Researchers will sequence and analyse samples from humans and animals to create profiles of various coronaviruses, including SARS-CoV-2, which causes COVID-19. The results will help inform the development of new treatments and vaccines to tackle coronavirus infections.
The U.S. Food and Drug Administration (FDA) has awarded $5,402,198 (£4,155,536) to support the initial three-year project.
The emergence of SARS-CoV-2 in 2019 and the associated COVID-19 pandemic, and prior SARS-CoV and MERS-CoV outbreaks, demonstrate the significant threat posed by coronaviruses. Since there are currently no licensed therapeutics or vaccines to prevent or treat infections from these specific viruses or coronaviruses in general, there is an urgent need to support development and evaluation of relevant medical countermeasures.
Building upon their expertise in coronaviruses and other highly infectious virus threats the teams will use advanced transcriptomic/proteomic, immunological and computational techniques to analyse clinical specimens from people and model systems infected with coronaviruses that can cause severe disease in humans. The study will also examine newly developed technologies such as organ-on-chips to rapidly characterise coronaviruses/novel diseases and medical countermeasures.
The project is led by Professor Julian Hiscox at the University of Liverpool, who said, 'The development of licensed drugs to treat severe coronavirus infection, and especially SARS-CoV-2, is a huge priority for the international community. There is a time sensitive need to assess the efficacy of novel COVID-19 interventions, address the continuing challenge of MERS and prepare for potential future coronavirus pandemics. Our international team is a great combination of coronavirologists, immunologists, physician scientists and experts in translational medicine.
'The data generated through this study will add unique and significant value to help in the development and evaluation of medical countermeasures. Importantly, this will be accomplished without the need for additional animal studies.'
This project is funded through the FDA MCMi Regulatory Science Extramural Research program, and is supported through partnership with the Office of Biodefense Research Resources, and Translational Research, Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH).
The FDA, an agency within the U.S. Department of Health and Human Services (HHS), protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. NIH/NIAID, also part of HHS, conducts and supports basic and applied research to better understand, treat and ultimately prevent infectious, immunologic and allergic diseases.
'FDA’s work with our international regulatory counterparts and key partners in academia and industry has paved the way for numerous critical collaborations on many scientific and regulatory fronts as part of our COVID-19 response,' said FDA Chief Scientist RADM Denise Hinton. 'FDA will continue to collaborate on important regulatory science projects like this one, as we seek to bring safe and effective COVID-19 vaccines and treatments to our citizens as quickly as possible.'
Professor Miles Carroll who will lead the project components at PHE Porton Down and Oxford University said, 'This programme will further our understanding of alternatives to animal models of coronavirus infection and complement ongoing studies at Oxford University to define protective immunity in support of COVID-19 vaccine development.'
For more information about the project please visit the FDA project page.