
CDC's Covid shot shift for pregnant women slammed
With help from Ruth Reader
Driving The Day
COVID VAX PUSHBACK — The Trump administration's decision to pull the Covid-19 vaccine from the CDC's list of recommended shots for healthy pregnant women was immediately questioned by public health groups that say the immunization is a critical tool to protect mothers and newborn infants.
HHS Secretary Robert F. Kennedy Jr. also said the CDC would no longer recommend the shots for healthy children — a position that drew less criticism — but opened questions about whether access to the shots could erode.
'We're now one step closer to realizing President Trump's promise to make America healthy again,' Kennedy said in a video posted on social platform X, standing beside FDA Commissioner Marty Makary and NIH Director Jay Bhattacharya.
It also bucks the recommendations of several European countries, ranging from Denmark to France, and the World Health Organization.
Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, said the group is concerned and extremely disappointed by the decision. He pointed to data showing that newborns can benefit from maternal antibodies from the vaccine for protection from Covid.
'In fact, growing evidence shows just how much vaccination during pregnancy protects the infant after birth, with the vast majority of hospitalized infants less than 6 months of age — those who are not yet eligible for vaccination — born to unvaccinated mothers,' Fleischman said.
The Society for Maternal-Fetal Medicine said it will continue to recommend that pregnant patients take the Covid vaccine because surveillance data 'clearly demonstrates the safety and efficacy of mRNA vaccines in pregnancy.'
'Maternal immunization is proven to protect patients and their infants against severe illness and death from infectious diseases,' the group, a medical professional society for obstetricians, said in a press release.
Insurance companies typically align their coverage decisions with the recommendations from the CDC and its outside panel of vaccine advisers. But the Advisory Committee on Immunization Practices did not vote on the change announced by Kennedy on Monday.
AHIP spokesperson Tina Stow said the insurer trade group is 'reviewing today's announcement closely' when asked whether any insurers it represents plan to alter coverage of the Covid vaccine.
On Capitol Hill, the decision was also questioned by a top Democrat.
'This reckless decision by the Trump Admin will make it harder for people to access the vaccine, but not impossible or illegal,' Rep. Frank Pallone (D-N.J.), ranking member of the Energy and Commerce Committee, posted on X. 'Please talk to your doctor and health care providers about your options.'
IT'S WEDNESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Do you have insight into how the decision to alter the CDC's vaccination schedule was made?
Send your tips to David Lim (dlim@politico.com, @davidalim or davidalim.49 on Signal) and Lauren Gardner (lgardner@politico.com, @Gardner_LM or gardnerlm.01 on Signal).
Eye on the FDA
MAKARY LAUNCHES PHARMA TOUR — The Trump administration hasn't endeared itself to the pharmaceutical industry — but FDA Commissioner Marty Makary and other top agency officials are kicking off a national tour to meet with drugmaker executives next week at the agency's headquarters.
The series of meetings will be held in major biotech cities across the U.S. — think Boston, New York, San Diego and San Francisco — in the coming weeks.
The goal? Meeting with the executives to get input on 'how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.'
The FDA is collecting registrations from firms with at least one investigational new drug, new drug application or a biologics license application actively on file.
Makary is bringing his number two, FDA Principal Deputy Commissioner Sara Brenner, and top vaccine regulator Vinay Prasad to the meetings.
AI ON THE MIND — The FDA has brought on Dr. Shantanu Nundy, former chief medical officer for care navigator Accolade Health, to lead its artificial intelligence policy work, Ruth reports.
Nundy is the latest addition to the agency's growing roster of AI leadership.
The FDA has already hired senior adviser Jeremy Walsh, formerly of government contractor Booz Allen Hamilton, to lead the FDA's broader AI efforts. It also rehired Sri Mantha, former director of the Center for Drug Evaluation and Research's Office of Strategic Programs, after he was cut as part of President Donald Trump's reduction in force. Now, Nundy has joined as a contractor to lead development of FDA's AI-related guidance and regulations.
