Taiwan Food & Drug Administration Approves Moderna’s COVID-19 mRNA Vaccine Targeting the SARS-COV-2 Variant JN.1

Rhea-AI Summary

Moderna (NASDAQ:MRNA) has received approval from the Taiwan Food & Drug Administration for an updated formulation of its COVID-19 mRNA vaccine Spikevax. This new version targets the SARS-CoV-2 variant JN.1 and is approved for active immunization against COVID-19 in individuals aged six months and older. The approval aligns with the World Health Organization's April 2024 recommendation for using a monovalent JN.1 lineage in COVID-19 vaccine compositions. Moderna is currently awaiting regulatory decisions on this updated vaccine from agencies worldwide, with outcomes expected in the near future.

Positive

• Approval of updated Spikevax vaccine by Taiwan FDA
• Vaccine targets the latest SARS-CoV-2 variant JN.1
• Approved for use in individuals 6 months and older
• Aligns with WHO recommendations for vaccine composition

Negative

• None.

Insights

Medical Research Analyst

The approval of Moderna's updated COVID-19 vaccine by Taiwan's FDA marks a significant milestone in the ongoing battle against the pandemic. This JN.1-specific formulation aligns with the WHO's recent recommendations, demonstrating Moderna's agility in adapting to emerging variants.

From a research perspective, this approval suggests that the vaccine has shown promising efficacy against the JN.1 variant in clinical trials. The broad age range approval (six months and older) indicates a favorable safety profile across demographics. However, it's important to note that real-world effectiveness data will be necessary to fully assess the vaccine's impact on transmission rates and severe disease prevention.

Investors should monitor upcoming regulatory decisions globally, as widespread approvals could significantly boost Moderna's market position and potentially impact vaccine sales projections for the coming year.

Financial Analyst

This regulatory approval in Taiwan represents a positive development for Moderna, potentially opening up a new market for their updated COVID-19 vaccine. While the immediate financial impact may be due to Taiwan's population size, it could serve as a catalyst for global approvals.

Investors should consider the following implications:

• Potential for increased revenue streams if global approvals follow
• Enhanced competitive positioning against other vaccine manufacturers
• Demonstration of Moderna's R&D capabilities and ability to quickly adapt to new variants

However, it's important to note that the COVID-19 vaccine market has become increasingly competitive and potentially saturated. The financial impact will largely depend on global vaccination strategies and public health policies moving forward.

CAMBRIDGE, MA / ACCESSWIRE / September 2, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the Taiwan Food & Drug Administration (FDA) has approved an updated formulation of the COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1., for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older.

In April 2024, the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) issued guidance recommending the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.

Regulatory applications for Moderna's updated COVID-19 vaccine are under review by regulatory agencies worldwide, with decisions anticipated in the coming weeks.

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 the 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: Moderna's pending regulatory applications worldwide for its updated COVID-19 vaccine and the anticipated timing for decisions from regulators. 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:

Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

Investors:

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

SOURCE: Moderna, Inc.

View the original press release on accesswire.com

FAQ

What is the latest approval for Moderna's COVID-19 vaccine (MRNA)?

The Taiwan Food & Drug Administration has approved Moderna's updated COVID-19 mRNA vaccine Spikevax, which targets the SARS-CoV-2 variant JN.1, for use in individuals 6 months and older.

When did the WHO recommend the use of JN.1 lineage for COVID-19 vaccines?

In April 2024, the World Health Organization's Technical Advisory Group on COVID-19 Vaccine Composition recommended the use of a monovalent JN.1 lineage for COVID-19 vaccine antigen composition.

Is Moderna (MRNA) seeking approval for its updated COVID-19 vaccine in other countries?

Yes, Moderna has submitted regulatory applications for its updated COVID-19 vaccine to agencies worldwide, with decisions expected in the coming weeks.

What age group is Moderna's updated COVID-19 vaccine approved for in Taiwan?

Moderna's updated COVID-19 mRNA vaccine Spikevax is approved in Taiwan for active immunization to prevent COVID-19 in individuals six months of age and older.