The Food and Drug Administration (FDA) has granted approval for Moderna’s mRNA-based flu vaccine for adults 50 and older, despite earlier regulatory concerns.
| PULSE POINTS |
❓ WHAT HAPPENED: The Food and Drug Administration (FDA) has approved Moderna’s mRNA-based seasonal flu vaccine. 📺 DETAIL: Named mFLUSIVA, the vaccine was approved on Wednesday. It is aimed at people aged 50 and older. The decision comes after the FDA initially declined to approve the vaccine back in February. Specifically, the vaccine was initially blocked as the clinical trial did not use the best available comparator for adults aged 65 and older. “We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible,” read a statement from Moderna, which further said the approval “reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.” This follows the decision of Secretary for Health and Human Services Robert F. Kennedy, Jr. to withdraw approximately $500 million for mRNA vaccine research and move funding toward traditional platforms. 🎯 IMPACT: The approval of the vaccine coincides with the appointment of the new Director of the Centers for Disease Control and Prevention (CDC). Dr. Erica Schwartz as the new in a party-line vote. Dr. Schwartz previously served as Deputy Surgeon General during President Donald J. Trump’s first term. This is significant as she replaced Susan Monarez, who was reportedly removed from her post due to an alleged disagreement with Secretary Kennedy Jr. over vaccines. 📺 FLASHBACK: There have been several major vaccine-related developments in recent weeks. In late July, Secretary Kennedy Jr. alleged that Dr. Anthony Fauci, the former Director of the National Institute of Allergy and Infectious Diseases (NIAID) and Chief Medical Advisor to former President Joe Biden, suffered an adverse event after receiving a COVID-19 vaccine in January 2021. “He got vaccinated… in January of [2021]. And then, five months later, he had… a pulmonary infarction, which is one of the adverse events that NIH, CDC, and FDA said are expected from the vaccine,” said Kennedy Jr. This was revealed roughly a week before the Senate Homeland Security Committee voted to hold Fauci in contempt of Congress after he invoked the Fifth Amendment 111 times, refusing to answer even questions about the color of his tie. |
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