FDA to Probe Safety of RSV Shot for Infants, Citing Deaths Reported in Clinical Trials

by Brenda Baletti, Ph.D.

The U.S. Food and Drug Administration (FDA) has launched a renewed safety review of the RSV shots given to infants to protect against the virus, Reuters reported today.

The agency plans to investigate two monoclonal antibody shots: Beyfortus, made by AstraZeneca and Sanofi, and Enflonsia, made by Merck. Both are currently recommended for most infants in the U.S.

The monoclonal antibody shots are not traditional vaccines. Instead, they’re designed to temporarily provide infants with “passive immunity” — which means antibodies, not created by their own immune systems, to fight the virus.

Safety questions about the shots first surfaced during the summer, when Tracy Beth Høeg, Ph.D., then a senior adviser to the FDA, raised concerns, U.S. Department of Health and Human Services (HHS) spokesperson Andrew Nixon told Reuters…

READ FULL ARTICLE HERE… (childrenshealthdefense.org)

 

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