The aim of this study was to clarify whether Protein kinase B (PKB)/AKT is nitrated in myocardial ischemia and reperfusion injury (MIRI) resveratrol (RSV)'s protective effect during this process.

METHODS:

We blocked blood flow of the left coronary artery (LAD) of mice and used H9c2 cells under an oxygen-glucose deprivation (OGD) environment as animal and cell models of MIRI. N-methyl-D-aspartic acid receptor (NMDAR) inhibitor MK801, neuronal nitric oxide synthase (nNOS) inhibitor 7-NI and RSV were used as interventions. Nitration of proteins, infarction area, cardiomyocyte apoptosis and AKT nitration sites were detected during this study.

RESULTS:

During in-vivo study, AKT nitration was induced through the NMDAR/nNOS/peroxynitrite (ONOO^-) pathway, leading to decreased phosphorylation of AKT and increased cardiomyocyte apoptosis. AKT nitration was decreased and phosphorylation was elevated when administrated with RSV, MK801 and 7-NI. In in-vitro study, AKT nitration and TUNEL positive cells was elevated when administrated with NO donor H9c2 cells after OGD/R, when administrated with RSV, MK801 and 7-NI, AKT nitration and apoptosis was deceased in H9c2 cells. Mass spectrometry revealed that nitration sites of AKT included 14 Tyrosine residues.

DISCUSSION:

RSV could inhibit AKT nitration and elevated phosphorylation through suppressing NMDAR/nNOS/ONOO^- pathway and further reduce the apoptosis of cardiomyocytes in of myocardial I/R.

31 Dec 2024·Human vaccines & immunotherapeutics

Perceptions about respiratory syncytial virus (RSV) and attitudes toward the RSV vaccine among the general public in China: A cross-sectional survey

Article

Author: Yang, Liuqing ; Wang, Qiang ; Lin, Leesa ; Xiu, Shixin ; Wang, Xuwen ; Shen, Yuan ; Yang, Min ; Wang, Weibing ; Li, Lan

Our study aims to assess the public's perceptions of respiratory syncytial virus (RSV) and attitudes toward the RSV vaccine and to identify associated factors in China. A nationwide cross-sectional survey conducted using an online platform between August 16 and September 14, 2023. Questions related to socio-demographics, awareness, knowledge, perceptions of susceptibility and severity of RSV, and attitudes toward the RSV vaccine were included in the questionnaire. We used the chi-square test and logistic regression model to explore the associated factors. Overall, 2133 individuals were included in this study. Nearly a quarter of participants (24.3%) indicated that they had never heard of RSV. The proportion of individuals aged over 50 years reporting never having heard of RSV (36.5%) and having a low knowledge level of RSV (55.3%) was significantly higher that of other younger age groups. More than half of individuals (55.7%) exhibited low level of perceptions of susceptibility concerning RSV infection. A total of 68.4% of the participants expressed willingness to receive the RSV vaccine. Younger age was positively associated with a higher willingness to be vaccinated. The most frequent reason for declining the vaccine was "Concern about vaccine's safety or side effects." About 60% of individuals considered a price of RSV vaccine below 200 CNY (28 USD) as acceptable. The awareness and perceived susceptibility to RSV infection were limited to the Chinese public. It is necessary to take measures to address the low awareness and knowledge of RSV and acceptability of the RSV vaccine among older adults.

31 Dec 2024·Journal of medical economics

A cost-consequence analysis of the Xpert Xpress CoV-2/Flu/RSV plus test strategy for the diagnosis of influenza-like illnesses

Article

Author: Miller, Cynthia ; Beaubrun, Anne ; Jensen, Ivar ; Davies, Shawn ; Boller, Emily ; Chase, Jordan

AIMS:

Influenza-like illnesses (ILI) affect millions each year in the United States (US). Determining definitively the cause of symptoms is important for patient management. Xpert Xpress CoV-2/Flu/RSV plus (Xpert Xpress) is a rapid, point-of-care (POC), multiplex real-time polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A/B, and respiratory syncytial virus (RSV). The objective of our analysis was to develop a cost-consequence model (CCM) demonstrating the clinico-economic impacts of implementing PCR testing with Xpert Xpress compared to current testing strategies.

METHODS:

A decision tree model, with a 1-year time horizon, was used to compare testing with Xpert Xpress alone to antigen POC testing and send-out PCR strategies in the US outpatient setting from a payer perspective. A hypothetical cohort of 1,000,000 members was modeled, a portion of whom develop symptomatic ILIs and present to an outpatient care facility. Our main outcome measure is cost per correct treatment course.

RESULTS:

The total cost per correct treatment course was $1,131 for the Xpert Xpress strategy compared with a range of $3,560 to $5,449 in comparators. POC antigen testing strategies cost more, on average, than PCR strategies.

LIMITATIONS:

Simplifying model assumptions were used to allow for modeling ease. In clinical practice, treatment options, costs, and diagnostic test sensitivity and specificity may differ from what is included in the model. Additionally, the most recent incidence and prevalence data was used within the model, which is not reflective of historical averages due to the SARS-CoV-2 pandemic.

CONCLUSION:

The Xpert Xpress CoV-2/Flu/RSV plus test allows for rapid and accurate diagnostic results, leading to reductions in testing costs and downstream healthcare resource utilization compared to other testing strategies. Compared to POC antigen testing strategies, PCR strategies were more efficient due to improved diagnostic accuracy and reduced use of confirmatory testing.

121

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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	Phase 1	GB	Reithera Srl	01 May 2013

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