The U.S. Food and Drug Administration (FDA) has approved Moderna’s mRNA-based respiratory syncytial virus (RSV) ‘vaccine’ for adults age 60 and older. “Moderna, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna,” Moderna announced in a press release. “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Moderna CEO Stéphane Bancel said. “mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19. With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases,” he added. FDA skips public hearing and quietly licenses new Moderna mRNA vaccine for RSV for adults. Pediatric studies are underway. https://t.co/Zn1EiXqnbw — Aaron Siri (@AaronSiriSG) June 3, 2024 “FDA Approves Moderna’s mRNA RSV Vaccine Without Any Long-Term Safety Data. The mRNA product was approved for public use without genotoxicity, oncogenicity, or long-term safety studies,” Vigilant News noted. FDA Approves Moderna’s mRNA RSV Vaccine Without Any Long-Term Safety Data The mRNA product was approved for public use without genotoxicity, oncogenicity, or long-term safety studies.https://t.co/tOSyeH19RG — Vigilant News (@VigilantNews) June 3, 2024 Per Moderna: The FDA’s approval of mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older in 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%). These results were published in The New England Journal of Medicine. A follow-up analysis of the primary endpoint was performed during FDA review, including cases that started before the primary analysis cut-off date but were not confirmed until afterward. The results were consistent with the primary analysis [VE 78.7% (CI 62.9%, 87.8%)] and were included in the U.S. package insert. An additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up. No serious safety concerns were identified in the Phase 3 trial. The most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia. Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season. Moderna has filed for mRNA-1345 approval with regulators in multiple markets around the world. “mRESVIA®is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines,” Moderna stated. Dr. Peter McCullough stated: Approval of Synthetic mRNA Product for Public Use with No Genotoxicity, Oncogenicity, or Long-Term Safety Studies The press release does not tell the public the absolute risk reduction for clinically significant outcomes was far below 1%, meaning this product will not have a significant clinical impact. Consumers should know that at the bare minimum, the following safety concerns exists for any pseudouridinated, synthetic mRNA product including mRESVIA(R): 1) Myocarditis because mRNA of all types targets the heart as shown by Krauson et al 2) Auto-immunity because of the generation of foreign RSV proteins and frameshifted peptides as shown by Boros et al 3) Genomic integration as shown by Alden et al 4) Oncogenicity as shown by Seneff et al BREAKING–Moderna Receives U.S. FDA Approval for mRNA RSV Vaccine mRESVIA(R) Approval of Synthetic mRNA Product for Public Use with No Genotoxicity, Oncogenicity, or Long-Term Safety Studies The press release does not tell the public the absolute risk reduction for clinically… pic.twitter.com/YSjfYDTsKB — Peter A. McCullough, MD, MPH® (@P_McCulloughMD) June 3, 2024 The Defender reports: The FDA approved the drug without input from the agency’s independent vaccine advisory committee, which typically makes recommendations about such drugs, because the FDA didn’t see any “concerns or controversial issues” that would make input necessary to the approval process, the agency said in its approval letter. Moderna is running at least 11 clinical trials for its new mRNA RSV drug on several other demographic groups, including young children, adolescents and healthy adults. The vaccine, marketed under the name mResvia, is Moderna’s second-ever FDA-approved drug. It uses the same mRNA platform as its COVID-19 Spikevax vaccine. “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Moderna CEO Stéphane Bancel. The Centers for Disease Control and Prevention (CDC) must recommend the drug before it can be used. The CDC’s advisory committee will discuss and vote on the vaccine at its meeting next month. If approved, the vaccine will provide a second revenue stream for Moderna, whose first-quarter sales fell 91% compared with same-quarter sales in 2023. The company said it expects to launch the vaccine in time for the 2024 fall vaccination season. The FDA’s approval of Moderna’s mRNA RSV vaccine comes a year after the agency approved GSK’s Arexvy and Pfizer’s Abrysvo RSV vaccines for the same age group.

