Moderna’s Covid Vaccine Gets Full FDA Approval For Use In Children 6 Months And Older

Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 vaccine Spikevax in children aged six months through 11 years who are at increased risk for the disease.

Moderna’s shares were up nearly 3% at the time of writing.

The vaccine was previously available for pediatric populations under Emergency Use Authorization only in times of a public health emergency.

"COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization," said CEO Stéphane Bancel.

Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.

Spikevax brought in $84 million in sales for Moderna in the first quarter of 2025, including $29 million of U.S. sales and $55 million of international sales. Since then, the company has gotten approval for a new Covid vaccine called mNEXSPIKE.

FDA approved mNEXSPIKE for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor, in late May.

Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. also in the 2025-2026 respiratory virus season, alongside Spikevax.

The company is also looking to file an application to the FDA for approval of its seasonal flu-covid combination vaccine later this year.

On Stocktwits, retail sentiment around Moderna is trending in the ‘bullish’ territory over the past 24 hours, coupled with ‘high’ message volume.

MRNA stock is down by 19% this year and by about 71% over the past 12 months.

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