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HHS collaborates on development of coronavirus treatment, vaccine

World Health Organization says it hopes to have a candidate vaccine in 16 weeks.

Susan Morse, Managing Editor

A task force website has been established for treatment developments to the novel coronavirus outbreak.A task force website has been established for treatment developments to the novel coronavirus outbreak.

The U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response is working with Janssen Research & Development to identify medicines that might be used to reduce the severity of illness of the coronavirus.

The Biomedical Advanced Research and Development Authority, which is part of the Assistant Secretary for Preparedness and Response, is also working with Janssen to develop a novel coronavirus vaccine.

The World Health Organization said it hopes to have a candidate vaccine within 16 weeks.

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In China, where the outbreak began, there are more than 72,000 confirmed cases and 1,868 people have reportedly died, according to NBC News.

In the U.S., the number of cases still stands at 15.

WHO yesterday said the transmission of the coronavirus has begun to slow. It stopped short of calling the COVID-9 coronavirus a pandemic, saying much of its spread is still localized to China.

WHY THIS MATTERS

Currently, there are no vaccines or therapeutics approved by the U.S. Food and Drug Administration to treat or prevent novel coronavirus infections.

The Biomedical Advanced Research and Development will identify compounds that have antiviral activity against SARS-CoV-2 as an initial step in developing new treatments.

To screen compounds, Janssen will work with the Rega Institute for Medical Research (KU Leuven) in Belgium, combining the institute's infrastructure, experience and capabilities for studying special pathogens with Janssen's drug development resources and antiviral expertise, HHS said.

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.

PRIVATE SECTOR INPUT

In addition to expanded collaboration with Janssen, the Biomedical Advanced Research and Development Authority 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. 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.

A task force website has been established for innovators and product developers to submit brief descriptions of their relevant diagnostics, therapeutics, vaccines, and other products or technologies that could be used in responding to the novel coronavirus outbreak.

The task force is particularly interested in identifying products and technologies that have progressed into or beyond non-clinical studies, have established large-scale commercial Good Manufacturing Practices manufacturing capability and/or utilize an FDA-cleared diagnostic platform.

To further support the novel coronavirus response, BARDA also opened an easy broad agency announcement, an EZ-BAA, specific to diagnostics that utilize FDA-cleared platforms, with a viable plan to meet requirements for the FDA to consider issuing an Emergency Use Authorization within 12 weeks of an award.

THE LARGER TREND

Janssen is part of Johnson & Johnson and already has an existing partnership with the HHS agency.

BARDA has previously collaborated with Janssen to develop treatments and vaccines to protect against multiple infectious diseases, such as Ebola and novel influenza viruses with pandemic potential.

To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance.

ON THE RECORD

"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. "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."

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com