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# FDA Using Emulate to Evaluate Covid Vaccine Safety
- URL: https://www.fdaweb.com/fda-using-emulate-to-evaluate-covid-vaccine-safety/
- Published: 2020-10-29T12:00:00.000Z
- Updated: 2026-09-14T16:34:36.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5147978

FDA has entered into a Cooperative Research and Development Agreement with Emulate, Inc., to enable multiple studies across FDA Centers in priority research areas, including programs to evaluate Covid-19 vaccines and understand human response against SARS-CoV-2\. Emulate [says](https://www.marketwatch.com/press-release/emulate-signs-collaborative-agreement-with-the-fda-to-apply-lung-chip-to-evaluate-safety-of-covid-19-vaccines-and-protective-immunity-against-sars-cov-2-2020-10-29?tesla=y&ref=fdaweb.com) that under the agreement the agency will use a range of its organ-chips to study the safety, efficacy, and mechanisms of drugs it regulates. The new agreement follows the successful completion of a 2017 agreement that focused on toxicity studies using the firm’s liver-chip.

“The initial studies use organ-chips, which are able to recreate the natural physiology of specific human tissues and organs, in areas where conventional cell culture and animal-based testing methods have limitations in reflecting human biology and disease mechanisms that are not yet understood, such as Alzheimer’s disease and Covid-19,” Emulate says.

The CBER Covid-19 study will look at why individuals experience a wide spectrum of disease severity and what constitutes real protection against future infection, the statement says. It says the Emulate human lung-chip that will be used recreates the microenvironment found in a human lung.