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infectious disease

RSV Vaccines: Safety, Effectiveness & Protection for Seniors & Infants

by Dr. Michael Lee – Health Editor October 4, 2025

written by Dr. Michael Lee – Health Editor

RSV Vaccines Show Meaningful Protection for Vulnerable Populations, New Data Reveal

Berlin, germany ‌ – Recent analyses confirm substantial benefits from newly approved RSV (respiratory syncytial virus) vaccines, ⁤offering significant⁤ protection to infants, young children, older adults, and pregnant individuals. A review of randomized studies indicates the vaccines reduced lower respiratory tract infections by 54‍ percent and lowered the risk of serious disease by 74 percent. Hospital stays linked to RSV were also reduced by 54 percent, according to the ⁣data.

RSV poses the greatest threat to children under⁢ two years old and older adults. “These are encouraging news for two ⁤of the most endangered groups,” stated Dr. KM Saif-UR-Rahman of the University of Galway ⁤in Ireland.

The findings are based ⁤on data from ‌randomized controlled trials, considered the “strongest available”⁤ evidence, according to Kate Olsson, a vaccine⁤ expert at the European Center for Prevention and Disease Control (ECDC). Real-world studies are currently underway to further assess vaccine safety and effectiveness, with additional analyses expected in the coming weeks. (DOI: 10.1002/14651858.CD016131)

Germany’s Approach: In Germany,⁣ an RSV vaccine is approved for pregnant women, but cost coverage by statutory ⁣health insurance requires a recommendation ‍from the Standing Vaccination Commission (STIKO). Currently, STIKO does ⁤ not recommend RSV vaccination for pregnant women. Rather, the commission recommends all newborns and infants receive a dose of the monoclonal antibody Nirsevimab either before or during their first RSV season (typically ⁣October to march).For babies born between April and‌ September, STIKO advises administering Nirsevimab in the autumn ‌prior to the season’s start, ⁢and as soon as possible after birth for those born during the season.

STIKO does recommend RSV vaccination for individuals aged 75 and‍ over, and for those aged⁢ 60 and over with underlying health conditions that‌ increase their risk of ‌severe ‍illness. Detailed information‍ is⁣ available on the RKI website.(https://www.rki.de/SharedDocs/FAQs/DE/Impfen/RSV/FAQ_Liste_RSV.html?nn=16777208#entry_16918914)

sources: STIKO: Epidemiologisches Bulletin 04/2025, Information on‌ RSV, Frequently asked questions about RSV vaccination.(https://www.rki.de/DE/Aktuelles/Publikationen/Epidemiologisches-Bulletin/2025/04_25.pdf?__blob=publicationFile&v=11, https://www.rki.de/DE/Themen/Infektionskrankheiten/Impfen/Impfungen-A-Z/RSV/rsv-node.html, https://www.rki.de/SharedDocs/FAQs/DE/Impfen/RSV/FAQ_Liste_RSV.html?nn=16777208#entry_16918914)

October 4, 2025 0 comments

Health

ACIP panel has rocky start as RFK Jr. advisers change vaccine schedule

by Dr. Michael Lee – Health Editor September 20, 2025

written by Dr. Michael Lee – Health Editor

ACIP Panel Faces turbulence as RFK Jr. Advisers Prompt Vaccine Schedule Shifts

The Centers for Disease ⁤Control adn Prevention’s Advisory Committee on Immunization Practices (ACIP) is experiencing⁣ internal friction and‌ a‍ revised agenda following the appointment of individuals⁣ with⁤ vaccine skepticism,‍ reportedly linked ‌to Robert F. Kennedy Jr., to key⁢ positions within the Department of ⁣Health and ‍Human Services (HHS). The ⁢panel’s recent deliberations,‍ particularly regarding COVID-19 vaccinations for pregnant people and infants,‍ have revealed deep divisions and a‌ reluctance to reaffirm existing recommendations.

The shift in focus comes as ⁤the ACIP prepares to review a broad range of already-approved vaccines, including those for vulnerable populations.⁤ Public health experts⁣ have expressed alarm over the potential for anti-vaccine influence within HHS, raising concerns about the committee’s ability to maintain a science-driven approach to immunization policy. The⁤ ACIP’s upcoming meetings are expected to be contentious as ‌members navigate the evolving landscape and address ongoing debates, such as‌ the hepatitis B ⁢vaccine schedule.

During internal discussions, members of a ⁤working group reportedly debated recommending the COVID-19 shot for pregnant ⁢individuals and babies, with a majority initially leaning against it. Ultimately, the group opted not to vote‍ on the matter. Dissenting members then presented data supporting vaccination for these groups,citing their vulnerability to the virus.

“Covid-19 vaccines are highly safe and effective. Or if⁣ we don’t want to say safe and effective, they work,” stated Henry Bernstein, a ⁢pediatrician and working group member.

ACIP member Dr. Melinda Levi acknowledged the scrutiny surrounding the group’s actions but⁤ defended its process. “I know there’s drama ⁤around every action the group is taking, but if you⁤ actually follow⁢ what we are doing, we are basically following our mission and doing it with a lot⁢ of engagement ⁢and I think in ⁣a very science-driven way,” she said.

