FDA cancels meeting to update next season's flu vaccines
The Food and Drug Administration unexpectedly canceled an annual meeting of its advisers to update next season's influenza vaccines, an adviser on the panel and multiple officials confirm to CBS News, potentially upending the process to start manufacturing next winter's flu shots.
"We're all left trying to understand what is going on. Why was this meeting canceled? It's an important meeting. What's the plan for flu vaccines this year," Dr. Paul Offit, a member of the FDA advisory committee and director of the Vaccine Education Center at Children's Hospital of Philadelphia, told CBS News.
Offit said he received the notification that the meeting was canceled shortly after 4 p.m. The FDA's Vaccines and Related Biological Products Advisory Committee was supposed to meet on March 13 to discuss how to update the shots for the next flu season, Offit said.
One former and one current federal health official also confirmed that the committee's upcoming meeting had been canceled without explanation.
An FDA spokesperson did not immediately respond to a request for comment.
The companies that manufacture influenza vaccines rely on the FDA each year to pick out the strains to use in shots made for the American market. The specific strains are chosen each year based on predictions of what flu variants will be circulating in the coming winter.
That selection is usually done by the committee in early March, drawing in large part on findings from a meeting of the World Health Organization's advisers reviewing data on influenza from across the Northern Hemisphere.
"Because the vaccine is grown in eggs, for the most part, it requires six months to produce. So March is six months before September, which is when these vaccines roll out," said Offit.
Last year, the FDA asked the committee to meet on March 5 to decide on how to update the influenza shots for the 2024 to 2025 season.
The agency usually announces these meeting dates around a month in advance. Next month's meeting had not yet been publicly disclosed.
Even if the meeting is eventually scheduled for later this year, a delay could affect availability of shots at the beginning of flu season.
"This delay will really put manufacturers behind. It takes time to optimize updated vaccine virus strain production. They need as much time as possible before the upcoming fall vaccine season," a former federal health official told CBS News.
Which strains are picked to be targeted by the vaccines can have a significant impact on how effective the shots are.
Early data from the Centers for Disease Control and Prevention's testing suggests that this past season's vaccine may have been a poor match for one of the common strains of the virus. More data on the effectiveness of the vaccine is expected to be released Thursday.
The cancellation is just the latest federal vaccine meeting to be disrupted.
A quarterly meeting of the CDC's Advisory Committee on Immunization Practices was unexpectedly postponed earlier this month, citing the need "to accommodate public comment in advance of the meeting."
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Atlantic
33 minutes ago
- Atlantic
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By formalizing their objections and signing their names to them, officials told me, they hope that Bhattacharya will finally feel compelled to respond. (To add to the public pressure, Jeremy Berg, who led the NIH's National Institute of General Medical Sciences until 2011, is also organizing a public letter of support for the Bethesda Declaration, in partnership with Stand Up for Science, which has organized rallies in support of research.) Scientists elsewhere at HHS, which oversees the NIH, have become unusually public in defying political leadership, too. Last month, after Health Secretary Robert F. Kennedy Jr.—in a bizarre departure from precedent—announced on social media that he was sidestepping his own agency, the CDC, and purging COVID shots from the childhood-immunization schedule, CDC officials chose to retain the vaccines in their recommendations, under the condition of shared decision making with a health-care provider. 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42 minutes ago
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Journey Medical Corporation Announces Emrosi™ Featured on 'The Balancing Act' Airing on Lifetime TV
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EMROSI may induce hyperpigmentation in many organs, including nails, bone, skin, eyes, thyroid, visceral tissue, oral cavity, sclerae and heart valves. Because of the potential for drug-resistant bacteria to develop during the use of EMROSI, use EMROSI only as indicated. If superinfection occurs, discontinue EMROSI and institute appropriate therapy. Perform periodic laboratory evaluations of organ systems, including hematopoietic, renal and hepatic studies. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088 For full prescribing information, please visit About The Balancing ActThe Balancing Act® is a morning show created and produced by BrandStar that offers sensible solutions and essential information in a fun, entertaining format; providing resources to help people do life better. The Balancing Act features everything from delicious recipes, style makeovers and dream getaways to parenting tips and the latest news in health and wealth. Tune in to The Balancing Act weekdays at 7:30 a.m. (ET/PT) on Lifetime® and find all previously aired episodes on About Journey Medical CorporationJourney Medical Corporation (Nasdaq: DERM) ('Journey Medical') is a commercial-stage pharmaceutical company that primarily focuses on the selling and marketing of FDA-approved prescription pharmaceutical products for the treatment of dermatological conditions through its efficient sales and marketing model. The Company currently markets eight FDA approved prescription drugs that help treat and heal common skin conditions. The Journey Medical team comprises industry experts with extensive experience in developing and commercializing some of dermatology's most successful prescription brands. Journey Medical is located in Scottsdale, Arizona and was founded by Fortress Biotech, Inc. (Nasdaq: FBIO). Journey Medical's common stock is registered under the Securities Exchange Act of 1934, as amended, and it files periodic reports with the U.S. Securities and Exchange Commission ('SEC'). For additional information about Journey Medical, visit Forward-Looking StatementsThis press release may contain 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. As used below and throughout this press release, the words 'the Company', 'we', 'us' and 'our' may refer to Journey Medical. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. The words 'anticipate,' 'believe,' 'estimate,' 'may,' 'expect,' 'will,' 'could,' 'project,' 'intend,' 'potential' and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include: the fact that our products and product candidates are subject to time and cost intensive regulation and clinical testing and as a result, may never be successfully developed or commercialized; a substantial portion of our sales derive from products that may become subject to third-party generic competition, the introduction of new competitor products, or an increase in market share of existing competitor products, any of which could have a significant adverse impact on our operating income; we operate in a heavily regulated industry, and we cannot predict the impact that any future legislation or administrative or executive action may have on our operations; our revenue is dependent mainly upon sales of our dermatology products and any setback relating to the sale of such products could impair our operating results; competition could limit our products' commercial opportunity and profitability, including competition from manufacturers of generic versions of our products; the risk that our products do not achieve broad market acceptance, including by government and third-party payors; our reliance third parties for several aspects of our operations; our dependence on our ability to identify, develop, and acquire or in-license products and integrate them into our operations, at which we may be unsuccessful; the dependence of the success of our business, including our ability to finance our company and generate additional revenue, on the successful commercialization of our recently approved product, EmrosiTM, and any future product candidates that we may develop, in-license or acquire; clinical drug development is very expensive, time consuming, and uncertain and our clinical trials may fail to adequately demonstrate the safety and efficacy of our current or any future product candidates; our competitors could develop and commercialize products similar or identical to ours; risks related to the protection of our intellectual property and our potential inability to maintain sufficient patent protection for our technology and products; our business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our or our third parties' cybersecurity; the substantial doubt about our ability to continue as a going concern; the effects of major public health issues, epidemics or pandemics on our product revenues and any future clinical trials; our potential need to raise additional capital; Fortress controls a voting majority of our common stock, which could be detrimental to our other shareholders; as well as other risks described in Part I, Item 1A, 'Risk Factors,' in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Reports on Form 10-Q, and our other filings we make with the SEC. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Company Contact:Jaclyn Jaffe (781) 652-4500ir@ Media Relations Contact:Tony Plohoros6 Degrees(908) 591-2839tplohoros@ in to access your portfolio
Fast Company
an hour ago
- Fast Company
Salmonella outbreak: Recalled eggs sold at Walmart, Safeway, and elsewhere sicken people in 7 states
A significant recall of 1.7 million dozen eggs is underway. The eggs were believed to be the source of a salmonella outbreak that has sickened dozens of people across seven states and so far led to 21 people being hospitalized. They were distributed to several major retailers, including Walmart and Safeway. Here's what you need to know about the recall and outbreak. Shell eggs recalled due to salmonella fears On June 6, the August Egg Company of Hilmar, California, issued a voluntary recall of 1.7 million dozen eggs produced at its facilities. The company initiated the recall after it discovered that the eggs are feared to have been contaminated with salmonella, a potentially deadly bacterium. On the same day, the U.S. Food and Drug Administration (FDA) published August Egg Company's recall notice on its