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Despite the CDC’s move to kick the COVID-19 vaccine off recommended immunization schedules for children and healthy pregnant women in the United States, a major pharmaceutical company has netted FDA approval to make its COVID-19 shot available to kids nationwide.
Moderna announced that its newest vaccine, “Spikevax,” has been approved by the FDA for use in children aged 6 months to 11 years old “who are at increased risk for COVID-19 disease.”
“COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions,” said Stephane Bancel, CEO of Moderna, in an official statement.
The company expects Spikevax to be available for the 2025-26 respiratory virus season.
Previously, the mRNA-based vaccine was available only under Emergency Use Authorization. The FDA approval makes its market presence permanent.
Modern’s FDA victory on Spikevax comes just months after Health and Human Services Secretary Robert F. Kennedy Jr. announced that the CDC would remove the somewhat controversial immunization from the recommended schedules for both children and healthy pregnant women in America.
“I couldn’t be more pleased to announce that, as of today, the COVID-19 vaccine for healthy children and healthy pregnant women has been removed from the CDC recommendation immunization schedule,” Kennedy said in May.
He explained that the Biden administration had pushed healthy children to receive booster shots of the COVID-19 vaccine “despite the lack of any clinical data to support the repeat booster strategy in children.”
According to Reuters, Kennedy earlier this year fired a 17-member panel comprising the CDC’s “Advisory Committee on Immunization Practices” in tandem with his directive on eliminating recommendations on routine COVID-19 vaccinations.
