Moderna Announces Positive Phase 3 Efficacy Data for mRNA-1283, the Company’s Next Generation COVID-19 Vaccine
Moderna announced that its Phase 3 trial of mRNA-1283, a next-generation COVID-19 vaccine, met its primary efficacy endpoint.
The vaccine demonstrated non-inferior efficacy compared to Spikevax in participants aged 12 and older and higher efficacy in adults 18 and older.
The trial involved 11,400 individuals, half receiving 10 μg of mRNA-1283 and the other half 50 μg of Spikevax.
mRNA-1283 showed higher neutralizing antibody responses against Omicron BA.4/5 and ancestral SARS-CoV-2, especially in adults and those aged 65 and older.
Safety profiles were similar between mRNA-1283 and Spikevax, with common side effects being injection site pain, fatigue, headache, and myalgia.
Moderna plans to present the data at an upcoming conference and submit it for publication while engaging with regulators on the next steps.
- mRNA-1283 achieved primary efficacy endpoint in Phase 3 trial.
- Higher efficacy observed in adults 18 and older compared to Spikevax.
- 11,400 participants involved in the trial, enhancing statistical validity.
- Showed higher neutralizing antibody responses against Omicron BA.4/5 and ancestral SARS-CoV-2.
- Consistent efficacy trend in participants aged 65 and older.
- Similar safety profile to Spikevax, with common side effects being manageable.
- Positive interim immunogenicity results previously reported in March 2024.
- mRNA-1283 is included in Moderna's combination vaccine candidate mRNA-1083, which also showed positive Phase 3 results.
- Moderna to present Phase 3 data at an upcoming conference and submit for publication.
- No specific financial data on profitability or cost-effectiveness of mRNA-1283.
- Lack of detailed long-term safety data beyond common side effects.
- Potential regulatory hurdles remain before mRNA-1283 can be marketed.
- Trial results are interim and pending full completion and peer review.
Insights
Moderna's announcement of positive Phase 3 efficacy data for its new COVID-19 vaccine, mRNA-1283, represents a significant advancement in the fight against the pandemic. The fact that mRNA-1283 demonstrated non-inferior efficacy compared to Spikevax, with even higher efficacy observed in adults aged 18 and older, suggests that the new vaccine could offer a robust defense against COVID-19 variants. The higher neutralizing antibody responses against Omicron BA.4/5 and the ancestral SARS-CoV-2 indicate its potential to be more effective against emerging strains.
The safety profile of mRNA-1283 being similar to that of Spikevax is also encouraging. Common side effects like injection site pain, fatigue, headache and myalgia are typical for vaccines and do not raise immediate red flags. This consistent safety profile is important for regulatory approval and public acceptance.
From a public health perspective, the inclusion of mRNA-1283 in Moderna's combination vaccine candidate against influenza and COVID-19 (mRNA-1083) could simplify vaccination strategies and improve compliance, especially in vulnerable populations like the elderly. This development aligns with the ongoing need for versatile and effective vaccination options as the virus continues to evolve.
Overall, the data supports the continued investment in and development of mRNA-1283 as a next-generation COVID-19 vaccine that could play a critical role in future vaccination campaigns.
From a financial perspective, Moderna's positive Phase 3 trial results for mRNA-1283 are a strong indicator of the company's future revenue potential. Given the higher efficacy observed in adults and the promising safety profile, regulatory approval is likely, which could lead to significant sales, especially if mRNA-1283 is adopted as a standard COVID-19 vaccine.
The trial's success also reinforces the credibility of Moderna's mRNA technology platform. Investors should note that this is the fifth vaccine program from Moderna to achieve positive Phase 3 results. This consistency in achieving clinical milestones can boost investor confidence and support the company's stock price.
Moreover, the potential inclusion of mRNA-1283 in a combination vaccine with influenza could open new revenue streams and market opportunities. Combination vaccines are strategically advantageous as they can reduce healthcare costs and increase patient compliance, making them attractive to healthcare providers and governments.
However, investors should remain aware of competitive dynamics in the vaccine market, regulatory hurdles and the ongoing need for efficacy against new variants. While the news is largely positive, there are always risks in pharmaceutical development and market adoption.
mRNA-1283 met its primary vaccine efficacy endpoint in a Phase 3 trial, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax® in participants 12 years of age and older
Higher efficacy was observed in mRNA-1283 compared to Spikevax in adults 18 years of age and older
CAMBRIDGE, MA / ACCESSWIRE / June 13, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1283, an investigational next-generation COVID-19 vaccine, has met its primary efficacy endpoint, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax. The Company also announced that higher efficacy was observed in adults 18 years of age and older compared to Spikevax (mRNA-1273), with a consistent trend observed in the subset of adults age 65 and older. Positive interim immunogenicity results for mRNA-1283 in this study were previously reported in March 2024.
"We are very pleased that mRNA-1283 has now met its primary vaccine efficacy endpoint in Phase 3, and showed higher efficacy in adults compared to Spikevax," said Stéphane Bancel, Chief Executive Officer of Moderna. "With five vaccine programs that have achieved positive Phase 3 results, Moderna's platform is consistently demonstrating its ability to address significant unmet needs in public health."
The ongoing Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498) is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older. Half of the participants received a 10 μg dose of mRNA-1283, while the other half received a 50 μg dose of mRNA-1273 (Spikevax). Today's vaccine efficacy data are consistent with the previously announced immunogenicity results from the study, which showed that mRNA-1283 had higher neutralizing antibody responses against both Omicron BA.4/5 and ancestral SARS-CoV-2 than mRNA-1273, with the highest geometric mean titer ratios observed in adults and in the subset of participants aged 65 years and older.
In the trial, mRNA-1283 was found to have a similar safety profile to Spikevax. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.
Moderna's combination vaccine candidate against influenza and COVID-19, mRNA-1083, includes mRNA-1283. That vaccine candidate recently announced positive results in its separate Phase 3 trial.
Moderna plans to present the Phase 3 clinical data for mRNA-1283 at an upcoming conference as well as submit it for publication. The Company will also engage with regulators on the next steps for the program.
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.
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 safety and efficacy of mRNA-1283; and the relative effectiveness of mRNA-1283 compared to Spikevax. 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, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, 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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