The U.S Department of Health and Human Services approved $43.18 million in funding to Sanofi Pasteur, the vaccine arm of French pharmaceutical giant Sanofi. This was to accelerate the development of a Zika vaccine, as part of efforts to prevent the infection.
Biomedical Advanced Research and Development Authority (BARDA) agreed to fund for the manufacture of inactivated Zika vaccine for the mid-stage Phase II development.
‘Developing an additional safe and effective Zika vaccine candidate and successful clinical trials could help prevent Zika virus infection and the devastating birth defects that Zika virus can cause.’
The company entered into a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate, in July.
The BARDA funding is to take WRAIR's Zika purified inactivated virus (ZPIV) vaccine into Phase II development with manufacturing and characterization of the vaccine product as well as optimization of the upstream process to improve production yields.
Sanofi Pasteur is in the process of creating a clinical development and regulatory strategy while WRAIR and the National Institute of Allergy and Infectious Diseases (NIAID) are conducting a series of Phase I ZPIV trials. Beyond the funding provided by BARDA for the two Phase I/II clinical trials, there is an option in the contract that BARDA can exercise for continuing support through Phase III industrial and clinical development.
The funding runs through June 2022, but if the data is positive, the contract includes an option for up to additional $130.45 million for late-stage trials necessary for eventual approval.
Hundreds of thousands of people are estimated to have been infected with Zika in the Americas and parts of Asia since the virus was detected in Brazil early last year. Most have no symptoms or experience only a mild illness.
However, the virus can penetrate the womb in pregnant women, causing a rare but crippling birth defect known as microcephaly. In adults, it has been linked to Guillain-Barre syndrome, a form of temporary paralysis.
"Given the devastating effects that this infectious disease can have on babies of infected mothers and the fact that the disease appears to rapidly spread, Sanofi Pasteur decided to get involved early on," said David Loew, Sanofi evp and head of Sanofi Pasteur. "We are very pleased that the U.S. government is committed to working with us to develop a Zika vaccine. Based on this collaboration, we can bring together resources and expertise that are essential in fighting this public health concern."
"Developing safe and effective vaccines is a priority in our strategy to protect the public health against the Zika virus," said Richard Hatchett, MD, BARDA's acting director. "This investment supports clinical trials and manufacturing of an additional Zika vaccine candidate that could help prevent Zika virus infection and the devastating birth defects that Zika virus can cause."