The panel is scheduled⁤ to reconvene next month, with‌ the possibility of‍ revisiting the hepatitis B vaccine debate and continuing its review of vaccines for pregnant people. Levi indicated the ‌ACIP will periodically “review every vaccine,” but did ‍not specify which vaccines would be prioritized.

Matthew Herper and Anil Oza⁢ contributed reporting.

September 20, 2025 0 comments

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ACIP Panel Debates Delaying Hepatitis B Vaccine for Newborns

by Dr. Michael Lee – Health Editor September 18, 2025

written by Dr. Michael Lee – Health Editor

ACIP ‌Panel Considers Delaying Hepatitis B Vaccine ‌for ⁣Newborns amidst‍ Trust Concerns

An⁤ advisory panel to the Centers for Disease Control and⁣ Prevention is weighing a potential shift‍ in the recommended schedule for the ⁣hepatitis B vaccine, currently given to⁤ newborns ‌shortly ‌after birth. ⁢The debate comes‍ as some question the integrity of the‌ committee’s recommendations, fueled by recent scrutiny during a Senate hearing involving the ousted⁣ CDC director and claims of political‍ influence.

The Advisory Committee on immunization⁣ Practices ⁣(ACIP) is considering ⁣whether to‍ delay the first dose of the hepatitis B vaccine, a move that would impact hundreds of ‍thousands of newborns annually. The discussion‌ centers on the balance between potential, though rare, side effects and ⁢the benefits of early protection against the virus. A decision could alter the standard ⁢childhood vaccination schedule and potentially create logistical hurdles ‍for pediatricians.

During a wednesday Senate hearing ⁣focused on the recent removal of the CDC director, ‌Senator Bill cassidy expressed distrust in⁢ ACIP’s guidance shoudl they recommend changes to the vaccination schedule. He stated that such recommendations “should not be trusted.” This sentiment ‍underscores a broader concern about the committee’s objectivity, especially after claims that former CDC officials cannot be trusted ‍unless they agree to a “public ‍debate,” as asserted ⁣by a federal vaccine advisor.

The CDC has released a review of available evidence,⁤ including eight studies,‍ which generally indicates a low risk ⁤of side effects associated with the hepatitis B⁣ vaccine.‍ The review is‌ available as a PDF document. though, delaying the first dose presents logistical challenges, as there are currently ⁤no other childhood vaccines exclusively recommended at one month of age. ⁤

Dr. Su Wang, a physician at Cooperman Barnabas Medical Center in New Jersey and an advisor to the ⁢Hepatitis B Foundation, noted the potential burden on ⁤pediatric offices, which would need‌ to schedule⁢ additional appointments ⁣and maintain vaccine stock. The current recommended childhood immunization‌ schedule ‍is ‍available on ⁣the CDC ‌website.

September 18, 2025 0 comments

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World Sepsis Day 2025: Addressing a Global Health Crisis

by Dr. Michael Lee – Health Editor September 12, 2025

written by Dr. Michael Lee – Health Editor

Sepsis Treatment Lags‍ Despite⁣ High Mortality,Fueling Call for Increased Investment

London,UK – Sepsis remains a important⁣ global health⁣ challenge,claiming hundreds of thousands ‌of⁣ lives annually and demanding urgent investment in novel therapies,according to new data and ⁣analysis. A ⁣recent report highlights a 26% mortality‌ rate⁤ across eight major markets (the ⁤US,‍ Canada, Germany, France, Italy, Spain, the UK and the US) in‍ 2024, with nearly 700,000 sepsis-related deaths.‍

The significant burden⁢ of sepsis – 1.4 million⁣ incident cases and 697,600 deaths in those eight countries alone last year – underscores a critical need for improved ‌recognition, diagnosis, and, crucially, more effective treatments.⁢ Current standards of care largely rely on generic antimicrobials and supportive therapies, but these approaches have‍ limitations ⁣as they don’t‌ address‌ the varied underlying causes of the condition.

A GlobalData survey of ‍170 high-prescribing⁤ physicians across the⁢ 8MM in 2025 revealed piperacillin/tazobactam,vancomycin and meropenem as the most commonly used antimicrobials. However, the report emphasizes a strong unmet need for therapeutics that specifically target⁤ the complex pathophysiological processes involved in sepsis.

while historically hampered by high clinical trial failure rates and limited investment, the sepsis pipeline⁢ is showing promise. Eleven products are currently in ⁣late-stage progress across the‌ 8MM, many utilizing‌ novel mechanisms of action. Adrenomed’s monoclonal antibody, enibarcimab, exemplifies this shift, employing a precision medicine approach guided by biomarkers like bio-ADM ‍and DPP3 to identify patients most likely to ‌benefit‍ from treatment, demonstrating improved organ function and reduced 28-day mortality in targeted groups during the AdrenOSS-2 Phase II ‍trial.

Experts suggest continued research⁣ and development investment⁤ in innovative therapeutics is ‌vital to address the diverse⁢ needs of sepsis ⁣patients⁤ and overcome the challenges that have historically discouraged investment in this critical area.

