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US Department of Health and Human Services calls for coronavirus product proposals

Move will fast-track the development of potential treatments

Coronavirus

The US Department of Health and Human Services (HHS) has asked for companies to submit proposals which focus specifically on the development of products to treat, prevent and diagnose the novel coronavirus.

The continued spread of the coronavirus – which causes the disease known as COVID-19 – has caused governments across the world to implement new measures and scale-up efforts to tackle the virus.

That includes the most recent update from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), which has now issued a broad agency announcement (BAA) in response to the outbreak which ‘solicit(s) proposals for advanced development and licensure of COVID019 diagnostics, vaccine or medicines such as therapeutics or antivirals’.

According to the HHS, BARDA will foot the costs, provide the expertise and core services in support of development projects selected through the BAA.

The HHS National Institute of Health (NIH) division is already supporting the development of a number of vaccines treatments for the coronavirus, including Moderna’s vaccine candidate mRNA-1273.

The first batch of Moderna’s vaccine was sent to the NIH and the National Institute of Allergy and Infectious Diseases (NIAID) for testing in a planned phase 1 study.

BARDA has also partnered with French drugmaker Sanofi Pasteur’s vaccines division on a project for the novel coronavirus, which will tap into the company’s earlier work on the SARS virus.

Sanofi’s prior work on SARS – another type of coronavirus which caused an epidemic back in 2002 – means that it can ‘fast-track’ a possible vaccine through development.

Johnson & Johnson’s Janssen division has also partnered with BARDA to accelerate the development of a possible vaccine candidate, as part of a ‘multi-pronged’ approach which will also include screening antiviral molecules for activity against COVID-19.

On the therapeutics front, the NIH has already initiated testing of Gilead’s anti-viral drug remdesivir in a phase 1 study in the US.

Participants in the study must have a laboratory-confirmed case of the novel coronavirus as well as evidence of lung involvement. That could include rattling sounds when breathing with as need for supplemental oxygen, abnormal chest X-rays or illness requiring mechanical ventilation.

The drug is also being tested across two trials in China, at the epicentre of the outbreak in Wuhan City, Hubei province.

“Amid the expanding global outbreak of COVID-19, Americans need diagnostics, vaccines, and medicines to mitigate the potential impact of this virus,” said BARDA director Rick Bright.

“To accelerate the availability of these lifesaving tools, BARDA took an important step today to request proposals for development of COVID-19 diagnostics, vaccines or therapeutics, many of which will be developed using existing platform technologies to permit rapid development,” he added.

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