The FDA Just Approved a New Covid Vaccine
3 minute readPublished: Saturday, May 31, 2025 at 9:16 pm
FDA Approves New Moderna COVID Vaccine Amidst Shifting Recommendations
The Food and Drug Administration (FDA) has approved a new COVID-19 vaccine from Moderna, called mNEXSPIKE, the company announced Saturday. This comes at a time of evolving recommendations regarding COVID-19 vaccinations, potentially impacting the vaccine's rollout and accessibility.
The newly approved vaccine is targeted towards adults aged 65 and older, as well as individuals aged 12-64 with underlying health conditions, as defined by the Centers for Disease Control and Prevention (CDC). These conditions include cancer, asthma, and HIV. Clinical trials involving over 11,000 participants showed mNEXSPIKE to be more effective than Moderna's previous vaccine. Moderna CEO Stéphane Bancel emphasized the importance of this new tool in protecting those at high risk of severe COVID-19 illness, highlighting that over 47,000 Americans died from the virus last year.
However, the announcement coincides with significant changes in CDC recommendations. Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced the removal of COVID-19 vaccine recommendations for healthy children and pregnant women. This decision, made outside the agency's formal expert review process, has drawn criticism from medical professionals. Experts like Dr. Sean O'Leary, chair of the American Academy of Pediatrics committee on infectious diseases, expressed concern about the process, emphasizing the importance of evidence-based decision-making. The CDC has since clarified its guidance, stating that healthy children can still receive the vaccine through shared clinical decision-making with their doctor. The guidance for pregnant adults currently reads "No Guidance/Not Applicable."
These shifting recommendations raise concerns about the future of vaccine access. Experts fear that changes in recommendations could lead to reduced insurance coverage, decreased availability in doctors' offices, and ultimately, lower vaccination rates.
BNN's Perspective: The approval of a new, potentially more effective vaccine is a positive development in the fight against COVID-19. However, the evolving and sometimes conflicting guidance from health authorities creates confusion and could undermine public trust in vaccination efforts. A clear, consistent, and evidence-based approach is crucial to ensure that those most vulnerable to the virus have access to the protection they need.
Keywords:
FDA, Moderna, COVID-19 vaccine, mNEXSPIKE, vaccine approval, CDC, vaccine recommendations, healthy children, pregnant women, vaccine access, Stéphane Bancel, Robert F. Kennedy Jr., vaccine efficacy, underlying health conditions, vaccine coverage, vaccine guidance.