Author: Duarte, Rener Mateus Francisco ; Spini, Vanessa Beatriz Monteiro Galassi ; Espindola, Foued Salmen ; Ribeiro-Barbosa, Erika Renata ; Ferreira, Frederico Rogério

Evidence suggests that prenatal maternal immunological stress is associated with an increased risk of neurological and psychiatric disorders in the developing offspring. Protecting the embryo during this critical period of neurodevelopment, when the brain is especially vulnerable, is therefore crucial. Polyphenols, with their antioxidant and anti-inflammatory properties, offer promising therapeutic approaches. This study demonstrated a series of behavioral changes induced by maternal immune activation (MIA) triggered by an antigenic solution derived from the H1N1 virus. These changes include significant differences in anxiety and risk assessment behaviors, increased immobility in the forced swim test, impairments in memory and object recognition, and social deficits resembling autism. The phenolic compound resveratrol (RSV) was evaluated for its in vitro antioxidant capacity and characterized using infrared spectroscopy. Administering RSV from embryonic day 14 (E14) to embrionyc day 19 (E19) during MIA effectively reduced its harmful effects on the offspring. This was evidenced by a significant restoration of social behaviors, memory, and recognition, as well as anxiolytic and antidepressant effects in the adult offspring. These findings contribute to new therapeutic strategies for preventing psychiatric disorders associated with neurodevelopmental stressors.

01 Jan 2025·Vaccine

Safety and immunogenicity of the Ad26/protein preF RSV vaccine in adults aged 18 to 59 years with and without at-risk comorbidities for severe respiratory syncytial virus disease: A phase 3, randomized, controlled, immunobridging trial

Article

Author: Yuste, Angela Cano ; Sotolongo, Roberto ; Schenkenberger, Isabelle ; Gymnopoulou, Efi ; Bastian, Arangassery Rosemary ; Buntinx, Erik ; Salas, Jose ; Askling, Helena H ; Von Engelhardt, Charlotte ; Callendret, Benoit ; Smith, William ; Heijnen, Esther ; Jastorff, Archana ; Comeaux, Christy ; Askling, Helena H. ; Ligtenberg, Nynke ; Merrall, Elizabeth ; Martin, Charlotte

BACKGROUNDRespiratory syncytial virus (RSV) causes a significant disease burden in adults with chronic comorbidities. Rates of severe RSV disease and death are as high, or higher in younger adults with risk factors than in healthy older adults in whom RSV vaccination is recommended. We conducted an immunobridging study using the Ad26/protein RSV preF vaccine, which previously demonstrated efficacy in adults aged ≥65 years to support extrapolation of efficacy demonstrated in an older population to younger adult populations at high risk of severe RSV disease.METHODSThis Phase 3 randomized, double-blind, placebo-controlled trial assessed the safety/tolerability and immunogenicity of Ad26/protein preF RSV in adults aged 18-59 years without (Cohort 1) and with (Cohort 2) chronic cardiac or pulmonary comorbidities, compared to adults aged ≥65 years (Cohort 3) in whom efficacy against RSV disease was demonstrated. Humoral and cellular immune responses were assessed at baseline, Days 15 and 183. Reactogenicity and safety were assessed in all participants.RESULTS1118 participants were enrolled (Cohort 1: 387; Cohort 2: 388; Cohort 3: 343). Compared to adults aged ≥65 years RSV neutralizing antibody titers were non-inferior in adults aged 18-59 years, including those at high risk. Levels of pre-F A IgG antibodies and frequencies of RSV-F specific interferon-gamma T-cells increased by Day 15 post-vaccination, and remained above baseline for at least 6 months in all cohorts. Reactogenicity and safety were clinically acceptable but age-dependent, with higher rates of Grade 3 systemic adverse events in adults aged 18-59-years than adults ≥65 years.CONCLUSIONAd26/protein preF RSV vaccine induced robust humoral and cellular immune responses in adults aged 18-59 years with or without chronic cardiac or pulmonary comorbidities, of similar magnitude to responses in older adults, allowing inference of efficacy and protection against RSV-associated respiratory disease in this population. www.CLINICALTRIALSgovNCT05070546.

