Moderna has halted its mRNA respiratory syncytial virus (RSV) vaccine trial for young children due to safety concerns. “A briefing document from the Food and Drug Administration (FDA) says that enrollment for all clinical studies of vaccines for respiratory syncytial virus (RSV) in infants is on hold over concerns about potential safety findings from a clinical trial involving two vaccine candidates,” the Center for Infectious Disease Research and Policy (CIDRAP) stated. According to the document, a phase I trial of two experimental Moderna RSV vaccines for infants aged five to eight months was paused in July. Reports stated five infants were hospitalized due to severe or very severe respiratory complications after receiving the experimental vaccine. “The observed imbalance in severe/very severe cases of RSV LRTI in the mRNA-1345 and mRNA-1365 vaccine development program among 5-month to <8-month-old recipients of mRNA-1345 (15 μg) and mRNA-1365 (15 μg) has uncertain implications for the ongoing and future pediatric development of other non-live attenuated RSV vaccines,” the FDA said, according to CIDRAP. MODERNA HALTS pediatric RSV trial after "at least five cases of severe or very severe RSV lower respiratory tract infections in infants immunized with Moderna’s investigational RNA vaccines." pic.twitter.com/EgVzeiqqtD — JaxenReport (@JaxenReport) December 11, 2024 Fortune reports: The document notes that a phase 1 trial of two experimental Moderna RSV vaccines in infants aged five to eight months was paused in July. The pause came after five cases of severe to very severe lower RSV respiratory tract infections were reported among the 40 babies who received the vaccine dose, compared with just one case in the placebo group of 20. Five infants required hospitalization, with one needing mechanical ventilation. It all “has uncertain implications for the ongoing and future pediatric development of other non-live attenuated [inactivated] RSV vaccines,” said the FDA, which put a hold on the trial after the July incident. You probably haven't read about this on the mainstream media… Moderna has been forced to pause trials of their new mRNA injection after five infants were hospitalized. Not safe and not effective.https://t.co/v24K95euhQ — PeterSweden (@PeterSweden7) December 17, 2024 According to Fierce Pharma, an FDA advisory panel expressed frustration about its inability to conclude the safety and effectiveness of the experimental shots. The simple conclusion should be that it is NOT SAFE AND NOT EFFECTIVE. Per Fierce Pharma: The halt was triggered by an “imbalance,” the FDA said, in cases of severe lower respiratory tract infections (LRTIs) in children in a phase 1 trial of two Moderna RSV vaccines. One of the shots, mRNA-1345, was approved by the FDA in May of this year and is dubbed mRESVIA. In that phase 1 trial—which was conducted in Panama and included infants as young as 5 months—five children developed severe LRTIs, with four going to the hospital. The trial had been opened up to younger children after there were no safety issues involving kids ages 8 to 23 months who had received one of the vaccines. There is some concern that the shots can cause or worsen the disease in the younger age group. No vote was taken during Thursday’s meeting to recommend regulatory action. The goal of the VRBPAC discussion was to inform future testing. After hearing presentations from Moderna on its trial findings and from the FDA, the advisory committee members generally agreed that RSV shots for infants should be examined on a “vaccine platform-by-vaccine platform basis,” according to Arnold Monto, M.D., an epidemiology professor at the University of Michigan. “The clinical trial for Moderna’s mRNA shot for RSV in children found ‘Severe illness was 26.3% in the vaccine groups compared with 8.3% in the placebo.’ Talk about “the more you inject, the more you infect!'” The Blaze Senior Editor Daniel Horowitz wrote. The clinical trial for Moderna's mRNA shot for RSV in children found “Severe illness was 26.3% in the vaccine groups compared with 8.3% in the placebo.” Talk about “the more you inject, the more you infect”! My latest @theblaze https://t.co/Z3OkzO1Af6 — Daniel Horowitz (@RMConservative) December 17, 2024 “The @US_FDA disclosed this week in a briefing document that rather than protecting babies as anticipated, the vaccine likely caused higher rates of severe RSV illness among the vaccinated babies enrolled in the Phase 1 clinical trials,” Children’s Health Defense noted. “FDA is trying to cover itself, to avoid claims of negligence. It should have anticipated VAERD, because it happened before in RSV trials — and killed babies — and because it is happening now with the COVID vaccines, which, after roughly 6 months, depending on age and dose, make the recipient more likely to get COVID,” Dr. Meryl Nass said, according to the outlet. Moderna Shuts Down mRNA RSV Vaccine Trial in Babies After Shots Linked to Severe Side Effects, FDA Document Reveals The @US_FDA disclosed this week in a briefing document that rather than protecting babies as anticipated, the vaccine likely caused higher rates of severe RSV… pic.twitter.com/2K82DStw7p — Children’s Health Defense (@ChildrensHD) December 12, 2024 From CIDRAP: Moderna was made aware of the safety signal and paused further enrollment on July 17 and notified the FDA of the study-wide pause on July 19, according to the document. The FDA then put a clinical hold on the trial. On September 12, Moderna announced that the RSV program for seronegative children—those without detectable RSV antibodies—younger than 2 years old was listed under discontinued programs. The trial also found that vaccine immune responses in infants who received mRNA-1345 and had previously been exposed to the monoclonal antibody nirsevimab were blunted compared with those who had not received nirsevimab, suggesting a possible interaction. Marketed under the brand name mRESVIA, mRNA-1345 was approved by the FDA in May for use in adults aged 60 and older. It’s one of three RSV vaccines that have been licensed for adults and pregnant women within the past 2 years. Moderna is conducting a phase 1 trial of mRNA-1365 as combination vaccine for RSV and human metapneumovirus. Read the FDA briefing document HERE.

