Public Health Emergency - Leading a Nation Prepared
A public-private partnership announced today between the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and Janssen Research & Development LLC, will drive advanced development of an entire portfolio of innovative products to prevent or treat infections caused by emerging infectious diseases, including influenza viruses with pandemic potential.
Through this partnership, the first of its kind for emerging infectious diseases and pandemic influenza preparedness, the Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, and Janssen will jointly oversee and share the cost of developing new approaches to address influenza, a formidable threat to national security and public health.
The portfolio initially will include an anti-influenza small molecule drug and a universal influenza vaccine, among other products in development. The partners will collaborate on decisions about adding or removing products from the portfolio.
Under the agreement, BARDA will provide up to $43 million in the first year and potentially up to $273 million over five years. Janssen Research and Development will provide an equal investment.
“Pandemic influenza is one of the greatest health threats that we face--a pandemic can lead to significant illness, loss of life, and social and economic disruption. We need new approaches to effectively address this persistent threat,” said BARDA Director Rick Bright, Ph.D. “This portfolio includes exciting products that could greatly improve our response to influenza and we’ve found that portfolio-based partnerships like this provide the flexibility and reliable funding to develop products needed for emergencies and for the commercial market. This agreement is a win-win-win for our partners, for preparedness, and for the taxpayer.”
Initially, the portfolio will include development of a potent small-molecule drug known as JNJ-5806. Small molecules are substances that can enter cells easily because of their low molecular weight. Once inside the cells, studies suggest that JNJ-5806 may interfere with an influenza virus’ ability to reproduce its genetic code and spread in the body. In clinical trials, this molecule worked against influenza virus types A and B, including influenza A viruses with pandemic potential.
The portfolio also will include development of an innovative influenza vaccine with the potential to protect against a broad range of seasonal and pandemic influenza viruses. The vaccine is being designed to act on a part of the influenza virus that seldom changes. If this approach is successful, the vaccine potentially could become a so-called universal vaccine.
Additional products in the portfolio include therapeutic monoclonal antibodies, while new products could be added to meet U.S. public health and biodefense needs.
Rather than a standard agreement, ASPR and Janssen Research and Development will collaborate under an agreement allowed by “other transaction authority” which was granted to HHS under the Pandemic and All Hazards Preparedness Act of 2006. The other transaction agreement provides a funding and collaboration vehicle to promote innovation in technology for advanced research and development.
This partnership is the fifth that BARDA has formed using other transaction authority. All of the partnerships focus on developing new products to address chemical, biological, radiological and nuclear (CBRN) threats, pandemic influenza, and of other emerging infectious diseases.
As a division of ASPR, BARDA takes a comprehensive integrated portfolio approach to advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for CBRN and naturally occurring public health medical emergencies. ASPR partners with other federal agencies, in particular the National Institutes of Health, as well as private industry to develop medical products needed to mitigate the health effects of disasters and other public health emergencies. Potential products may transition from basic research and early clinical trials at NIH to BARDA for support of the advanced development necessary to support approval or licensure by the U.S. Food and Drug Administration.
HHS is the principal federal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. ASPR leads HHS in preparing the nation to respond to and recover from adverse health effects of emergencies, supporting communities’ ability to withstand adversity, strengthening health and response systems, and enhancing national health security.
For more information on national public health and medical preparedness, visit www.phe.gov and to learn more about partnering with BARDA in public health preparedness visit www.medicalcountermeasures.gov.
# # #
Connect with HHS and sign up for HHS email updates
Home | Contact Us | Accessibility | Privacy Policies | Disclaimer | HHS Viewers & Players | HHS Plain Language
Assistant Secretary for Preparedness and Response (ASPR), 200 Independence Ave., SW, Washington, DC 20201
U.S. Department of Health and Human Services | USA.gov |
HealthCare.gov in Other Languages