This study will determine the functional status of the nasal immune environment with LAIV exposure in COPD persons with frequent exacerbations (defined as individuals with two or more episodes of worsening in COPD symptoms requiring treatment with antibiotics and/or steroids in the prior 12 months) and COPD persons without frequent exacerbations to determine acute exacerbation of COPD (AECOPD)-associated dysfunction in a) cytokines and immune effector cells of the nasal mucosa and b) viral replication. The investigators hypothesize that: 1) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate altered mucosal immune responses to LAIV exposure, and 2) COPD frequent exacerbators, compared to COPD infrequent exacerbators, will demonstrate increased markers of influenza viral replication after LAIV exposure.

开始日期2022-10-03

申办/合作机构

The University of North Carolina at Chapel Hill

[+1]

CTRI/2021/11/037859

/ Not yet recruiting临床3期IIT

Study of humoral and cellular immune responses to influenza vaccinein healthy adult volunteers. - NIL

开始日期2021-11-15

申办/合作机构-

EUCTR2019-001186-33-ES

/ Unknown status临床4期

Clinical trial, phase IV, randomized, double-blind, controlled, in children aged 12 to 35 months, of the vaccine against seasonal influenza to estimate efficacy against influenza and other respiratory infections - VIGIRA

开始日期2019-09-27

申办/合作机构

Fisabio Foundation

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2025-04-01·VACCINE

Determinants of seasonal influenza vaccination uptake, intention and recommendations among Lebanese physicians

Article

作者: Basha, Ihab ; Ghosn, Nada ; Maison, Patrick ; Bazant, Eva S ; Saleh, Nadine ; Farah, Zeina ; Moen, Ann

The most effective way to prevent influenza infection and its severe outcomes is through vaccination. Influenza vaccination is recommended for high-risk groups, including health care workers who have high occupational exposure. Hesitancy is a major challenge affecting vaccine uptake. This study aims to identify the determinants of seasonal influenza vaccine uptake, intention and recommendation to target groups of physicians in Lebanon. A cross-sectional study was conducted targeting physicians working in Lebanon. Data was collected on Kobo Toolbox using an online questionnaire developed based on the Health Belief Model. A random sample of physicians was selected from the Order of Physicians database. The link to the questionnaire was sent by email or message. Univariate, bivariate and multivariable analyses were performed using R software. The total number of responses was 1019. Half (49 %) of the participants received the vaccine in the 2022-2023 season, and 73 % intend to get it if recommended and offered for free. The perception of vaccine effectiveness was associated with vaccine uptake (adjusted OR = 2.54, 95 %CI = 1.98-3.31), intention to be vaccinated (adjusted OR = 17.5, 95 %CI = 7.21-50.5) and vaccine recommendation. Perception of vaccine safety, type of healthcare facility and physician's specialty were also associated with flu uptake. Other predictors for intention were: perception of disease severity and flu uptake during the previous season. Other predictors for flu vaccine recommendation were: province of residence, number of years in healthcare, specialty and intention to take the flu vaccine (adjusted OR = 21.0, 95 %CI = 7.58-71.3). Influenza vaccine uptake among participating physicians is suboptimal, yet intention to take the vaccine is higher. The study identified several factors associated with the vaccine uptake, intention and recommendation. A multifaceted approach and targeted education activities are needed in a sustainable vaccination program to increase physicians' influenza vaccine uptake.

2025-04-01·VACCINE

A randomised phase 2 immunogenicity and safety study of a MF59-adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine (aQIVc) in adults aged 50 years and older

Article

作者: Isakov, Leah ; Albano, Frank R ; Vermeulen, Wim ; de Rooij, Richard ; Essink, Brandon J ; Casula, Daniela ; Andrade, Coralie

