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Lawmakers decry Army’s planned Zika vaccine license to Sanofi

Lawmakers decry Army’s planned Zika vaccine license to Sanofi

by fiercepharma

February 24, 2017

After some nonprofit organizations made noise about the U.S. Army’s plans to license a Zika vaccine to Sanofi, several lawmakers are chiming in to say it’s a bad idea.

Eleven congressional Democrats wrote to Acting Secretary of the Army Robert Speer to "strongly urge" against the move, first announced in a Federal Register post in December.

Among the first to oppose that plan was Knowledge Ecology International (KEI), a nonprofit that argued the license wouldn’t be necessary to motivate Sanofi to develop the shot through to the market. Further, the group is concerned about future pricing of a vaccine that was developed with public funds.

RELATED: U.S. Army's planned Zika vaccine license to Sanofi raises nonprofit's ire

Worldwide charity Médecins Sans Frontières came out against the plan last month with arguments that the license could be a barrier to access.

Now, members of the House, including frequent pharma critic Rep. Elijah Cummings, write that the license as planned doesn’t have enough pricing and access safeguards. They too say it was developed with public funds, and "implore" the Army to "instead issue a limited license" with more restrictions.

If the plan does go through, the lawmakers would like to see the license enable the federal government to intervene if Sanofi priced it out of reach to "millions of Americans" who might need a shot "they paid to develop."

On Thursday, a Sanofi spokesperson agreed that "anything that curtails innovation in healthcare R&D would not be best for the public good." As the world's top flavivirus vaccine developer, Sanofi is "well-positioned" to work with the Army's candidate, she said, and "is capable of making it available to those areas that need it most."

Sanofi partnered with the U.S. Army on the technology—dubbed Zika purified inactivated virus (ZPIV)—back in July and later won a $43 million grant from the government to support the work. The company could ask for further financial support "if all goes well," a spokesperson previously told FiercePharma.

Responding to KEI’s initial concerns, a Sanofi spokesperson said the drugmaker is "sharing inherent risks" in developing the vaccine. The company has "modeled various scenarios" for the virus and its prevalence, and the vaccine’s profitability will depend on the "nature of the epidemiology and spread of the virus."

Experts have predicted a Zika vaccine could be an opportunity worth $1 billion or more, because travelers could pay a high price for protection.

RELATED: Thanks to travelers, Zika could be a $1B+ vaccine opportunity

Among the dozens of other companies and organizations to get involved in Zika research are major pharmas GlaxoSmithKline and Takeda.

In addition to Cummings, also signing the letter were House Democrats Jan Schakowsky, Lloyd Doggett, John Conyers Jr., Judy Chu, Mark Pocan, Rosa DeLauro, Pramila Jayapal, Keith Ellison, Michelle Lujan Grisham and Peter Welch.

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