FDA approves Moderna's new lower-dose COVID-19 vaccine
3 minute readPublished: Saturday, May 31, 2025 at 8:31 pm
Moderna's New, Lower-Dose COVID-19 Vaccine Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved a new COVID-19 vaccine from Moderna, marking a significant development in the ongoing fight against the virus. This new vaccine, dubbed mNexspike, is designed as a "next-generation" option, offering a lower dose compared to Moderna's existing Spikevax vaccine.
The key difference? mNexspike utilizes a refined immune target, allowing for a dose just one-fifth the size of Spikevax. This approval is not a replacement for the original vaccine but rather a second option, specifically targeted at high-risk individuals.
The FDA has authorized mNexspike for adults aged 65 and older, as well as individuals aged 12 to 64 with at least one underlying health condition that increases their risk from COVID-19. This mirrors the restrictions placed on Novavax's COVID-19 vaccine. Moderna's CEO, Stephane Bancel, hailed the approval as a crucial tool to protect vulnerable populations.
The FDA's decision was based on a study involving over 11,400 participants aged 12 and older. The study compared mNexspike to the original Moderna vaccine and found it to be safe and at least as effective, and in some measures, even more so.
This approval comes amidst a backdrop of shifting vaccine strategies. Notably, the Trump administration recently canceled funding for Moderna's development of a pandemic flu vaccine, despite promising early results. Moderna plans to offer both its original and new vaccine options this fall.
BNN's Perspective: This approval is a positive step, offering a potentially more efficient and targeted approach to COVID-19 vaccination. While the restrictions on who can receive the new vaccine are understandable given the focus on high-risk groups, it's crucial to ensure clear communication and accessibility to avoid confusion and maintain public trust in vaccination efforts. The availability of multiple vaccine options is a good thing, but it's important to balance this with clear guidance from health officials.
Keywords: Moderna, mNexspike, COVID-19 vaccine, FDA approval, lower dose, Spikevax, next-generation vaccine, high-risk individuals, elderly, underlying health conditions, vaccine effectiveness, vaccine safety, pandemic flu, Robert F. Kennedy Jr., Trump administration, vaccine options.