Influenza poses a significant global healthcare burden, with up to 1 billion infections annually, and poorer outcomes in vulnerable populations such as older adults. Vaccination effectiveness is often lower in elderly individuals. By adding an adjuvant and using cell-based vaccine production methods, the MF59-adjuvanted quadrivalent cell-based influenza vaccine (aQIVc) may boost immunogenicity and vaccine effectiveness in this population. We report the results of a randomised proof-of-concept study, investigating the immunogenicity and safety of aQIVc. Eligible participants aged ≥50 years were randomised 1: 1:1:1 to receive aQIVc (n = 116), a non-adjuvanted quadrivalent cell-based influenza vaccine (QIVc; n = 119), an MF59-adjuvanted quadrivalent egg-based influenza vaccine (aQIV; n = 116), or a high-dose quadrivalent recombinant influenza vaccine (QIVr; n = 120). The primary objective was to assess immunogenicity of aQIVc vs the comparators by haemagglutination inhibition (HI) assay 28 days post-vaccination. Secondary objectives included immunogenicity of aQIVc vs comparators 28 days and 180 post-vaccination by microneutralisation assay and 180 days post-vaccination by HI assay; and reactogenicity and safety of all study vaccines. Compared with QIVc and aQIV, aQIVc elicited a higher immune response (adjusted geometric mean titre [GMT] ratio range 1.18-1.85) against all four influenza strains at Day 29. Against QIVr, aQIVc elicited lower responses against A strains (adjusted GMT ratio range 0.79-0.84), and higher responses against B strains (adjusted GMT ratio range 1.15-1.26). Estimated GMT ratios were generally higher in the subgroup of participants aged ≥65 years vs those aged 50-64 years. aQIVc was well tolerated, eliciting similar rates of solicited local adverse events (AE) and slightly higher rates of solicited systemic AE than aQIV, and a higher rate of all solicited AE than QIVc and QIVr. No safety concern was identified. These data support further investigation of additional formulations of aQIVc in adults aged ≥50 years. Clinical trial registry:NCT04576702.

2025-04-01·Journal of the International Association of Providers of AIDS Care

Determinants of COVID-19 Vaccine Uptake Among People Living with Human Immunodeficiency Virus

Article

作者: Terlikbayeva, Assel ; Rosenthal, Susan L ; Mergenova, Gaukhar ; DeHovitz, Jack ; Denebayeva, Alfiya Y ; Davis, Alissa ; Primbetova, Sholpan ; Darisheva, Meruyert ; Bukharbayeva, Assel

Background:

Human immunodeficiency virus (HIV) cases are rising in Central Asia and Kazakhstan. People living with HIV (PLWH) in Kazakhstan are at heightened risk of severe COVID-19. We conducted a study to evaluate determinants of COVID-19 vaccine uptake among PLWH in Kazakhstan.

Methods:

In this cross-sectional study, 196 PLWH were recruited from the Almaty City AIDS Center (July 2022-January 2023). We used logistic regression to evaluate how multilevel factors are associated with COVID-19 vaccine uptake among PLWH in Kazakhstan.

Results:

COVID-19 vaccine non-uptake was associated with higher HIV stigma scores (AOR = 1.08, 95%CI:1.02,1.16, P = 0.017), a lower level of education (AOR = 2.53, 95%CI: 1.04,6.17, P = 0.0412), and never receiving the flu vaccine (AOR = 15.64, 95%CI:3.66,66.89, P = 0.0002). Participants with at least mild anxiety symptoms (AOR = 0.15, 95%CI:0.03,0.64, P = 0.0107) and a positive attitude towards vaccination (AOR = 0.79, 95%CI: 0.73,0.86, P < 0.0001) were less likely to remain unvaccinated against COVID-19.

Conclusions:

COVID-19 vaccination campaigns should be tailored for PLWH and incorporate stigma reduction interventions within healthcare settings.

116

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2025-04-08

·astrazeneca.com

AstraZeneca showcases innovation in infectious disease protection at ESCMID Global 2025

