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OAN Staff Blake Wolf
3:57 PM – Monday, June 2, 2025
The Food and Drug Administration (FDA) approved Moderna’s next generation lower-dose COVID-19 vaccines.
The new vaccine, called mNEXSPIKE was approved on Saturday for adults aged 65 and older, along with people aged 12 to 64 with at least one medical condition placing them at higher risk of COVID-19.
The newly approved vaccine is not a replacement for Moderna’s current COVID vaccine, but rather an additional choice for patients seeking a lower-dose option, as it contains one-fifth of Moderna’s other COVID vaccine, Spikevax.
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“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at righ risk of severe disease from COVID-19,” stated Moderna CEO Stéphane Bancel.
The approval is limited for individuals who previously received a COVID vaccine.
The new vaccine is much more limited than Moderna’s Spikevax vaccine which was offered to anyone older than 6 months.
The mNEXSPIKE vaccine marks the first approved vaccine by the Trump administration prior to Health and Human Services Secretary Robert F. Kennedy Jr. revealing that the Centers for Disease Control and Prevention would remove the COVID-19 vaccination recommendation for children and healthy pregnant women.
Kennedy Jr.’s new policy is in efforts to return the federal health agencies back to a “Gold Standard” of scientific research, forcing pharmaceutical companies to undergo clinical trials with a placebo in order to get new COVID vaccines approved.
Moderna’s new vaccine was tested against previously approved versions – claiming that the mNEXSPIKE generated higher levels of antibodies in comparison. The FDA approved the new vaccine based on a study of 11,400 individuals aged 12 and older.
The mNEXSPIKE vaccine is expected to be available in the fall.
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