Moderna Gains FDA Approval for New Coronavirus Vaccine
This approval, which was based on the results of a Phase III trial demonstrating a higher relative efficiency of the new vaccine compared with the old version, marks the third for the company from the FDA.
The U.S. FDA has granted marketing authorization approval to Moderna for its new messenger RNA (mRNA) COVID-19 vaccine, mRNA-1283 (mNEXSPIKE), in adults aged 65 years and older or patients aged 12–64 years who have one or more underlying risk factors (1). This approval marks the third for the company from the U.S. regulatory body.
“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,” said Stéphane Bancel, Chief Executive Officer of Moderna, in the company press release about the regulatory decision (1). “COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health.”
This regulatory decision has been made based on results from a randomized, observer-blind, active-controlled Phase III clinical trial, which assessed the efficacy of the vaccine in comparison to the company’s original COVID-19 vaccine, mRNA-1273 (Spikevax). The clinical trial included 11,400 participants who were aged 12 years and older.
Half of the trial participants were administered a 10 µg dose of mRNA-1283 and the other half were administered a 50 µg dose of mRNA-1273. In the participants who had received mRNA-1283, the trial researchers found that there was a 9.3% higher relative vaccine efficacy when compared with mRNA-1273. Additionally, when analyzing a sub-group of the patient population, comprising patients over 65 years of age, the researchers found that the relative vaccine efficiency of mRNA-1283 was 13.5% higher than mRNA-1273 (2).
“We are very pleased that mRNA-1283 has now met its primary vaccine efficacy endpoint in Phase III, and showed higher efficacy in adults compared to Spikevax,” said Bancel in a press release about the trial results (2). “With five vaccine programs that have achieved positive Phase III results, Moderna's platform is consistently demonstrating its ability to address significant unmet needs in public health.”
Moderna is also working on an mRNA-based vaccine for pandemic influenza, which is currently being investigated in a Phase I/II clinical trial to evaluate its safety and immunogenicity (3). The focus for the investigational vaccine, mRNA-108, is the H5 avian influenza virus subtype and the interim data have demonstrated a rapid, potent, and durable immune response of the vaccine in approximately 300 adults.
Initially, Moderna had expected to advance the program with funding from the U.S. Department of Health and Human Services (HHS); however, the company recently announced that HHS has terminated the funding award (3).
“While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase I/II study of our H5 avian flu vaccine and we will explore alternative paths forward for the program,” explained Bancel, in the company press release (3). “These clinical data in pandemic influenza underscore the critical role mRNA technology has played as a countermeasure to emerging health threats.”
References
Moderna. Moderna Receives U.S FDA Approval for COVID-19 Vaccine mNEXSPIKE. Press Release, May 31, 2025.
Moderna. Moderna Announces Positive Phase III Efficacy Data for mRNA-1283, the Company’s Next Generation COVID-19 Vaccine. Press Release, June 13, 2024.
Moderna. Moderna Announces Update on Investigational Pandemic Influenza Program. Press Release, May 28, 2025.