FDA expands approval of Moderna's RSV vaccine to some adults under age 60
The U.S. Food and Drug Administration expanded its approval of Moderna's respiratory syncytial virus (RSV) vaccine on Thursday to include adults under the age of 60 at increased risk of the disease.
Previously, the vaccine, known as mRESVIA, had been licensed for use for those aged 60 and older.
Approval for mRESVIA came after Moderna conducted a late-stage clinical trial showing the vaccine helped boost immune responses in younger adults.
MORE: Despite 'game-changing' new RSV shots, uptake lagged among infants, adults: Experts
More than one-third of adults between ages 18 and 59 have at least one underlying condition that puts them at increased risk of RSV, according to Moderna.
"RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," Stéphane Bancel, CEO of Moderna, said in a press release. "We appreciate the FDA's review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV."
Although the FDA approves vaccines and may expand approvals for certain age groups, the Centers for Disease Control and Prevention sets recommendations regarding who should get vaccines and when.
Currently, the CDC recommends RSV vaccination only for those aged 75 and older and for those aged 60 and over at increased risk.
The CDC's independent vaccine advisory committee will need to vote to recommend that the new age group be eligible for the shot, followed by a final recommendation from the director of the CDC.
Earlier this week, Kennedy removed all 17 sitting members of the committee and replaced them with eight new members. It remains unclear how the new members of the panel will decide to approach recommendations for the RSV vaccine.
MORE: Respiratory virus activity remains 'high' in US and will 'continue for several more weeks': CDC
As of Friday, the CDC director role remains vacant and Health and Human Services Secretary Robert F. Kennedy Jr. has been making final recommendations. In an April meeting, the prior advisory committee voted to recommend RSV vaccination for those aged 50 to 59 with increased risk of disease, but Kennedy did not adopt the recommendations.
Instead, it appears Kennedy plans to have the new committee re-discuss the recommendations for RSV vaccination as well as discuss HPV and COVID vaccinations in their meeting scheduled to be held between June 25 and June 27
Moderna's RSV vaccine is based on mRNA technology, which some of the new members have expressed skepticism about, especially in relation to COVID-19 vaccines.
Despite availability, RSV vaccination has been lagging. As of April 26, the latest date for which CDC data is available, an estimated 47.5% of adults aged 75 and older and 38.1% of adults aged 60 to 74 with a high-risk condition reported ever having received an RSV vaccine.
FDA expands approval of Moderna's RSV vaccine to some adults under age 60 originally appeared on abcnews.go.com
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
5 hours ago
- Yahoo
Perspective Therapeutics Commences Recruitment for [212Pb]VMT-α-NET in the Third Dose Escalation Cohort of its Ongoing Phase 1/2a Clinical Trial
[212Pb]VMT-α-NET Phase 1/2a study is advancing into Cohort 3 with a fixed administered dose that is up to 20% higher (6 mCi) than the dose administered to patients in Cohort 2 Dosimetry sub-study analysis presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting to advance utility of dosimetry in clinical development when considered with clinical data On track to submit further clinical updates to scientific congresses in 2H 2025, including longer safety follow-up on all patients who have received at least one treatment of [212Pb]VMT-α-NET and anti-tumor activities in patients dosed to date who have had the opportunity to receive at least one scan after their full treatment SEATTLE, June 21, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, today announced that alignment was reached with the U.S. Food and Drug Administration (FDA) to open the third dosing cohort (Cohort 3) of its ongoing Phase 1/2a clinical trial for [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies (RPT). "We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile. Meanwhile, we remain committed to engaging with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of our proprietary RPTs." Patients in Cohort 3 will receive up to four fixed administered doses of [212Pb]VMT-α-NET at 6 mCi every eight weeks if they weigh more than 60kg (133lb), or 100μCi/kg of body weight if they weigh less than or equal to 60kg. Observations of dose limiting toxicities (DLTs) in up to eight patients within 42 days of the first treatment cycle will be used to assess whether this cohort of patients have received maximum tolerated dose (MTD) or maximum feasible dose (MFD). Once a safety monitoring committee (SMC) has reviewed the data from these initial patients, it may recommend exploring alternative dosing and/or recruit more patients into Cohort 3. Perspective is notifying sites that Cohort 3 is now open for recruitment. Patients currently being evaluated for entry into the study will enroll into Cohort 3 if they qualify. Pending feedback from sites on operationalizing enrollment into Cohort 3, an update on pace of recruitment will be provided in due course. About [212Pb]VMT-α-NETPerspective designed [212Pb]VMT-α-NET to target and deliver 212Pb to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study ( identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received a prior RPT. Interim update with a data cut-off date of April 30, 2025 were reported in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2025. Cohort 2 was reopened in August 2024. During 2H 2025, some of the 33 additional patients enrolled after the cohort reopened and through April 30, 2025 will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to receive at least one scan after their full treatment (up to four doses every eight weeks), if