AstraZeneca will share new data across its Vaccines & Immune Therapies portfolio at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global 2025) in Vienna, Austria, from 11-15 April 2025. With 13 abstracts, including two oral presentations and two late-breaking poster presentations, the Company will highlight progress in advancing novel immunisations against bacterial and viral infectious diseases and share real-world evidence showing the burden of respiratory viral infections and the continued need for protection. Benjamin Moutier, Senior Vice President, Vaccines & Immune Therapies, AstraZeneca said: “AstraZeneca is building an innovative portfolio of antibodies and vaccines to tackle two of the top global public health threats – serious bacterial infections and respiratory viral infections. At ESCMID, we’ll share data on three novel monoclonal antibodies targeting high-priority pathogens, highlighting our ambition to redefine care for serious bacterial infections. In addition, we will present 20 years of effectiveness data for Fluenz/FluMist, as well as real-world data highlighting the ongoing burden of RSV and hMPV, two leading causes of respiratory illnesses.” Advancing potential new options for serious bacterial infection prevention and treatment Serious bacterial infections pose significant and growing threats to global health, linked to an estimated 7.7 million deaths a year globally, leading to increasing morbidity and mortality for patients and a substantial burden on health systems.1 At ESCMID, the Company will share preclinical data on investigational monoclonal antibodies (mAbs) targeting three of the top five pathogens identified as urgent risks by the Centers for Disease Control and Prevention: Staphylococcus aureus (S. aureus): Oral presentation on in vivo expression of an mRNA-encoded multi-mechanistic mAb combination against S. aureus. There are millions of methicillin-resistant S. aureus (MRSA) infections annually worldwide, and MRSA is resistant to many types of antibiotics, making treatment highly complex. A pathogen-specific treatment strategy with mAbs targeting some S. aureus virulence factors represents an alternative to broad spectrum antibiotics.2 Pseudomonas aeruginosa (P. aeruginosa): Preclinical data showing that gremubamab, an anti-P. aeruginosa bispecific human mAb, may enhance neutrophil-mediated killing of P. aeruginosa in bronchiectasis patients. P. aeruginosa is a pathogen that colonizes one-third of patients with bronchiectasis, a chronic lung condition impacting about one million people globally and drives significant disease morbidity and mortality.3 Klebsiella pneumoniae (K. pneumoniae): Research on the development and characterisation of bispecific antibodies that protect against bacteraemia and pneumonia from the major serotypes of antibiotic-resistant K. pneumoniae in mouse models. Infections caused by K. pneumoniae are responsible for more than 700,000 yearly deaths worldwide.4 Real-world data examining the impact of respiratory infections AstraZeneca is presenting 20 years of real-world data on Fluenz/FluMist (live attenuated influenza vaccines, LAIV), recently approved in the U.S. as the only vaccine for self- or caregiver administration for the prevention of influenza, demonstrating long-term effectiveness comparable to that of inactivated (IIV) influenza vaccines in children.5 The Company will also present two late-breaking posters featuring real-world studies in patients with haematological malignancies who are highly susceptible to severe respiratory infections. The studies show that outcomes from human metapneumovirus (hMPV) and respiratory syncytial virus (RSV) were similar to those from influenza and COVID-19, highlighting the need for development of novel options for preventing disease caused by hMPV and RSV.6,7 Retrospective analyses from Valencia, Spain, where there is systematic testing for multiple respiratory viruses, highlight the impact of RSV and influenza on severe disease and mortality in older adults throughout the COVID-19 pandemic, and suggest a potentially greater proportion of mechanical ventilation use and in-hospital death from RSV than influenza in adolescents and adults.8,9 Additional real-world data from France highlight the extensive healthcare resource utilisation due to hMPV and RSV and underline the need for routine testing for hMPV to accurately assess its true burden.10 Additionally, data being presented by our partner, Sanofi, confirm the significant public health impact and real-world effectiveness of Beyfortus in reducing RSV disease and hospitalisations in infants.11 Furthering Research in COVID-19 Prevention Data on AZD6563, an investigational novel COVID-19 mRNA vaccine-like particle (VLP) vaccine, demonstrating that a low dose may elicit equivalent cell-mediated immunity to a licensed mRNA vaccine will also be shared.12 Additionally, data will be presented increasing confidence in a SARS-CoV-2 variant-agnostic threshold which could be used as a surrogate endpoint for benchmarking expected efficacy of novel mAbs for the prevention of COVID-19 against emerging variants.13 Key AstraZeneca presentations during ESCMID 2025 Abstract Title Presentation Details Abstract Title Early Science: Serious Bacterial Infections and Respiratory Viral Infections Abstract Title In vivo expression of an mRNA encoded multi-mechanistic mAb combination against Staphylococcus aureus and protection in disease model Presentation Details Oral Presentation Session Title: Around the Lab in 80 Ways: A Journey Through Innovative Therapeutics Date: Saturday 12 April 2025 Time: 11 AM – 12 PM CEST Location: Hall 13 Abstract Title Low dose of a novel SARS-COV-2 mRNA VLP vaccine elicits equivalent cell-mediated immunity to a licensed mRNA vaccine Presentation Details Poster Presentation Session Title: COVID-19 Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title A Bispecific Monoclonal Antibody Targeting Psl and PcrV Enhances Bronchiectasis Patient Neutrophil-Mediated Killing Of Pseudomonas aeruginosa Presentation Details Poster Presentation Session Title: Drug Discovery and New Compounds Mechanisms of Action & Spectrum, Preclinical Data & Basic Pharmacology Date: Sunday 13 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Broad coverage of antibiotic-resistant Klebsiella pneumoniae by multi-specific antibodies against the lipopolysaccharide O-antigen Presentation Details Poster Presentation Session Title: Drug Discovery and New Compounds Mechanisms of Action & Spectrum, Preclinical Data & Basic Pharmacology Date: Sunday 13 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Real-World Evidence: Respiratory Infections Abstract Title Comparative outcomes of hMPV, influenza, and SARS-CoV-2 infections in haematologic malignancy patients: A matched cohort analysis Presentation Details Late-Breaking Poster Presentation Session Title: Outbreaks and Public Health Emergencies Date: Tuesday 15 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Matched cohort study comparing the impact of RSV, influenza, and SARS-CoV-2 infections in patients with haematological malignancies Presentation Details Late-Breaking Poster Presentation Session Title: Outbreaks and Public Health Emergencies Date: Tuesday 15 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Similar proportions and temporal patterns of influenza, RSV, and hMPV among ESKD patients tested between 2020-2023 Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Characterization of hMPV and RSV cases in the French national hospital claims database during the 2022-2023 season Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Shifting viral landscapes: the impact of SARS-CoV-2 on hospitalization, ICU admission, and mortality in respiratory infections among older adults in Valencia, Spain Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Respiratory syncytial virus (RSV)-associated hospitalised influenza-like illness (ILI) and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015-2019/2020: the VALSARI study Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title Real-world effectiveness of live attenuated (LAIV) and inactivated (IIV) influenza vaccines in children: a systematic literature review (SLR) and network meta-analysis (NMA) Presentation Details Poster Presentation Session Title: Influenza and Respiratory Viruses Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Abstract Title COVID-19 mAbs Abstract Title Pharmacokinetics and immunogenicity of AZD7442 (Tixagevimab/Cilgavimab) in hospitalised COVID-19 patients: results from the DisCoVeRy trial Presentation Details Oral Presentation Session Title: New developments in prophylaxis and treatment of COVID-19 Date: Saturday 12 April 2025 Time: 11:00 Location: Hall 6 Abstract Title A threshold of protection model for monoclonal antibody pre-exposure prophylaxis against COVID-19 enabling rapid development for future SARS-CoV-2 variants Presentation Details Poster Presentation Session Title: COVID-19 Date: Saturday 12 April 2025 Time: 12 PM – 1:30 PM CEST Location: Poster Area in Hall D Notes AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. GBD 2019 Antimicrobial Resistance Collaborators. Global mortality associated with 33 bacterial pathogens in 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2022 Dec 17;400(10369):2221-2248. 2. Tkaczyk C, Newton M et al. In vivo expression of an mRNA encoded multi-mechanistic mAb combination against Staphylococcus aureus and protection in disease model. Oral Presentation. ESCMID Global 2025; Vienna, Austria. 2025. 3. Long MB, Gilmour A et al. A bispecific monoclonal antibody targeting Psl and PcrV enhances bronchiectasis patient neutrophil-mediated killing of Pseudomonas aeruginosa. Poster Presentation #P3642. ESCMID Global 2025; Vienna, Austria. 2025. 4. Doyle M, Smith A et al. Broad coverage of antibiotic-resistant Klebsiella pneumoniae by multi-specific antibodies against the lipopolysaccharide O-antigen. Poster Presentation #P2377. ESCMID Global 2025; Vienna, Austria. 2025. 5. Stuurman AL, Enxing J et al. Real-world effectiveness of live attenuated (LAIV) and inactivated (IIV) influenza vaccines in children: a systematic literature review (SLR) and network meta-analysis (NMA). Poster Presentation #P0120. ESCMID Global 2025; Vienna, Austria. 2025. 6. Salmanton-Garcia J, Marchesi F et al. Comparative outcomes of hMPV, influenza, and SARS-CoV-2 infections in haematologic malignancy patients: a matched cohort analysis. Poster Presentation #P5067. ESCMID Global 2025; Vienna, Austria. 2025. 7. Marchesi F, Salmanton-Garcia J et al. Matched cohort study comparing the impact of RSV, influenza, and SARS-CoV-2 infections in patients with haematologic malignancies. Poster Presentation #P5066. ESCMID Global 2025; Vienna, Austria. 2025. 8. Mira-Iglesias A, Herring T et al. Respiratory syncytial virus (RSV)-associated hospitalisations and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015–2019/2020: the VALSARI study. Poster Presentation #P0131. ESCMID Global 2025; Vienna, Austria. 2025. 9. Mira-Iglesias A, Herring T et al. Respiratory syncytial virus (RSV)-associated hospitalisations and clinical progression in adolescents and adults in Valencia, Spain, 2014/2015–2019/2020: the VALSARI study. Poster Presentation #P0132. ESCMID Global 2025; Vienna, Austria. 2025. 10. Binh Luong Nguyen L, et al. Characterisation of hMPV and RSV hospitalisations in the French national hospital claims database during the 2022-2023 season. Poster Presentation #P0183. ESCMID Global 2025; Vienna, Austria. 2025. 11. Mallah N, Pardo-Seco J, et al. Effectiveness of universal prophylaxis with nirsevimab for prevention of infant hospitalisations due to respiratory syncytial virus : full 2023-24 season analysis of the NIRSE-GAL study. Poster Presentation #P0124. ESCMID Global 2025; Vienna, Austria. 2025. 12. Swanson PA II, Padilla M et al. Low dosage of a novel SARS-COV-2 mRNA VLP vaccine elicits equivalent cell-mediated immunity to a licensed mRNA vaccine. Poster Presentation # P0482. ESCMID Global 2025; Vienna, Austria. 2025. 13. Edge R, Matthews S et al. A validated threshold of protection model for monoclonal antibody pre-exposure prophylaxis against COVID-19 enabling rapid development for future SARS-CoV-2 variants. Poster Presentation #P0448. ESCMID Global 2025; Vienna, Austria. 2025. Corporate and financial

