New COVID vaccine approved by US FDA: Here's all about it
"Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as 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 pharma maker has said in a press release.
COVID killed 47,000 Americans in 2024.
"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health.
by Taboola
by Taboola
Sponsored Links
Sponsored Links
Promoted Links
Promoted Links
You May Like
Buy Brass Idols - Handmade Brass Statues for Home & Gifting
Luxeartisanship
Buy Now
Undo
"
What is mNEXSPIKE?
mNEXSPIKE is a COVID-19 vaccine meant for folks who've already had a previous COVID shot. It's mainly for people aged 65 and older, or anyone between 12 and 64 who's at high risk of getting really sick from the virus. Just a heads-up though—like all vaccines, it's not a guaranteed shield for everyone, but it does offer an extra layer of protection for those who need it most.
"You should not get mNEXSPIKE if you hada severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), or any Moderna COVID-19 vaccine or to any ingredient in these vaccines," Moderna has warned. The side effects are trouble breathing, swelling of face and throat, fast heart beat, rashes, dizziness and weakness.
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.
One step to a healthier you—join Times Health+ Yoga and feel the change
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Indian Express
43 minutes ago
- Indian Express
US FDA approves blockbuster weight loss drug for severe fatty liver disease: What this means for you?
The US Food and Drug Administration (FDA) has approved the popular weight-loss drug semaglutide for the treatment of the liver condition called metabolic associated steatohepatitis (MASH) — previously referred to as non-alcoholic steatohepatitis. It is a more severe form of non-alcoholic fatty liver disease, where the fat deposition on the liver leads to inflammation and liver cell damage. The medicine was first approved in 2017 for the treatment of diabetes. It has since been approved for the treatment of obesity and associated cardiovascular diseases. The condition starts off as non-alcoholic, or as it is now known metabolic-associated, fatty liver disease. This fat build-up, over time, leads to inflammation and scarring of the liver, reducing the efficiency of the organ. Importantly, it can further progress to severe scarring called cirrhosis and then liver cancer. The challenge is that most people remain unaware of the condition in the initial stages. It is only when there has been significant damage to the organ that people experience symptoms such as abdominal pain, fatigue and weakness, loss of appetite, weight loss, and jaundice (yellowing of the eyes and skin caused by bilirubin buildup when the liver does not function properly). With obesity on the rise, there has been an increase in the incidence of MASH. For most people diagnosed to have fat accumulation in the liver, doctors suggest diet and exercise as a means of reducing body fat as well as the fat deposition in the abdomen and various organs, including the liver. Yet, it was only last year that the very first treatment for the condition was approved by the US FDA. Resmetirom, along with diet and exercise, was shown to resolve MASH and prevent worsening of the liver scarring. It works by activating a receptor that controls processes such as lipid metabolism, thereby reducing fat in the liver and its inflammation. Semaglutide, on the other hand, works by addressing underlying risk factors such as obesity, abdominal deposition of fat, diabetes, and insulin resistance. A phase III trial of 800 people — randomly prescribed semaglutide (534 participants) or placebo (266 participants) — showed that 63 per cent receiving the drug saw resolution of MASH and no worsening of the liver scarring as compared to 34 per cent receiving placebo. The interim trial data also shows that 37 per cent of the participants on semaglutide showed improvement in liver scarring and no worsening of MASH as compared to 22 per cent receiving placebo at 72 weeks after initiating treatment. 'The trial will continue for a total of 240 weeks to determine whether inflammation and scarring improvements seen after 72 weeks translate into decreases in death, liver transplant and other liver-related events,' the FDA said in a statement. It is estimated that anywhere between nine per cent and 32 per cent of the population in India is living with metabolic associated fatty liver disease — the beginning stage of MASH. A study published earlier this year showed more than 84 per cent of the IT sector employees in Hyderabad had increased liver fat accumulation, indicating MAFLD. The study — based on data from 345 IT employees — found that 76.5 per cent had high levels of bad cholesterol, 70.7 per cent were obese, and 20.9 per cent had higher than normal fasting blood glucose levels.