Nundy, a primary care physician who studied medicine at Johns Hopkins University, has known Makary for some 20 years. The two wrote an op-ed in 2021, arguing that the CDC was not adequately guiding businesses on how to safely bring staff back to work. Separately, Nundy has advocated for making data from the CDC's vaccine-safety reporting platform V-safe, public to help combat vaccine hesitancy.
He has spent much of his career in startups trying to bring the health care industry into the digital age. Before Accolade, he was director of the nonprofit arm of the Human Diagnosis Project, an Andreessen Horowitz-backed platform where doctors can consult one another on medical diagnoses and treatments.
Research Corner
KENNEDY BASHES MEDICAL JOURNALS — HHS Secretary Kennedy has threatened to stop government scientists from publishing their work in major medical journals as part of his escalating war on institutions he says are influenced by pharmaceutical companies.
Speaking on the 'Ultimate Human' podcast Tuesday, Kennedy said The New England Journal of Medicine, JAMA and The Lancet, three of the most influential medical journals in the world, were 'corrupt' and publish studies funded and approved by pharmaceutical companies.
The remarks come after FDA Commissioner Makary chose to publish a framework for how his agency will review Covid vaccines moving forward in NEJM last week. It also comes after JAMA and NEJM received letters from the Department of Justice probing them for partisanship.
A JAMA spokesperson said the journal had nothing to add when asked about Kennedy's remarks, while NEJM and The Lancet did not respond to requests for comment. HHS also did not respond to requests for comment.
WHAT WE'RE READING
Young scientists are reconsidering their career opportunities and abandoning research amid drastic cuts to NIH grants, The Boston Globe's Chris Serres and STAT's J. Emory Parker report.

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Boston Globe
26 minutes ago
- Boston Globe
Fall vaccines: Here's what you need to know about COVID, flu and RSV shots
Amid uncertainty at the federal level, the Globe spoke with experts to guide readers on which vaccines are available, what doctors are recommending, and where to find reliable sources of information. Related : Advertisement COVID-19 Though the CDC's Advisory Committee on Immunization Practices has yet to officially weigh in on the COVID-19 vaccine, Kennedy While the Advertisement The Food and Drug Administration is also weighing whether to revoke its The American Academy of Pediatrics continues to recommend that all children starting at six months receive the COVID vaccine, even if they're healthy, Anders Pring said. According to Anders Pring recommends every child starting at age six months receive the 'primary series,' the two initial doses. For older children, Anders Pring recommends getting an annual booster, just like the flu shot. Naima Joseph, a maternal fetal medicine specialist at Boston Medical Center, recommends pregnant patients also receive the COVID-19 vaccine. Insurance companies are mandated to cover ACIP's recommendations. But since the panel's final recommendation has not been released, insurance companies have promised to accept the guidance from medical societies, Joseph said. 'We are hopeful that given AHIP has stated an intent to continue coverage of vaccines, it won't be a problem,' Joseph said. 'We will continue to partner with clinicians, pharmacists, community health workers to ensure equitable distribution of vaccines.' Advertisement Influenza The CDC still recommends the flu vaccine for everyone six months and older. But, in late June, Kennedy approved the CDC advisory committee's recommendation to Thimerosal, a mercury-based chemical compound, is used like a preservative in multi-dose vials. The ingredient has long been pushed by the anti-vaccine movement as being connected to autism, though that The move should not affect the supply of flu vaccines, doctors said, as thimerosal is used in less than 5 percent of U.S. flu vaccinations. Manufacturers Boston Medical Center is 'proactive in looking at supply chains throughout the year to ensure that we have sufficient stock,' said Cassandra Pierre, an infectious disease physician there. RSV Respiratory syncytial virus, which causes infections of the lungs and respiratory tract, primarily infects young children under 2 years old. It