疫苗上市批准免疫疗法临床研究信使RNA

2025-03-19

·BioSpace

Sarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon Whiplash, PDUFAs in Cardio

Sarepta will update Elevidys’ label after a patient died following treatment; the FDA issues flu vaccine recommendations without advisor input; Trump CDC nominee Dave Weldon pulled at last minute; and FDA decisions expected for Alnylam’s Amvuttra in ATTR-CM and Milestone’s etripamil in tachycardia. > Listen on Spotify > Listen on Apple Podcasts > Listen on Amazon Music > Listen on iHeart A patient with Duchenne muscular dystrophy taking Sarepta’s gene therapy Elevidys has died of acute liver failure, possibly related to a recent viral infection. Sarepta, which said it will update Elevidys’ label to reflect the new safety signal, saw its shares drop 22% on the news but analysts still seem positive on the drug, as treatment options for Duchenne remain limited. Meanwhile, both AstraZeneca and Taiho Pharmaceuticals announced acquisitions worth up to $1 billion or more in two sizzling therapeutic spaces, cell therapy and antibody-drug conjugates, respectively. Despite canceling a vaccine advisory committee late last month, the FDA on Thursday selected flu strains to be targeted in the upcoming 2025-2026 flu season. And at another federal agency, the Centers for Disease Control and Prevention, employees will have to wait a bit longer to see who will take the helm under Donald Trump, as the president’s nominee, Dave Weldon , was pulled hours before he was set to appear before a Senate committee on Thursday. Like HHS Secretary Robert F. Kennedy Jr., Weldon has expressed anti-vaccine views in the past, particularly his continued suggestion of the link between vaccines and autism. Guggenheim Partners called the move to revoke Weldon’s nomination “a positive sign for reigning in vaccine criticism.” In the weight loss arena, BioSpace takes deep dives into the tendency for biopharma to develop fast-followers, or me-too drugs—following a pattern seen with PD-1 checkpoint inhibitors after the approvals of Merck’s Keytruda and Bristol Myers Squibb’s Opdivo. One key difference between these two markets, however, is that when it comes to GLP-1s for weight loss, patients are not staying on these medicines. Drug developers are trying several approaches to improve treatment persistence , including titration, combinations and even secondary drugs that address side effects. They’re also making other moves to differentiate themselves, including focusing on overall health outcomes —in areas like cardiovascular, sleep apnea and kidney disease. Following on BioSpace ’s coverage of the major patent cliffs that many Big Pharma companies are facing in coming years, we also take a look back at some of the companies that have already weathered such loss of exclusivity. It’s rarely a straightforward story of sales crashing off patent, as companies take various tacks to extend their blockbuster sales. Finally, the cardiovascular space is expecting some movement this week. First, Alnylam is anticipating a decision on its RNAi silencer Amvuttra in ATTR-CM. An approval—which is widely expected—would make three companies on the market in this rapidly expanding space after Pfizer’s tafamidis was approved in May of 2019, and BridgeBio’s Attruby got the greenlight in November last year. And second, Milestone Pharmaceutical has a PDUFA coming up for etripamil in paroxysmal supraventricular tachycardia.

