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influenza vaccine (Inflexal V / Invivac / Inflexal Berna)

✓ Approved

Johnson & Johnson Services, Inc. · Vaccine · Vaccine

What is influenza vaccine?

influenza vaccine is a vaccine developed by Johnson & Johnson Services, Inc.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection or subcutaneous injection.

Drug Profile

Brand NamesInflexal V, Invivac, Inflexal Berna
CompanyJohnson & Johnson Services, Inc.
Drug ClassVaccine, Large Molecules
RouteInjectable (Others), Intramuscular (IM) Injection, Subcutaneous Injection
StatusApproved
Sources: ClinicalTrials.gov, Johnson & Johnson Services, Inc.

Related Research Articles

PubMedClinical infectious diseases : an official publication of the Infectious Diseases Society of America2026-11-11

People With Influenza Requiring ICU Admission During the 2025-2026 Season, Marked by the Emergence of Influenza A(H3N2) Subclade K: A French Prospective Nationwide Cohort Study.

de Prost Nicolas N, Bay Pierre P, Le Goff Marie M, Préau Sébastien S et al.

Intense influenza activity has been reported alongside the emergence of influenza A(H3N2) subclade K. While epidemiological studies have reported heterogeneous findings regarding public health impact, data remain lacking on its impact on clinical phenotype of people requiring intensive care unit (ICU) admission. Prospective, multicenter, observational SEVARVIR cohort study including people admitted in 42 French ICUs with laboratory-confirmed influenza infection during the 2024-2025 and 2025-2026 seasons. Primary end point was day-28 mortality. Seven hundred twenty-six people were admitted for influenza in 2024-2025 (n = 360) and 2025-2026 (n = 366). In 2025-2026, influenza subtype was available for 265 people; 49% (n = 129) had A(H1N1)pdm09 and 51% (n = 136) had A(H3N2) subtype infection. Among the 40 people with A(H3N2) infection for whom whole-genome sequencing was available, 33 (82.5%) belonged to subclade K. In multivariable Cox analysis of the 2025-2026 season, age (adjusted hazard ratio, aHR = 1.04 [1.01;1.09]; P = .015), Clinical Frailty Scale (aHR = 1.59 [1.28;1.98]; P < .001), and sequential organ failure assessment score (aHR = 1.15 [1.05;1.26]; P = .003) were associated with an increased risk of death. In the 2024-2025/2025-2026 seasons or 2025-2026 season alone, influenza subtype was not associated with a significant risk of day-28 mortality. Phylogenetic analyses from our ICU cohort together with 600 contextual sequences from community-acquired influenza cases collected during the period showed no clustering according to severity. There was no evidence of an increased risk of death among critically ill people with influenza during the 2025-2026 season, despite the emergence of influenza A(H3N2) subclade K. NCT05162508.

PMID 43012657
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PubMedJournal of sleep research2026-11-11

2010 and 2013 Incidence Peaks in Narcolepsy and Idiopathic Hypersomnia Linked to Type A H1N1 and Type B Victoria Influenza Strains.

Zhang Zhongxing Z, Gool Jari K JK, Sirotkin Pavel P, Dauvilliers Yves Y et al.

Increased narcolepsy type-1 (NT1) incidence rates were reported globally in 2010, linked to the H1N1 2009-2010 influenza pandemic and Pandemrix vaccination. A child-specific NT1 peak was observed in Europe in 2013, further raising questions about the relationship between NT1 and influenza infections. This study analysed annual European incidence patterns of central disorders of hypersomnolence (CDH) in relation to influenza severity. All NT1 (N = 981) and a combined group of narcolepsy type-2 (NT2) and idiopathic hypersomnia (IH) (N = 545) cases from eight European centers were studied from 1995 to 2019. Linear mixed models and Spearman correlations were applied to investigate the relationships between CDH incidence and the severity of preceding influenza seasons, including H1N1, H3N2, and for the Netherlands, influenza Type B Victoria and Yamagata. Peaks in NT1 incidence were present in 2010 and 2013, while a 2010 child-specific peak was identified in NT2 and IH. Both groups showed a significantly positive correlation with H1N1 influenza severity and a negative correlation with H3N2. NT1 was also significantly associated with influenza Type B Victoria in the Netherlands, particularly in children. These findings suggest that, beyond H1N1, influenza Type B Victoria may be a novel trigger for NT1. Similar to NT1, the 2010 children peak in NT2 and IH may indicate possible immune-related pathophysiologies linked to the 2009-2010 H1N1 pandemic. Further immunological studies are warranted to unravel the complexities of these relationships and their implications for CDH.

