Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine
Moderna's mRNA-1283 COVID-19 vaccine shows a higher immune response than mRNA-1273.222, paving the way for a combination vaccine against influenza and COVID-19. The Phase 3 trial demonstrated efficacy across different virus strains and age groups, with positive safety profiles and potential storage advantages.
The recent announcement by Moderna regarding the success of mRNA-1283 in its Phase 3 clinical trial is significant in the context of public health and the pharmaceutical industry's response to infectious diseases. The reported increased immune response in individuals, especially those above 65, is a promising development. This age group is known to have a higher vulnerability to severe COVID-19 outcomes and an improved vaccine could lead to a reduction in hospitalizations and mortality rates.
Furthermore, the potential for mRNA-1283 to be part of a combination vaccine, mRNA-1083, targeting both influenza and COVID-19, could streamline vaccination efforts and improve compliance rates. This dual-protection approach may also reduce the logistical and financial burden on healthcare systems, particularly during peak seasons when both viruses are circulating. However, the long-term efficacy and the public's acceptance of a combination vaccine remain to be seen.
The advancements in vaccine technology, as demonstrated by Moderna's mRNA-1283, could have a notable impact on the vaccine market landscape. The mention of improved storage and shelf life addresses a critical pain point in vaccine distribution, especially in developing regions where cold chain logistics are a challenge. This could open up new markets for Moderna and potentially increase their global market share.
Moreover, the pre-filled syringe presentation is an innovation that may enhance vaccine delivery efficiency. It's important to consider the competitive advantage this offers over other vaccines that require more complex preparation and administration. The ease of use could make mRNA-1283 more attractive to healthcare providers and patients alike, potentially influencing stock market perceptions positively.
Moderna's progress with mRNA-1283 is likely to be closely watched by investors, given the company's history of stock volatility in response to vaccine-related news. The successful Phase 3 trial outcomes could potentially lead to future revenue streams from both the stand-alone COVID-19 vaccine and the combination vaccine with influenza. However, it is essential to remain cautious as the market has previously shown sensitivity to both positive and negative news in the biotech sector.
Investors will be keen on the detailed analysis of the clinical data, which could provide further insight into the vaccine's market potential. The ability to maintain a competitive edge in the vaccine market is important for Moderna's financial health, especially as patents expire and more players enter the mRNA space.
03/26/2024 - 07:00 AM
mRNA-1283 induced a more robust immune response compared to Spikevax® COVID-19 vaccine, mRNA-1273.222 Next-generation mRNA vaccine design offers the potential of longer shelf life and storage advantages, and paves the way for combination vaccine against influenza and COVID-19, mRNA-1083 CAMBRIDGE, MA / ACCESSWIRE / March 26, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1283, the Company's next-generation COVID-19 vaccine, has successfully met the primary endpoints of its Phase 3 clinical trial, demonstrating a higher immune response against SARS-CoV-2 when compared to mRNA-1273.222, Moderna's licensed COVID-19 vaccine.
"We are excited to announce our fourth infectious disease vaccine program with positive Phase 3 data, further validating our robust mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna. "mRNA-1283 is a critical component of our combination vaccine against flu and COVID-19, mRNA-1083, and this milestone gives us confidence in our ability to bring this much needed vaccine to market."
In the NextCOVE (NCT05815498) Phase 3 pivotal trial, mRNA-1283 was shown to elicit a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared to mRNA-1273.222. Importantly, this benefit was most acutely seen in participants over the age of 65 years, the population that remains at highest risk for severe outcomes from COVID-19. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events included headache, fatigue, myalgia and chills.
The NEXTCove clinical trial is a randomized, observer-blind, active-controlled study of approximately 11,400 individuals aged 12 years and older in the United States, United Kingdom and Canada. mRNA-1283 was found to have a similar safety profile to Moderna's approved COVID-19 vaccines.
The storage, shelf life and pre-filled syringe presentation of mRNA-1283 could alleviate healthcare provider burden and potentially increase access into new settings to serve public health. A detailed analysis of the Phase 3 clinical trial data for mRNA-1283 will be shared at the Company's Vaccines Day event on March 27 and presented at upcoming scientific conferences.
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 potential longer refrigerator shelf life and storage advantages of mRNA-1283 compared to Spikevax; and the ability of mRNA-1283 to maintain effectiveness 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@modernatx.com
Investors:Lavina.Talukdar@modernatx.com
SOURCE: Moderna, Inc.
press release on accesswire.com
mRNA-1283 showed a more robust immune response against SARS-CoV-2 compared to mRNA-1273.222 in the Phase 3 clinical trial.
mRNA-1283 offers longer shelf life, storage advantages, and serves as a critical component of a combination vaccine against influenza and COVID-19.
mRNA-1283 demonstrated a higher immune response against Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, especially in participants over 65 years.
The most common solicited local adverse event was injection site pain, while systemic adverse events included headache, fatigue, myalgia, and chills.
mRNA-1283's storage, shelf life, and pre-filled syringe presentation could reduce healthcare provider burden and increase access in new settings.
