FDA Approves Moderna's New Lower-Dose COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) has officially authorized a new, lower-dose version of Moderna's COVID-19 vaccine, designed to enhance protection in high-risk populations. This innovative vaccine, known as mNexspike, is a significant advancement in coronavirus immunization technology. It features a dose that is approximately one-fifth of the standard amount used in Moderna's Spikevax, achieved through a targeted design that aims to provoke a more focused immune response. Importantly, this new vaccine is not intended to replace the existing Moderna COVID-19 shot but rather to serve as an additional option.

mNexspike is approved specifically for individuals aged 65 and older who have been previously vaccinated with any COVID-19 vaccine, as well as for those aged 12 to 64 who possess at least one underlying health condition that increases their risk of severe illness from COVID-19. This limited authorization aligns with the approval of other targeted vaccines like Novavax's last month.

In the upcoming fall, Moderna plans to offer both Spikevax and mNexspike, providing flexibility in COVID-19 vaccination strategies. The current primary vaccine remains widely accessible for individuals aged 6 months and older without restrictions.

Moderna’s CEO, Stephane Bancel, emphasized that the new lower-dose vaccine is a valuable addition to the arsenal of tools available to protect high-risk groups against severe COVID-19 outcomes. The approval marks an important step in refining vaccine strategies to better address the ongoing pandemic.

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