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.

Start Date03 Oct 2022

Sponsor / Collaborator

The University of North Carolina at Chapel Hill

[+1]

NCT04110366

/ CompletedNot ApplicableIIT

Kinetics of Mucosal and Systemic Immune Responses to Intranasal Live Attenuated Influenza Vaccine (LAIV)

Intranasal live attenuated influenza vaccine (LAIV; trade name FluMist/Fluenz-Tetra, manufactured by AstraZeneca/Medimmune) is the standard influenza vaccine given to children aged 2-17 years of age in the UK. It is also licensed to be given to adults up to the age of 49 years in the USA. The systems biology of the human blood response to influenza vaccines has been studied in great detail, but there is a paramount need to study innate and specific, soluble and cellular immune responses at the nasal mucosal site of influenza infection. In this way this study aims to determine correlates of efficacy and vaccine take in serum and nasal mucosal lining fluid (MLF).

Start Date14 Jun 2018

Sponsor / Collaborator

Imperial College Healthcare NHS Trust

NCT03143101

/ CompletedPhase 4

A Phase 4 Double-blind Study to Evaluate the Shedding and Immunogenicity of Trivalent and Quadrivalent Formulations of FluMist in Children 24 to < 48 Months of Age

This study is being conducted to compare the immunogenicity, safety, and viral shedding of a new A/H1N1 strain that will be incorporated into the FluMist quadrivalent formulation for the 2017-2018 influenza season with the previous A/H1N1 strain that was included in the vaccine in the 2015-2016 influenza season.

Start Date08 May 2017

Sponsor / Collaborator

MedImmune LLC

[+1]

100 Clinical Results associated with Influenza vaccine live(MedImmune LLC)

100 Translational Medicine associated with Influenza vaccine live(MedImmune LLC)

100 Patents (Medical) associated with Influenza vaccine live(MedImmune LLC)

969

Literatures (Medical) associated with Influenza vaccine live(MedImmune LLC)

01 Jun 2025·CLINICAL PEDIATRICS

Factors Associated With Repeat Pediatric Influenza Vaccination Among Inconsistent Vaccinators

Article

Author: Abraham, Claire ; Walsh, Kathleen E. ; Galbraith, Alison A. ; Hickingbotham, Madison R. ; Gilkey, Melissa B.

Promoting consistent vaccination practices may help improve suboptimal influenza vaccination rates. This study evaluated the prevalence and correlates of repeat influenza (flu) vaccination among children who had previously received the vaccine inconsistently. An online survey study was conducted in 2022 among parents of commercially insured children ages 3 to 19 years who were previously inconsistently vaccinated. Of 317 respondents, 85% reported that their child received a flu vaccine in the 2021 to 2022 flu season. Among these parents, 61% reported concern that their child would get sick from flu as the most important reason for vaccinating. Repeat vaccination was less likely among parents who reported that school/daycare requirements were a reason for vaccinating in the prior season (odd ratio [OR] = 0.17, 95% confidence interval [CI] = 0.05-0.55). Our findings suggest that school policies may improve vaccination rates among inconsistent vaccinators.

01 Jun 2025·VACCINE

Practice, beliefs and intent in influenza vaccination among Hispanic patients during the pandemic: An interventional study

Article

Author: Villarreal, Norma ; Castañeda, Heide ; Sherls-Jones, Jamilia ; Smith, Cynthia ; LaSalle, Gretchen ; Mou, Jin ; Mays, Jessica ; Pflugeisen, Chaya ; Zaragoza, Gerson

BACKGROUND:

The largest minority in the United States, Hispanic populations are also one of the least vaccinated groups. Promoting vaccine confidence and uptake among Hispanics is critical to reducing health inequalities.

METHODS:

We investigated the effectiveness of an intervention that combined a bilingual flu vaccine brochure plus culturally tailored, primary care physician (PCP) led influenza vaccination Question and Answer (Q&A) videos. We measured patients' vaccination attitudes/beliefs, practices, and intentions.

RESULTS:

In total, 693 Hispanic patients participated in the baseline survey and 199 took the follow-up survey. At baseline, 32.7 % did not get the flu vaccine in the previous flu season. Disagreement of or feeling unsure about the statement "vaccines are a good thing" was 20.2 %. Univariate analysis showed that lower household income was negatively associated with patients' flu vaccine uptake (55.7 % with < $75,000 household income vs. 66.7 % with $75,000 or above, p = 0.04). After the intervention, 78.4 % agreed or strongly agreed that they would get the flu vaccine, compared to 50.3 % at baseline. Also, 87.4 % of the respondents agreed or strongly agreed that "vaccines are a good thing" and 39.6 % have improved vaccine beliefs. Of all who didn't get a flu vaccine, 54.5 % agreed or strongly agreed to get one in the next season; and of those who didn't get a COVID vaccine at baseline, 38.5 % would like to get a flu vaccine in the future. Regarding positive changes on flu vaccination intent, the intervention worked the best among those who had never graduated high schools (Odds Ratio (OR) = 16.72, 95 %CI: 2.44-114.71, p = 0.004) and those whose beliefs in vaccines increased following the intervention (OR = 3.57, 95 %CI: 1.03-12.38, p = 0.045).