上市批准并购疫苗IPO

2025-02-28

·drugs

Severe Flu Season Raises Concerns About Brain Complications in Kids

FRIDAY, Feb. 28, 2025 -- As this year’s severe flu season rages across the country, federal health officials are investigating a rise in rare but life-threatening brain complications in children. The U.S. Centers for Disease Control and Prevention (CDC) says at least 19,000 people have died from the flu so far this winter, including 86 children. New data show that nine of those child deaths involved serious brain complications tied to the flu, the CDC reported Feb. 27 in it's Morbidity and Mortality Weekly Report (MMWR). The condition, known as influenza-associated encephalopathy or encephalitis (IAE), is a rare type of brain inflammation triggered by the flu. In severe cases, children can develop acute necrotizing encephalopathy (ANE), a dangerous form of brain damage linked to viral infections like flu. While IAE is rare, the CDC’s preliminary data for the 2024-25 flu season link 13% of child flu deaths to these brain complications. Among 1,840 pediatric flu deaths reported to the CDC since 2010, 166 children (9%) had these brain complications. In some past seasons, the percentage was lower (4% in 2013-14 and 0% in 2020-21 when flu dropped to historic a low during the COVID pandemic). In other seasons, it was as high as 14% (2011-12 season). One challenge for public health experts, The Associated Press reported, is that there’s no official system to track IAE or ANE cases in the U.S.. This makes it hard to know if this year’s numbers are higher than usual. The CDC has asked state health departments to report any additional cases this season. It is encouraging hospitals to test for flu in children with severe neurological symptoms and to report those cases to local health departments. So far this season, four of the nine children with flu-linked brain complications had the most severe type (ANE). All were under age 5. Two of these children had received their flu shots, and two had not. All four required mechanical ventilation (life support to help them breathe), and two experienced seizures during their hospital stay, according to MMWR . Doctors and hospitals have previously warned to watch for symptoms such as seizures or hallucinations in children with the flu. "Progression to severe neurologic impairment and death from IAE can occur rapidly after onset of influenza symptoms," the report read. "Thus, prompt recognition and intervention are crucial, including neurocritical supportive care for patients with increased intracranial pressure and management of multiorgan failure." Despite the severe flu season, only about 45% of Americans have received their flu shots so far. While not great at blocking infections, the vaccine’s main role “is to keep you out of the hospital and to keep you alive,” Vanderbilt University vaccine expert Dr. William Schaffner told The Associated Press . Effectiveness of the shot varies from year to year. Preliminary CDC data released Thursday show the flu shot reduced the risk of hospitalization by 64% to 78% for vaccinated children and 41% to 55% for vaccinated adults. Health officials stress it’s not too late to roll up your sleeve. “If you haven’t gotten your flu shot yet, get it because we’re still seeing high flu circulation in most of the country,” Dr. Sean O’Leary of the American Academy of Pediatrics urged. The growing concern about flu complications comes amid uncertainty over next year’s flu vaccine. The Trump administration canceled a March 13 meeting where experts were supposed to help choose which flu strains to target in next season shot. “We have historically worked really hard to get transparency around all of these vaccine discussions,” O’Leary said. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

