Moderna Reports Positive Phase 3 Results for Next-Gen COVID-19 Vaccine

Moderna, Inc. (NASDAQ: MRNA) announced on June 13, 2024, that its investigational next-generation COVID-19 vaccine, mRNA-1283, achieved its primary efficacy goal in a Phase 3 clinical trial. The trial demonstrated that mRNA-1283 is not inferior in vaccine efficacy against COVID-19 when compared to Spikevax® (mRNA-1273) in participants aged 12 and older. Additionally, the vaccine showed higher efficacy in adults aged 18 and older compared to Spikevax, with a consistent trend observed in participants aged 65 and older. This follows the positive interim immunogenicity results for mRNA-1283 reported in March 2024.

Stéphane Bancel, Chief Executive Officer of Moderna, expressed satisfaction with the trial results, noting the higher efficacy of mRNA-1283 in adults. He emphasized that Moderna's platform continues to meet significant public health needs, as evidenced by five vaccine programs reaching positive Phase 3 outcomes.

The ongoing Phase 3 trial (ClinicalTrials.gov Identifier: NCT05815498) is a randomized, observer-blind, active-controlled study involving about 11,400 participants aged 12 and older. Half of the participants received a 10 μg dose of mRNA-1283, while the other half were administered a 50 μg dose of mRNA-1273 (Spikevax). The efficacy data align with previous immunogenicity results, which indicated that mRNA-1283 elicited higher neutralizing antibody responses against both the Omicron BA.4/5 variant and the original SARS-CoV-2 strain than mRNA-1273. The strongest geometric mean titer ratios were observed in adults and particularly in those aged 65 and older.

The safety profile of mRNA-1283 was found to be similar to that of Spikevax. Common side effects included pain at the injection site, fatigue, headache, and muscle aches.

Moderna also provided updates on its combination vaccine candidate against influenza and COVID-19, mRNA-1083, which includes mRNA-1283. This candidate showed positive results in its own Phase 3 trial.

Moderna intends to present the Phase 3 data for mRNA-1283 at an upcoming conference and submit the findings for publication. The company will also engage with regulatory authorities to discuss the next steps for the vaccine program.

Moderna is a pioneer in the field of mRNA medicine, leveraging mRNA technology to revolutionize medicine development and disease treatment. Over more than a decade, the company has developed a range of therapeutics and vaccines at an unprecedented pace and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna's mRNA platform has facilitated the creation of treatments for infectious diseases, cancer, rare diseases, and autoimmune conditions. The company operates with a unique culture and a global team committed to transforming human health through responsible innovation in mRNA medicine.