request for comment on the letters.
Sanofi partnered with the U.S. Army last summer and has since won $43 million in government funds to support the project. Another $130 million could be awarded for future work. Army scientists originally developed the candidate. Market-watchers have predicted the Zika vaccine market could be worth $1 billion per year or more.