Time of India
43 minutes ago
- Time of India
VKTX stock tumbles 29% today — Viking Therapeutics weight-loss trial results fuel massive investor sell-off and market jitters
Viking Therapeutics stock plunged after the release of its Phase 2 trial data, as safety questions overshadowed promising efficacy company's oral obesity drug candidate, VK2735, delivered up to 12.2% weight loss over just 13 weeks, a result that easily cleared trial goals and initially looked like a breakthrough. But investor enthusiasm evaporated when details revealed a 28% discontinuation rate among patients—far higher than the placebo group. That raised red flags about tolerability and long-term use, sending Viking shares tumbling nearly 40% in pre-market trading and sparking sharp debate among analysts over the drug's commercial future. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like This Could Be the Best Time to Trade Gold in 5 Years IC Markets Learn More Undo A promising obesity drug meets market skepticism Viking Therapeutics (NASDAQ: VKTX) delivered headline-grabbing results from its Phase 2 VENTURE trial this week. The company's oral obesity drug candidate, VK2735, showed up to 12.2% average body weight reduction over 13 weeks , a figure that easily cleared both primary and secondary trial endpoints. ALSO READ: XRP crashes below $3 today: a critical juncture — buy now or wait for the next surge? here's what analysts say Live Events On paper, that kind of efficacy would typically excite investors. Instead, shares collapsed in early trading—dropping more than 37% pre-market —as attention shifted from efficacy to tolerability. Why Wall Street reacted so sharply The sticking point was the 28% discontinuation rate among patients on VK2735, compared with 18% on placebo. That gap immediately raised concerns over long-term adherence and whether side effects could undermine commercial viability. Investors, who had bid VKTX up more than 100% year-to-date, hit the sell button. By mid-morning, the stock traded near $29.80 , a steep fall from Monday's close of $42.09. While some bargain hunters re-entered during intraday swings, sentiment clearly shifted. Analysts split: efficacy strong, but tolerability divides opinion Research houses wasted no time weighing in. Mizuho analysts compared Viking's candidate to Eli Lilly's oral GLP-1 therapy , highlighting that VK2735's discontinuation rate was significantly higher—a potential red flag for prescribers. On the other hand, JPMorgan's Hardik Parikh struck a more balanced tone. He emphasized that at higher doses, patients lost 7.5–11% more weight than placebo , arguing that side effects appeared 'manageable' and not disqualifying. That divide between analyst camps underscores the central tension: does efficacy outweigh tolerability, or will safety worries cap enthusiasm until larger trials provide clarity? Technicals add another layer of complexity Just days before the data release, VKTX had been flashing strength. Its Relative Strength (RS) rating climbed from 61 to 82 in two sessions, placing it among the top-performing biotech names. However, the stock had already run far past its earlier $3.50 breakout level, leaving little cushion for bad news. For traders, that meant a sharp pullback was almost inevitable once sentiment turned. What this means for investors now For retail and institutional investors alike, the message is clear: volatility isn't going away. VKTX will likely trade in wide ranges as the market digests whether discontinuation rates can be reduced in Phase 3 trials or if formulation adjustments are needed. If you're a long-term believer in GLP-1 innovation: VK2735's efficacy profile is hard to ignore. Future trial designs may incorporate patient-selection strategies or titration protocols that improve tolerability. If you're trading short-term momentum: VKTX is extended beyond classic buy points and is now vulnerable to deeper pullbacks. A retracement toward moving averages or the formation of a 'three-weeks tight' pattern could offer cleaner entries. If you're cautious: wait for updated Phase 3 trial timelines, safety disclosures, or regulatory commentary before committing capital. Broader context: the GLP-1 arms race The weight-loss drug market, led by Novo Nordisk's Wegovy and Eli Lilly's Zepbound , is one of the most lucrative races in pharma. Viking's data puts it on the map as a legitimate contender, but execution will matter more than early efficacy headlines. Competitors have already set a high bar on both safety and commercial rollout, meaning any hint of tolerability weakness is magnified. FAQs: Q1: Why did Viking Therapeutics stock drop after its Phase 2 trial results? Because investors worried about the high 28% discontinuation rate despite strong weight-loss efficacy. Q2: Is Viking Therapeutics still a strong contender in the obesity drug market? Yes, its efficacy is strong, but tolerability concerns must be addressed in Phase 3 trials.