also impacts the elderly, especially those with weakened immune systems and chronic lung conditions. RSV infections are As of Aug. 4, the CDC In June, the federal panel approved a recommendation for Advertisement For pregnant women, the CDC recommends a single dose of the maternal RSV vaccine — in particular, Pfizer's Abrysvo — during weeks 32 through 36 of pregnancy. The RSV vaccine given to mothers allows antibodies to be passed to the baby before birth. Doctors agree that RSV vaccines are recommended for these populations. Pneumonia Pneumonia vaccines are available throughout the year, Pierre said. The It also recommends it for individuals who have underlying health conditions that put them at high risk for severe disease. That includes people with HIV, asthma or significant pulmonary disease, or diabetes, according to Pierre. Where can I find reliable information about vaccines? Pierre said guidance from professional organizations, like the American Academy of Pediatrics and the American Medical Association, are resources to look to. She added state and local boards for public health are 'wonderful unsung gems.' The While such resources exist, doctors ultimately urged patients to consult with their own clinicians. 'From a public health perspective, we as pediatricians love to talk with our patients and work with them,' Anders Pring said. Advertisement Jessica Ma can be reached at


Time Business News
36 minutes ago
- Time Business News
Next-Gen Breakthroughs Reshaping the In Vitro Diagnostics
In vitro diagnostics (IVD) refers to tests on blood, tissue, or other samples taken from the human body to detect diseases, conditions, or infections. These tests are usually used in laboratories or at the point of care for diagnosis, monitoring and treatment guidance. IVD market has increased due to increased chronic and infectious diseases, increasing demand for early and accurate diagnosis, progress in clinical technologies (eg molecular diagnosis and AI-operated equipment), expansion of elderly population, and globally more healthcare awareness. Key Growth Drivers and Opportunities Increased Chronic and Infectious Diseases: An increase in chronic and infectious diseases increases in vitro diagnostics (IVD) market, as these conditions require initial, accurate and continuous testing for effective treatment and management. Chronic diseases such as diabetes, cancer, and heart disease demand regular monitoring through blood tests, biomarkers and genetic screening, while infectious diseases such as Covid -19, HIV and tuberculosis increase the need for rapid and large -scale clinical solutions. This increased disease burden increases the demand for advanced IVD tools, which is motivated to adopt health care systems more efficient, automatic and accurate clinical technologies to improve the results of the patient. Challenges In vitro diagnostics (IVD) market faces several borders, including high costs, regulatory complications, and reimbursement challenges of advanced clinical technologies that obstruct market access. Limited infrastructure and skilled workers also prohibit adoption in low- and moderate-income countries. Additionally, concerns over the accuracy and standardization of some rapid or point-key-care tests can affect confidence in reliability and results, slowing out extensive implementation. Innovation and Expansion Launch of a New HealthTech Hub to Promote In Vitro Diagnostics In March 2025, Industry, academia, and the healthcare sector convened at the NIHR HealthTech Research Centre in In Vitro Diagnostics (HRC IVD) opening event to deliberate on the Center's goals and priorities. The HRC IVD, which is hosted by Imperial College London and Imperial College Healthcare NHS Trust and funded by the National Institute for Health and Care Research (NIHR), will aid in the advancement and uptake of diagnostics. The HRC IVD provides experience in regulatory clearances, real-world evidence creation, health economics, and overcoming adoption hurdles, with a focus on cancer, infectious and respiratory illnesses, critical care, and primary and social care. MP Biomedicals Releases Next-Generation GI Disease Diagnostic Kits In August 2024, MP Biomedicals has added new qualitative fast tests based on immunochromatography to their suite of in vitro diagnostic assays for infectious disorders. The new diagnostic kits from MP Biomedicals use state-of-the-art technology