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适应症	国家/地区	公司	日期
流感病毒感染	欧盟	MedImmune LLC	2011-01-27
流感病毒感染	冰岛	MedImmune LLC	2011-01-27
流感病毒感染	列支敦士登	MedImmune LLC	2011-01-27
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适应症	最高研发状态	国家/地区	公司	日期
哮喘	临床3期	比利时	MedImmune LLC	2002-10-01
反复呼吸道感染	临床3期	以色列	MedImmune LLC	2002-10-01
反复呼吸道感染	临床3期	西班牙	MedImmune LLC	2002-10-01
水痘	临床3期	-	MedImmune LLC	2000-12-01
麻疹	临床3期	-	MedImmune LLC	2000-12-01
腮腺炎	临床3期	-	MedImmune LLC	2000-12-01
风疹	临床3期	-	MedImmune LLC	2000-12-01
肿瘤	临床1期	美国	MedImmune LLC	2005-08-01
流感样症状	临床1期	-	MedImmune LLC	2002-08-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04110366 (Flu-M3, CTgov)	N/A	流感病毒感染	48	Live attenuated influenza vaccine (Live Attenuated Influenza Vaccine)	壓衊憲網鬱蓋願簾遞積 = 積簾網鑰願醖齋觸夢鹽膚製廠鑰觸襯構憲艱憲 (艱願衊鑰觸範積觸鏇膚, 製範鬱選鏇範鏇鑰淵簾 ~ 築繭糧鹽壓淵襯醖製齋) 更多	-	2021-12-06
				Vehicle Control (Mucosal Immune Stability Cohort)	齋構選夢窪膚餘壓遞蓋(鑰顧憲願鑰壓鑰鹽衊艱) = 鑰觸淵願鹽齋衊醖衊鹹蓋鏇願範鏇鑰醖衊餘醖 (築襯衊顧築繭衊糧壓襯, 築醖糧鏇窪遞構簾願鏇 ~ 遞鏇鹹範鹹簾積膚鏇積) 更多
NCT03143101 (FluMist, CTgov)	临床4期	流感病毒感染	200	FluMist trivalent (FluMist Trivalent (2015-2016))	憲選鬱鹽糧築蓋鑰襯築 = 蓋願憲壓醖憲壓廠繭構築鏇憲築窪醖鏇網餘製 (鹹選醖構衊築艱醖網膚, 襯憲衊製糧鹽淵醖鬱餘 ~ 淵鑰憲窪淵鬱選鹽鏇廠) 更多	-	2018-12-11
				FluMist Quadrivalent (FluMist Quadrivalent (2015-2016))	憲選鬱鹽糧築蓋鑰襯築 = 鹹醖鹽艱憲鬱淵範廠夢築鏇憲築窪醖鏇網餘製 (鹹選醖構衊築艱醖網膚, 齋遞遞獵鹽壓鏇襯壓艱 ~ 鹽築鏇顧窪鬱齋網鏇鏇) 更多
NCT00138294 (CEI, CTgov)	临床4期	流感病毒感染	29,255	Influenza virus vaccine(Sanofi)+Influenza vaccine live(MedImmune LLC) (Intervention Cities)	齋遞醖積糧鹹夢鬱簾鏇 = 窪襯糧糧顧積衊積膚蓋鏇艱繭廠夢簾憲鹽積餘 (憲廠壓廠衊選築膚壓齋, 窪憲窪餘願廠壓鹹鏇憲 ~ 憲鹽蓋顧築鏇製淵觸觸) 更多	-	2017-05-19
				Influenza virus vaccine(Sanofi)+Influenza vaccine live(MedImmune LLC) (Comparison Cities)	齋遞醖積糧鹹夢鬱簾鏇 = 廠餘簾餘憲衊鹹膚夢選鏇艱繭廠夢簾憲鹽積餘 (憲廠壓廠衊選築膚壓齋, 鬱淵繭襯廠觸構範蓋簾 ~ 製範壓衊襯壓艱夢網鹽) 更多
NCT03022435 (CTgov)	临床4期	流感病毒感染	22	LAIV (Group B: 18-30 yo Identical Twins (LAIV))	簾網蓋簾齋鹹鑰顧願觸 = 構餘製獵願製遞餘觸願餘積顧繭艱遞夢醖顧淵 (齋積築鏇構窪構鑰鬱願, 網廠膚糧壓齋簾鏇範蓋 ~ 餘簾築鹽蓋鬱簾壓窪糧) 更多	-	2017-03-09