website, while the U.S. Centers for Disease Control and Prevention (CDC) announced an investigation into a multistate outbreak of salmonella linked to eggs. Dozens sickened and hospitalized across 7 states The CDC's investigation has found that eggs produced by August Egg Company are linked to dozens of cases of people becoming ill after consuming them. The agency's latest data shows that there are so far 79 cases linked to the August Egg Company's recalled products. Of those cases, 21 have resulted in hospitalizations. Thankfully, no deaths have been reported so far. The cases are spread across seven states: Arizona, California, Kentucky, Nebraska, New Jersey, Nevada, and Washington. Of those states, California has the most number of cases, at 63, followed by Washington and Nevada, with four cases each. Arizona has had three cases, Nebraska and New Jersey two cases, and Kentucky has one. However, many people who become sick with salmonella see their symptoms resolve without contacting a health professional, so the actual number of cases could be higher. When and where were the eggs distributed? According to the notice posted on the FDA's website, the recalled eggs were distributed between February and May. The retail locations that received the eggs include: Walmart Save Mart FoodMaxx Lucky Smart & Final Safeway Raleys Food 4 Less Ralphs The eggs were distributed between February 3 and May 15, 2025, to Save Mart, FoodMaxx, Lucky, Smart & Final, Safeway, Raleys, Food 4 Less, and Ralphs locations in California and Nevada. Those eggs had sell-by dates ranging from March 4 to June 4, 2025. The eggs were also distributed between February 3 through May 6, 2025, to Walmart stores in California, Washington, Nevada, Arizona, Wyoming, New Mexico, Nebraska, Indiana, and Illinois. Those eggs had sell-by dates ranging from March 4 to June 19, 2025. What eggs are included in the recall? Over two dozen egg products packaged under multiple brands are included in the recall. The recall notice states that the eggs were packaged in fiber or plastic cartons and have a plant code number P-6562 or CA5330 with the Julian Dates between 32 to 126. Photographs of the cartons can be found here. The item names of the egg products included in the recall, along with their plant number and carton UPC are: Item Name Plant Number Carton UPC Clover Organic Large Brown 12 eggs P-6562 or CA-5330 070852010427 First Street Cage Free Large Brown Loose 1 case=150 eggs P-6562 or CA-5330 041512039638 Nulaid Medium Brown Cage Free 12 eggs P-6562 or CA-5330 071230021042 Nulaid Jumbo Brown Cage Free 12 eggs P-6562 or CA-5330 071230021011 O Organics Cage Free Large Brown 6 eggs P-6562 or CA-5330 079893401522 O Organics Large Brown 12 eggs P-6562 or CA-5330 079893401508 O Organics Large Brown 18 eggs P-6562 or CA-5330 079893401546 Marketside Organic Large Cage Free Brown 12 eggs P-6562 or CA-5330 681131122771 Marketside Organic Large Cage Free Brown 18 eggs P-6562 or CA-5330 681131122801 Marketside Large Cage Free Brown 12 eggs P-6562 or CA-5330 681131122764 Marketside Large Cage Free Brown 18 eggs P-6562 or CA-5330 681131122795 Raley's Large Cage Free Brown 12 eggs P-6562 or CA-5330 046567033310 Raley's Large Cage Free Brown 18 eggs P-6562 or CA-5330 046567040325 Raley's Organic Large Cage Free Brown 12 eggs P-6562 or CA-5330 046567028798 Raley's Organic Large Cage Free Brown 18 eggs P-6562 or CA-5330 046567040295 Simple Truth Medium Brown Cage Free 18 eggs P-6562 or CA-5330 011110099327 Simple Truth Large Brown Cage Free 18 eggs P-6562 or CA-5330 011110873743 Sun Harvest Organic Cage Free Large Brown 12 eggs P-6562 or CA-5330 041512131950 Sun Harvest Organic Cage Free Large Brown 18 eggs P-6562 or CA-5330 041512145162 Sunnyside Large Brown Cage Free 12 eggs P-6562 or CA-5330 717544211747 Sunnyside Large Brown Cage Free 18 eggs P-6562 or CA-5330 717544211754 Sunnyside Organic Cage Free Large Brown 12 eggs P-6562 or CA-5330 717544201441 Sunnyside Organic Cage Free Large Brown 18 eggs P-6562 or CA-5330 717544211761 Loose Small Brown Cage Free-1 box= 6 flats (1 flat= 30 eggs) P-6562 or CA-5330 NA Loose Medium Brown Cage Free -1 box= 6 flats (1 flat= 30 eggs) P-6562 or CA-5330 NA Loose Medium Brown Organic -1 box= 6 flats (1 flat= 30 eggs) P-6562 or CA-5330 NA Loose Large Brown Organic-1 box= 6 flats (1 flat= 30 eggs) P-6562 or CA-5330 NA Loose Jumbo Brown Cage Free -1 box=5 flats(1 flat=20 eggs) P-6562 or CA-5330 NA Loose Jumbo Brown Organic -1 box=5 flats(1 flat=20 eggs) P-6562 or CA-5330 NA What is Salmonella? Salmonella is a potentially deadly bacterium that is usually contracted after eating contaminated foods. The CDC says that typical symptoms of a salmonella infection include diarrhea, fever, and stomach cramps, which typically present between six hours and six days after exposure to the bacteria. Typical salmonella infections last between four and seven days, and most people recover without treatment. However, salmonella infections can also cause severe illness in individuals, especially those who are younger than five, older than 65, or have weakened immune systems. What should I do if I have the recalled eggs? According to the CDC, if you have the recalled eggs in your possession, you should not consume them. Instead, you should throw the eggs out or return them to their place of purchase for a refund. You should also sanitize all surfaces that may have come into contact with the eggs.
