FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 vaccine as a post-approval commitment, a source familiar with the matter told CNN.
The terms need to be negotiated before Novavax's vaccine could be granted full approval, the source said, declining to be named because they weren't authorized to speak on behalf of the FDA.
Novavax had anticipated full approval of its vaccine by April 1, but the FDA delayed the decision because it sought more data, a source told CNN at the time.
'We can confirm we have responded to the FDA's Post Marketing Commitment (PMC) request and are awaiting feedback from the agency,' Novavax said in a statement Friday. 'PMCs are not unusual with many approved drugs / biologics having at least one PMC or requirement. We continue to believe that our application is approvable, and we look forward to our continued engagement with the FDA about their request for a PMC and to moving to approval as soon as possible.'
A spokesperson for the US Department of Health and Human Services, the FDA's parent agency, said Friday that it 'remains committed to our promise: ensuring products are safe for the American people and grounded in gold-standard science.'
The Novavax Covid-19 vaccine, which uses more traditional protein-based technology than the newer mRNA vaccines from Pfizer/BioNTech and Moderna, has been subject to emergency use authorization since 2022. But with FDA action, it would be the third vaccine against Covid-19 to receive full FDA approval, which could provide additional reassurance to people seeking the shot.
The missed deadline came at the same time the FDA named Dr. Scott Steele acting director of the Center for Biologics Evaluation and Research, which oversees vaccine regulation, days after former director Dr. Peter Marks was forced out. In his resignation letter, Marks cited 'efforts being advanced by some on the adverse health effects of vaccination' that he called 'concerning.'
HHS Secretary Robert F. Kennedy Jr., a longtime anti-vaccine advocate, has falsely called vaccines for Covid-19 'the deadliest vaccine ever made' and more recently made misleading statements about the safety of the measles vaccine amid a deadly outbreak centered in West Texas.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
41 minutes ago
- Yahoo
In letter, more than 300 scientists rebuke Trump research cuts, NIH director
June 9 (UPI) -- Hundreds of scientists via the National Institute of Health signed a published letter in protest to NIH leadership and recent cuts by the Trump administration. "We are compelled to speak up when our leadership prioritizes political moment over human safety and faithful stewardship of public resources," more than 300 scientists wrote Monday to NIH Director Jay Bhattacharya in a so-called "Bethesda Declaration" published by Stand Up For Science in rebuke to Trump administration research funding cuts and staff layoffs. They added in the letter to U.S. Health and Human Services Secretary Robert F. Kennedy Jr. and members of Congress overseeing NIH that they "dissent" to Trump's policies that "undermine" the NIH mission, "waste" public resources and harm "the health of Americans and people across the globe." In the open letter, they said the current endeavor to "Make America Healthy Again" referred to "some undefined time in the past." "Keeping NIH at the forefront of biomedical research requires our stalwart commitment to continuous improvement," the letter's writers said, adding that the life-and-death nature of NIH work "demands that changes be thoughtful and vetted." According to the letter, the Trump administration terminated at least 2,100 NIH research grants since January, totaling around $9.5 billion and contracts representing some $2.6 billion in new research. "We urge you as NIH Director to restore grants delayed or terminated for political reasons so that life-saving science can continue," the letter added in part. "This undercuts long-standing NIH policies designed to maximize return on investment by working with grantees to address concerns and complete studies," it said. It further accused the White House of creating a "culture of fear and suppression" among NIH researchers. Bhattacharya, a Stanford University professor and health researcher, called the agency the "crown jewel of American biomedical sciences" and said he had the "utmost respect" for its scientists and mission during his confirmation hearing in March. On Tuesday, Bhattacharya is scheduled to testify before the Senate's Appropriations Committee on Trump's 2026 NIH budget proposal which seeks to cut roughly 40% of NIH's $48 billion budget. "This spending slowdown reflects a failure of your legal duty to use congressionally-appropriated funds for critical NIH research," the scientists penned to Bhattacharya. The letter goes on to characterize it as "dissent" from Trump administration policy, quoting Bhattacharya during his confirmation as saying "dissent is the very essence of science." "Standing up in this way is a risk, but I am much more worried about the risks of not speaking up," says Jenna Norton, a program officer at the NIH's National Institute of Diabetes and Digestive and Kidney Diseases. "If we don't speak up, we allow continued harm to research participants and public health in America and across the globe," Norton said in a statement, adding that if others don't speak up, "we allow our government to curtail free speech, a fundamental American value."
