Congresswoman Marjorie Taylor Greene criticized the FDA’s approval of Moderna’s new lower-dose COVID-19 vaccine, mNEXSPIKE, deeming it inconsistent with Robert F. Kennedy Jr.’s “Make America Healthy Again” initiative. The vaccine, approved for high-risk individuals aged 12 and older, follows a Phase 3 clinical trial and aims to combat ongoing COVID-19 threats. This announcement comes amidst shifting CDC guidance on COVID-19 vaccination for pregnant women and healthy children, a change welcomed by Kennedy Jr. Moderna’s CEO lauded the approval as adding a crucial tool in protecting vulnerable populations.
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The FDA has granted full approval to the Novavax COVID-19 vaccine, but with significant limitations. Access will be restricted to individuals aged 12 and older with pre-existing conditions putting them at high risk of severe COVID-19. This decision, impacting healthy adults and raising concerns about future variant protection, has drawn criticism for potentially reflecting the influence of vaccine skepticism within the administration. The restricted availability contrasts with the full approval granted to Pfizer-BioNTech and Moderna vaccines in 2022.
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The FDA has approved Teal Health’s Teal Wand, the first at-home alternative to the Pap smear in the U.S. This self-collection device uses a swab to gather a vaginal sample for HPV testing, mailed to a lab for analysis. Clinical trials demonstrated the at-home method’s efficacy and overwhelming preference among women, potentially increasing screening rates and reducing cervical cancer diagnoses. Available by prescription starting next month in California, the device aims to improve access to crucial preventative care.
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The FDA approved Novo Nordisk’s Ozempic to treat chronic kidney disease in patients with Type 2 diabetes, expanding its use beyond diabetes management. This approval allows Ozempic to reduce the risk of kidney disease progression, kidney failure, and cardiovascular death in this patient population. A late-stage trial demonstrated Ozempic significantly reduced severe kidney outcomes by 24%, slowed kidney function decline, and lowered cardiovascular event risk. The approval highlights the broader health benefits of GLP-1 drugs, impacting treatment for comorbid conditions frequently found together.
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John Q. Hosedrinker