Indian Express
2 hours ago
- Indian Express
Amid monsoon, cases of malaria, chikungunya on rise in Mumbai; BMC advises caution
Mumbai has witnessed a significant increase in monsoon-related vector-borne diseases this year, with malaria and chikungunya cases rising sharply, according to the Brihanmumbai Municipal Corporation's (BMC) recent reports. The early onset of rains in May this year has contributed to favourable mosquito breeding conditions, driving the surge. The data indicates that between January and August 14, 2025, Mumbai recorded 4,825 malaria cases, up 20 per cent from 4,021 cases during the same period in 2024. Chikungunya cases increased by over 56 per cent, reaching 328 compared to 210 last year. Dengue cases, however, showed a decline from 1,979 to 1,564. Leptospirosis cases dropped significantly from 553 to 316, and gastroenteritis cases fell to 5,510 from 6,133. Hepatitis rose slightly to 703 from 662, while Covid-19 cases reduced to 1,109 from 1,775, the data shows. Listing the symptoms of each disease, Dr Rituja Ugalmugle, consultant (internal medicine) at Wockhardt Hospitals said malaria causes chills and body ache, while chikungunya brings joint pain lasting weeks. 'If you have a fever for over 24 hours with severe symptoms, get tested immediately at a hospital,' she added. 'Avoid anti-inflammatory drugs until your blood tests are clear. Use paracetamol and complete your treatment. Remove stagnant water, use mosquito nets and repellents, and wear protective clothing. Early testing and personal precautions are key to controlling the spread,' Dr Ugalmugle advised. BMC's July 2025 report showed a similar rise in cases. Malaria cases nearly doubled to 4,151 compared to 2,852 in July 2024. Dengue infections increased moderately to 1,160 from 966. Remarkably, chikungunya surged more than five fold, with 265 cases against just 46 the previous year. Hepatitis cases rose to 613 from 493, while leptospirosis and gastroenteritis showed slight declines to 244 and 5,182, respectively. Covid-19 cases decreased to 1,094 from 1,646. Between August 1 and 14 this year, the BMC intensified its public health measures. Surveys covered 4,78,283 houses and over 2.2 million residents. Contact tracing involved collecting 79,375 blood slides. Vector control work inspected 27,600 breeding sources, detecting 1,954 Anopheles and 9,890 Aedes mosquito breeding sites. As many as 30,655 discarded articles and tires were removed and fogging was conducted in 22,599 buildings and 341,275 huts. Extensive sensitisation efforts reached 1,015 housing societies and 1,321 private practitioners to improve reporting, diagnosis, and treatment. Additionally, 32 health camps and 2,816 workplace interventions were organised. The municipal body relaunched its 'Aapli Chikitsa Yojana,' providing accessible, affordable diagnostic tests to residents. 'BMC's surveillance and fogging are essential but insufficient without citizen participation. Source reduction at the home and society level is critical since a single water collection point can seed an outbreak,' Dr Ugalmugle said. The BMC advises citizens to eliminate stagnant water around their homes, avoid clutter where water accumulates, and use mosquito nets or repellents, especially while sleeping during the day and night. Residents are also urged to drink boiled water, avoid street food to prevent gastroenteritis and hepatitis, and seek prompt medical attention if fever develops, avoiding self-medication. While hospitalisations remain under control and mortality rates, including among pregnant women, are reportedly low, officials emphasise vigilance due to the severe joint pain associated with chikungunya and the overall impact of malaria on daily life.