Yahoo
41 minutes ago
- Yahoo
Dr. Pepper Is Being Recalled Right Now—Here's What to Know
Over 19,000 cases of Dr. Pepper Zero Sugar are being recalled. This is because select cans of the 'zero sugar' product may contain sugar. The recalled soda was sold in three an ongoing recall on Dr. Pepper products, according to the Food & Drug Administration. This is due to mislabeling for their zero-sugar soda. The products impacted by this recall are Dr. Pepper Zero Sugar aluminum cans sold in 12- and 24-packs. Approximately 19,203 cases were affected and were sold at retail locations in Florida, Georgia and South Carolina. The recalled cases contain a production code of 'XXXXRS05165' and best-by date of February 16, 2026, printed on the packaging. Although the soda is labeled to be 'zero sugar,' the cans may contain the full-sugar product, thus the recall. The FDA just classified this recall as a Class II, meaning that the recalled product could cause 'temporary health consequences' if consumed. Check your Dr. Pepper Zero Sugar, and if it contains the recall information, dispose of it or return it to your place of purchase for a potential refund. For questions about this recall, call 1-888-INFO-FDA (1-888-463-6332). Read the original article on EATINGWELL
Yahoo
an hour ago
- Yahoo
Zacks Industry Outlook Penumbra, Integer and AngioDynamics
Chicago, IL – June 9, 2025 – Today, Zacks Equity Research discusses Penumbra PEN, Integer Holdings ITGR and AngioDynamics ANGO. Link: Over the past year, advancements in artificial intelligence (AI) and predictive analytics have rapidly revolutionized the Medical Instruments industry, driving innovation in diagnostics, patient monitoring and personalized treatment. AI-powered devices now process large datasets in real time, delivering accurate predictions and actionable insights. Predictive analytics supports early disease detection, risk assessment, maintenance optimization, and cost reduction. According to a January 2025 report, genAI is already generating synthetic medical images, simulating disease progression, and accelerating drug discovery. However, it also introduces new regulatory challenges around safety, transparency, and data integrity. In response, the FDA is implementing a Total Product Lifecycle (TPLC) oversight model with a risk-based approach and enhanced post-market monitoring. Going by data, global AI in the healthcare market is projected to witness a CAGR of 38.5% from 2024 to 2030. However, a deteriorating geopolitical situation, tariffs and supply chain bottlenecks, resulting in a tough situation related to raw material and labor costs, freight charges, as well as healthcare staffing shortages, have put the industry in a tight spot again. Meanwhile, industry players like Penumbra, Integer Holdings and AngioDynamics have adapted well to changing consumer preferences and have been witnessing an uptrend in their stock prices. The Zacks Medical - Instruments industry is highly fragmented, with participants engaged in research and development (R&D) in therapeutic areas. This FDA-regulated sector encompasses a vast array of products, from transcatheter valves and orthopedic devices to advanced imaging equipment and robotics. Recent trends highlight the integration of AI in diagnostics, the expansion of telemedicine, the rise of robotic-assisted surgeries, and developments in 3D printing, continuous glucose monitoring systems, gene editing, and nanomedicine. The emergence of generative AI is also reshaping MedTech, prompting the FDA to adopt a TPLC regulatory approach. Over the past couple of years, there has been a significant increase in the adoption of genAI within the medical instruments space, with "hyper-personalization" being the primary feature of genAI-driven treatment options. Added to this, genAI is rapidly paving the way for efficient operational management within the industry. GenAI, while analyzing vast and complex genetic and molecular data, is expected to help healthcare reach new heights in terms of predictive treatment options and smart hospital systems. A December 2024 report says that global genAI in the healthcare market was valued at $1.8 billion in 2023 and is expected to witness a CAGR of 33.2% from 2024 to 2032. Rapid advancement in deep learning and natural language processing, increasing demand for personalized treatment, growing investment in healthcare AI and rising healthcare data volumes are the major growth factors. This apart, the application of AI in the diagnostics space is growing enormously with the market expected to witness a CAGR of 24.6% by 2034. : The medical instruments space has been benefiting from the ongoing merger and acquisition (M&A) trend. It is a known fact that smaller and mid-sized industry players attempt to compete with the big shots through consolidation. The big players attempt to enter new markets through a niche product. Going by a J.P. Morgan report of 2025, in 2024, MedTech acquisition activity exceeded the previous two years in both deal count and total announced value. A total of 305 M&A transactions were announced, totaling over $63.1 billion for companies in medical devices, diagnostics, therapeutic digital health and commercial research tools, up from 134 deals in 2023. In 2025 so far, notable examples of M&A include Stryker's $4.9 billion acquisition of Inari Medical to expand its peripheral thrombectomy portfolio, Thermo Fisher's $4.1 billion purchase of Solventum's Purification & Filtration business, and Boston Scientific's $664 million acquisition of Bolt Medical to strengthen its position in intravascular lithotripsy solutions. : Per IMF's April 2025 World Economic Outlook, global growth is expected to remain lackluster over the next couple of years. At 2.8% in 2025 and 3.0% in 2026, the forecasts for growth are below the historical (2000–19) average of 3.7%. A few countries, especially low-income developing countries, have seen sizable downside growth revisions, often as a result of increased