Clinical Research – Government and Industry Team to Provide Hope in the Crisis
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Necessity is the mother of invention, and it’s hard to remember a time when humanity has been more motivated to resolve a crisis. Times like this, though, generally bring out the best in all of us – the best in government, the best in industry, and the best in individuals. The COVID-19 research and development response by all partners is helping provide hope during these difficult times. A few of these promising developments are as follows:
Convalescent Plasma Research – researchers and health care providers looking to COVID-19 survivors’ blood plasma for a possible therapy in the fight against the virus. The FDA is allowing emergency Investigational New Drug applications for serious or life-threatening COVID-19 infections. The FDA recently published guidance to researchers on COVID-19 Convalescent Plasma.
Diagnostic Testing – the FDA has worked with more than 220 test developers who have indicated they will be submitting emergency use authorizations (EUA) request to FDA for COVID-19 testing. As of March 26, 18 EUA have been approved including one real-time diagnostic test for COVID-19, and more than 100 laboratories have begun testing for the virus. The FDA continues to keep up-to-date the COVID-19 Diagnostics FAQ.
Vaccine Development – the first phase 1 clinical trial for an investigational vaccine to protect against COVID-19 is underway at Kaiser Permanente. The trial will evaluate the safety and reactogenicity of the vaccine mRNA-1273 in healthy adults. The trial enrolled approximately 45 subjects and will last approximately one year.
3D Printing – as the need for critical medical products outpaces the supply chain, many are using 3D printing to assist in meeting the demand for certain products, such as PPE, ventilators and ventilator component parts. The FDA recently published FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic, and has authorized an EAU for ventilators, ventilator tubing connectors, and ventilator accessories, which could include items such as 3D-printed tubing connectors for multiplexing ventilator use. The FDA also is collaborating with the Department of Veterans Affairs (VA) Innovation Ecosystem, America Makes Public-Private Partnership, and the National Institutes of Health (NIH) 3D Print Exchange, a resource from the National Institute of Allergy and Infectious Diseases at the NIH, to deploy the nation’s manufacturing resources to help effectively and safely meet the needs of the health care industry.
These are only a handful of the remarkable research and development efforts ongoing across the country. Those interested in following the latest research developments in the fight against COVID-19 can visit the FDA’s Coronavirus Update: Daily Roundup.