they receive all four doses of treatment per protocol. About Perspective Therapeutics, Therapeutics, Inc. is a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity. The Company's melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. The Company is growing its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations. For more information, please visit the Company's website at Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include statements concerning, among other things, the Company's ability to pioneer advanced treatments for cancers throughout the body; the Company's belief that it is on track to submit further clinical updates to scientific congresses in 2H 2025 and the planned content of such updates; the Company's ability to explore a higher dose level of VMT-α-NET; the Company's commitment to engage with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of its proprietary RPTs; the Company's expectation that patients currently being evaluated for entry into its VMT-α-NET study will enroll into Cohort 3 if they qualify; the ability of the Company's proprietary technology utilizing the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties; the Company's prediction that the use of complementary imaging diagnostics that incorporate the same targeting moieties provides the opportunity to personalize treatment and optimize patient outcomes; the Company's belief that its "theranostic" approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company's ability to grow its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations; and other statements that are not historical fact. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC"), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Media and Investor Relations Contacts: Perspective Therapeutics IR:Annie J. Cheng, CFAir@ Russo Partners, LLCNic JohnsonPerspectiveIR@
Yahoo
7 hours ago
- Yahoo
Pandemic preparedness ‘dramatically eroding' under Trump, experts say
Amid controversial dismissals for independent advisers and staff at health agencies, alongside lackluster responses to the bird flu and measles outbreaks, experts fear the US is now in worse shape to respond to a pandemic than before 2020. H5N1, which has received less attention under the Trump administration than from Biden's team, is not the only influenza virus or even the only variant of bird flu with the potential to spark a pandemic. But a subpar response to the ongoing US outbreak signals a larger issue: America is not ready for whatever pathogen will sweep through next. 'We have not even remotely maintained the level of pandemic preparedness – which needed a lot of work, as we saw from the Covid pandemic,' said Angela Rasmussen, an American virologist at the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada. 'But now, we essentially have no pandemic preparedness.' Related: Bird flu reinfections at US poultry farms highlight need for vaccines, experts say 'I'm concerned on a number of fronts,' said Jennifer Nuzzo, professor of epidemiology and director of the Pandemic Center at Brown University School of Public Health. Those concerns include a lack of quality information from officials, weakened virus monitoring systems, and public health reductions at the federal, state and local levels. 'The thing that I am most concerned about is the veracity of information coming out of the health agencies,' Nuzzo said. In the ongoing outbreaks of measles, for example, Robert F Kennedy Jr, the secretary of health and human services, has downplayed the severity of the disease, spread misinformation about the highly effective vaccine to prevent measles, and pushed unproven treatments. 'The communications on measles gives me deep worries about what would happen in a pandemic,' Nuzzo said. 'If a pandemic were to occur today, the only thing we would have to protect ourselves on day one would be information.' The H5N1 outbreak has been plagued by incomplete information, an issue that began in the Biden administration but has amplified under Trump. In Arizona, 6 million chickens were killed or culled at a Hickman's Family Farms location because of H5N1 in May. That's about 95% of the company's hen population in the state. Hundreds of workers, including inmate laborers, are now being dismissed as Arizona braces for egg shortages. We're not testing – it's not that there are no new cases Angela Rasmussen Yet even as H5N1 outbreaks continue to spread on farms and wreak havoc on the food supply, no new bird flu cases have been reported in people for months. 'I am concerned that we may not be finding new infections in humans,' Nuzzo said – and a lack of testing may be the culprit. 'We're not testing – it's not that there are no new cases,' Rassmussen said. The last bird flu case in a person was listed by the US Centers for Disease Control and Prevention (CDC) on 23 February. At that point, at least 830 people in the US had been tested after contact with sick animals. This kind of testing – monitoring the health of people who regularly work with H5N1-infected animals – is how the vast majority of cases (64 out of 70) have been found in this outbreak. But then, several CDC officials overseeing the bird flu response were fired on 1 April. Since then, only about 50 people in the US have been tested after exposure to sick animals – and no positive cases have been announced. It's also been difficult to understand the extent of the outbreak and how the virus spreads among animals. 'We still just don't have a good picture of the scope and scale of this outbreak – we never really have. And until we have that, we're not going to be able to contain it,' Rasmussen said. 'It's extremely bad,' she continued. 'We don't have any information about what's happening right now. The next pandemic could be starting, and we just don't know where that's happening, and we don't have any ability to find out.' We're seeing health departments scrambling. That infrastructure is just dramatically eroding Jennifer Nuzzo Huge reductions in the public health workforce and resources has led to less monitoring of outbreaks, known as disease surveillance. 