COVID-19 News

FDA official recaps global meeting on COVID-19 vaccine efforts

Peter Marks, MD, PhD, the director of the Center for Biologics Evaluation and Research at the US Food and Drug Administration, on Tuesday published a statement in which he briefly summarized the March 18 global regulatory meeting on COVID-19 vaccine development.

The FDA 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.

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