FDA, EMA Collaborate on SARS-CoV-2 Vaccine Development

On March 23, 2020, FDA announced that on March 18, FDA and the European Medicines Agency (EMA) co-chaired the first global regulators meeting to discuss regulatory strategies to streamline vaccine development for SARS-CoV-2, which causes the respiratory disease COVID-19.

FDA’s Europe office organized the audio/video conference, which was conducted with the support of the International Coalition of Medicines Regulatory Authorities (ICMRA), an international executive-level coalition that brings together regulators around the world to facilitate access to safe, effective, high-quality products. More than 60 experts representing 25 agencies and 17 countries participated in the meeting, as well as the World Health Organization.

On March 24, EMA announced that global regulators published a report presenting the outcomes of the meeting. The report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key points:

Pre-clinical data required to support proceeding to first-in-human clinical trials with investigational products

The need to address the known theoretical risk for vaccine-induced disease enhancement, which is when vaccinated individuals who are subsequently infected with a virus develop a disease that is worse than if they had not received a vaccine at all.

In the meeting, regulators acknowledged the urgency of entering human clinical trials with SARS-CoV-2 candidate vaccines in light of the current COVID-19 pandemic, yet stressed the importance of preclinical and clinical risk mitigation strategies so that those enrolled in clinical trials are not exposed to unreasonable risk, as stated by FDA. 

The meeting also aimed to encourage exchange of information about the global efforts toward developing new vaccines against COVID-19 through an open dialogue between regulatory authorities worldwide. FDA and EMA intend to conduct additional meetings with other global regulators to enable the sharing of data from upcoming clinical trials, to ensure global preparedness, and to promote regulatory convergence for streamlining SARS-CoV-2 vaccine development.