'Cutting back on that surveillance is leaving us more in the dark,' Nuzzo said. The CDC clawed back $11.4bn in Covid funding in March. This funding was used to monitor, test, vaccinate and otherwise respond to public health issues at the state, local, territorial and tribal level. 'We're seeing health departments scrambling,' Nuzzo said. 'That infrastructure is just dramatically eroding.' International monitoring programs to address outbreaks before they expand across borders have also been cancelled. 'We have taken for granted all of those protections, and I fear that we are poised to see the consequences,' Nuzzo said. Trump's crackdown on immigration also poses a major challenge in detecting cases and treating patients during outbreaks. 'A lot of the people who are most at risk are strongly disincentivized to report any cases, given that many of them are undocumented or are not US citizens,' Rasmussen said. 'Nobody wants to go get tested if they're going to end up in an Ice detention facility.' When cases are not detected, that means patients are not able to access care. Although it's rare for people to become sick with H5N1, for instance – the virus is still primarily an avian, not a human, influenza – this variant of bird flu has a 52% mortality rate globally among people with known infections. Allowing a deadly virus to spread and mutate under the radar has troubling implications for its ability to change into a human influenza without anyone knowing. And if such changes were detected, widening gaps in communication could be the next hurdle for preventing a pandemic, Nuzzo said. 'Communication is our most important public health intervention. People, in order to be able to know how to protect themselves, need to have access to facts, and they need to believe in the messengers. And the communication around the measles outbreaks are deeply eroding our standing with the American people.' Even stockpiled vaccines and other protective measures, like personal protective equipment, take time to distribute, Nuzzo added. 'And flu is a fast-moving disease that could cause a lot of damage in the months it would take to mount a vaccination campaign.' The US government's cancellation of its $766m contract with Moderna to research and develop an H5N1 vaccine also signals a concerning strategy from health officials, Nuzzo and Rasmussen said. Other restrictions on vaccine development, like a new plan to test all vaccines against saline placebos, is 'going to make it extremely difficult to approve any new vaccine' and would 'have a devastating impact on our ability to respond to a potential pandemic', Rasmussen said – especially in a rapidly moving pandemic where speed matters. 'You don't have time for that if this virus causes a human-to–human outbreak,' Rasmussen said. All of these policies mean the US is less prepared for a pandemic than it was in 2020, she said. And it also means there will be preventable suffering now, even before the next big one strikes. 'We are actively making people less safe, less healthy and more dead,' Rasmussen said.
Time Business News
9 hours ago
- Time Business News
Prozenith Reviews 2025: The Pink Salt Trick That's Melting Fat Fast!
Official Website: Click Here What is ProZenith? ProZenith is a natural dietary supplement formulated to support effective weight management and overall well-being. It is designed for individuals seeking to enhance their metabolism, increase energy levels, and support fat burning without the use of harsh chemicals or stimulants. By promoting the body's natural ability to burn fat and boost energy, ProZenith helps users achieve and maintain a healthier lifestyle. The supplement is manufactured in FDA-registered and GMP-certified facilities, ensuring its quality and safety. It also supports better mental clarity, digestive health, and immune function. With consistent use and alongside a balanced diet and exercise, ProZenith becomes a reliable ally for anyone on a weight loss or wellness journey. Its plant-based formula makes it a suitable option for those who prefer natural health solutions. Users often report improvements not only in physical performance but also in mood, focus, and daily motivation. The Science Behind ProZenith ProZenith operates on the scientific principle of metabolic enhancement. It helps the body enter a state where fat is used as the primary source of fuel rather than carbohydrates, a process similar to ketosis. This metabolic shift increases energy efficiency and encourages fat loss. Additionally, it supports hormonal balance and appetite regulation, helping reduce unnecessary cravings. This supplement promotes better nutrient absorption and reduces bloating, which further supports the weight loss process. By combining natural compounds known for their holistic benefits, ProZenith addresses various aspects of health to provide a science-backed, safe path to sustainable weight management. Ingredients of ProZenith The ingredients in ProZenith are carefully selected natural compounds known for supporting weight management, energy production, and overall wellness. Each component plays a unique role in promoting metabolism, enhancing fat burning, reducing inflammation, and supporting hormonal balance. Pumpkin Seed Pumpkin seed is renowned for its high antioxidant content and essential fatty acids, which work synergistically to support prostate and urinary health. These nutrients help regulate hormonal balance, reduce inflammation, and protect against oxidative stress. Regular consumption can lead to improved bladder control and decreased discomfort, enhancing daily comfort and urinary function. Lycopene Lycopene is a potent antioxidant primarily found in tomatoes, celebrated for its ability to neutralize harmful