Dr. Amit Rakhit

To help us understand COVID-19, viruses in general and the ways in which vaccines, tests and treatments are created, we reached out to Dr. Amit Rakhit, faculty member at the Katz School of Science and Health, who has over 20 years of experience in clinical practice and the pharmaceutical and biotechnology industries. Dr. Rakhit is currently President and Chief Medical Officer of Ovid Therapeutics, a publicly traded biotechnology company.

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What is the typical process in developing and producing a viral vaccine?  Developing a vaccine is a multistep process, much of which is intended to ensure the quality and safety of the final product. These steps include cultivation of bacteria and virus cells, harvesting and purification of antigens, inactivation of microbes, formulation of all the vaccine ingredients, and filling vials or syringes with the final product. Finally, scientists freeze-dry the formulations to ensure better stability and conservation, packaging the vaccine according to regulatory requirements. Afterwards, the vaccine is transported at just above freezing temperature to keep it stable and extend its shelf-life. How are biotech companies responding to the urgent need for treatment, testing and vaccines? Several companies are now cleared for creating diagnostic tests for COVID-19. For those working on rapid testing, the U.S. Food and Drug Administration and other global health authorities have expedited the process to meet the urgent need. Similarly, companies working on vaccine trials have been given priority to start and are already in Phase 1 trials (human testing of healthy volunteers). In addition, several companies are assessing therapeutic options with already available or experimental anti-viral treatments. How are these vaccines and tests getting rapidly developed and deployed? How has the process been changed? Most of the effort seems to be with companies already in the vaccine or testing space, with a good deal of collaboration among researchers, government officials and regulatory bodies to expedite reviews and resources. There has also been greater speed in allowing these developments to go from the design phase to first-in-human trials, which is somewhat unprecedented but also noteworthy because it has led to many different groups coming together for a common purpose. What advice would you give the biotech industry right now? Continue to collaborate and innovate with others in the health care community. Understand the information from health care professionals in countries like Italy and China to help us get through this pandemic. Ultimately, the industry needs to ensure that patients have access to the medicines they need.