PMID 43012367
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PubMedMedComm2026-11-11

Therapeutic and Prophylactic Agents for Viral Diseases: Current Status, Challenges, and Future Prospects.

Khan Sawar S, Nisar Ayesha A, Li Xiaoxu X, Yu Hao H et al.

Viral diseases remain a major global health challenge despite substantial advances in vaccination, antiviral therapeutics, and public-health interventions. However, current antiviral strategies are still constrained by important gaps, including rapid viral evolution, limited broad-spectrum efficacy, immune escape, antiviral resistance, incomplete durability of protection, and inequitable global access to prevention and treatment. This review provides a comprehensive and integrated overview of contemporary antiviral prevention and therapeutic strategies, spanning vaccines, monoclonal antibodies, direct-acting antivirals, host-targeted therapies, immunomodulators, RNA-based therapeutics, gene-editing technologies, and cellular immunotherapies. We discuss the mechanistic foundations, clinical applications, pharmacologic considerations, and translational challenges associated with each modality across major human viral pathogens, including HIV, HBV, HCV, influenza, SARS-CoV-2, RSV, Ebola virus, arboviruses, and herpesviruses. Particular emphasis is placed on emerging innovations such as long-acting prophylaxis, Fc-engineered monoclonal antibodies, nanoparticle and mucosal vaccine platforms, CRISPR-based antiviral systems, and broadly protective host-directed approaches designed to overcome resistance and enhance pandemic preparedness. In addition, we highlight the growing importance of real-time genomic surveillance and equitable global deployment strategies in shaping future antiviral responses, collectively underscoring that the next generation of antiviral medicine will depend on the convergence of universal immunization strategies, durable therapeutics, precision immune modulation, and rapidly deployable platform technologies capable of addressing both endemic and emerging viral threats.

PMID 43011527
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PubMedBMC infectious diseases2026-11-11

Early oseltamivir initiation and influenza outcomes in kidney transplant recipients: a multicenter real-world study.

Zhou Yongting Y, Yu Liang L, Wang Jianping J, Hou Wenjing W et al.

Influenza infection poses a significant clinical threat to kidney transplant recipients due to their immunocompromised status. Although current guidelines recommend early antiviral therapy, real-world evidence supporting the effectiveness of oseltamivir, particularly regarding the optimal timing of initiation in this vulnerable population remains scarce. To identify independent factors associated with clinical improvement and time to symptom resolution in kidney transplant recipients infected with the influenza virus and treated with oseltamivir. We conducted a multicenter retrospective study enrolling adult kidney transplant recipients diagnosed with influenza virus infection across five centers between October 2023 and March 2024. Clinical outcomes were assessed using a validated Composite Symptom Score (range: 0-21) based on seven typical influenza symptoms. Clinical improvement was defined as achieving a score of ≤ 1 on the fifth day after oseltamivir initiation. Univariable and multivariable logistic regression analyses were performed to identify factors independently associated with clinical improvement, and linear regression was used to evaluate factors influencing time to symptom resolution. Given the small number of events, the multivariable logistic model was estimated using Firth's penalized likelihood method and restricted to two core predictors. A total of 58 kidney transplant recipients were included. After one course of oseltamivir, 46 patients (79.3%) achieved clinical improvement. Compared with the improved group, patients without improvement had a significantly lower rate of early oseltamivir initiation (≤ 48 h: 58.3% vs. 84.8%, P = 0.044) and tended to present with higher baseline symptom scores. In multivariable logistic regression, oseltamivir initiation > 48 h was the only factor independently and significantly associated with reduced likelihood of clinical improvement (adjusted OR = 0.16, 95% CI: 0.03-0.76, P = 0.030), after adjusting for onset symptom score using Firth's penalized likelihood logistic regression to account for the small number of events. Higher baseline onset symptom score was also significantly associated with unfavorable outcomes (adjusted OR = 0.77, 95% CI: 0.63-0.91, P = 0.007). Consistently, multivariable linear regression confirmed that late oseltamivir initiation was independently associated with prolonged time to symptom resolution (β = 5.02, 95% CI: 3.00-7.04, P < 0.001). Neither dosage adjustment nor treatment duration extension was significantly associated with clinical outcomes. In this multicenter real-world study, early oseltamivir initiation (≤ 48 h) was the strongest independent predictor of both clinical improvement and a shorter symptom resolution time in kidney transplant recipients with influenza. Baseline disease severity showed a trend-level association with unfavorable outcomes, suggesting a narrowing "window of opportunity" for a therapeutic response in patients with a higher symptom burden. These findings reinforce the critical importance of prompt antiviral intervention in immunocompromised transplant recipients and provide real-world evidence to support clinical decision-making for early treatment prioritization.

