Racing to develop a vaccine against the 2019 novel coronavirus, the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response has engaged Sanofi Pasteur, the vaccines global business unit of Sanofi.
The Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, will provide expertise and reallocated funds to support the vaccine’s development. Sanofi will use its egg-free, recombinant DNA platform to produce a recombinant 2019 novel coronavirus vaccine candidate.
The technology produces an exact genetic match to proteins of the virus. The protein’s DNA will be combined with DNA from a virus harmless to humans, and used to rapidly produce large quantities of antigen which stimulate the immune system to protect against the virus. The antigens will be separated and collected from these cells and purified to create working stocks of vaccine for advanced development.
“Flexibility and scalability are cornerstones of rapid response to an emerging infectious disease,” said BARDA Director Rick A. Bright, Ph.D. “Using this proven technology, we can pivot immediately to address this new global health threat. Our goal is a licensed vaccine to provide long-term health security against this latest virus and prevent future coronavirus outbreaks.”
BARDA has worked with Sanofi since 2004 and in 2009 began collaborating with Protein Sciences of Meridian, Connecticut, now owned by Sanofi, to develop a recombinant technology with the flexibility to make millions of doses of vaccine quickly in an influenza pandemic. In 2016, BARDA added this vaccine to the U.S. National Pre-pandemic Influenza Vaccine Stockpile. When Sanofi purchased the company and its technology in 2017, BARDA continued working with Sanofi on pandemic vaccine development, and in December 2019 the partners began focusing on increasing manufacturing capacity for recombinant influenza vaccine in the United States, in accordance with a presidential executive order to enhance national security and the public health by modernizing influenza vaccines and technologies.
This expanded collaboration with Sanofi is BARDA’s second program to focus on developing a novel coronavirus vaccine candidate in the past few weeks. There is currently no approved vaccine, treatment, or diagnostic for novel coronavirus infections; however, the U.S. Food and Drug Administration has issued an emergency use authorization (EUA) to enable emergency use of a diagnostic test developed by the Centers for Disease Control and Prevention.
BARDA also is working with counterparts across the government, including within HHS and with the Department of Defense. The team is reviewing potential vaccines, treatments and diagnostics from across the public and private sectors, particularly products in development for Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS), to identify promising candidates for development and licensure to detect, protect against or treat novel coronavirus infections.
To obtain information about any potential products in development in the private sector that could be used in responding to the novel coronavirus outbreak, the U.S. government launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies relevant to this new virus.
Federal agencies are particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices (cGMP) manufacturing capability, and/or have utilized a platform already approved by the U.S. Food and Drug Administration (FDA).
BARDA also opened an easy broad agency announcement, an EZ-BAA, specific to diagnostics that utilize platforms already cleared by the FDA, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization (EUA) within 12 weeks of an award.