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FDA Requires RSV Vaccine Labels to Include Guillain-Barré Syndrome Risk

FDA Requires RSV Vaccine Labels to Include Guillain-Barré Syndrome Risk

On Jan. 7, 2025, the U.S. Food and Drug Administration (FDA) mandated and approved changes to the safety labeling for the Prescribing Information of two Respiratory Syncytial Virus (RSV) vaccines: Abrysvo (manufactured by Pfizer)1 and Arexvy (manufactured by GlaxoSmithKline Biologicals).2 This label change update is being required to inform both the public and health care […]

COVID Shot Injury Claims Rarely Being Paid by U.S. Government

COVID Shot Injury Claims Rarely Being Paid  by U.S. Government

A report from the U.S. Government Accountability Office (GAO) showed that claims made under the Health and Human Services (HHS) Countermeasures Injury Compensation Program (CICP) during the first few years of the COVID-19 pandemic have risen 27 percent since the program started receiving claims in 2009. However, only three percent of the COVID shot injury […]

COVID-19 Shots Linked to Higher Incidence of Alzheimer’s Disease

COVID-19 Shots Linked to Higher Incidence of Alzheimer’s Disease

Several studies during the past two years have shown a link between COVID-19 vaccination and the development of neurological complications involving different types of brain dysfunction, including Alzheimer’s disease. The most recent of these studies was published earlier this year in the British medical journal QJM: An International Journal of Medicine. Researchers investigated the association between COVID […]

CDC Narrows RSV Vaccine Guidelines Due to Safety Concerns

CDC Narrows RSV Vaccine Guidelines Due to Safety Concerns

The U.S. Centers for Disease Control and Prevention (CDC) has recently narrowed its original recommendations for the respiratory syncytial virus (RSV) vaccine, citing concerns over the risk of a side effect that can lead to paralysis or death. The recommendations originally stated adults over the age of 60 should receive the vaccine, but updates in […]

Guillain-Barré Syndrome ‘More Common Than Expected’ in Early RSV Vaccine Trial

Guillain-Barré Syndrome ‘More Common Than Expected’ in Early RSV Vaccine Trial

Reports of the nervous system disorder Guillain-Barré syndrome (GBS) were “more common than expected” in the older adult population who received the new vaccine for respiratory syncytial virus (RSV). The data, reported by the U.S. Centers for Disease Control and Prevention (CDC), matched trial data reported earlier this year.1 GBS is a “polio-like” inflammatory autoimmune […]

New Study Documents COVID-19 Vaccine Harms—Low Platelets, GBS, Myocarditis

New Study Documents COVID-19 Vaccine Harms—Low Platelets, GBS, Myocarditis

There’s a new paper out now in the journal Vaccine, and it’s about the COVID-19 vaccine and some of the harms due to the vaccine. It’s the largest observational analysis of 99 million people, and it’s entitled “COVID-19 Vaccines and Adverse Events of Special Interest: A Multinational Global Vaccine Data Network Cohort Study of 99 […]

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