CONCLUSIONS:

A low-cost physician-led, culturally tailored, bilingual, and low-cost intervention improved Hispanic patients' positive vaccine beliefs and intent to be vaccinated.

12 May 2025·Journal of the American Medical Directors Association

Which Enhanced Influenza Vaccine Has the Greatest Immunogenicity in Long-Term Care Residents: The Adjuvanted or the High-Dose Formulation?

Article

Author: Wilson, Brigid M ; Buss, Emily ; Didion, Elise M ; Wilk, Dennis J ; Kass, Joseph D ; Canaday, David H ; Frischmann, Sarah-Michelle ; Banks, Richard ; Gravenstein, Stefan ; Rubeck, Sabina

OBJECTIVES:

This study compares enhanced influenza vaccines recommended for older adults, adjuvanted flu vaccine (aTIV, FLUAD) vs high-dose flu vaccine (HD-IIV3, FLUZONE HD) to determine if they met noninferiority standards for older long-term care facility (LTCF) residents.

DESIGN:

A phase 4, randomized, active-controlled, noninferiority trial on influenza vaccine immunogenicity conducted over 2 influenza seasons (2018-2019 and 2019-2020) (NCT03694808).

SETTING AND PARTICIPANTS:

Residents of LTCFs ≥65 years of age.

METHODS:

Participants were randomized 1:1 to receive either aTIV or HD-IIV3 using computer-generated randomization. Only laboratory personnel were blinded. Hemagglutination inhibition (HAI) and neuraminidase inhibition (NI) assays measured antibody responses at baseline and 28 days postvaccination. The primary outcome compared the geometric mean titers (GMTs) at day 28. Secondary outcomes included seroconversion rates and NI titers.

RESULTS:

We randomized 387 LTCF residents to receive either aTIV (n = 194) or HD-IIV3 (n = 193) over 2 flu seasons. We observed noninferior HAI levels at postvaccination day 28 to A/H1N1 and A/H3N2 for aTIV and HD-IIV3 (GMT ratio, 1.03; 95% CI, 0.76-1.4; and GMT ratio, 1.04; 95% CI, 0.73-1.48, respectively), meeting noninferiority criteria with 95% CI upper bounds <1.5. However, noninferiority criteria were not met for influenza B HAI levels (GMT ratio, 1.21; 95% CI, 0.91-1.61). Also, noninferiority criteria for HAI seroconversion were not met for any of the 3 strains. Applying the same noninferiority criteria to NI, both day 28 titer and seroconversion in aTIV were noninferior to HD-IIV3 for A/H1N1 and A/H3N2 strains.

CONCLUSIONS AND IMPLICATIONS:

Overall the antihemagglutinin and antineuraminidase titers demonstrate similarities between the vaccines and support them both being in the enhanced flu vaccine category preferentially recommended by the Centers for Disease Control and Prevention for people >65 years of age.

107

News (Medical) associated with Influenza vaccine live(MedImmune LLC)

08 Apr 2025

·www.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

VaccineDrug ApprovalImmunotherapyClinical StudymRNA

19 Mar 2025

·www.biospace.com

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.

Drug ApprovalAcquisitionVaccineIPO

28 Feb 2025

·www.drugs.com

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.

Vaccine

100 Deals associated with Influenza vaccine live(MedImmune LLC)

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KEGG	Wiki	ATC	Drug Bank
-	Influenza vaccine live(MedImmune LLC)	J07BB03	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Influenza, Human	European Union	MedImmune LLC	27 Jan 2011
Influenza, Human	Iceland	MedImmune LLC	27 Jan 2011
Influenza, Human	Liechtenstein	MedImmune LLC	27 Jan 2011
Influenza, Human	Norway	MedImmune LLC	27 Jan 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Asthma	Phase 3	Belgium	MedImmune LLC	01 Oct 2002
Recurrent respiratory tract infections	Phase 3	Israel	MedImmune LLC	01 Oct 2002
Recurrent respiratory tract infections	Phase 3	Spain	MedImmune LLC	01 Oct 2002
Chickenpox	Phase 3	-	MedImmune LLC	01 Dec 2000
Measles	Phase 3	-	MedImmune LLC	01 Dec 2000
Mumps	Phase 3	-	MedImmune LLC	01 Dec 2000
Rubella	Phase 3	-	MedImmune LLC	01 Dec 2000
Hematologic Neoplasms	Phase 1	United States	MedImmune LLC	01 Aug 2005
Neoplasms	Phase 1	United States	MedImmune LLC	01 Aug 2005
Solid tumor	Phase 1	United States	MedImmune LLC	01 Aug 2005