conflicts and recent tariff shocks. The good news is that global headline inflation is expected to decline to 4.3% in 2025 and to 3.6% in 2026, with advanced economies reaching the targets sooner than emerging market and developing economies. However, the IMF apprehends that the current policy-generated disruptions to the ongoing disinflation process could interrupt the pivot to easing monetary policy, with implications for fiscal sustainability and financial stability. Further, there are chances of higher nominal wage growth, which in some cases reflects the catch-up of real wages, accompanied by weak productivity, which could make it difficult for firms to moderate price increases, especially when profit margins are already squeezed. The Zacks Medical Instruments industry's Zacks Industry Rank, which is basically the average of the Zacks Rank of all the member stocks, indicates gloomy near-term prospects. The industry, housed within the broader Zacks Medical sector, currently carries a Zacks Industry Rank #131, which places it in the bottom 46% of 244 Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. We will present a few stocks that have the potential to outperform the market based on a strong earnings outlook. But it's worth taking a look at the industry's shareholder returns and current valuation first. The industry has underperformed the Zacks S&P 500 composite but outperformed the sector in the past year. The industry has declined 12.7% compared with the broader sector's decline of 14.7%. The S&P 500 has surged 12.8% in a year. On the basis of the forward 12-month price-to-earnings (P/E), which is commonly used for valuing medical stocks, the industry is currently trading at 29.04X compared with the broader industry's 19.18X and the S&P 500's 21.83X. Over the past five years, the industry has traded as high as 40.60X, as low as 25.62X and at the median of 32.52X. Integer Holdings: Plano, TX-based Integer Holdings is a medical device contract development and manufacturing organization. Its strategic focus on portfolio optimization, including the divestiture of its Non-Medical business, supports its long-term inorganic growth plans. Integer Holdings has established a solid position in the MedTech industry and continues to invest in research and product development, which bodes well for innovation and future revenue growth. The Zacks Consensus Estimate for this Zacks Rank #1 (Strong Buy) company's 2025 sales is pegged at $1.87 billion, indicating a 7.7% rise from 2024. The consensus mark for Integer Holdings' 2025 EPS is pegged at $6.33, indicating an increase of 19.4% from 2024. AngioDynamics: Headquartered in Latham, NY, AngioDynamics' solid prospects with NanoKnife and an increased focus on cancer treatment markets are encouraging. The company boasts a robust product pipeline and strong momentum in geographic expansion. Continued strong sales of Auryon, AlphaVac, and NanoKnife products further strengthen AngioDynamics' outlook. The consensus estimate for this Zacks Rank #1 company's fiscal 2026 sales is pegged at $305 million, indicating a 6.3% rise from fiscal 2025. The consensus mark for AngioDynamics' fiscal 2026 EPS is pegged at a loss of 24 cents, indicating an improvement of 14.9% from the year-ago period figure. Penumbra: Alameda, CA-based Penumbra's consistent revenue growth momentum is being driven by strong patient outcomes with Lightning Flash 2.0, Lightning Bolt 7 and RED 72. The company's vascular and neuro businesses are showing encouraging growth trends. Penumbra's Immersive Healthcare business too is making progress. The Zacks Consensus Estimate for Penumbra's 2025 sales is pegged at $1.35 billion, indicating a 13.4% rise from 2024. The consensus mark for Penumbra's 2025 EPS is pegged at $3.72, indicating an improvement of 67.6% from the year-ago period figure. Penumbra has a Zacks Rank #2 (Buy) currently. You can see the complete list of today's Zacks #1 Rank stocks here. Why Haven't You Looked at Zacks' Top Stocks? Since 2000, our top stock-picking strategies have blown away the S&P's +7.7% average gain per year. Amazingly, they soared with average gains of +48.4%, +50.2% and +56.7% per year. Today you can access their live picks without cost or obligation. See Stocks Free >> Join us on Facebook: Zacks Investment Research is under common control with affiliated entities (including a broker-dealer and an investment adviser), which may engage in transactions involving the foregoing securities for the clients of such affiliates. Media Contact Zacks Investment Research 800-767-3771 ext. 9339 support@ Past performance is no guarantee of future results. Inherent in any investment is the potential for loss. This material is being provided for informational purposes only and nothing herein constitutes investment, legal, accounting or tax advice, or a recommendation to buy, sell or hold a security. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. It should not be assumed that any investments in securities, companies, sectors or markets identified and described were or will be profitable. All information is current as of the date of herein and is subject to change without notice. Any views or opinions expressed may not reflect those of the firm as a whole. Zacks Investment Research does not engage in investment banking, market making or asset management activities of any securities. These returns are from hypothetical portfolios consisting of stocks with Zacks Rank = 1 that were rebalanced monthly with zero transaction costs. These are not the returns of actual portfolios of stocks. The S&P 500 is an unmanaged index. Visit for information about the performance numbers displayed in this press release. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report AngioDynamics, Inc. (ANGO) : Free Stock Analysis Report Penumbra, Inc. (PEN) : Free Stock Analysis Report Integer Holdings Corporation (ITGR) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Sign in to access your portfolio