31 Dec 2024·Expert Review of Vaccines

Cost-effectiveness analysis of respiratory syncytial virus vaccination with the adjuvanted prefusion F protein vaccine (RSVPreF3 OA) for adults ≥60 years old in Japan

Article

Author: Matsuki, Taizo ; Verelst, Frederik ; Ho, Yufan ; Mizukami, Akiko ; Molnar, Daniel ; Kurai, Daisuke ; Preckler, Victor

OBJECTIVESOlder adults (OA) are at risk of morbidity and mortality from respiratory syncytial virus (RSV), a major cause of seasonal acute respiratory illness. The first RSV vaccine for OA (RSVPreF3 OA) was recently launched in Japan. With the already large and growing OA population in Japan, and limited RSV treatments, prevention is key. The aim of this study was to assess the cost-effectiveness of introducing RSVPreF3 OA for Japanese adults aged ≥60 years.METHODSA static multicohort Markov model was adapted to assess the cost-effectiveness of a single dose of RSVPreF3 OA versus no vaccination over a three-year time horizon. Deterministic and probabilistic sensitivity analyses were conducted to assess parameter uncertainty.RESULTSRSVPreF3 OA vaccination prevented 1,008,499 cases and 6,840 deaths, with 109,119 quality-adjusted life-years (QALYs) gained. The incremental cost-effectiveness ratio was Japanese yen (JPY) 4,180,084/QALY gained from a payer perspective and JPY 4,041,917/QALY gained from a societal perspective (with productivity loss from RSV disease), thus vaccination was considered cost-effective. Base case results were robust to changes in sensitivity and scenario analyses.CONCLUSIONSRSVPreF3 OA vaccination for adults ≥60 years can provide substantial health benefits and is a cost-effective intervention to reduce the RSV burden in Japan.

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News (Medical) associated with Respiratory syncytial virus vaccine(Okairos AG)

06 Nov 2024

·www.pharmaceutical-technology.com

GSK’s RSV vaccine approved in Canada for adults aged 50 to 59

The vaccine was previously approved in Canada for adults aged 60 and over. Credit: MargJohnsonVA/Shutterstock. GlaxoSmithKline (GSK) has received approval for its vaccine, AREXVY, in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50 to 59 at increased risk for the disease. This expanded age indication approval stems from the positive outcomes of a Phase III, placebo-controlled, observer-blind, randomised, multi-country immunogenicity trial. The study evaluated the immune response and safety of the RSV vaccine in adults aged 50 to 59 and those with underlying medical conditions at increased risk for RSV-LRTD. Regulatory submissions have also been made by the company to prolong the use of the vaccine to the same age group in Japan and other regions. The decisions are currently under review by the respective regulatory bodies. Further trials are underway to assess the vaccine’s immunogenicity and safety in adults aged 18 to 49 at increased risk, and immunocompromised adults aged 18 and above. The outcomes will be announced in late 2024. AREXVY was previously approved in Canada for use in adults aged 60 and above. It is recommended by the National Advisory Committee on Immunization (NACI) for all adults aged 75 and over, and for those in nursing homes and chronic care facilities aged 60 and older. NACI also suggests that adults aged 60 to 74 may consider RSV vaccination after consulting with a healthcare provider. The approval of AREXVY’s expanded age indication in Canada aligns with similar approvals in the European Union (EU) and the US. GSK interim country medical director Michelle Horn stated: “The natural age-related decline in immune function we all experience, which can increase our vulnerability to viruses like RSV, becomes more evident the older we get. “Not surprisingly, the incidence of RSV-associated hospitalisations in adults starts to increase at the age of 50. For adults with underlying medical conditions, RSV can worsen these conditions and lead to serious consequences.” GSK recently agreed to acquire Chimagen Biosciences’ CMG1A46, designed to target B cell-driven autoimmune diseases.

