FDA reviewing safety of infant RSV injections
The U.S. Food and Drug Administration said Dec. 9 it has opened a safety review of injectable RSV drugs used for babies and toddlers, a nationwide regulatory step that could affect pediatric care in the Twin Cities. The agency did not announce a recall but said it is assessing safety reports and will issue guidance if needed.
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đ Relevant Data
In 2022, the peak RSV infection rate for Black children under 5 years was 2,135 cases per 1,000,000 person-days, which is 195% higher than for White children at 723 cases per 1,000,000 person-days. ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/))
In 2022, the peak RSV infection rate for Hispanic children under 5 years was 2,734 cases per 1,000,000 person-days, which is 278% higher than for White children at 723 cases per 1,000,000 person-days. ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC9727767/))
RSV is the leading cause of hospitalization among infants in the United States. ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/)) ([PMC](https://pmc.ncbi.nlm.nih.gov/articles/PMC12566779/))
Treatment-related adverse events occurred in 2.1% of infants in the nirsevimab group. ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189)) ([NEJM](https://www.nejm.org/doi/full/10.1056/NEJMoa2309189))
Nirsevimab for Prevention of Hospitalizations Due to RSV in Infants â NEJM
đ Key Facts
- Agency action: FDA opened a safety review on Dec. 9, 2025
- Scope: injectable RSV medications administered to babies and toddlers
- Status: review underway; no recall announced at time of report
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