International – FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development

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…