PMID 43009834
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PubMedClinical pharmacology and therapeutics2026-11-11

Antiviral Activity and Safety of Molnupiravir in Healthy Participants Inoculated With Influenza Virus: A Phase 2a, Randomized, Human Challenge Trial.

Nussbaum Jesse J, Mann Alex J AJ, Liao Laura E LE, Zhao Tian T et al.

Influenza viruses cause substantial global morbidity and mortality. Molnupiravir, an orally administered prodrug of β-D-N4-hydroxycytidine, has broad activity against RNA viruses, including influenza. A phase 2a, randomized, two-part human challenge trial in healthy adults (NCT05818124) was conducted to evaluate molnupiravir for influenza infection. In Part 1, 20 participants were inoculated with 106.26TCID50 of A/France/759/21 (H1N1) to establish infectivity, pathogenicity, and safety. After assessment of Part 1, a 10-fold lower virus dose was selected for Part 2 to delay time to peak viral load (PVL). In Part 2, 141 participants were randomized 1:1:1:1 to receive molnupiravir (5 days, 800 mg twice daily) postexposure prophylaxis (PEP; initiated 12 hours after inoculation), molnupiravir treatment (initiated 48 hours after inoculation), oseltamivir treatment (5 days, 75 mg twice daily, initiated 48 hours after inoculation), or placebo. Primary endpoints, assessed by quantitative viral culture, were PVL in all participants for PEP and viral load area under the curve (VL-AUC) in participants with confirmed infection for treatment. Lowering the viral inoculum delayed PVL by ~12 hours, although infection rates in the Part 2 placebo arm (40%) were lower than in Part 1 (75%). Molnupiravir PEP did not significantly reduce PVL compared with placebo but was associated with lower viral burden (difference in mean log10 VL-AUC -2.21 day*log10TCID50/mL; P = 0.03). No significant antiviral effect was observed with molnupiravir or oseltamivir treatment compared with placebo. Molnupiravir was well tolerated, with an adverse event profile similar to placebo. Although primary endpoints were not met, early administration of molnupiravir showed antiviral activity.

PMID 43010566
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PubMedNPJ vaccines2026-11-11

A structure-guided trivalent subunit vaccine confers maternal protection to neonatal piglets against PEDV and PDCoV.

Liu Jia J, Chen Longping L, Li Dan D, Wang Zhuo Z et al.

Antigenic divergence among porcine epidemic diarrhea virus (PEDV) genotypes and porcine deltacoronavirus (PDCoV) limits the cross-protection provided by current commercial vaccines. Here, employing a structure-guided antigen design strategy, we developed a trivalent subunit vaccine concurrently targeting PEDV G2a, PEDV G2b, and PDCoV. The vaccine antigen set comprises optimized spike ectodomain antigens, featuring stabilizing mutations, a heptad repeat 2 (HR2) deletion, a fused neutralizing epitope, and a flagellin adjuvant fused to the N-terminus. Formulated with MF59+CpG adjuvants, this trivalent vaccine elicited robust PEDV- and PDCoV-specific neutralizing antibody responses and Th1/Th2-associated cellular immune responses characterized by IFN-γ, IL-2, and IL-4 production in mice. Immunization of pregnant sows with 300 μg dose induced high-titer IgG, IgA, and colostral secretory IgA (SIgA) against all three target viruses. Although neutralizing antibody titers were comparable between the 100 μg and 300 μg dose groups, the 300 μg group showed higher and more persistent levels of colostral binding IgG and SIgA. Following maternal immunization, piglets that acquired maternal antibodies through colostrum exhibited reduced clinical diarrhea, lower fecal viral RNA shedding, and less severe intestinal lesions after challenge with PEDV G2a, PEDV G2b, or PDCoV. These findings support this structure-guided trivalent subunit vaccine as a promising candidate for maternal immunization against co-circulating porcine enteric coronaviruses.

PMID 43009510
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