[Ip-health] ​SANOFI STATEMENT ON ZIKA VACCINE LICENSE

Jamie Love james.love at keionline.org
Sat Sep 2 17:03:25 PDT 2017


​Sanofi announces it will no longer "seek a license from, the Walter Reed
Army Institute of Research for the Zika vaccine candidate at this time."

Sanofi does not mention the directive on pricing from the Senate Armed
Services Committee.

Sanofi does mention a reduction in BARDA funding of the Zika vaccine trials
and development, due to "a profound reduction in the number of new Zika
cases in the United States and around the world in 2017," and notes without
details that in light of the results of the government run Phase I study
"it was necessary to substantially extend our projected vaccine development
timelines."

Sanofi ends the statement by saying "we continue to believe that
public-private partnerships are the right model to address these public
health challenges and should continue to play a major role in response to
emerging infectious diseases."

Not really sure what to make of this announcement.  It does come after the
Armed Services Committee drive on pricing and Bayh-Dole rights, and right
before license was supposed to be concluded, but also clearly the BARDA
decision to re-purpose its funding to other projects was very
consequential.

The story on this vaccine is probably not over, but on pause for now.

http://www.news.sanofi.us/Sanofi-Statement-on-Zika-Vaccine-License

SANOFI STATEMENT ON ZIKA VACCINE LICENSE

Sep 1, 2017

On August 17, 2017, Sanofi Pasteur was informed by The Biomedical Advanced
Research and Development Authority (BARDA) within the Office of the
Assistant Secretary for Preparedness and Response in the U.S. Department of
Health and Human Services that they completed an assessment of all
Zika-related projects they are funding and have decided to focus on a more
limited set of goals and deliverables.

As a result of their review, Sanofi Pasteur has been notified of BARDA’s
decision to “de-scope” its contract with Sanofi Pasteur to fund the
manufacture and clinical development of an inactivated Zika vaccine and
will limit its funding to a case definition and surveillance study as well
as any activities required to advance our vaccine development to a point
where development would be indefinitely paused but could be restarted if
the epidemic re-emerges.

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.

We are proud of our contributions to the productive collaboration to date,
which will result in significant contributions to science and to others who
may continue pursuing licensure for an effective and safe Zika vaccine.

One of the ways Sanofi Pasteur will continue to contribute to the field of
knowledge on Zika is by completing, with partial BARDA support, the ongoing
case definition and surveillance study which will provide guidance on Zika
epidemiology and diagnosis that can be applicable to any vaccine
subsequently developed to prevent the disease.  The case-definition and
surveillance study is currently being conducted in 4 countries—Colombia,
Honduras, Mexico, and Puerto Rico—and we are looking to enroll 2,400
volunteers.

Given the evolving epidemiology of Zika, which has seen a profound
reduction in the number of new Zika cases in the United States and around
the world in 2017, as well as the results of the Phase I study, it was
necessary to substantially extend our projected vaccine development
timelines.  Therefore, we respect BARDA’s decision to re-purpose limited
resources to meet their priorities.

In February 2016, Sanofi Pasteur urgently responded to the WHO’s
declaration of a public-health emergency of international concern (PHEIC).
In doing so, we assumed significant opportunity costs and delayed other
internal pipeline priorities to lend our expertise to the Zika global
public-health threat.  The epidemiology of the disease has changed
significantly since that time, but we continue to believe that
public-private partnerships are the right model to address these public
health challenges and should continue to play a major role in response to
emerging infectious diseases.


--
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love​



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