CAMBRIDGE, MA - Moderna , Inc. (NASDAQ:MRNA) has announced successful results from the Phase 3 trial of its mRNA-1283 vaccine, which has met its primary efficacy endpoint.
The vaccine demonstrated non-inferior efficacy against COVID-19 when compared to the company's previously authorized vaccine, Spikevax, in individuals 12 years and older. Notably, mRNA-1283 showed higher efficacy in the adult population, particularly among those aged 18 and over, including a subset of participants aged 65 and older.
During the randomized, observer-blind, active-controlled trial, approximately 11,400 participants were enrolled. They received either a 10 µg dose of mRNA-1283 or a 50 µg dose of the earlier vaccine, Spikevax (mRNA-1273). The data indicated that mRNA-1283 elicited higher neutralizing antibody responses against both the Omicron BA.4/5 variants and the original SARS-CoV-2 strain, with the most significant increases observed in the adult cohorts.
The trial also confirmed that mRNA-1283 has a comparable safety profile to Spikevax. The most common side effects reported were pain at the injection site, fatigue, headache, and muscle pain. These findings are consistent with the interim immunogenicity results reported in March 2024.
Moderna's CEO, Stéphane Bancel, expressed satisfaction with the results, highlighting that mRNA-1283's success in Phase 3 adds to the company's track record of developing effective vaccines. The company's mRNA platform has been instrumental in addressing public health needs, as evidenced by its multiple vaccine programs yielding positive Phase 3 outcomes.
Furthermore, mRNA-1283 is also a component of Moderna's combination vaccine candidate against influenza and COVID-19, mRNA-1083, which has recently shown positive results in its separate Phase 3 trial.
Looking ahead, Moderna intends to present the complete data from the mRNA-1283 trial at an upcoming conference and submit it for publication in a peer-reviewed journal. The company also plans to discuss the next steps for the vaccine program with regulatory authorities.
This press release statement is based on information provided by Moderna, Inc.
In other recent news, Moderna's collaborative work with Merck has also resulted in promising results. Their combined therapy of mRNA-4157 and KEYTRUDA has shown a significant reduction in the risk of recurrence or death in high-risk melanoma patients, as reported in a Phase 2b clinical trial. Piper Sandler and RBC Capital Markets have both maintained positive ratings on Moderna shares, reflecting these recent developments.
Moderna's mRESVIA, an mRNA-based vaccine targeting the Respiratory Syncytial Virus (RSV), has received FDA approval, marking another significant milestone.
InvestingPro Insights
As Moderna, Inc. (NASDAQ:MRNA) announces the promising results of its mRNA-1283 vaccine trial, investors and stakeholders are keen to understand the financial health and market performance of the company. According to InvestingPro data, Moderna's market capitalization stands at a robust $56.61 billion. Despite the challenges in the biotech sector, Moderna has shown exceptional price performance with a 17.55% return over the last month and an impressive 87.94% return over the last six months.
InvestingPro Tips suggest that while Moderna holds a strong cash position relative to its debt, analysts are anticipating a sales decline in the current year. This could be attributed to the volatile nature of the biotech market and the rapid evolution of the COVID-19 pandemic affecting vaccine demand. Moreover, the company's gross profit margins have been weak, with the last twelve months showing a significant downturn in profitability.
For investors looking for more in-depth analysis and additional tips, there are 12 more InvestingPro Tips available for Moderna, which could provide valuable insights into the company's financials and market prospects. To explore these further, interested parties can visit the dedicated page for Moderna at https://www.investing.com/pro/MRNA. Additionally, by using the coupon code PRONEWS24, users can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, unlocking a wealth of financial data and expert analysis to inform their investment decisions.
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