Moderna COVID-19 Vaccine mNEXSPIKE FDA-Approved Under New Eligibility Guidelines

The FDA on Sunday approved Moderna's mRNA-1283 vaccine against COVID-19 ( mNEXSPIKE), making the shot the second approved under new federal guidelines that restrict eligibility. The agency approved mNEXSPIKE for 2 populations, all adults 65 and older and individuals aged 12-64 years with at least one underlying risk factor that puts them at risk of severe illness as defined by the CDC,¹ according to a company statement.

_{©desertsands/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,” Moderna CEO Stéphane Bancel said in the statement. “COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”¹

The FDA based its approval on results from a randomized, observer-blind, active-controlled phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498) that enrolled approximately 11,400 participants aged 12 years and older. The study was designed to demonstrate the vaccine's noninferiority compared to mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine, starting 14 days post-vaccination.¹

Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. The primary efficacy analysis demonstrated that mRNA-1283 achieved a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older. In a descriptive sub-group analysis of adults aged 65 and older, mRNA-1283 showed a 13.5% higher rVE.¹

The safety profile of mRNA-1283 was reported as similar to that of mRNA-1273 with a modest benefit observed for local reactions and comparable systemic reactions. The most commonly reported solicited adverse events included injection site pain, fatigue, headache, and myalgia.

Moderna expects the new shot to be available in the US for the 2025-2026 respiratory virus season, according to the news release.

Shifting Federal Vaccine Guidance

These age-restricted approval guidelines reflect significant policy changes in federal COVID-19 vaccination recommendations.² In a social media announcement May 27 on X (formerly Twitter) HHS Secretary Kennedy and leaders from the NIH and FDA stated that the FDA no longer recommends annual COVID-19 vaccines for pregnant women and healthy children, focusing the need for the shot on high-risk populations, specifically denoting adults aged 65 years and older and individuals aged 6 months and older with underlying conditions such as asthma, diabetes, and cancer.³ Kennedy et al instructed the CDC to removed the recommendation from the agency's published Child and Adolescent Immunization Schedule by Age.²

However, rather than strike the guidance altogether, the CDC amended language on the schedule in the COVID-19 vaccination section. Under the section headed "Routine vaccination" the agency has added a section on "Shared clinical decision making." In lieu of routine vaccination for healthy children aged 6 months to 17 years "who are not moderately or severely immunocompromised," the CDC now states⁴:

The date for the most recent update of content on the page is noted as May 29.⁴

The American Academy of Pediatrics in a statement on May 30 said it was "relieved" to see the CDC had updated it schedules for child and adolescent vaccinations "...to allow families to maintain the choice to immunize their children against Covid in consultation with their doctor."⁵

The update came after "confusing, mixed messages from leaders at Health and Human Services (HHS) earlier this week," the AAP continued. “The deeply flawed process to reach the recommendation raises serious concerns about the stability of the nation’s immunization infrastructure and commitment by federal leaders to make sure families can access critical immunizations, whether for COVID or other infectious diseases,” AAP president Susan Kressly, MD, said in the statement.⁵

“American families deserve better,” Kressly said. “They deserve clear messages from all involved in their health that are based on facts so they can continue to benefit from the success story of vaccines.”⁵

References

1. Moderna receives US FDA approval for COVID-19 vaccine mNEXSPIKE. News release. Moderna. May 31, 2025. Accessed June 2, 2025.
https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx
2. Mazzolini C. RFK Jr ends COVID-19 vaccine recommendation for healthy children, pregnant women. Patient Care. May 27, 2025. https://www.patientcareonline.com/view/rfk-jr-ends-covid-19-vaccine-recommendation-for-healthy-children-pregnant-women
3. Kennedy R. Announcement on X. May 27, 2025. Accessed May 27, 2025. https://x.com/seckennedy/status/1927368440811008138?s=46
4. Child immunization schedule notes. Recommendations for ages 18 years or younger, United States, 2025. Centers for Disease Control and Prevention. May 29, 2025. Accessed June 2, 2025. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-notes.html#note-covid-19
5. AAP statement on COVID vaccine recommendations for children. News release. American Academy of Pediatrics. May 30, 2025. Accessed June 2, 2025. https://www.aap.org/en/news-room/news-releases/aap/2025/aap-statement-on-covid-vaccine-recommendations-for-children/