RFK Ends COVID-19 Shot Recommendations For Healthy Kids, Pregnant Women
Robby Soave and Lindsey Granger discuss HHS Secretary RFK Jr. removing Covid-19 shots from recommended vaccines for healthy kids and pregnant women.
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Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals
The U.S. Food and Drug Administration (FDA) on Saturday approved Moderna, Inc.'s (NASDAQ:MRNA) mNexspike (mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). 'The FDA approval of our third product, mNEXSPIKE...,' said Stéphane Bancel, Chief Executive Officer of Moderna. The FDA's approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 trial, which enrolled approximately 11,400 participants aged 12 years and primary efficacy objective was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNexspike compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older. In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia. Moderna expects to have mNexspike available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the company's approved respiratory syncytial virus (RSV) vaccine. William Blair writes, 'Approval of mRNA-1283 is an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.'s negative public opinion on mRNA COVID-19 vaccines, and we continue to see autonomy and data-driven decisions at the FDA.' 'We do not see approval of mRNA-1283 as a massive boost to Moderna's COVID-19 vaccine sales, which we believe are primarily driven by sentiment surrounding the vaccination market in general, but this is a critical step in the regulatory path for the combo flu/COVID vaccine product, mRNA-1083, which uses mRNA-1283 as the COVID-19 component of its formulation,' analyst Myles Minter writes. Analyst Minter says Moderna is still facing challenges from new government policies, including losing about $700 million in funding from the Department of Health and Human Services for its bird flu vaccine project. In addition, William Blair writes that the company's goal to break even by 2028 is overly optimistic since it would need to more than double its revenue—based on cash costs—to reach that target. In May, the FDA approved Novavax, Inc.'s (NASDAQ:NVAX) Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, diabetes, obesity, smoking). Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi SA (NASDAQ:SNY). Price Action: MRNA stock is up 4.82% at $27.84 during the premarket session at the last check on Monday. Read Next:Photo by Wolfilser via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? MODERNA (MRNA): Free Stock Analysis Report This article Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
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Marjorie Taylor Greene slams FDA green lighting of mNEXSPIKE COVID-19 vaccine: 'Not MAHA at all!!!'
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SYNCADOL® Provides Consistent, Optimized Vitamin D Dosage
Research Continues to Reinforce the Importance of Consistent Vitamin D Intake for Immune Support. SYNEVIT®'s Vitamin D Supplement Addresses the Need. FORT LAUDERDALE, Fla., June 2, 2025 /PRNewswire/ -- Vitamin D is a critical nutrient that impacts countless areas of life. From bone and teeth support to muscle function, reducing inflammation, and regulating calcium absorption, it provides cross-functional bodily support. New research shows that vitamin D must come in consistent, optimized doses. SYNCADOL® is a vitamin D supplement built on SYNEVIT®'s belief that high-quality nutraceuticals with optimized formulas in the correct packaging can ensure that the body is getting the vitamin support it needs on a daily basis. Vitamin D deficiency is a worldwide concern. It is a health problem linked to a variety of issues, including musculoskeletal health and the prevention of extraskeletal diseases. Recent research filled a knowledge gap not just in the importance of vitamin D in these areas, but the critical nature of proper, consistent intake. The study, which was originally presented in a special Vitamin D-focused issue of the industry publication Nutrients, presented substantial scientific evidence that argued "for a daily vitamin D supplementation with 2000 international units (IU) (50 µg) of vitamin D3 to prevent and treat vitamin D deficiency." The information was supported by randomized control trials at scale and concluded, "A daily vitamin D supplementation with 2000 IU (50 µg) may be considered a simple, effective, and safe dosage to prevent and treat vitamin D deficiency in the adult general population." "Quantity is important in supplementation," said George Cvetkovski, founder and CEO of the nutraceutical brand SYNEVIT®. "You can't just take a lot of something and expect the right results." As an example, Cvetkovski references the COVID-19 pandemic. "People were taking 50g of zinc per day. You only need 15g. That's the recommended daily allowance." Excessive intake is wasteful in the best of circumstances and harmful in many cases. "We follow the rules because it's good for the patient," Cvetkovski continued." It's good for our customers. It's good for you, no matter who you are. That's why standards like RDA [Recommended Daily Allowance] exist." The company's vitamin D supplement, SYNCADOL®, is a natural solution for consistent vitamin D supplementation to address a deficiency. It is optimized at every level, starting with a consistent 2,000 IU dosage taken daily after breakfast. This is provided in pharmaceutical-grade blister packaging, as well, ensuring quality and slowing oxidation. Each box provides 30 softgel capsules, making it possible to maintain a consistent, clean source of vitamin D that can boost immunity, support bone health, increase calcium absorption, and more. About SYNEVIT®Launched in 1998 by CEO George Cvetkovski, SYNEVIT® traces its roots to North Macedonia (ex: Yugoslavia). The brand is currently headquartered out of North Macedonia with offices in Serbia and Rochester, New York. SYNEVIT® is an in-house brand of vitamins and minerals with unique, perpetually improved formulas informed by on-staff doctors and pharmacists and designed for therapeutic effect in patients. Learn more at Media Contact:George Cvetkovski395993@ (02) 3225 843 View original content: SOURCE Synevit Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