Drug ApprovalPhase 3VaccineClinical ResultImmunotherapy

04 Nov 2024

·endpts.com

BioNTech eases 2024 revenue outlook despite hefty Covid vaccine third-quarter sales

Despite strong third-quarter revenues, BioNTech has softened its 2024 sales guidance in light of changes to Covid-19 vaccine uptake, pricing and seasonal variations. The company’s €1.2 billion ($1.3 billion) in Q3 revenues significantly beat analyst consensus estimates of €439 million ($478 million). But BioNTech said that it expects its total 2024 revenue to sit at the lower end of the €2.5 billion ($2.7 billion) to €3.1 billion ($3.4 billion) range. The adjustment partly “reflects some risk of write-downs and other charges by our collaboration with Pfizer,” chief financial officer Jens Holstein said on its earnings call Monday. BioNTech’s Covid partner Pfizer has projected $5 billion in full-year sales for the vaccine. And last week, Pfizer upped its guidance for 2024 by $1.5 billion due to its Covid prophylactic antibody Paxlovid. Late last month, TD Cowen analysts said Covid vaccine sales would likely lag this year due to “Covid fatigue,” adding that the potential for growth in upcoming years is also uncertain. The strong quarter for BioNTech’s Covid vaccine was somewhat foreshadowed last week. GSK reported that sales of its RSV vaccine dropped 72% from the same time in 2023, with CEO Emma Walmsley partially attributing the dip to the prioritization of Covid vaccinations over those for RSV. BioNTech has been working to diversify its pipeline beyond vaccines. The company is particularly focused on oncology, where it is advancing mRNA-based candidates alongside other modalities, such as its PD-L1xVEGF bispecific antibody .

VaccinemRNAEmergency Use Authorization

30 Oct 2024

·endpts.com

GSK remains ‘very confident’ in RSV vaccine amid competition, sales slump

Competition is heating up in the RSV space, despite a lukewarm quarter for vaccine uptake. Pfizer beat GSK’s Arexvy for the first time in the third quarter, as Arexvy sales dipped 72% from the year prior. GSK attributed the slide to “changes in ACIP guidelines, prioritization of Covid-19 vaccinations in the quarter, lower seasonal infections and a tough comparator following launch stocking last year.” Despite a strong launch, Arexvy generated just £188 million in Q3 sales, or about $244 million, compared to $356 million for Pfizer’s Abrysvo. GSK’s stock $GSK was down nearly 4% early Wednesday morning. Nonetheless, CEO Emma Walmsley touted GSK’s “very strong market share.” The company reported on Wednesday in its third-quarter earnings that Arexvy maintains about two-thirds of retail market share year-to-date. RSV vaccine uptake this year has been sluggish overall , with Jefferies analysts reporting earlier this month that just 900,000 prescriptions have been issued compared to 1.5 million at this time last year. Moderna will report the first sales figures for its rival mResvia next week. GSK lowered its overall vaccine guidance for the second time this year, now anticipating vaccine sales to decrease by a low single-digit percentage. Sales for its shingles vaccine Shingrix were also down 7% last quarter due to lower demand in the US. Walmsley told reporters that she remains “very confident” in Arexvy’s growth prospects, even with “some pressure short-term.” The company faced a setback in June, when the CDC’s Advisory Committee on Immunization Practices declined to recommend vaccination for people aged 50 to 59, a key group where GSK hopes to expand. “We are truly in the early days of this vaccine,” Walmsley said. “We are in the foothills of geographic expansion. Eighty percent of the consumers for whom ACIP do recommend a vaccine still haven’t yet been vaccinated, so there’s more room for penetration.”

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Indication	Highest Phase	Country/Location	Organization	Date
Respiratory Syncytial Virus Infections	Discovery	GB	Reithera Srl	01 May 2013

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