by Suzanne Burdick, Ph.D., Childrens Health Defense:
The children were mistakenly administered either Pfizer’s Abrysvo or GSK’s Arexvy respiratory syncytial virus, or RSV, vaccines. Both are approved by the U.S. Food and Drug Administration for adults ages 60 and older — but not for children or babies.
Nearly 130 pregnant women and 25 children under age 2 were given the wrong respiratory syncytial virus (RSV) vaccine, according to the Centers for Disease Control and Prevention (CDC).
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The children were mistakenly administered either Pfizer’s Abrysvo or GSK’s (formerly GlaxoSmithKline) Arexvy RSV vaccines. Both are approved by the U.S. Food and Drug Administration (FDA) for adults ages 60 and older — but not for children or babies.
For babies, the CDC recommends a monoclonal antibody — nirsevimab (Beyfortus) — produced by AstraZeneca and Sanofi. The CDC also recommends Beyfortus for children ages 8-19 months who are at increased risk of severe RSV.
Although Arexvy and Abrysvo are approved for older adults, only Abrysvo is approved for pregnant women to prevent RSV in their babies. All of the 128 pregnant women who received the wrong vaccine were administered Arexvy.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms.
The virus has recently received a lot of media attention as therapies protecting against it “are now sort of a boon” for Big Pharma, according to Dr. Meryl Nass, internist and member of the Children’s Health Defense scientific advisory committee.
The CDC said in a Jan. 22 Clinical Outreach and Communication Activity alert that the agency had detected the administration errors through the Vaccine Adverse Event Reporting System (VAERS).
Most of these errors occurred in outpatient settings when treating babies under 8 months old, the CDC said.
Commenting on the news, Nass said it was a “big problem” that vaccines only approved for use in adults were administered to babies. “It’s also a big problem that pregnant women were given a vaccine with no approval data for its use during pregnancy.”
“Clearly, the labels on these products were not very good and did not make clear what they were for,” Nass told The Defender. “That means the FDA screwed up and maybe the manufacturers screwed up, creating a situation where they’d be misused.”
Nass noted that Pfizer and GSK chose names for their RSV vaccines starting with the letter “a,” which may have led to the mishap of giving pregnant women the wrong shot. “Why did they do that?” she asked.
“Part of FDA’s job is to make labeling clear and not mix up products,” Nass said. “They failed in that duty.”
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