He’s one of the most recognizable people in today’s world. Nearly every day, you see  Zelenskyy on television. With his distinctive green shirt and camo pants, he has become a regular on TV news, especially in America. But as famous and well-known as he is today, many analysts feel that his most critical days lie […] The post Who Is Volodymyr Zelenskyy? appeared first on www.independentsentinel.com.

The following excerpt is from Detrans: True Stories Escaping the Gender Ideology Cult, a new book authored by Daily Signal’s senior reporter Mary Margaret Olohan. The excerpt has been edited for brevity. Helena’s lonely late-night shifts working at the cookie shop were giving her plenty of time to think about the choices she had made. “In some ways, it was a bit maddening, but dispersed within the general neuroticism were moments of clarity,” she writes. “I remember deciding to take my chest binder off at work for the first time, because it was just me and one other worker who always sat in the back, and that f****** thing hurt. It felt so much more natural not to have anything constricting my chest underneath my work shirt.” And she started skipping testosterone injections, mostly because of how anxious they made her. At this point, she says, she was only injecting herself with testosterone once or twice a month. And as a result, the frequency of her “episodes” dramatically decreased. She started wondering what this meant. Why was she feeling better, not worse, when she took less “T”? And what if transitioning wasn’t, in fact, helping her mental health? That’s a forbidden question in transgender circles, she quickly found. “I remember browsing trans subreddits in hopes I would get some answers for what to do if transitioning wasn’t improving my mental health,” Helena said. “There were many posts asking this question, and by far the most common answer was to ‘just keep going’ and that one day, when you passed well enough, it would all be worth it.” Regnery/Skyhorse Publishing. Helena began questioning her life choices up to this point. All these things she had done thinking they would “save” her had not done anything of the sort. “The only thing I didn’t outright question was my choice to be transgender,” she writes. “That would require a more up-front reality check.” Helena started thinking about the comfortable clothing she used to wear before she started her transition process, back when she didn’t have to worry about whether or not her feminine clothes would make people doubt whether she was transgender. She thought about how much she hated the way she looked in men’s clothing (and “the way masculine styles looked on me in general”). “I also wished I ‘wasn’t trans,’ and even recall making a reddit post to this effect, lamenting how even though ‘being trans’ was making me miserable, I knew it was who I really was and after I got surgeries it would be right for me,” she wrote. “This kind of thinking, I now realize after talking to so many detransitioners, is common in the weeks or months leading up to detransition,” she shared. Helena’s “a-ha” moment happened in February of 2018. Her friend Jamie, a biological woman who also identified as transgender at the time and with whom Helena was then in a romantic relationship, made a video montage with pictures of Jamie and Helena showing the progression of their relationship since the day they had met — which was two days after Helena started testosterone. “As I watched the video, I saw the way my face changed from so young, hopeful, and most of all, recognizable, to weary, deadpan, and foreign,” Helena said. “I began to sob uncontrollably,” she recounts. “At first, Jamie thought I was crying because I loved the video so much, but I quickly informed her it was something else, but I wouldn’t say what. I cried, and cried, and cried. Every memory those photos evoked was flashing before my eyes, all the pain I knew was behind my eyes was emerging vividly. I saw innocence turn to anguish and I knew I had been on the wrong path for a long, long time. I didn’t know. I didn’t know it would be this way. I was just a kid,” she wrote. “How could I have been so stupid?” * * * Copyright © 2024 Mary Margaret Olohan. Excerpted by permission of Skyhorse Publishing Inc. Note: A portion of this article comes from Helena Kerschner’s Substack, “By Any Other Name,” prude posting, February 19, 2022, https://lacroicsz.substack.com/p/by-any-other-name. Mary Margaret Olohan is a senior reporter for The Daily Signal and the author of “Detrans: True Stories of Escaping the Gender Ideology Cult.” She previously reported for both The Daily Caller and The Daily Wire. The views expressed in this book excerpt are those of the author and do not necessarily represent those of The Daily Wire.