Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change to a new drug application for its Omicron-targeting bivalent COVID-19 booster, mRNA-1273.214 (Spikevax Bivalent Original/Omicron BA.1). Spikevax Bivalent Original/Omicron contains mRNA-1273 (Spikevax) and a vaccine candidate targeting the Omicron variant BA.1.
"COVID-19 continues to threaten public health in Japan, as infections by Omicron and its subvariants continue. mRNA-1273.214 has demonstrated the ability to trigger significantly higher antibody titers against Omicron BA.1 and BA.4/5 subvariants when compared with mRNA-1273," said Rami Suzuki, President & Representative Director of Moderna Japan. "We will continue to work with the Ministry of Health, Labour and Welfare to bring this important vaccine to people in Japan as soon as possible to help protect against COVID-19."
The approval from the MHLW is based on clinical trial data from a Phase 2/3 trial, in which mRNA-1273.214 met all primary endpoints, including superior neutralizing antibody response against Omicron (BA.1) when compared to the currently authorized 50 µg booster dose of Spikevax (mRNA-1273) in previously uninfected participants. A booster dose of Spikevax Bivalent Original/Omicron (mRNA-1273.214) increased neutralizing geometric mean titers (GMT) against Omicron approximately 8-fold above baseline levels. In addition, Spikevax Bivalent Original/Omicron (mRNA-1273.214) elicited higher neutralizing antibody titers against the Omicron subvariants BA.4 and BA.5 when compared to Spikevax (mRNA-1273) regardless of prior infection status or age, including in those aged 65 and older. mRNA-1273.214 was generally well tolerated, with a reactogenicity and safety profile consistent with the currently authorized booster.
Moderna has received authorization decisions for Omicron-targeting bivalent boosters in the United States, Australia, Canada, Europe, Switzerland, South Korea, Taiwan, and the UK to date and has completed regulatory submissions worldwide. In Japan, Takeda Pharmaceutical Co. Ltd. continues to provide distribution support for Spikevax Bivalent Original/Omicron under the current national vaccination campaign for Moderna's COVID-19 vaccines for a transitional period. Supply is expected to commence during September.
Authorized Use
Spikevax bivalent Original/Omicron is indicated as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. One 0.5 mL dose is provided intramuscularly.
https://finance.yahoo.com/news/ministry-health-labour-welfare-japan-110000701.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.