Ministry of Health, Labour and Welfare in Japan Approves Partial Change Application for Moderna's COVID-19 mRNA Vaccine Targeting SARS-COV-2 Variant JN.1

Rhea-AI Summary

Moderna (NASDAQ:MRNA) has received approval from Japan's Ministry of Health, Labour and Welfare for an updated COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1. This aligns with recommendations from a Japanese health ministry panel and the WHO for the 2024/2025 national immunization program. The program will offer vaccination to individuals aged 65 and older, as well as qualifying individuals aged 60-64.

Japan, with about 30% of its population aged 65 and above, aims to reduce the disease burden and pressure on the health system. Moderna has also entered an agreement with Mitsubishi Tanabe Pharma for co-promotion of its mRNA respiratory vaccine portfolio in Japan.

Positive

• Approval of updated COVID-19 vaccine targeting JN.1 variant in Japan
• Alignment with Japanese health ministry and WHO recommendations
• Inclusion in Japan's national immunization program for 2024/2025
• Partnership with Mitsubishi Tanabe Pharma for co-promotion in Japan

Negative

• target population (primarily 65+ and qualifying 60-64 year-olds)
• Voluntary vaccination outside the program requires personal expense

Medical Research Analyst

The approval of Moderna's updated COVID-19 mRNA vaccine targeting the JN.1 variant in Japan is a significant development in the ongoing fight against the pandemic. This tailored approach demonstrates the adaptability of mRNA technology to address emerging variants. The alignment with WHO recommendations underscores the global coordination in vaccine strategy.

The inclusion of this vaccine in Japan's national immunization program, particularly for the 65+ age group, is important given Japan's demographic profile. With 30% of the population in this age bracket, this targeted vaccination effort could substantially reduce healthcare burdens and mortality rates. The option for voluntary vaccination outside the program provides flexibility but may raise questions about equity in access.

Moderna's partnership with Mitsubishi Tanabe Pharma for co-promotion in Japan could enhance distribution efficiency and potentially increase vaccine uptake, which is vital for effective population-level protection against COVID-19.

Financial Analyst

The approval of Moderna's updated COVID-19 vaccine in Japan represents a positive market opportunity for the company. Japan's large elderly population provides a substantial customer base, potentially leading to significant revenue from the national immunization program. The co-promotion agreement with Mitsubishi Tanabe Pharma could further enhance market penetration and distribution efficiency.

However, investors should note that the voluntary vaccination option at individual expense may limit uptake outside the NIP. The transition of COVID-19 vaccination to a routine inoculation similar to seasonal flu suggests a more predictable, annualized revenue stream for Moderna, albeit potentially at lower volumes compared to pandemic peaks.

This approval reinforces Moderna's position in the global vaccine market and demonstrates its ability to rapidly adapt its mRNA platform to new variants, which could be viewed favorably by investors considering the company's long-term prospects and potential applications of its technology beyond COVID-19.

CAMBRIDGE, MA / ACCESSWIRE / August 23, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for a partial change application for an updated formulation of its COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1.

"We appreciate the Ministry of Health, Labour and Welfare approval decision for our updated COVID-19 mRNA vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "It is important that people are vaccinated with the latest updated COVID-19 vaccines that can protect against circulating strains. With COVID-19 vaccination becoming a routine inoculation similar to seasonal flu vaccines, individuals will be able to receive their updated COVID-19 vaccine alongside their flu vaccine this fall."

In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated to target the JN.1 family of Omicron subvariants for the 2024/2025 national immunization program (NIP). This guidance aligns with the recommendations from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) on the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.

The NIP in Japan will offer COVID-19 vaccination to individuals aged 65 and older, as well as qualifying individuals aged 60 to 64.^[1] Japan has the highest proportion of older adults worldwide, with approximately 30% of its population aged 65 and above. Given that respiratory viruses are a leading disease burden in people older than 65, NIPs are crucial in reducing the burden of disease and, ultimately, future pressure on the health system. Individuals requesting COVID-19 vaccination outside of the regular program will have the option of voluntary vaccination at their own expense.

In July, Moderna entered into an agreement with Mitsubishi Tanabe Pharma Corporation to support the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan, including Moderna's COVID-19 vaccine, Spikevax.

About Moderna
Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Moderna Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the authorization of Moderna's updated JN.1-targeting COVID-19 vaccine by the Ministry of Health Labor and Welfare in Japan; the ability of Moderna's updated COVID-19 vaccine to induce an immune response and provide protection against circulating SARS-CoV-2 variants; and Moderna's ability to supply its COVID-19 vaccine to support Japan's COVID-19 national immunization program. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts
Media :
International media
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

Moderna Japan
Communications & Media
japan-pr@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

^[1] Qualifying individuals include those aged 60-64 with severe cardiac, renal or respiratory impairments that significantly restrict daily activities, or those with immune deficiencies due to Human Immunodeficiency Virus (HIV), making daily life exceedingly difficult.

SOURCE: Moderna, Inc.

View the original press release on accesswire.com

FAQ

What new approval did Moderna (MRNA) receive in Japan?

Moderna received approval from Japan's Ministry of Health, Labour and Welfare for an updated COVID-19 mRNA vaccine targeting the SARS-CoV-2 variant JN.1.

Who will be eligible for Moderna's (MRNA) updated COVID-19 vaccine in Japan's 2024/2025 immunization program?

The program will offer vaccination to individuals aged 65 and older, as well as qualifying individuals aged 60 to 64.

What partnership did Moderna (MRNA) enter for vaccine promotion in Japan?

In July, Moderna entered an agreement with Mitsubishi Tanabe Pharma to support the co-promotion of Moderna's mRNA respiratory vaccine portfolio in Japan.

How does Japan's demographics impact Moderna's (MRNA) vaccine strategy?

Japan has the highest proportion of older adults worldwide, with approximately 30% of its population aged 65 and above, making it a significant market for Moderna's COVID-19 vaccine.