				TIV (Group B: 18-30 yo Identical Twins (TIV))	簾網蓋簾齋鹹鑰顧願觸 = 鹹艱簾鹹選構鹹願衊衊餘積顧繭艱遞夢醖顧淵 (齋積築鏇構窪構鑰鬱願, 夢蓋繭襯積襯觸願網鬱 ~ 壓遞蓋餘觸廠網壓膚鏇) 更多
NCT02473510 (FluMist, CTgov)	临床4期	流感病毒感染	301	Placebo (Placebo)	鏇鑰顧鹽鹹鏇膚網簾製 = 選醖範壓窪繭願鹹窪鹹繭積選衊繭鬱夢窪製壓 (願鏇襯遞鑰鑰艱壓鑰膚, 壓繭獵餘壓網淵鑰齋醖 ~ 製製鹽鏇餘製廠壓遞範) 更多	-	2016-11-28
				Trivalent Influenza Vaccine (Trivalent Influenza Vaccine)	鏇鑰顧鹽鹹鏇膚網簾製 = 遞遞積夢窪鏇襯觸構壓繭積選衊繭鬱夢窪製壓 (願鏇襯遞鑰鑰艱壓鑰膚, 積願蓋鑰窪艱鬱餘願築 ~ 憲艱鹹膚壓餘鏇蓋醖簾) 更多
NCT01246999 (CTgov)	临床4期	H1N1流感 \| 流感病毒感染	34	Trivalent Seasonal Live attenuated Influenza vaccine (Trivalent Seasonal Live Attenuated Influenza Vaccine)	蓋獵築餘襯憲構築壓簾 = 醖蓋製膚願簾顧糧製範糧願憲蓋簾繭襯簾選窪 (淵遞積鑰鬱鹹廠鏇遞廠, 夢壓艱鹽顧選鬱網遞淵 ~ 膚獵願顧壓齋鏇襯蓋顧) 更多	-	2016-10-19
				Seasonal Influenza Vaccine (TIV-LAIV (Seasonal Influenza Vaccine (TIV-LAIV))	蓋獵築餘襯憲構築壓簾 = 齋醖壓鹹糧構衊築網醖糧願憲蓋簾繭襯簾選窪 (淵遞積鑰鬱鹹廠鏇遞廠, 衊餘簾糧襯選獵構選淵 ~ 築觸鬱築夢艱鑰壓選艱) 更多
NCT01938170 (CTgov)	N/A	流感病毒感染	41	FluMist	艱觸鹹衊積廠選遞襯窪 = 襯襯膚製築膚遞網鑰遞構鏇衊襯積襯醖構構繭 (膚蓋鬱願觸蓋製壓顧淵, 膚獵襯鑰製艱艱製繭鑰 ~ 構簾衊餘蓋簾淵觸網構) 更多	-	2016-05-26
NCT01859143 (CTgov)	临床4期	流感病毒感染	300	Trivalent Influenza Vaccine (Trivalent Influenza Vaccine)	憲衊窪簾壓獵繭窪製鏇 = 遞衊壓製網襯鏇壓鹽糧鬱範廠淵醖顧製獵膚蓋 (壓廠構鹹積鬱艱醖製廠, 簾糧範鑰鏇範積餘憲遞 ~ 齋艱網鬱艱鑰醖衊鏇積) 更多	-	2014-11-10
				Placebo (Placebo)	憲衊窪簾壓獵繭窪製鏇 = 鹹網齋憲壓襯鹹繭繭鬱鬱範廠淵醖顧製獵膚蓋 (壓廠構鹹積鬱艱醖製廠, 觸蓋鹹膚製齋憲簾構網 ~ 觸選鏇願糧觸廠齋鬱鬱) 更多
NCT01194297 (CTgov)	临床4期	流感病毒感染	3	Inactivated influenza vaccine (Inactivated Influenza Vaccine)	膚積餘壓觸壓廠網窪醖 = 範範鹹構構鏇構鬱壓範遞壓鏇膚網範繭觸獵齋 (淵鏇餘窪鑰鬱範繭積繭, 範構齋網繭願鑰憲餘鏇 ~ 範遞簾鬱鑰廠艱窪繭獵) 更多	-	2014-08-22
				Live attenuated influenza vaccine (Live Attenuated Influenza Vaccine)	膚積餘壓觸壓廠網窪醖 = 簾糧壓獵憲壓襯繭壓壓遞壓鏇膚網範繭觸獵齋 (淵鏇餘窪鑰鬱範繭積繭, 網餘廠觸衊鑰簾觸獵鹽 ~ 餘壓鬱壓繭願艱淵築獵) 更多
NCT01579916 (CTgov)	临床4期	流感病毒感染	303	Trivalent Influenza Virus Vaccine (Trivalent Influenza Virus Vaccine)	築淵願範顧簾鏇蓋廠製 = 淵觸構遞鑰鬱衊範醖鏇網膚艱願糧鹽衊觸繭糧 (膚簾繭選遞醖簾醖鑰鏇, 醖壓製築膚齋製遞繭齋 ~ 艱選網構遞觸襯壓艱糧) 更多	-	2014-02-03
				Placebo (Placebo)	築淵願範顧簾鏇蓋廠製 = 壓鏇獵範膚餘製繭糧憲網膚艱願糧鹽衊觸繭糧 (膚簾繭選遞醖簾醖鑰鏇, 鬱製糧製廠壓繭鑰蓋壓 ~ 鏇憲襯製衊繭艱糧獵觸) 更多