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FDA Approves GSK’s 5-in-1 Meningococcal Vaccine

FDA Approves GSK’s 5-in-1 Meningococcal Vaccine

On Feb. 14, 2025, British pharmaceutical and biotechnology company GSK plc announced that the U.S. Food and Drug Administration (FDA) approved its 5-in-1 meningococcal vaccine PENMENVY for licensure and use in individuals aged 10 through 25 years. The vaccine targets five major serogroups of the bacterium Neisseria meningitidis (A, B, C, W, and Y), which […]

FDA Clears Investigational New Drug Application for Inhaled COVID Biologic

FDA Clears Investigational New Drug Application for Inhaled COVID Biologic

Biotech company Ocugen, Inc. has announced that the U.S. Food and Drug Administration (FDA) has cleared their Investigational New Drug (IND) application for a novel inhaled vaccine against SARS-CoV-2. The biologic uses novel chimpanzee adenovirus-vectored (ChAd36) technology. The approval will allow the company to initiate Phase I clinical trials for the inhaled vaccine, OCU500. The […]

COVID-19 Shot Safety, Efficacy Concerns Exposed by Florida Grand Jury

COVID-19 Shot Safety, Efficacy Concerns Exposed by Florida Grand Jury

While recent news headlines proclaim that a Florida Grand Jury has found no evidence of crimes committed by the manufacturers of COVID-19 shots, the actual report published earlier this month paints a more thorough picture. Two years after Florida’s Governor Ron DeSantis called for a federal investigation into the experimental mRNA COVID biologics for “any […]

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 […]

Moderna Halts RSV Pediatric Vaccine Trial After Five Infants Hospitalized

Moderna Halts RSV Pediatric Vaccine Trial After Five Infants Hospitalized

On Dec. 11, 2024, the U.S. Food and Drug Administration (FDA) announced that clinical trials for Moderna’s pediatric mRNA RSV vaccines have been paused due to safety concerns. The recent phase 1 trials of two experimental respiratory syncytial virus (RSV) vaccines for infants not only failed to provide adequate protection but may have worsened respiratory […]

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