Days ago, Putin warned that NATO crossed their red line, suggesting that NATO nations are fair game. He talked about the fear-mongering against Russia. Then, after the speech, they murdered Lt. Gen. Kirillov. Who murdered him? Ukraine with the backing of NATO and the CIA, who have been behind this since at least 2014. The […] The post A Most Serious Escalation: Forcing Trump Into War appeared first on www.independentsentinel.com.

The transgender-identifying teenager who voices a character in Disney’s new animated series, “Win or Lose,” is upset that the studio cut out a trans storyline from the show. The Pixar series, which will air its first episode on February 19, follows a co-ed middle school softball team preparing for its big championship game. Initially, the series was slated to include a story arc about a player identifying as transgender, but Disney removed those references, a rep confirmed to The Hollywood Reporter. “When it comes to animated content for a younger audience, we recognize that many parents would prefer to discuss certain subjects with their children on their own terms and timeline,” the Disney spokesperson said in a statement.  The outlet noted that the character will still appear in the show, but the lines about gender identity have been removed. Now, the voiceover artist who is voicing that character is speaking out.  Chanel Stewart learned about the role while scrolling social media and seeing a casting call for a “14-year-old transgender girl” to voice the part, per Deadline.  “I was exactly what they wanted to a T, and that’s why it felt so right. It felt just so right,” Stewart told the outlet. “I immediately asked my mom if I could do it, because I just felt like if I don’t do this, it wouldn’t make sense. You know what I mean?” CHECK OUT THE DAILY WIRE HOLIDAY GIFT GUIDE “Oh my God, it was crazy,” Stewart, now 18, said of landing the role. “I wore it as a badge. I wore it with pride. I wore it with honor because it meant so much to me. The thought of authentically portraying a transgender teenage girl made me really happy. I wanted to make this for transgender kids like me.” Stewart’s mom, Keisha, told Deadline that the call from Disney about the storyline being cut was “upsetting.” “It was upsetting because my daughter is transgender and this is her life. I felt like it was very important that we not hide that fact,” she told the outlet. “There may be some parents out there who are not ready to have that conversation, but this is the world that we live in and everyone should be represented,” she went on. “Everyone deserves to be recognized. And it felt like it was just another setback for the LGBTQ community, because it’s very hard on transgender teenagers … transgender people, period. Especially when you’re young and you’re trying to figure out how to navigate this world that you live in and be able to grow into your own person.” “I was very disheartened,” Stewart agreed. “From the moment I got the script, I was excited to share my journey to help empower other trans youth. I knew this would be a very important conversation. Trans stories matter, and they deserve to be heard.” “It’s just that my character would now be a cis girl, a straight cis girl,” Stewart continued. “So yeah, that’s all they really told me and that I was still a part of the show.” “I’m definitely one of the first [transgender girls] to do this!” the teen said. “It’s a true honor to be a part of queer history.” Disney films that include LGBT storylines, such as “Onward” and “Lightyear,” have not performed well with audiences and have inspired negative attention from parents who feel the themes are not appropriate for younger audiences.

