FDA Approves Moderna's mNEXSPIKE Vaccine for Aged 65 & Above

• FDA approves Moderna’s new COVID-19 vaccine mNEXSPIKE for seniors and at-risk individuals.
• mNEXSPIKE can be stored in refrigerators, easing distribution, especially in low-resource settings.
• CDC affirms COVID vaccines remain optional for healthy kids, easing investor concerns.

The U.S. Food and Drug Administration (FDA) has given Moderna’s approval for mNEXSPIKE to be used in seniors aged 65 and above. They also approved the vaccine for people 12 to 64 who are dealing with at least one serious health problem. The drug was approved under the FDA's newest rules which now mean large-scale studies are done in healthy people, making it easier for some people to get access.

The mNEXSPKE vaccine is planned to be used during the 2025–2026 respiratory virus season. It can be stored just like usual in a refrigerator, making it last longer and easier to distribute; this is very helpful in places where establishing a cold-chain is hard.

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The vaccine was approved even as Health and Human Services Secretary Robert F. Kennedy Jr., who has long questioned vaccines, pressured the agency for increased scrutiny. The FDA is now using a stricter supervision approach because of these changes. With this, the CDC stated healthy kids can still receive COVID vaccines if parents and doctors decide together, challenging Kennedy’s earlier words on removing the vaccines from the immunization schedule. The news puts investors at ease because it promises seniors and high-risk groups will still have the option to be vaccinated.