Moderna Announces Positive Phase 3 Data for Combination Vaccine Against Influenza and COVID-19
Moderna announced positive results from its Phase 3 trial of the combination vaccine mRNA-1083 against influenza and COVID-19. The trial showed the vaccine elicited higher immune responses than licensed flu and COVID vaccines in adults 50 years and older. The study included approximately 8,000 participants split into two age cohorts: 50-64 and 65+. In both groups, mRNA-1083 significantly outperformed comparator vaccines for three influenza strains and the SARS-CoV-2 Omicron variant. The vaccine was found to be non-inferior in terms of safety and tolerability, with most adverse reactions being mild. Moderna plans to present these findings at a medical conference and seek regulatory approvals.
- mRNA-1083 met its primary endpoints, showing higher immune responses compared to existing vaccines.
- The trial included a large sample size of approximately 8,000 adults.
- The vaccine was effective against multiple influenza strains and the SARS-CoV-2 Omicron variant.
- mRNA-1083 showed acceptable safety and tolerability with most adverse reactions being mild.
- Moderna plans to present data at an upcoming medical conference and engage with regulators.
- The trial results showed non-inferiority rather than superiority in some aspects.
- The B/Yamagata influenza strain was included in the trial despite its disappearance from circulation.
- Ongoing regulatory approvals are still required before the vaccine can be marketed.
Insights
Moderna's latest Phase 3 trial results for its combination vaccine mRNA-1083 are a substantial development within the pharmaceutical and biotechnology sector. This vaccine has shown higher immune responses against both influenza and COVID-19 compared to licensed vaccines. The trial's primary endpoints were met, suggesting strong efficacy, which is particularly significant for the target demographic of adults aged 50 and older.
A combination vaccine like mRNA-1083 offers multiple advantages. Firstly, it simplifies the vaccination process, potentially improving compliance rates among older adults who are more susceptible to severe outcomes from these illnesses. Secondly, combining vaccines may reduce the logistical burden on healthcare systems, which is a critical factor, especially during the peak flu season or in the context of ongoing COVID-19 threats.
Notably, the statistically significant higher immune responses against multiple influenza strains and the SARS-CoV-2 Omicron variant are promising. The tolerability and safety profile is consistent with existing vaccines, indicating no new safety concerns. However, investors should look out for the regulatory review process and subsequent market adoption, which will ultimately determine the financial impact.
From a market perspective, Moderna's announcement positions the company favorably within the competitive landscape of vaccines. The ability to offer a combination vaccine targeting both influenza and COVID-19 is a unique selling proposition not currently matched by competitors. This could significantly boost market share and provide a competitive edge.
Furthermore, the timing is crucial. As the world continues to manage COVID-19 and annual flu seasons, having an effective combination vaccine could lead to higher sales and sustained revenue growth. This is especially relevant given the ongoing demand for COVID-19 vaccines and the established market for flu vaccinations.
However, the true market impact will depend on the regulatory approval and the speed at which Moderna can scale production and distribution. The company's ability to engage effectively with regulators and healthcare providers will be key to capitalizing on this opportunity.
For investors, the financial implications of Moderna's positive Phase 3 data are promising. Meeting primary endpoints in a late-stage trial often leads to regulatory approval, opening the door for commercialization. Given the high demand for effective vaccines, especially in the post-pandemic landscape, this could result in significant revenue generation.
Moderna's stock (NASDAQ:MRNA) is likely to see positive movement due to this announcement. However, investors should remain cautious about potential roadblocks in the regulatory process or any future safety concerns that might arise. The company’s ability to secure approval and rapidly bring mRNA-1083 to market will be critical for this potential revenue to materialize.
In the short term, investors can expect a positive market reaction. Long term, the combination vaccine could become a staple in annual vaccination programs, providing steady revenue and contributing to Moderna’s financial stability.
mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza virus and SARS-CoV-2 than licensed flu and COVID vaccines in adults 50 years and older, including an enhanced influenza vaccine in adults 65 years and older
CAMBRIDGE, MA / ACCESSWIRE / June 10, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial.
"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," said Stéphane Bancel, Chief Executive Officer of Moderna. "Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine. Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health."
mRNA-1083 comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. Each investigational vaccine has independently demonstrated positive Phase 3 clinical trial results.
The ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier:NCT06097273) is a randomized, observer-blind, active control study evaluating the safety, reactogenicity and immunogenicity of mRNA-1083 in two independent age group cohorts of approximately 4,000 adults each. One cohort, consisting of adults 65 years and older, compared mRNA-1083 to co-administered Fluzone HD®, an enhanced influenza vaccine, and Spikevax®, Moderna's currently licensed COVID-19 vaccine. The other cohort of adults 50 to 64 years of age compared mRNA-1083 to co-administered, Fluarix®, a standard dose influenza vaccine, and Spikevax.
The immune responses from a single dose of mRNA-1083 were found to be non-inferior versus the co-administered, routinely recommended, licensed comparators. In both age cohorts, mRNA-1083 also elicited statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2. In the 65 years and older cohort, overall Geometric Mean Ratios (GMRs) of the mRNA-1083 group compared to the Fluzone HD group for the influenza strains were 1.155 (
In the 50 to 64 years of age cohort the GMRs of the mRNA-1083 group compared to the Fluarix group for the influenza virus strains were 1.414 (
Immunogenicity was also tested against the B/Yamagata strain of influenza and mRNA-1083 met non-inferiority criteria in both age cohorts. Due to the disappearance of the B/Yamagata lineage from circulation, WHO has recommended a trivalent influenza vaccine composition without B/Yamagata for 2024/2025 vaccines.
mRNA-1083 showed an acceptable tolerability and safety profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial. The most commonly solicited adverse reactions were injection site pain, fatigue, myalgia and headache.
Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference as well as submit it for publication. The Company will engage with regulators on next steps.
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.
Spikevax® is a registered trademark of Moderna.
Fluzone HD® is a registered trademark of Sanofi Pasteur.
Fluarix® is a registered trademark of the GlaxoSmithKline group of companies.
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 potential for mRNA-1083 specifically, and combination vaccines generally, to reduce the burden of respiratory virus season; the safety and efficacy of mRNA-1083; and Moderna's plans to present data related to mRNA-1083 and to engage with 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:
Elise Meyer
Sr. Director, Corporate Communications
+1 617-852-7041
Elise.Meyer@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
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