The Food and Drug Administration (FDA) granted full approval of Moderna’s COVID-19 jab, Spikevax, in children 6 months through 11 years of age considered “increased risk” for COVID-19.

“Today we announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for Spikevax®, our COVID-19 vaccine, in children 6 months through 11 years of age who are at increased risk for COVID-19 disease,” Moderna stated.

“Our COVID-19 vaccine, mRNA-1273, was previously available for pediatric populations under Emergency Use Authorization,” it added.

“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,” Moderna Chief Executive Officer Stéphane Bancel said.

“We appreciate the FDA’s diligent scientific review and approval of Spikevax for pediatric populations at increased risk for COVID-19 disease,” he added.

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“Moderna expects to have its updated Spikevax vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season,” Moderna stated in a press release.

Upon the FDA’s latest approval, Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years considered “increased risk” for COVID-19.

X users criticized the FDA for the approval:

The approval follows the FDA requiring COVID-19 jabs from Moderna and Pfizer/BioNTech to use expanded warning labels about the risk of heart conditions, such as myocarditis and pericarditis, following inoculation.

“Federal regulators on June 25 updated labels for the Pfizer-BioNTech and Moderna COVID-19 vaccines to expand warnings regarding heart inflammation,” Epoch Health stated.

CNN stated in May:

The CDC last month told its independent vaccine advisers that research showed Covid-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis. The incidents were rare, however, and “there is no increased risk observed with the doses administered in subsequent years,” the agency said.

In the rare case that someone did develop heart inflammation after vaccination, the CDC told the advisers, acute myocarditis typically resolves quickly.

The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer’s; the new warnings for both vaccines will be for males age 16 to 25.

 

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