Moderna Doses First Patient in Japanese Study of COVID-19 Vaccine

Moderna recently announced that clinical trial researchers have dosed the first in the Phase 1/2 study of its mRNA COVID-19 vaccine, mRNA-1273, in Japan, led by Takeda Pharmaceuticals.  

The placebo-controlled Phase 1/2 study will enroll 200 participants aged 20 years and older in Japan to evaluate the safety and immunogenicity of two doses of mRNA-1273 given 28 days apart. 

Each participant will be assigned to receive a placebo or a 100 μg dose at both vaccinations and will be followed for 12 months after the second vaccination.

“We are pleased that this Phase 1/2 study of our COVID-19 vaccine in healthy adults in Japan has begun. This is the first clinical trial of a Moderna product in Japan and we thank Takeda for partnering with us to potentially protect the Japanese population from COVID-19 with a vaccine,” Stéphane Bancel, chief executive officer of Moderna, said in the announcement. 

At the end of October, Takeda Pharmaceuticals announced that it will import and distribute 50 million doses of mRNA-1273 starting in the first half of 2021, pending licensure in Japan. 

This initiative is part of a three-way agreement between Takeda Pharmaceuticals, Moderna, and the Government of Japan’s Ministry of Health Labour and Welfare (MHLW).

In mid-May, Moderna announced positive clinical data for mRNA-1273 from the Phase I study led by the National Institutes of Allergy and Infectious Diseases (NIAID) in the US.

In the trial, the vaccine candidate was safe and well-tolerated. Specifically, levels of neutralizing antibodies at Day 43 were at or above levels normally seen in blood samples of people who have recovered from COVID-19.

In August, HHS and the Department of Defense (DoD) announced an agreement with Moderna to manufacture and deliver 100 million doses of the company’s vaccine candidate. 

Under the agreement, Moderna manufactured the vaccine doses while clinical trials were still underway. The federal government will own the doses and will be able to acquire up to an additional 400 million doses of mRNA-1273.

Three months later, Moderna announced that the vaccine proved 95 percent effective in a Phase 3 clinical trial and met statistical criteria pre-specified in the study protocol for efficacy in a majority of US participants. 

But in December, Moderna released a second primary analysis of the vaccine, which found that it was 94.1 percent effective against the coronavirus in a total of 196 cases. Out of the 196 cases, 185 were in the placebo group and 11 were in the mRNA-1273 group. 

New evidence at the time showed that there was one death related to COVID-19 in the study, which occurred in the placebo group. The most common solicited adverse event reactions were injection site pain, myalgia, arthralgia, and headache, which were consistent with the first analysis. No additional safety concerns were identified. 

In mid-December, Moderna dosed the first adolescent patients in the Phase 2/3 study of mRNA-1273.

The randomized study will evaluate the safety and immunogenicity of two vaccinations 28 days apart in 3,000 participants aged 12 and under to 18 years. 

At the time, the company was on track to manufacture 500 million to 1 billion doses globally by the end of this year. But at the beginning of January, Moderna announced that it is increasing its base-case global production estimate to 600 million doses in the same time frame. 

The company hopes to build that estimate to 1 billion doses by the end of 2021 based on continued investments and the addition of more staff.

Nearly 100 million of those doses to be available in the US by the end of the first quarter of 2021, with 200 million doses total available by the end of the second quarter.