FDA approves Moderna's next-gen COVID-19 vaccine for seniors
What's the story
The US Food and Drug Administration (FDA) has approved Moderna's next-generation COVID-19 vaccine, mNEXSPIKE, for people aged 65 and above.
This is the first approval since the FDA tightened its requirements.
The vaccine has also been authorized for individuals aged between 12 and 64 with underlying health conditions that increase their risk of severe illness from COVID-19.
Executive statement
Moderna's CEO comments on FDA approval
Moderna's CEO, Stephane Bancel, expressed his views on the FDA approval.
He said, "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19."
The company plans to make this vaccine available for the upcoming 2025-2026 respiratory virus season.
Vaccine distribution
Regulatory scrutiny on vaccines
The Department of Health and Human Services, led by Robert F. Kennedy Jr., is tightening regulatory scrutiny on vaccines.
The FDA has proposed that drugmakers test their COVID-19 booster shots against an inert placebo in healthy adults under 65 for approval.
This effectively limits the vaccine's use to older adults and those at risk of severe illness.
Vaccine logistics
Storage and distribution benefits
The Moderna vaccine, mNEXSPIKE, comes with the added advantage of being stored in refrigerators instead of freezers.
This feature extends its shelf life and simplifies distribution, especially in developing countries where supply-chain issues can hinder vaccination efforts.
The approval was based on late-stage trial data showing that mNEXSPIKE was as effective as Spikevax in people aged 12 years and older.