As part of the rapid global response to the 2019 novel coronavirus disease (COVID-19), the U.S. Department of Health and Human Services' (HHS’) Office of the Assistant Secretary for Preparedness and Response (ASPR) is collaborating with existing partner Janssen Research & Development, part of Johnson & Johnson, to help develop treatments for coronavirus infections, and new partner Sanofi Pasteur, the vaccines global business unit of Sanofi, to help develop a COVID-19 vaccine.
The Biomedical Advanced Research and Development Authority (BARDA), part of ASPR, will collaborate with Janssen to identify medicines that might be used safely and effectively to reduce the severity of illness and treat coronavirus infections. The company also will identify compounds that have antiviral activity against SARS-CoV-2 as an initial step in developing new treatments. Currently, there are no vaccines or therapeutics approved by the Food and Drug Administration (FDA) to treat or prevent novel coronavirus infections.
"This is the third coronavirus to emerge and cause severe respiratory disease in humans within 18 years, and there are still no proven therapies to treat this disease," said BARDA Director Rick A. Bright, Ph.D. "In partnering with Janssen, BARDA is breaking this barrier to protect against this, as well as the next, coronavirus outbreak. This partnership may accelerate discovery and development of a new potentially lifesaving medicines for people with coronavirus infections."
This library to be screened consists of approved therapeutics as well as investigational therapeutics that have completed some clinical trials so that basic safety and pharmacology data are available for these compounds. If screening is promising, candidates then could be considered for further development, including assessment in additional clinical studies. To screen compounds, Janssen will work with the Rega Institute for Medical Research (KU Leuven) in Belgium. The arrangement couples the Institute's infrastructure, high throughput screening experience, and capabilities for studying special pathogens with Janssen's drug development resources and antiviral expertise.
BARDA is also working with Janssen to develop a COVID-19 vaccine. BARDA has collaborated with the company to develop treatments and vaccines to protect against multiple infectious diseases, such as Ebola and novel influenza viruses with pandemic potential.
Sanofi will use its egg-free, recombinant DNA platform to help produce a recombinant COVID-19 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. BARDA will provide expertise and reallocated funds to support the vaccine’s 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 COVID-19 vaccine candidate. There is currently no approved vaccine, treatment, or diagnostic for COVID-19 infections; however, the FDA has issued an emergency use authorization (EUA) to enable emergency use of a diagnostic test developed by the Centers for Disease Control and Prevention (CDC).
BARDA additionally 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 to identify promising candidates that could be developed to detect, protect against or treat people with coronavirus infections. These products include those in development to treat and prevent Middle East Respiratory Syndrome (MERS) or Severe Acute Respiratory Syndrome (SARS), which are caused by coronaviruses related to SARS-CoV-2.
HHS has the announcement on Janssen.