to provide reliable findings, allowing medical practitioners to quickly and accurately detect Vibrio cholerae serogroups O1 and O139, Salmonella typhi, and Helicobacter pylori. These cutting-edge diagnostic technologies have the potential to completely transform the field of gastrointestinal health diagnostics by giving medical practitioners dependable instruments for enhanced patient outcomes and early identification with previously unheard-of precision. These kits provide doctors, lab workers, and researchers useful tools that may be used in both clinical and research contexts. Inventive Sparks, Expanding Markets The key players operating the in vitro diagnostics market includes, Abbott, Qiagen, Agilent Technologies Inc., bioMerieux SA, Siemens Healthineers, Sysmex Corp., Danaher Corporation, F-Hoffman-La Roche Ltd., Charles River Laboratories, Becton Dickinson and Company, and Others. About Author: Prophecy is a specialized market research, analytics, marketing and business strategy, and solutions company that offer strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high value opportunities in the target business area. Also, we help our client to address business challenges and provide best possible solutions to overcome them and transform their business. TIME BUSINESS NEWS
Yahoo
an hour ago
- Yahoo
BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update
Conference call and webcast scheduled for 8:30 a.m. Eastern Time Today, Thursday, August 14, 2025 NEW YORK, Aug. 14, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. "BrainStorm remains focused on executing our clinical development plan for NurOwn®. We reached an important milestone in Q2 with FDA clearance to initiate our Phase 3b trial, designed to generate confirmatory data to support a potential BLA submission," said Chaim Lebovits, President and CEO. "We are also advancing key operational activities, including discussions with clinical sites as well as ongoing engagement with our selected CDMO partners to ensure readiness for clinical drug supply. We are encouraged by the ongoing interest and support from clinicians and the ALS community, and we remain confident that, if approved, NurOwn has the potential to make a meaningful difference for patients and their families." Mr. Lebovits continued, "We support the FDA's consideration of the Citizen Petition, which may provide a fresh opportunity for an objective evaluation of the scientific evidence. We continue to stand behind the integrity and rigor of our data and will continue to engage with clinicians and the ALS community." Recent Highlights NurOwn (MSC-NTF) for ALS FDA has cleared the company to initiate the Phase 3b clinical trial of NurOwn® The Phase 3b trial, known as ENDURANCE, is expected to enroll approximately 200 participants at leading academic medical centers and will consist of a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension in which all participants will receive NurOwn. The primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R). Successful completion of the double blind portion of the study (Part A) is expected to generate the clinical data needed to support a new BLA submission. Details of the trial, including a list of anticipated participating clinical sites, are available on ID NCT06973629. A Citizens Petition submitted to the FDA by ALS Community requesting a new review of the NurOwn data The company acknowledges that the FDA's consideration of the petition provides a new opportunity to reaffirm NurOwn's potential as a therapy for ALS. BrainStorm was not involved in drafting or submitting this petition or its contents. New survival data from NurOwn Expanded Access Program show that 100% of participants (10/10) in the EAP survived more than 5 years from the onset of ALS symptoms, compared to published estimates indicating that approximately 10% of individuals with ALS would survive beyond 5 years. The single death in the cohort occurred following elective euthanasia. The median survival observed in the EAP cohort was 6.8 years (range: 6 to 7 years) from symptom onset. Although the EAP cohort included participants earlier in their disease course, these results are encouraging and support further study. Manufacturing Partnership with Minaris BrainStorm has signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn for the upcoming Phase 3b clinical trial. NurOwn® data selected as Breakthrough Science