Moderna Confirms Discussions with the Ministry of Health, Labour and Welfare to Supply Japan with 40 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna confirmed that the Company is engaged in discussions with the Ministry of Health, Labour and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19, to support Japan’s aim of providing vaccines to the public as soon as possible. Under the terms of this arrangement, the vaccine would be supplied by Moderna, Inc. and distributed in Japan by Takeda Pharmaceutical Co., Ltd. (NYSE: TAK) beginning in the first half of 2021, if the vaccine receives regulatory approval. Kato Katsunobu, Minister of MHLW, announced the discussions in a meeting with media today in Japan.
Moderna to Present New Interim Clinical Data About mRNA Vaccine Against COVID-19 (mRNA-1273) at Advisory Committee on Immunization Practices (ACIP) Meeting - Moderna announced its presentation at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) August Meeting. The live presentation can be viewed online here.This presentation includes new interim safety and immunogenicity data from the cohorts of older adults in the NIH-led Phase 1 study of mRNA-1273, Moderna’s vaccine candidate against COVID-19. The ACIP presentation slides will be available under “Events and Presentations” in the Investors section of the Moderna website.
Moderna Confirms Advanced Discussions with European Commission to Supply Europe with 80 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - Moderna has concluded advanced exploratory talks with the European Commission to supply 80 million doses of mRNA-1273 as part of the European Commission’s goal to secure early access to safe and effective COVID-19 vaccines for Europe.The potential purchase agreement with the European Commission of 80 million doses provides for an option for Member States to purchase an additional 80 million doses for a total of up to 160 million doses. The discussions are intended to ensure that Member States have access to Moderna’s vaccine. The Phase 3 study of mRNA-1273 began on July 27 and enrollment of approximately 30,000 participants is on track to complete in September.
Moderna Announces Supply Agreement with U.S. Government for Initial 100 Million Doses of mRNA Vaccine Against COVID-19 (mRNA-1273) - The U.S. government has secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the American people. The award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of mRNA-1273 including incentive payments for timely delivery of the product. With the previous award of up to $955 million from BARDA for the development of mRNA-1273 to licensure, this announcement brings the U.S. government commitments for early access to mRNA-1273 to up to $2.48 billion.
Moderna Receives FDA Fast Track Designation for mRNA Vaccine (mRNA-1273) Against Novel Coronavirus - Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 μg or a 250 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.
see also: https://www.modernatx.com/modernas-work-potential-vaccine-against-covid-19 - This page summarizes key milestones to advance mRNA-1273, Moderna's vaccine candidate against the novel coronavirus.