Moderna submits data for potential COVID vaccine authorization in Switzerland

A rolling review of Moderna’s coronavirus vaccine is underway for potential authorization in Switzerland, the company announced, a process that can move quickly while maintaining safety standards.

Moderna submitted the application for authorization to Swissmedic, the national authorization and supervisory authority for drugs and medical products in Switzerland.

“This rolling review process allows Swissmedic to review data from ongoing clinical trials as soon as it is available. This process can reduce time to authorization while maintaining usual high standards of safety, efficacy, and quality,” said Moderna in a press release on Friday.

In a rolling review, companies can also can submit updated data continuously without having to wait for the conclusive results from all studies, said Swissmedic.

Moderna started the rolling submission of vaccine data for potential authorization provided it meets Swissmedic’s standards of safety, effectiveness and quality standards.

The Swiss Confederation already signed an agreement with Cambridge-based Moderna for 4.5 million vaccine doses, according to Swissmedic.

“We appreciate the collaboration we have had to date with Swissmedic to address this ongoing public health emergency,” said Stephane Bancel, CEO of Moderna. “We are pleased with the encouraging Phase 1 interim analysis of mRNA-1273 in the older adult population, which we recently published together with the NIH.”

The Phase 1 interim analysis showed that the vaccine, called mRNA-1273, was generally well-tolerated across all age groups and triggered rapid and strong immune responses.

This is the third authorization procedure initiated in Switzerland for a coronavirus vaccine. The other two candidates include vaccines by AstraZeneca and Pfizer.

from Boston Herald https://ift.tt/2H0kkAR