Daiichi Sankyo files for Japanese approval of mRNA COVID vaccine as booster
CROCOTHERY


Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) submitted an application to the regulatory authorities in Japan seeking approval of its mRNA COVID-19 vaccine DS-5670 as a booster shot.
The Japanese drugmaker said the application was backed by data from a phase 1/2/3 trial (original strain) in about 5K healthy adults and elderly, who received a primary series (two doses) of an mRNA vaccine approved in Japan.

Daiichi Sankyo noted that it started prior assessment discussions for drugs with the Pharmaceuticals and Medical Devices Agency in September 2022 based on non-clinical, clinical, and quality data available up to now to get marketing approval at an earlier date.
In addition, Daiichi Sankyo said it plans to develop DS-5670 for the Omicron strain in order to respond to new variants of the coronavirus, along with the development for the original strain.
MRNA COVID vaccines currently approved in Japan include, Comirnaty â from Pfizer (PFE) and BioNTech (BNTX) â and Spikevax from Moderna (MRNA).