News & analysis on the clinical development and manufacture of large molecule drugs
Fast-tracking COVID-19 vaccine approval
By Jane Byrne
- Last updated on
The story grabbing all the attention in October was the piece on Moderna engaging with international regulators to accelerate approval of its experimental COVID-19 vaccine - mRNA-1273.
The developer's rolling submission was accepted under the Canadian Minister of Health's Interim Order, which permits companies to present safety and efficacy data and information as they become available, without waiting for studies to end. Such an approach to reviews could speed up the process of approving a successful COVID-19 vaccine.
The company also announced that its application for real-time review of mRNA-1273 in Europe had been accepted by the European Medicines Agency (EMA).