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04110366 (Flu-M3, CTgov)	Not Applicable	Influenza, Human	48	Live attenuated influenza vaccine (Live Attenuated Influenza Vaccine)	dvjbbfgcvz = pjqcuvzhae jscqjgfqxr (kmyvcpvswh, zzhdlaniep - cxydivrlqz) View more	-	06 Dec 2021
				Vehicle Control (Mucosal Immune Stability Cohort)	dutwljhfeo(avfzyhochk) = brqqmkryzt sbtxpatfzt (doauytjmds, qpzuwcpdiz - bydjmqdwfr) View more
NCT03143101 (FluMist, CTgov)	Phase 4	Influenza, Human	200	FluMist trivalent (FluMist Trivalent (2015-2016))	cztrpsjqfm = xevjvpxuct bxfbfmgojw (ibmtxeszuy, zzdlnzubwe - fpvfwrhevp) View more	-	11 Dec 2018
				FluMist Quadrivalent (FluMist Quadrivalent (2015-2016))	cztrpsjqfm = rpzpkctoim bxfbfmgojw (ibmtxeszuy, wkxydugueo - lcgtbuviyi) View more
NCT00138294 (CEI, CTgov)	Phase 4	Influenza, Human	29,255	Influenza virus vaccine(Sanofi)+Influenza vaccine live(MedImmune LLC) (Intervention Cities)	pxkxzmizdy = paptrclxfc ehxaczynlc (cqgqdsmmhx, swwmtomylu - ayaaudzuwn) View more	-	19 May 2017
				Influenza virus vaccine(Sanofi)+Influenza vaccine live(MedImmune LLC) (Comparison Cities)	pxkxzmizdy = xkauestyca ehxaczynlc (cqgqdsmmhx, uetgqzjlyg - kfdvdolejj) View more
NCT03022435 (CTgov)	Phase 4	Influenza, Human	22	LAIV (Group B: 18-30 yo Identical Twins (LAIV))	oiftlmjppj = lhfwjznnks qcbjzccupx (yyokzfrrvi, bntyvpsqeb - ayxgbgulau) View more	-	09 Mar 2017
				TIV (Group B: 18-30 yo Identical Twins (TIV))	oiftlmjppj = pucjdrcywl qcbjzccupx (yyokzfrrvi, puopfgfzzo - eoyjnjcrgg) View more
NCT02473510 (FluMist, CTgov)	Phase 4	Influenza, Human	301	Placebo (Placebo)	mkxqlanlms = dhxmlsucha oprbxxjpoh (dyazanjwjo, tsbhfoyjtw - yeejdemhue) View more	-	28 Nov 2016
				Trivalent Influenza Vaccine (Trivalent Influenza Vaccine)	mkxqlanlms = pdletwlmax oprbxxjpoh (dyazanjwjo, xlbzazhjjc - fdvpyqmpww) View more
NCT01246999 (CTgov)	Phase 4	influenza A subtype H1N1 infection \| Influenza, Human	34	Trivalent Seasonal Live attenuated Influenza vaccine (Trivalent Seasonal Live Attenuated Influenza Vaccine)	oapwxozwnp = fvuyqshgqn ahtabdmefb (ljpgowaglu, rwewgwvllp - uzvxdnrzpm) View more	-	19 Oct 2016
				Seasonal Influenza Vaccine (TIV-LAIV (Seasonal Influenza Vaccine (TIV-LAIV))	oapwxozwnp = evxmbdjuds ahtabdmefb (ljpgowaglu, awtduqfbgw - nernzvkfqa) View more
NCT01938170 (CTgov)	Not Applicable	Influenza, Human	41	FluMist	uvpsfjqlvi = yprklanmpo zcorljxzmh (qjfqtzrdgr, aobojfgjil - qeairqigoa) View more	-	26 May 2016
NCT01859143 (CTgov)	Phase 4	Influenza, Human	300	Trivalent Influenza Vaccine (Trivalent Influenza Vaccine)	egqobqbfeo = umenhqoudz vcxujhaegj (thqzizcpjt, kcrbkiivrl - ncyoarewwx) View more	-	10 Nov 2014
				Placebo (Placebo)	egqobqbfeo = nhaldubbgn vcxujhaegj (thqzizcpjt, ydkrrhsplw - dqpmatjewu) View more
NCT01194297 (CTgov)	Phase 4	Influenza, Human	3	Inactivated influenza vaccine (Inactivated Influenza Vaccine)	vknglgljoc = ovjssfxuvc urkkkwgajq (mredwhhwjy, fxjctkwcmx - nuudqluapr) View more	-	22 Aug 2014
				Live attenuated influenza vaccine (Live Attenuated Influenza Vaccine)	vknglgljoc = kudlucykze urkkkwgajq (mredwhhwjy, zxdwyivhsh - ykzadybycm) View more
NCT01579916 (CTgov)	Phase 4	Influenza, Human	303	Trivalent Influenza Virus Vaccine (Trivalent Influenza Virus Vaccine)	wdldxeuiav = ucfsihelga phshzcqvgc (zjuxctnuoe, kzvdvrhzly - kavodhdgsh) View more	-	03 Feb 2014
				Placebo (Placebo)	wdldxeuiav = vtuvjlronv phshzcqvgc (zjuxctnuoe, mjzqvcjphc - cfdjvqirvc) View more

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