Albert Einstein College of Medicine, Inc.

Public Domain Writing in separate editorials in two leading medical journals, former chiefs of federal scientific agencies issued warnings about the changes being proposed to vaccine frameworks by current officials. More than a dozen former FDA and CDC officials warned of potential changes to federal vaccine policy in dual editorials published in two prominent medical journals on Wednesday. The warnings come as the final 2025 meeting of the CDC’s Advisory Committee on Immunization Practices gets underway, where a number of changes, including to the birth dose of the hepatitis B vaccine, are set to be debated. In an editorial in the New England Journal of Medicine published Wednesday, a dozen former FDA commissioners wrote that they are “deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most.” Led by former commissioners Robert Califf and Janet Woodcock, the officials warned that proposed changes in a memo sent by Center for Biologics and Evaluation Research chief Vinay Prasad would “upend” in a “unilateral” manner longstanding policies around vaccine development and updates. Among a series of changes, Prasad’s memo, according to the writers, “rejects” the FDA’s use of immunobridging studies, which serve as “a reliable correlation with effectiveness” for well-understood vaccines with existing safety data, particularly for viruses that mutate frequently, like COVID-19 and influenza, and need seasonally updated vaccines. Epidemiologists use immunobridging studies to compare updated vaccines to previous iterations, using immunological markers like neutralizing antibody titers to infer effectiveness. Also on Wednesday, three infectious disease specialists and epidemiologists, led by former CDC chief Rochelle Walensky, published an editorial in the Journal of the American Medical Association , warning of the risks of changing the CDC’s policies around birth dose hepatitis B vaccination, the topic of the first day of ACIP’s December meeting. In their JAMA piece, the authors, including Michael Abers, an infectious disease doctor at the Albert Einstein College of Medicine in New York and Angela Ulrich, an epidemiologist at the University of Minnesota, estimated the number of perinatal infections that occur under the revised guidelines. Pushing the birth dose of hepatitis B, given to newborn infants, to one month post-birth would immediately increase hepatitis cases 8%, according to an analysis done by the authors. Further restricting the birth dose only to infants born to mothers testing positive for hepatitis B—another potential change under discussion at ACIP—would raise perinatal cases by 63%-76%. While the authors said that they “applaud” revisiting routine vaccine recommendations as new data emerges, they warned that “delaying the first hepatitis B vaccine dose beyond the newborn period introduces risks that have lifelong detrimental consequences and no measurable health benefit.”

LONG ISLAND, NY, UNITED STATES, December 2, 2025 / EINPresswire.com / -- Dr. Jeremy M. Liff , one of the region's most extensively trained neurovascular specialists, is making it easier for patients across Long Island and New York City to access advanced, catheter-based treatments for brain aneurysms, carotid artery disease, and other complex vascular conditions of the brain and spine. Dr. Liff holds a rare triple board certification in Neurology, Vascular Neurology, and Endovascular Neurosurgery. That means he's trained not just to diagnose neurovascular conditions, but to treat them using some of the most sophisticated minimally invasive techniques available today. He works with patients facing unruptured and ruptured brain aneurysms, carotid stenosis, chronic subdural hematomas, arteriovenous malformations, intracranial stenosis, and a range of other conditions affecting blood flow to and within the brain. His approach is interventional and image guided. Using real-time imaging and tiny catheters threaded through blood vessels, Dr. Liff can seal off aneurysms before they rupture, open blocked carotid and intracranial arteries, treat bleeding in the brain, and address vascular malformations without traditional open surgery. The procedures he performs include aneurysm coiling and stenting, carotid artery stenting for stenosis, intracranial angioplasty and stenting, and mechanical thrombectomy when needed. He also specializes in middle meningeal artery embolization for patients with chronic subdural hematomas, embolization for vascular tumors and AVMs, venous sinus stenting for pulsatile tinnitus and intracranial hypertension, and treatment for severe epistaxis (nosebleeds) that won't stop. Beyond neurovascular care, Dr. Liff treats patients with complex spine conditions through lumbar epidural injections and myelography, and administers intrathecal chemotherapy for cancers affecting the central nervous system. He performs these procedures at three respected hospitals: St. Francis Hospital in Roslyn, NYU Langone Hospital Long Island in Mineola, and Lenox Hill Hospital in Manhattan. Dr. Liff' s training began at Johns Hopkins University, where he studied Cognitive Science, and continued at SUNY Upstate Medical University, where he earned his medical degree. He completed his neurology residency at Albert Einstein College of Medicine and Montefiore Medical Center, serving as Chief Resident. From there, he pursued fellowship training in Vascular Neurology at Mt. Sinai Hospital and Endovascular Neurosurgery at NYU Langone Medical Center. His research has been presented at the American Academy of Neurology and at the LINNC Conference in Paris, and his work has appeared in journals like Clinical Neurology and Neurosurgery and the Journal of ECT. He's a senior member of the Society of Neurointerventional Surgery. A Long Island native, Dr. Liff has built his practice around a simple principle: patients shouldn't have to travel far for specialized neurovascular care. "My goal is to make sure patients on Long Island and in New York City have access to advanced, minimally invasive treatment options for conditions like aneurysms, carotid disease, and other vascular problems affecting the brain," he said. In addition to aneurysms and carotid disease, Dr. Liff treats patients with intracranial artery stenosis, venous outflow problems like pulsatile tinnitus and intracranial hypertension, arteriovenous malformations, chronic subdural hematomas, lumbar spine disease, and sciatica. Patients can schedule an appointment at Dr. Liff's office at 2200 Northern Boulevard, Suite 207, Greenvale, NY 11548. The office can be reached at 516-612-9409 or 516-466-1029, or by email at jliff@intneuro.org. Media Contact: Ryan McCormick Goldman McCormick PR +1 516-901-1103 email us here Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

An under-the-radar Wuhan-based biotech startup says that its gene therapy for an inherited form of vision loss has generated early but promising results in a handful of patients. The startup, Zhongmou Therapeutics, has attracted little public notice in the West and appears to have raised only a fraction of what is typical for Western companies working on gene therapies. But in a small trial of people with retinitis pigmentosa who were legally blind, the company said that seven of nine patients treated with the injected gene therapy showed a clinically meaningful improvement in vision. The participants were able to better navigate a simple maze, and some even experienced improved ability to see colors — something the company believes its therapy may be the first to do. The one-year results were shared exclusively with Endpoints News and have not been published or presented previously. Retinitis pigmentosa can be caused by hundreds of mutations in dozens of genes, the majority of which are incredibly rare. Luxturna, a gene therapy sold by Roche, treats one narrow form of the ailment by replacing a broken gene. But Zhongmou is using an experimental approach known as optogenetics to develop a universal therapy that could help anyone with the condition, which causes the breakdown of the eye’s light-sensing cells. “We really focused on how we can find good tools, put them in the retina, and then with just one shot of AAV, it can bring the light,” Zhongmou founder and CEO Yin Shen told Endpoints News in an interview. In a video, the company showed Endpoints, one patient in the trial who was unable to walk through a simple maze before treatment was able to swiftly navigate it four weeks after treatment, even at much dimmer light. (The maze was rearranged to prevent memorization). Another video showed a patient riding her bicycle in the evening, something she couldn’t do before. Zhongmou was founded in 2019 by Shen, who is director of the Eye Institute of Wuhan University. Shen has studied retinal diseases for more than 20 years, including a stint in the US at the Albert Einstein College of Medicine in New York and then at Stanford, before moving back to China in 2011. The company kept a low profile until this year, when it began presenting early glimpses from its investigator-initiated study at ophthalmology and gene therapy conferences in the US. In July, it announced new financing “worth tens of millions” of Chinese Yuan. (¥10 million is roughly $1.4 million.) But it wouldn’t specify how much it has raised or where the money came from. Alvin Luk, who previously served as head of clinical research and operations at Luxturna developer Spark Therapeutics, chairs Zhongmou’s scientific advisory board. Zhongmou’s emergence comes during a year of record dealmaking between Western pharma companies and Chinese biotechs. While many of the deals center on crowded, well-understood drug targets, Zhongmou falls into a small but growing set of Chinese companies working on cutting-edge cell and gene therapies that, in some cases, are pulling ahead of elite US competitors. Zhenghong Gao, the startup’s chief strategy officer, told Endpoints the company is in talks with bigger drugmakers to help develop the therapy in the US. It’s also working with Stanford to start a Phase 1/2 trial in the US next year. When Luxturna was approved by the FDA in 2017, eye doctors hoped it would spur the development of many more gene therapies for other forms of the disease. But progress has been slow, and sales of Luxturna have been uninspiring. Luxturna replaces a single broken gene, RPE65, that impairs the eye’s photoreceptors. But Zhongmou, instead of working through the long list of mutations linked to blindness, is one of a handful of companies taking a broader approach. While the photoreceptors are responsible for seeing light, two other kinds of cells downstream of them process the signals and transmit them to the brain. Zhongmou’s therapy essentially rewires that visual circuitry by giving those other cells the ability to sense light themselves. To pull off that trick, the company uses an AAV gene therapy to deliver instructions for a light-sensitive protein called channelrhodopsin, derived from a marine alga. The approach, broadly known as optogenetics, was first developed two decades ago, but making the proteins sensitive and fast enough to be useful for restoring vision has been difficult. Zhongmou believes that it has solved that problem with a new channelrhodopsin engineered in Shen’s lab . In mice, the protein restored the electrical signal from eye to brain , and now it appears to work in humans too. Zhongmou believes its approach could partly restore vision in all forms of advanced retinitis pigmentosa and even in advanced AMD, where photoreceptors have died. “We can cure all those photoreceptor degeneration diseases. Not only RPE65, but all the mutations,” Shen said. Zhongmou tested its treatment, called ZM-02, in an investigator-initiated trial. Those IIT trials, which have become common in China, are overseen by a research hospital rather than national drug regulators and can quickly speed experimental therapies through the first steps of human research. The company recruited 12 patients with advanced retinal degeneration caused by mutations in a number of different genes. Two patients got a low dose injected into one eye, seven patients got a high dose, and three got a sham injection. According to data the company shared with Endpoints, all nine treated patients had some improvement in vision, and seven had clinically significant improvement in their vision, measured on a scale known as best-corrected visual acuity, or BCVA. On average, patients who received the gene therapy improved by around 30 letters on an eye chart. Patients in the placebo group didn’t improve. Remarkably, Zhongmou also said that patients went from seeing in almost entirely grayscale to being able to perceive colors. Their perception of those colors was far from perfect and it was based on the company’s own custom-made test, but Gao said he believes that this result may be unique among gene therapies. Zhongmou has submitted its clinical data to a medical journal, Shen said. There were no serious adverse events or dose-limiting toxicities, according to the presentation, but some patients had mild transient inflammation that cleared up with topical medication. Zhongmou will face competition from other companies developing one-size-fits-all approaches, including Nanoscope Therapeutics, which has already asked the FDA to approve its optogenetics gene therapy. In Nanoscope’s pivotal study of its treatment, seven of 18 patients experienced clinically significant improvement in BCVA. In addition, two other companies, Ocugen and SparingVision, are working on their own gene therapies. Bayer subsidiary BlueRock Therapeutics treated its first patient with a stem-cell-derived therapy this summer. And the San Francisco-based Science Corporation has developed a tiny electronic implant that mimics photoreceptors. The approach restored the ability to read in some people with advanced AMD.