for Presentation at ISCT 2025 Meeting The new pharmacogenomic data were delivered in an oral presentation at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in May 2025, in New Orleans. The data highlight the impact of the UNC13A genotype on clinical outcomes for ALS patients treated with NurOwn. The presentation was featured in the ISCT public announcement regarding the meeting, which indicated that the data were "carefully reviewed and selected by the ISCT 2025 Planning Faculty, to explore the latest breakthroughs in the clinical translation of Mesenchymal Stem/Stromal Cells and how they will shape the future of cell therapies." Financial Results for the Second quarter Ended June 30, 2025 Cash, cash equivalents, and restricted cash were approximately $1.03 million as of June 30, 2025. Research and development expenditures, net, for the quarter ended June 30, 2025 were $1.1 million, compared to $0.9 million for the quarter ended June 30, 2024. General and administrative expenses for the quarter ended June 30, 2025 were approximately $1.4 million, compared to approximately $2.1 million for the quarter ended June 30, 2024. Net loss for the quarter ended June 30, 2025, was approximately $2.9 million, as compared to a net loss of approximately $2.5.4 million for the quarter ended June 30, 2024. Net loss per share for the three months ended June 30, 2025, and 2024 was $0.34 and $0.60, respectively. Conference Call and Webcast Participant Numbers: Toll Free 877-545-0320 International 973-528-0002 Participant Access Code 601260 Webcast The replay of the conference call can be accessed by dialing the numbers below and will be available until August 28. Replay Numbers: Toll Free 877-481-4010 International 919-882-2331 Reply Passcode 52831 About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection. NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" — a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. CONTACTS Investors:Michael WoodPhone: +1 646-597-6983mwood@ Media: Uri Yablonka, Chief Business OfficerPhone: +1 917-284-2911uri@ CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data) June 30,December 31, 20252024 UnauditedAudited U.S. $ in thousands ASSETSCurrent Assets: Cash and cash equivalents$ 824$ 187 Other accounts receivable 106 63 Prepaid expenses and other current assets 585 135 Total current assets$ 1,515$ 385Long-Term Assets: Prepaid expenses and other long-term assets $ 24$ 22 Restricted Cash 201 184 Operating lease right of use asset (Note 3) 495 807 Property and Equipment, Net 331 434 Total Long-Term Assets$ 1,051$ 1,447Total assets$ 2,566$ 1,832LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)Current Liabilities: Accounts payables$ 5,997$ 6,080 Accrued expenses 367 619 Short-term loans (Note 7) 101 300 Operating lease liability (Note 3) 381 549 Employees related liability 1,682 1,430 Total current liabilities$ 8,528$ 8,978Long-Term Liabilities: Operating lease liability (Note 3) 95 171 Warrants liability (Note 4) - 447 Total long-term liabilities$ 95$ 618Total liabilities$ 8,623$ 9,596Stockholders' Deficit: Stock capital: (Note 5) 16 14 Common Stock of $0.00005 par value - Authorized: 250,000,000 shares at June 30, 2025 and at December 31, 2024 respectively; Issued and outstanding: 10,120,109 and 6,141,762 shares at June 30, 2025 and December 31, 2024 respectively Additional paid-in-capital 226,446 218,974 Treasury stocks (116) (116) Accumulated deficit (232,403) (226,636) Total stockholders' deficit$ (6,057)$ (7,764)Total liabilities and stockholders' deficit$ 2,566$ 1,832 BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) U.S. dollars in thousands (Except share data) Six months ended Three months ended June 30, June 30, 2025202420252024 UnauditedUnaudited Operating expenses:Research anddevelopment, net$ 2,424$ 1,883$ 1,120$ 922 General and administrative 3,238 3,573 1,453 2,060Operating loss (5,662) (5,456) (2,573) (2,982)Financial income (expense), net (284) 43 (330) 30Gain (loss) on change in fair value of Warrants liability (Note 4) 179 529 - (411)Net loss$ (5,767)$ (5,942)$ (2,903)$ (2,541)Basic and diluted net lossper share from continuing operations$ (0.77)$ (1.35)$ (0.34)$ (0.60)Weighted average numberof shares outstanding usedin computing basic and diluted net loss per share 7,487,495 4,531,801 8,620,400 4,747,699 Logo - View original content to download multimedia: SOURCE BrainStorm Cell Therapeutics Inc.