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Moderna's COVID-19 vaccine mNEXSPIKE gains FDA approval

Moderna's next-gen COVID-19 vaccine, mNEXSPIKE, has FDA approval for adults 65+ and high-risk individuals aged 12–64, marking the first approval under revised vaccine guidelines.

Alivia Kaylor, MSc
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Published: 02 Jun 2025

On May 31, 2025, Moderna announced it gained FDA approval for its next-generation COVID-19 vaccine, mNEXSPIKE, formerly called mRNA-1283. The vaccine is approved for adults aged 65 and older and individuals aged 12–64 who have underlying health conditions that increase their risk of severe COVID-19.

"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, Chief Executive Officer of Moderna, said in the company's press release. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone."

Improved formulation and efficacy

FDA approval followed positive Phase 3 clinical data involving approximately 11,400 participants aged 12 and older. The trial demonstrated that mNEXSPIKE provided a 9.3% higher relative vaccine efficacy compared to Moderna’s original SPIKEVAX vaccine (mRNA-1273) in participants aged 12 and older, with an even more pronounced efficacy improvement (13.5%) in adults aged 65 and older.

The new formulation reduces dosage requirements to 10 µg per dose, one-fifth of the SPIKEVAX dose, which could potentially result in fewer side effects and reduced manufacturing costs.

Additionally, mNEXSPIKE can be stored at standard refrigeration temperatures (2–8°C) for up to 90 days, a substantial improvement over SPIKEVAX's 60-day refrigerated shelf life. The vaccine also maintains stability at temperatures between 8°C and 25°C for twice as long, significantly easing distribution logistics.

The safety profile of mNEXSPIKE is comparable to SPIKEVAX's, with fewer local reactions observed and common systemic reactions such as injection-site pain, fatigue, headache and myalgia.

Regulatory implications

mNEXTSPIKE's FDA approval arrives amid increased vaccine scrutiny and financial uncertainty. The FDA recently introduced a new regulatory guidance that ends universal COVID-19 vaccine boosters for individuals aged between 6 months and 64 years without risk factors and COVID-19 vaccine recommendations for healthy children and pregnant individuals, sidestepping the CDC’s advisory committee process.

Despite investor concerns over payer coverage and increased criticism of vaccines, the company intends to offer mNEXSPIKE alongside SPIKEVAX during the upcoming 2025–2026 respiratory virus season.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.

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