September 12, 2025 0 comments

Health

KFF Global Health Budget Summaries

by Dr. Michael Lee – Health Editor September 11, 2025

written by Dr. Michael Lee – Health Editor

Tracking‍ U.S. global Health Funding: ⁣A ⁤Look Back at FY2014 Budget Developments

Washington,⁣ D.C. ‍ – A series of ⁢legislative actions and ⁢presidential requests in 2013⁣ and 2014 shaped the landscape of U.S. ⁢funding for global health initiatives,⁣ according to⁤ summaries⁢ tracked⁢ by the⁣ Kaiser Family Foundation ⁢(KFF). These developments, ranging from initial budget requests to final appropriations, offer a detailed⁤ timeline of the financial⁢ commitments made during that⁣ period.

Understanding these historical⁣ funding levels is crucial as policymakers and global health stakeholders ⁣currently navigate evolving health challenges and budgetary constraints.‍ The⁤ FY2014 process provides a benchmark for assessing current funding priorities and anticipating future shifts in resource allocation,impacting programs addressing HIV/AIDS,malaria,tuberculosis,maternal and ‌child health,and ‍other critical global health needs.

The process began with the White House releasing its FY2014 budget request on April 10, 2013, followed by a more detailed fact sheet on U.S. funding for global health on May‍ 23, 2013. Legislative bodies‍ then ‌began their work. The Senate‍ appropriations Committee first approved the FY 2014 State and Foreign Operations Appropriations Bill⁤ on July 25, 2013, and subsequently approved the FY14 Health & Human Services Appropriations Bill on July 11, 2013. Mirroring this activity, the House Appropriations Committee ⁣approved the FY 2014⁣ State and Foreign Operations Appropriations Bill on july 24, 2013.

The culmination of these efforts arrived with the⁢ release‌ of the FY14 Omnibus Appropriations Act ⁣on⁣ January 13,2014,representing the final enacted ‌funding levels for the‌ fiscal year.KFF’s summaries provide links to ⁤further details on ⁣each of these key stages in the⁣ budget⁤ process.

September 11, 2025 0 comments

Health

FDA Clears CDI-988 Human Trial for Norovirus Prevention

by Dr. Michael Lee – Health Editor September 9, 2025

written by Dr. Michael Lee – Health Editor

FDA Authorizes First-in-Class‍ Human Challenge Study for Oral Norovirus Antiviral

September 9, 2025 ‍ – ⁢The ⁤Food and Drug ⁤Administration has⁢ cleared Cocrystal Pharma to proceed with a phase 1b human challenge study evaluating CDI-988, a potential oral antiviral drug for the ⁤prevention and treatment of norovirus. This marks a significant step toward developing the first antiviral ‌specifically targeting the highly contagious virus.

Norovirus causes approximately 21 million infections annually in the United States, leading to over 100,000 hospitalizations and nearly 900⁤ deaths each year.The virus spreads easily through contaminated⁢ food, surfaces, and close contact, ‍posing a particular⁢ risk to ⁣immunocompromised individuals, ⁢infants, and older adults, who can remain‌ contagious for weeks after recovering.

Preclinical studies have‍ demonstrated CDI-988’s broad antiviral activity, and initial phase 1 testing indicated the⁣ drug ⁤was well-tolerated. The upcoming challenge study will assess ‍its efficacy in preventing ⁤or ‍treating norovirus infection.

“This milestone⁣ marks an significant step in advancing CDI-988 into clinical development,” said Sam Lee, ‍PhD, president and co-CEO of Cocrystal Pharma. “The planned challenge study will ‌help determine ⁢its efficacy ⁢in preventing or treating norovirus infection.”

Cocrystal ⁣utilizes a structure-based drug ⁢discovery ⁣platform,‌ enabling detailed modeling of drug-target interactions⁤ to design ‌novel antivirals. Beyond norovirus, ⁤CDI-988‍ has also shown activity against‌ coronaviruses and is currently under investigation as a potential ‍COVID-19 therapy, having received approval from the Australian ‌Human Research Ethics⁤ Committee (HREC) to ‌initiate a phase I trial in 2023.

References

Cocrystal Pharma Receives FDA IND Clearance ‌for Challenge Study‍ of Oral Broad-Spectrum Protease Inhibitor CDI-988, a ⁢Potential ‌First Antiviral for Norovirus Prevention and Treatment. BioSpace. September 9,2025. Accessed September 9, 2025. https://www.biospace.com/press-releases/cocrystal-pharma-receives-fda-ind-clearance-for-challenge-study-of-oral-broad-spectrum-protease-inhibitor-cdi-988-a-potential-first-antiviral-for-norovirus-prevention-and-treatment?utmsource=chatgpt.com

Cocrystal Pharma’s norovirus antiviral⁤ study receives‌ FDA clearance. ClinicalTrialsArena. September 9, 2025. Accessed‌ September ‍9, 2025. https://www.clinicaltrialsarena.com/news/cocrystal-norovirus-study/?utmsource=chatgpt.com&cf-view

September 9, 2025 0 comments

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