FDA Greenlights Moderna's New Lower-Dose COVID Vaccine for High-Risk Groups

Published 1 days agoMRNA

FDA Greenlights Moderna's New Lower-Dose COVID Vaccine for High-Risk Groups

The U.S. Food and Drug Administration has officially approved mNEXSPIKE, a new lower-dose COVID-19 vaccine by Moderna. This vaccine has been specially approved for individuals aged 65 and older as well as for those between 12 and 64 with underlying health conditions that make them more vulnerable to COVID-19. This development marks a targeted approach in vaccination efforts amid the ongoing battle against the pandemic.

mNEXSPIKE, as reported by Reuters, contains only a fifth of the dose found in Moderna's original Spikevax vaccine. This adjustment results from a refined focus on enhancing immune response while maintaining safety and efficacy, as demonstrated in clinical trials with 11,400 participants. These trials showed that the vaccine is not only safe but may prove more effective than its predecessor in some measures. Additionally, the ability to store the vaccine in regular refrigerators enhances its shelf life and makes distribution more manageable.

Moderna plans to release mNEXSPIKE alongside the original Spikevax vaccine this fall, aligning with the FDA's updated regulatory standards that now require placebo-controlled trials for younger healthy adults. This move reflects a more restrictive phase of vaccine accessibility, similar to the approach adopted with Novavax's recent vaccine, representing a shift towards focusing on higher-risk populations. The changes in policy indicate a strategic adjustment in public health measures as the pandemic evolves.

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