RSV Vaccines May Increase Risk of Rare Neurological Condition

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from The Epoch Times:

CDC officials are investigating a potential link between two recently approved RSV vaccines and increased reports of Guillain-Barré syndrome in adults over 60.

Recently approved vaccines for respiratory syncytial virus (RSV) for older adults may be linked to a rare nervous system disorder that causes the body’s immune system to attack its own nerves.

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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.

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