Moderna Receives Project Award through BARDA's Rapid Response Partnership Vehicle Consortium to Accelerate Development of mRNA-based Pandemic Influenza Vaccine

Rhea-AI Summary

Moderna (NASDAQ:MRNA) announced a $176 million project award from BARDA’s Rapid Response Partnership Vehicle (RRPV) to accelerate mRNA-based pandemic influenza vaccine development. Funded by the U.S. Department of Health and Human Services (HHS), the project supports late-stage development for a pre-pandemic H5 influenza vaccine, addressing the highly infectious avian influenza virus. The agreement also includes options for future public health threat responses. Moderna’s CEO, Stéphane Bancel, highlighted the advantages of mRNA technology demonstrated during the COVID-19 pandemic. A Phase 1/2 study initiated in 2023 for the mRNA-1018 vaccine in adults will provide safety and immunogenicity data by 2024, informing Phase 3 plans.

Positive

• Moderna received a $176 million project award to accelerate mRNA-based pandemic influenza vaccine development.
• The award supports late-stage development for a pre-pandemic H5 influenza vaccine.
• The agreement includes options to prepare and accelerate responses to future public health threats.
• Moderna's Phase 1/2 study for mRNA-1018 initiated in 2023 will inform Phase 3 development plans.

Negative

• There is no immediate data or results available from the Phase 1/2 study for the mRNA-1018 vaccine, with results expected only in 2024.

Financial Analyst

Moderna's $176 million project award funded by BARDA is a significant boost for the company's financial outlook. This fund injection will primarily support the late-stage development of an mRNA-based pandemic influenza vaccine. From a financial perspective, this development showcases Moderna's ability to secure substantial governmental support, which is critical for funding high-cost, high-reward biotechnological advancements.

By focusing on a vaccine for the highly infectious H5 influenza virus, Moderna positions itself as a key player in pandemic preparedness, potentially opening additional revenue streams. Moreover, the added options in the agreement to accelerate responses to future public health threats suggest potential for further funding, validating the company's strategic alignment with public health priorities.

Investors should note that Moderna's successful history with mRNA technology, especially during the COVID-19 pandemic, provides a strong foundation for this new venture. However, the reliance on federal funding also introduces a degree of dependency on government budgets and priorities, which could be a risk factor in the long term.

Medical Research Analyst

The mRNA-based pandemic influenza vaccine project aligns well with Moderna's existing expertise in mRNA technology. This platform has proven its efficacy and speed in development, particularly seen in the COVID-19 vaccine rollout. The focus on H5 avian influenza virus is particularly noteworthy due to its high infectivity and severe disease in birds, which poses a risk of spillover into human populations. The proactive development of a pre-pandemic vaccine for such threats highlights Moderna's foresight in addressing potential outbreaks before they occur.

The ongoing Phase 1/2 study for the investigational pandemic influenza vaccine, with results expected in 2024, will be a key milestone. Positive outcomes could propel the vaccine into Phase 3 trials, significantly accelerating its path to market. However, it’s essential to recognize that vaccine development is fraught with uncertainties and success in early trials does not always guarantee positive results in later stages.

CAMBRIDGE, MA / ACCESSWIRE / July 2, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced a project award of $176 million through the Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS).

The project award will support late-stage development for an mRNA-based vaccine to enable the licensure of a pre-pandemic vaccine against H5 influenza virus. This subtype of influenza virus causes a highly infectious, severe disease in birds called avian influenza and poses a risk for spillover into the human population. The agreement also includes additional options to prepare and accelerate aresponse to future public health threats.

"mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks."

In 2023, Moderna initiated a Phase 1/2 study to generate safety and immunogenicity data of investigational pandemic influenza vaccine (mRNA-1018) in healthy adults 18 years of age and older. The study includes vaccine candidates against H5 and H7 avian influenza viruses. Results from the study are expected in 2024 and will inform Phase 3 development plans.

This project is being funded with federal funds from the Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction (OT) number: 75A50123D00005.

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: the funding of $176 million from BARDA to support late-stage development for an mRNA-based influenza vaccine; the advantages of Moderna's mRNA platform for vaccine development; the timing for potential clinical study results from Moderna's pandemic influenza vaccine candidate; and the risk to humans of infection from avian influenza. 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:
Chris Ridley
Global Head of Media
+1 617-800-3651
Chris.Ridley@modernatx.com

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

SOURCE: Moderna, Inc.

View the original press release on accesswire.com

FAQ

What recent award did Moderna receive for pandemic influenza vaccine development?

Moderna received a $176 million project award from BARDA's Rapid Response Partnership Vehicle (RRPV) to accelerate the development of mRNA-based pandemic influenza vaccines.

How much funding did Moderna receive from BARDA for influenza vaccine development?

Moderna received $176 million in funding from BARDA.

What is the focus of the $176 million award Moderna received?

The focus is on accelerating the development of an mRNA-based pre-pandemic H5 influenza vaccine.

When are the results from Moderna's Phase 1/2 study for the mRNA-1018 vaccine expected?

The results are expected in 2024.

What is the significance of the mRNA-1018 vaccine study initiated by Moderna in 2023?

The study aims to generate safety and immunogenicity data for the pandemic influenza vaccine, which will inform Phase 3 development plans.