A bipartisan group of members of Congress from Florida has asked the acting secretary of the U.S. Army to hold public hearings before awarding exclusive rights to a French pharmaceutical manufacturer to develop a Zika vaccine using technology invented by the Walter Reed Army Institute of Research and funded by American taxpayers.
The lawmakers expressed concern about the affordability of a Zika vaccine once one becomes available because the pharmaceutical manufacturer, Sanofi Pasteur, rejected a request from the U.S. Army to set an affordable price for the drug.
In a June 13 letter to Robert Speer, acting secretary of the U.S. Army, nine Florida members of the House led by Rep. Debbie Wasserman Schultz, a Weston Democrat, said they were “especially concerned of the potential for monopolistic practices” that would place a Zika vaccine out of financial reach for many.
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U.S. Sen. Bill Nelson of Florida also wrote to Speer this week asking the Army to obtain assurances from Sanofi that the vaccine will be affordable before awarding the company exclusive license to technology developed with American taxpayer funds.
“If the Army chooses to move forward with its plan to provide Sanofi Pasteur an exclusive license to sell this vaccine,” Nelson wrote, “it must first obtain assurances that the vaccine will be affordable to all who need it.”
Scientists with Walter Reed, which is part of the Department of Defense, and the National Institutes of Health have performed all of the pre-clinical research for the vaccine and are currently conducting early stage clinical trials.
The Army partnered with Sanofi last June to develop a vaccine that builds on a platform developed by Walter Reed scientists for other viruses that are similar to Zika, such as Japanese encephalitis and dengue.
In December, the Army announced its intention to transfer the technology used to develop the vaccine to Sanofi, which has the capability to run large-scale clinical trials and to mass produce and distribute drugs — capabilities that the Army currently lacks, according to a recent letter from Speer to U.S. Sen. Bernie Sanders of Vermont, who first raised concerns about the deal.
Sanofi Pasteur has already received $43 million in research grants from the Department of Health and Human Services, with an option for an additional $130 million for late stage clinical trials if needed.
There are currently several Zika vaccine trials underway, and many receive U.S. government funding. But Sanofi is the only pharmaceutical manufacturer in line to receive exclusive licensing from the U.S. Army using technology developed with taxpayer funds.
Ashleigh Koss, a spokeswoman for Sanofi, said in a written statement that the pharmaceutical manufacturer is too early in the development process to be able to commit to a price for a Zika vaccine.
“It is 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,” Koss said. “We have demonstrated this commitment in the past, and, if we bring a Zika vaccine to market, we intend to do so for Zika.”
But Andrew Goldman of Knowledge Ecology International, a nonprofit advocate for affordable drug pricing, said in a written statement that the Army’s intention to grant Sanofi exclusive license to its Zika vaccine technology is an unnecessary incentive for the drug maker to bring a vaccine to market.
“The two letters from members of Congress in Florida highlight the absurdity of paying for virtually all of the R&D [research and development] for the vaccine, giving a French company a monopoly until 2036, and not having any conditions on the price before signing the license,” Goldman said.
The Army is expected to make a final decision on granting a license to its Zika vaccine technology by fall.
Zika is spread primarily by the bite of an infected Aedes aegypti and Aedes albopictus species mosquito. The virus also spreads through sexual contact, and from a pregnant woman to her fetus. Infection during pregnancy can cause certain birth defects, including microcephaly.