The Biomedical Advanced Research and Development Authority (BARDA), a division of the Department of Health and Human Services informed the vaccine giant in mid-August that it was reducing its financial assistance for the Zika vaccine project.
Yet, the company stated that, “consequently, Sanofi does not intend to continue development of, or seek a license from, the Walter Reed Army Institute of Research for the Zika vaccine candidate at this time.” Walter Reed is the US’s National Medical Centre that serves military beneficiaries.
The decision meant that no further development or licensing would occur for the promising Zika vaccine candidate, despite BARDA committing a USD43 million in research funding and another USD130 million if the vaccine advanced into later-stage testing.
“Evolving epidemiology” to be blamed for resultsThe partners blamed Zika’s “evolving epidemiology” for the change as the virus’ spread has slowed after an explosive early outbreak.
Both Jon Heinrichs, the Sanofi executive who was spearheading the Zika project and Rick Bright, BARDA director were not available for interview.
Bright, has however commented briefly in an email pertaining to the agency’s shift in funding plans – stating that BARDA is still funding a Zika-related study.
“Zika remains a public health threat, and BARDA plans to continue working with industry partners including Sanofi on developing Zika vaccines and diagnostics to make them available commercially as quickly as possible,” Bright told a news website, STAT. “The specific activities of development projects often change based on a variety of technical and epidemiological factors.”
BARDA also said that “development would be indefinitely paused but could be restarted if the epidemic re-emerges.”
Critics demanded pricing guaranteeThe project was under intense public and political scrutiny as experts and critics demanded pricing guarantees if a commercial vaccine was funded by taxpayers.
The candidate was originally developed by scientists with the US Army and Sanofi sought collaboration. Sanofi executives however, insisted that the company contributed through its own development resources – risking money, staff and time to pursue a project that might never yield a commercial product.
It also played defence, stating that the candidate was a potential vaccine – a far cry from being an actual produce – that discussing about pricing guarantees in early stages was not logical.
From a technical point of view, early testing suggested that a Zika vaccine would not be too difficult to produce, with US officials making bold promises that a vaccine might be available within two years.
The future of a Zika vaccine marketHowever, there were also questions as to whether there would be enough Zika activity to be able to run trials, and if sales prospects would be sufficiently robust to convince companies to bring them to market.
“That’s something we talk about a lot,” said Heinrichs. “We have models that suggest there is no profitability for this vaccine, and we have models that suggest it could be profitable. Time will tell.”
The US government has also partnered with GlaxoSmithKline (GSK) and Takeda on two separate Zika vaccine candidates – with Takeda’s collaboration with BARDA worth up to USD312 million.
Other smaller companies are also working on a Zika vaccine, as well as the US National Institute of Allergy and Infectious Diseases (NIAID).
Dr Anthony Fauci, director of the NIAID, expressed that he remains hopeful that a Zika vaccine can be brought to market, despite the testing challenges caused by the low level of Zika activity.
“There’s something about protecting babies that gets people more energised in putting investments in,” remarked Fauci. MIMS
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