By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research
Vaccines offer a way to build immunity to a disease-causing microorganism before one has ever been exposed to it. They have been highly effective in preventing a whole range of serious infectious diseases. But there is currently no vaccine available to protect the public from the highly contagious coronavirus known as SARS-CoV-2 that is spreading globally, causing the respiratory disease COVID-19, and we know that is a major global public health concern.
That’s why commercial vaccine manufacturers and other entities are aggressively working to develop vaccine candidates. So far, they’ve been able to accelerate the development timelines to enter into initial clinical trials in humans (Phase 1 studies) as expeditiously as possible.
The global regulatory community is doing all that it can to help advance these efforts. On March 18, the U.S Food and Drug Administration and the European Medicines Agency (EMA) jointly chaired the first global regulators meeting to discuss regulatory strategies to facilitate the development of SARS-CoV-2 vaccines. The purpose of this discussion was to promote, to the extent possible, regulatory convergence with the goal of streamlining global SARS-CoV-2 vaccine development.
The FDA’s Europe Office organized the audio/video conference, which was conducted under the auspices of the International Coalition of Medicines Regulatory Authorities—an international executive-level coalition that brings together key regulators from every region of 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.
Regulators focused on the preclinical data needed to demonstrate safety and thus support proceeding to first-in-human clinical trials. Their discussions included the need for data evaluating the theoretical risk for vaccine-induced disease enhancement, which is when vaccinated individuals who are subsequently infected with a virus develop disease that is worse than if they had not received a vaccine at all. Regulators acknowledged the urgency of proceeding to 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 work progresses, frequent communication among global regulators regarding progress of clinical trials is essential.
This first global regulators discussion was a critically important exchange of information and views. The FDA and the EMA intend to convene additional meetings with other global regulators to enable sharing of data from upcoming clinical trials to help ensure global preparedness and promote regulatory convergence, with the goal of streamlining global SARS-CoV-2 vaccine development.
The FDA remains steadfast in helping to foster the development of safe and effective medical products to address this pandemic. Agency staff are working around the clock to facilitate SARS-CoV-2 prevention and treatment options as part of the agency’s response to this outbreak.
Additional Resources: Vaccine Product Approval Process