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After analyzing 5,147 RSVPreF3, 2,734 RSVpreF, and 35 mRNA-1345 reports, 91, 103, and 8 positive PT signals were found, respectively. Among serious reports, both RSVPreF3 and RSVpreF were associated with 9 important medical events (IMEs), including immune thrombocytopenia, which was also classified as a designated medical event (DME). Three pregnancy-related IME signals–hemorrhage in pregnancy, fetal death, and fetal hypokinesia – were reported for RSVpreF. Descriptive analysis of time-to-onset complemented the overall safety profiling, and sensitivity analysis offered further support for the observed disproportional reporting trends in certain adverse events (AEs). Our study utilized real-world data from large-scale spontaneous reporting systems to detect AEs that were disproportionately reported following RSV vaccination, thereby generating early safety signals to inform hypothesis development and support clinical awareness.
In a Feb. 29 meeting of the Advisory Committee on Immunization Practices, health officials presented data that appears to show a slightly elevated rate of Guillain-Barré syndrome (GBS) among people who received RSV vaccines by Pfizer and GlaxoSmithKline (GSK).
A data mining alert on Jan. 19 for disproportional reporting was detected by the U.S. Food and Drug Administration (FDA) for Pfizer’s Abrysvo RSV vaccine and GBS but has not been reported to date for GSK’s RSV vaccine Arexvy, according to Dr. Tom Shimabukuro, deputy director of the CDC’s influenza division and former director of the CDC’s immunization safety office.
The FDA uses data mining to identify statistical associations between products and events in their respective safety databases. If there is disproportionate reporting of an event for a particular product, this could suggest a statistical association between the adverse event and the product.
According to data from the Vaccine Adverse Event Reporting System (VAERS) presented by Dr. Shimabukuro, data show 35 reports of GBS with 18 cases attributed to Pfizer’s vaccine, Abrysvo, 16 cases attributed to GSK’s Arexvy, and one case that was not reported under either brand name.
The CDC verified 23 cases of GBS reported to VAERS as of Feb. 16—all occurring within 22 days of RSV vaccination. Of the 23 cases, 15 were attributed to Pfizer’s vaccine and eight to GSK’s vaccine. Fourteen males experienced the condition compared with nine females. There was one death reported in a 70-year-old man who developed GBS after receiving Arexvy.
“Certainly 23 cases of GBS within 22 [days] of RSV vaccination is not a ‘small signal’ given the woeful underreporting in VAERS,” Brian Hooker, chief scientific officer at Children’s Health Defense, who holds a doctorate in biochemical engineering, told The Epoch Times in an email.
“What is always missing with VAERS is a good denominator. Given that these vaccines have been distributed for less than a year (since May 31, 2023), I would expect the uptake to still be fairly low,” he added.
According to the Department of Health and Human Services (HHS), underreporting is one of the main limitations of a passive surveillance system like VAERS. “The term, underreporting refers to the fact that VAERS receives reports for only a small fraction of actual adverse events,” HHS states on its website. A November 2020 article published in Vaccine showed sensitivity for capturing GBS after three different vaccines ranged from 12 to 64 percent, suggesting more cases of GBS are occurring than are being captured.
https://www.zerohedge.com/medical/rsv-vaccines-may-increase-risk-rare-neurological-condition