FDA Approves New Moderna COVID-19 Vaccine for Older Adults, High-Risk Patients
The new approval is in line with recommendations that suggest booster vaccination for older adults and patients aged 12 to 64 with at least 1 or more underlying risk factors.
The FDA approved mRNA-1283 (mNexspike) for adults aged 65 years and older to prevent COVID-19 infection. It is also indicated for individuals aged 12 to 64 years with at least 1 or more underlying risk factors.1
The new approval is in line with recommendations that suggest booster vaccination for older adults and patients aged 12 to 64 with at least 1 or more underlying risk factors. | Image Credit: Rido - stock.adobe.com
"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," Stéphane Bancel, CEO of Moderna, said in a news release.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."
The approval is based on results from the NextCOVE (NCT05815498) phase 3 clinical trial, enrolling approximately 11,400 patients 12 years and older. Investigators of the study aimed to determine the relative vaccine efficacy, safety, reactogenicity, and immunogenicity of mRNA-1283 compared with mRNA-1273. In part 1, investigators included patients that previously received a primary series of an authorized or approved COVID-19 vaccination, and for patients older than 18, a booster dose was also required. In part 2, no prior vaccination was required.1,2
The primary outcomes included geometric mean ratio (GMR) of Omicron BA.4/5 mRNA-1283.222 over the Omicron BA.4/5 mRNA-1273.222, seroresponse rate difference, GMR of the ancestral severe SARS-CoV-2, seroresponse rate difference of the ancestral SARS-CoV-2, relative vaccine efficacy to prevent the first event of COVID-19, number of individuals with solicited local and systemic reactogenicity adverse reactions, number of individuals with unsolicited adverse events (AEs), and number of individuals with any serious AEs.
Secondary outcomes included geometric mean titers of Omicron BA.4/5 and ancestral SARS-CoV-2, seroresponse rate against both variants, number of individuals with a COVID-19 infection, and number of individuals with severe COVID-19.2
The COVID-19 vaccine met the primary outcomes of the phase 3 trial, eliciting a stronger response against both variants of COVID-19 compared with Spikevax. The protection was strongest for patients 65 years and older. The safety profile was also comparable to other approved COVID-19 vaccinations, with the most common AEs being injection site pain, headache, fatigue, myalgia, and chills.3
The approval and recommendation are in line with the CDC removing healthy children and pregnant women from the COVID-19 recommended immunization schedule. The World Health Organization also released a statement on COVID-19 vaccines, which now recommends monovalent vaccines, suggesting manufacturers include monovalent JN.1 or KP.2 vaccines. They add that monovalent LP8.1 is a suitable alternative vaccine antigen.4,5
Moderna expects the vaccine to be available for the 2025-2026 respiratory season alongside Spikevax, another COVID-19 vaccination, and mResvia, a respiratory syncytial virus vaccination.1
READ MORE: COVID-19 Resource Center
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