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Home Daiichi Sankyo Enrolls First Participant in Phase 2 Trial of COVID-19 mRNA Vaccine DS-5670 Amid Global Cases Surpassing 255 Million

Daiichi Sankyo Enrolls First Participant in Phase 2 Trial of COVID-19 mRNA Vaccine DS-5670 Amid Global Cases Surpassing 255 Million

Nov 18, 2021 01:30 CST Updated 01:30
Daiichi-Sankyo

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PMDA

The PMDA is responsible for preventing adverse reactions to pharmaceuticals and biologics, as well as conducting timely assessments and responses to such risks, thereby helping to enhance the quality, efficacy, and safety of medicinal products and improve public health. Its scope of work includes providing relief for adverse drug reactions, reviewing pharmaceuticals, medical devices, and related businesses in accordance with the law, ensuring the safety of pharmaceuticals and medical devices, and disseminating information on safety measures and medical products.


COVID-19 Vaccine (Image Source: medicaltrend.org)

News on November 18, 2021 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，As of 00:00 on November 18, 2021, the global cumulative confirmed casesMore than 250 million cases (255.24 million), with more than 5.13 million deaths.

Daiichi Sankyo recently announced the evaluation of the COVID-19 mRNA vaccine DS-5670 in a Japanese Phase 2Clinical TrialThe first subject has been vaccinated.

The trial is being conducted in 80 healthy unvaccinated adults using a batch of DS-5670 produced with an optimized manufacturing process to evaluate safety and determine the recommended dose of DS-5670. If successful, DS-5670's Phase 3Clinical TrialWill be launched within the fiscal year 2021.

Daiichi Sankyo will continue to collaborate with Japan's Ministry of Health, Labour and Welfare (MHLW) and the Japanese Pharmaceuticals andMedical DeviceDiscussions will be held with the PMDA to determine the next steps, with the aim of starting the development of a supplemental (booster) dose of DS-5670 by January 2022.

As a Japanese pharmaceutical company specializing in vaccine development, Daiichi Sankyo is striving to help restore societal safety and security by eradicating COVID-19 as soon as possible. The company aims to achieve this goal by developing and commercializing DS-5670 in Japan by 2022.

DS-5670 is an mRNA vaccine for COVID-19 that utilizes a novel nucleic acid delivery technology discovered by Daiichi Sankyo.。DS-5670 Targets the Receptor Binding Domain (RBD) of the Novel Coronavirus (SARS-CoV-2), it is expected to be safe and effective.

The clinical development of DS-5670 is being conducted through the "Coronavirus Disease (COVID-19) Vaccine Development (Second Round)" initiative launched by the Japan Agency for Medical Research and Development (AMED), as well as the "Emergency Improvement Project for Vaccine Manufacturing Systems" supported by the MHLW. (Bioon.com)