Decorating with festive decor is half the fun of the holiday season. And sure, you could simply go out and buy ornaments that are already made, but have you ever considered making some of your own? A teacher, who goes by Wallen online, has the perfect “hack” to do just that. In fact, this year, she helped her students with the process. Now, she’s sharing it with the rest of us, too! To get started on this DIY ornament, you will need a plastic cup. More specifically, you will need one that is non-toxic. Wallen says cups that are non-toxic will be marked with the number six on them, likely marked at the bottom. Next, it’s time to use permanent marker to decorate the cups. Finally, it’s time to bake these ornaments-to-be. Okay, so maybe bake isn’t the most accurate word… but you’ll see what I mean in the video below! @wallen327 Cup ornaments #christmas #december #teachersoftiktok #momsoftiktok #sundayfunday ♬ Christmas Music Background – HitsLab By warming the cups up in an oven, they shrink down to the size of an ornament. From here, Wallen says she uses a hole punch to create the perfect opening for a ribbon or hook to hang the ornament from. Needless to say, the folks in her comment section are endlessly fascinated by this hack — and they have lots of questions.  This Creative Teacher’s DIY Christmas Ornament Will Blow You Away @wallen327 Replying to @PoodlePawCreations ♬ original sound – wallen Luckily, Wallen answered many of these questions in the video above. If you do plan on giving this DIY a shot, we highly recommend you watch the video. And, of course, please be careful whenever a project involves plastic and an oven. “Make sure the cups have ridges or it doesn’t work as well (I learned that last year),” Wallen adds in a comment on her video. “Oven at 350° and as soon as they are flat, take out to cool.” You can find the source of this story’s featured image here! The post Teacher Shares Unique DIY Ornament “Hack” With Her Students appeared first on InspireMore.

Our ocean is full of all sorts of interesting creatures. Sure, there are some we’d prefer to stay far, far away from us, but discovering them is still oh-so cool! And while quite a few discoveries have been made lately, this latest by the Schmidt Ocean Institute has folks especially in awe. This odd underwater animal, a new species, was found in the Pacific Ocean at the junction of three tectonic plates. Although this creature is still new to us, there are some things we do know about it. For example, it is a polychaete. This is a class of marine worms that is characterized by their bristle-like body parts. It’s these very parts that have people calling this sea worm a “forbidden toilet scrubber” and “two eyelashes put together.” See one of them for yourself in the video below! @dailymail A never-before-seen creature has been spotted while researchers from the Schmidt Ocean Institute used an underwater robot to scour the seabed. The animal is a polychaete – a class of marine worms, more widely known as bristle worms. ‘To describe this polychaete, one simply must use jazz hands — it is the only way to capture this deep-sea worm’s dazzle!’ the experts said in a post about the polychaete. Footage of the creature has garnered huge interest, with some dubbing the animal a ‘forbidden toilet scrubber’, while another joked: ‘It looks like two eyelashes put together.’ #science #seacreatures #news #worms #ocean ♬ Inspirational – neozilla “To describe this polychaete, one simply must use jazz hands — it is the only way to capture this deep-sea worm’s dazzle!” the institute writes in a social media post, adding that, “polychaetes play a vital role throughout our global Ocean…” For example, polychaetes help create more carbon dioxide. How? By eating organic debris found on the ocean floor. This carbon dioxide is then taken up by plankton which, through photosynthesis, convert carbon dioxide into food, releasing oxygen into the water and atmosphere.  This Odd New Species of Underwater Worm is Both Fascinating and a Little Unsettling    It doesn’t come as much of a surprise that a fascinating creature like this was found at its location. Turns out, the junction of tectonic plates is a spot where many underwater animals love to gather. In other words, there’s no telling what will be discovered next! “The confluence of tectonic forces and terrestrial influences makes this margin a natural laboratory for investigating chemosynthetic and deep-sea environments that host animals like this [queue jazz hands] shimmering deep-sea worm,” the institute explains. You can find the source of this story’s featured image here! The post Researchers Capture Footage Of New Species During Deep Sea Dive appeared first on InspireMore.

Kash Patel Wants The FBI Out Of The Spying Game -- Here's Where He Could Start

A viral video shared on X purports to show Luigi Mangione, the 26-year-old Maryland native accused of killing UnitedHealthcare CEO Brian Thompson, skateboarding. ?BREAKING? Cultural Touchstone Luigi Mangione stuns in newly discovered footage displaying his incredible skateboarding skills! #LuigiCrave #LuigiMangione pic.twitter.com/eXsQrRVYaz — Luigi Mangione Updates (@LuigiCrave) December 16, 2024 Verdict: False The claim is false. […]