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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 […]

Atrial Fibrillation Linked to Age, COVID-19 and Vaccination on the Rise

Atrial Fibrillation Linked to Age, COVID-19 and Vaccination on the Rise

Previous research has indicated that approximately 3 million people in the United States have atrial fibrillation (AFib); however, a 2024 study conducted by researchers from the University of California, San Francisco and published in the Journal of the American College of Cardiology has found that AFib is actually three times more prevalent in the U.S. […]

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 […]

Health Canada’s Blind Trust in Pfizer: A Global Vaccine Rollout Lacking Proper Oversight

Health Canada’s Blind Trust in Pfizer: A Global Vaccine Rollout Lacking Proper Oversight

Pfizer has assured Health Canada that their [COVID-19] vaccine is safe and effective, not based on solid clinical trials or proven efficacy but simply because it has been widely administered to billions of people worldwide. Recent access to information disclosure seeking information on the contaminants found by independent scientists in Pfizer’s novel modified RNA injection […]

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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