MRNA-1283 COVID Vaccine Approved: 65+ & High-Risk Groups
Breaking: Moderna’s mNEXSPIKE COVID vaccine receives full FDA approval, offering enhanced protection for adults 65+ and individuals with underlying health risks. Clinical trials reveal this next-generation mRNA vaccine,mRNA-1283,demonstrates superior efficacy compared to Moderna’s original vaccine,Spikevax. The FDA’s decision underscores the ongoing commitment to combatting the virus and aligns with updated guidelines prioritizing vaccines for high-risk groups.This approval is a notable advancement in the fight against COVID-19, particularly for vulnerable populations. Stay informed with News Directory 3 for comprehensive updates on this and other critical health developments. Discover what’s next in the ongoing evolution of COVID-19 vaccine strategies.
Moderna’s mNEXSPIKE COVID Vaccine Receives FDA Approval
Updated June 03, 2025
Moderna’s next-generation COVID-19 vaccine, mRNA-1283 (mNEXSPIKE), has secured FDA approval for adults aged 65 and older, as well as individuals between 12 and 64 who have underlying risk factors for severe COVID-19, according too a company announcement. This approval marks a significant step in the ongoing effort to combat the virus.
Clinical trial data indicates that the mNEXSPIKE COVID vaccine offers improved protection compared to Moderna’s original mRNA-based vaccine, Spikevax (mRNA-1273). The phase 3 study (NCT05815498), involving approximately 11,400 participants aged 12 and older, revealed that mRNA-1283 demonstrated noninferior vaccine efficacy against COVID-19 when compared to mRNA-1273. Notably, adults aged 18 and older showed higher efficacy with mNEXSPIKE, a trend that remained consistent among those 65 and older.
Specifically, the relative vaccine efficacy (rVE) of mRNA-1283 was 9.3% higher than mRNA-1273 in individuals aged 12 and older. A subgroup analysis showed an even more pronounced difference in adults aged 65 and older,with mNEXSPIKE exhibiting a 13.5% higher rVE.
Earlier results from the trial also highlighted that mRNA-1283 produced stronger neutralizing antibody responses against both the Omicron BA.4/5 variant and the original SARS-CoV-2 strain compared to mRNA-1273. The most significant increases in geometric mean titer ratios were observed in adults,notably those aged 65 and older. furthermore,mNEXSPIKE’s safety profile was comparable to that of Spikevax,with common side effects including fatigue,injection site pain,and headache.
“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. “COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”
The FDA’s decision to approve mRNA-1283 aligns with its recently updated guidance, which prioritizes COVID-19 vaccine recommendations for adults 65 and older and individuals with at least one risk factor for severe illness. novavax’s COVID-19 vaccine Nuvaxoid was also recently approved under these revised parameters.
Amidst evolving COVID-19 vaccine guidelines, pharmacists play a crucial role in staying informed and ensuring patients receive the most up-to-date recommendations. Despite recent changes to the vaccine recommendation process, updated vaccines are expected to be widely available for the upcoming respiratory season, making pharmacists indispensable in vaccinating eligible individuals in time for the 2025-2026 season.
What’s next
As the 2025-2026 respiratory season approaches, pharmacists will be at the forefront of administering the updated COVID-19 vaccinations, including Moderna’s mNEXSPIKE COVID vaccine, to eligible patients, ensuring that high-risk populations receive the necessary protection against severe illness.