free radicals and prevent cellular damage. This compound contributes significantly to immune system support and reduces inflammation throughout the body. Its protective effects extend to promoting heart health and maintaining a healthy prostate, making it a vital nutrient for overall wellness. Broccoli Broccoli is a nutrient-dense vegetable rich in sulforaphane, a natural compound with powerful detoxifying and anti-inflammatory properties. Sulforaphane helps protect cells from damage, supports the body's detoxification pathways, and enhances immune defenses. Additionally, broccoli supports digestive health by improving gut function and reducing inflammation in the digestive tract. Beta Sitosterol Beta Sitosterol is a plant-derived sterol known for its ability to improve urinary flow and support prostate health. It helps maintain balanced cholesterol levels and promotes hormonal equilibrium, which is essential for men experiencing symptoms of an enlarged prostate. Beyond urinary benefits, Beta Sitosterol also supports cardiovascular health and overall well-being. Pygeum Africanum Bark Extracted from the African cherry tree, Pygeum Africanum Bark has a long history in traditional medicine for supporting urinary tract and prostate health. It helps reduce inflammation, ease discomfort during urination, and lessen the frequency of nighttime bathroom visits. Its anti-inflammatory and soothing properties contribute to improved urinary flow and enhanced quality of life. Benefits Accelerated Fat Burning: Helps your body shift into a fat-burning mode by enhancing metabolism, promoting sustainable weight loss. Helps your body shift into a fat-burning mode by enhancing metabolism, promoting sustainable weight loss. Appetite Control: Naturally reduces cravings and supports better portion control to help avoid overeating. Naturally reduces cravings and supports better portion control to help avoid overeating. Increased Energy Levels: Boosts energy without relying on stimulants, helping you stay active and alert throughout the day. Boosts energy without relying on stimulants, helping you stay active and alert throughout the day. Enhanced Mental Clarity: Supports cognitive functions like focus, memory, and motivation—key for staying consistent with health goals. Supports cognitive functions like focus, memory, and motivation—key for staying consistent with health goals. Improved Digestive Health: Aids gut function by reducing bloating and enhancing nutrient absorption for better overall health. Aids gut function by reducing bloating and enhancing nutrient absorption for better overall health. Immune System Support: Strengthens your body's natural defenses to keep you healthier while managing weight. Pros Natural formula Supports weight loss Boosts energy Enhances focus Improves mood Reduces cravings Promotes fat burning Aids digestion Non-GMO and stimulant-free Backed by a money-back guarantee Cons Only available online Not suitable for children Results may vary Requires consistent use How To Use? Take two ProZenith capsules daily with a glass of water, preferably before meals. For best results, follow a consistent routine and support it with a healthy diet and regular physical activity. This helps maximize the supplement's benefits and promotes long-term well-being. Any Side Effects? ProZenith has no side effects when taken as directed, thanks to its natural, non-GMO, plant-based ingredients. Users commonly report increased energy levels and enhanced metabolism without any discomfort or adverse reactions. Its gentle and carefully crafted formula is designed for daily use and is well-tolerated by most individuals. This makes ProZenith a safe and reliable option for those looking to support their health and weight management naturally, without the worry of unwanted side effects or harsh stimulants. Money Back Guarantee ProZenith comes with a 60-day money-back guarantee, giving you the confidence to try it risk-free. If within 60 days you feel the supplement doesn't meet your expectations or you're not satisfied with the results, you can easily request a full refund by contacting customer support. This generous refund policy ensures you have ample time to evaluate the product's effectiveness without any financial worry. With this guarantee, ProZenith offers a worry-free opportunity to invest in your health and well-being, making it a trustworthy choice for those seeking natural support. Pricing & Availability Basic Pack (2 Bottles): $158 + $9.99 Shipping Most Popular (3 Bottles): $207 with Free Shipping Best Value (6 Bottles): $294 with Free Shipping and the biggest savings Where to Buy? ProZenith can be purchased exclusively through its official website. This ensures you're getting the authentic product, complete with quality assurance, secure checkout, and eligibility for bonuses and money-back guarantees. Avoid third-party platforms that may sell counterfeit versions. Buying directly also gives you access to customer support and the latest promotional offers. For your safety and best experience, always purchase from the verified source. Conclusion As an expert, I strongly recommend ProZenith for anyone seeking a natural and effective solution to support weight management and overall wellness. This supplement uses powerful plant-based ingredients that work together to boost metabolism, increase energy, and promote fat burning without harsh chemicals or stimulants. It also enhances mental clarity and supports digestive health, making it ideal for daily use. With regular use, ProZenith helps achieve sustainable results while strengthening the immune system. Supported by positive customer reviews and a 60-day money-back guarantee, it offers a risk-free way to improve your health. If you want a reliable, natural boost to your wellness journey, ProZenith is definitely worth trying. >> (LIMITED SUPPLIES) Click Here to Buy ProstaVive for The Lowest Price Online << TIME BUSINESS NEWS
