Public Health Emergency - Leading a Nation Prepared
Author: Rick A. Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response Published Date: 2/22/2020 10:35:00 AM
Category: Medical Countermeasures; Public Health Preparedness;
On January 31, 2020, Health and Human Services Secretary Alex Azar declared a nationwide public health emergency in response to the novel coronavirus outbreak. Three days later, BARDA entered into the first in a series of expanded public-private partnerships to develop a new medical countermeasure. BARDA is acting with unprecedented speed to initiate research and development to spur innovative medical countermeasures to fight the 2019 novel coronavirus.
In less than a month, BARDA has expanded agreements with three companies to develop medical countermeasures that enhance national health security, and we continue to seek insight from our partners in the private and public sectors to identify promising technologies.
Strengthening health security in the face of the novel coronavirus outbreak will take more than one single product. To protect the American people from this new coronavirus, healthcare professionals need medical countermeasures that enable them to diagnose patients quickly and accurately, vaccinate people to prevent the spread of the virus, and treat infected people with effective therapeutics or antivirals.
To help protect the American people from COVID-19, we have invested in two novel coronavirus vaccines. On February 11, we announced that we were expanding our
collaboration with Janssen Research & Development, part of Johnson & Johnson, to expedite the development of vaccines that protect against this new coronavirus. BARDA and Janssen will share the research and development costs to help move Janssen’s investigational novel coronavirus vaccine into clinical evaluation. The candidate coronavirus vaccine will be developed using Janssen’s flexible, rapid vaccine platform. BARDA and Janssen have collaborated in the recent past to combat another threat to health security: Ebola. The Ebola vaccine developed by Janssen is being used to fight the disease in the Democratic Republic of the Congo today.
On February 18, BARDA expanded our
partnership with Sanofi to develop a novel coronavirus vaccine candidate using the company’s recombinant DNA platform. This technology will be leveraged to produce a vaccine in the U.S. with an exact genetic match to proteins of the virus. Sanofi has worked with us in the past to strengthen health security in another area: pandemic influenza preparedness. We have worked with Sanofi since 2004, to meet a number of pandemic preparedness milestones, most recently on licensure of recombinant technology for influenza vaccines and on increasing domestic manufacturing capacity for these vaccines.
BARDA is also investing in therapeutics to treat patients who are infected with the virus. On February 4, we announced that we are
expanding our existing agreement with Regeneron to develop multiple monoclonal antibodies that, individually or in combination, could be used to treat COVID-19. Two weeks later, on February 18, BARDA and Janssen agreed to expand our existing collaboration to screen libraries of compounds with the potential to treat coronavirus infections and minimize the severity of the illness. Under this expanded agreement, Jansssen will evaluate approved medicines and investigational compounds that have antiviral activity against the novel coronavirus – an important first step in developing treatments
Vaccines and treatments are vital, but so is accurate, timely diagnosis. Bringing diagnostics closer to the patient helps ensure that patients get prompt, appropriate care. To spur innovation, BARDA has issued its business-friendly, streamlined
Easy Broad Agency Announcement (EZ-BAA) for COVID-19 molecular diagnostics. The diagnostics must leverage FDA-cleared platforms and have a viable plan to meet requirements for the FDA to consider
Emergency Use Authorization (EUA) within 12 weeks of an award.
This week we broadened that EZ-BAA even further to include abstracts for nonclinical assays and models to support the development of multiple medical countermeasures to protect the American people. If your company has an innovative coronavirus diagnostic or nonclinical assays underway,
submit your abstract through the EZ-BAA.
In addition, the federal government established a single point of entry for product developers to submit their research on 2019 novel coronavirus medical countermeasures. If your organization has research available,
submit an abstract through our market research initiative.
BARDA and its partners throughout the federal government continue to look for new ways to collaborate on promising technologies. This is the third coronavirus in less than 20 years, and it is time for us to get new medical countermeasures over the finish line.
We have been able to move quickly in the current coronavirus response because of the flexibility built into the agreements with these private sector collaborators. With these and other private sector partners, we have built portfolios of products that address complex health security challenges, including emerging infectious diseases like the 2019 novel coronavirus. Our partnerships with industry and with counterparts from across the federal government have brought products over the regulatory finish line to protect the American people, strengthen health security and, ultimately, save lives.
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