As the quest for a COVID-19 vaccine intensifies, companies at the forefront of research need to grapple with complex legal issues at all stages of the work, from the science of creating a safe and effective vaccine to the logistics of distribution and the management of risk. Karen Linehan, executive vice president of legal affairs and general counsel of Sanofi, the French-based pharmaceutical giant, took time out recently to discuss how her team gets involved in her company’s efforts to bring a COVID-19 vaccine to market.

Sanofi has a large presence and long track record in vaccines. What are the key issues in vaccine development and production that come immediately to your attention as general counsel?