Psychometric evaluation of the Symptoms of Infection with Coronavirus-19 (SIC): results from a cross-sectional study and a phase 3 clinical trial.

Background: The Symptoms of Infection with Coronavirus-19 (SIC) is a 30-item patient-reported outcome (PRO) measure scored by body system composites to assess signs/symptoms of coronavirus disease 2019 (COVID-19). In addition to cross-sectional and longitudinal psychometric evaluations, qualitative exit interviews were conducted to support the content validity of the SIC.

Methods: In a cross-sectional study, adults diagnosed with COVID-19 in the United States completed the web-based SIC and additional PRO measures.

Development of a novel patient-reported outcome measure to assess signs and symptoms of COVID-19.

Background: Given the urgent need for vaccines and treatments for coronavirus disease 2019 (COVID-19), the Symptoms of Infection with Coronavirus-19 (SIC), a comprehensive, patient-reported outcome (PRO) measure of signs and symptoms associated with COVID-19, was developed in full alignment with current US regulatory guidance to support evaluations of vaccines and treatments in development.

Methods: An initial version of the SIC was developed to address concepts identified through a targeted literature review and consultation with experts in infectious diseases and clinicians routinely managing COVID-19 in a hospital setting. A qualitative study was conducted in sites in the United States among 31 participants aged ≥ 18 years who were English-speaking and willing and able to provide informed consent and a self-reported history by telephone or online method.

Burden of opioid use for pain management among adult herpes zoster patients in the US and the potential impact of vaccination.

PLAIN LANGUAGE SUMMARY Herpes zoster or shingles and its complications such as postherpetic neuralgia - a painful condition that affects the nerve fibers and skin - may lead to complex pain that can be addressed using opioids in some patients.The recombinant zoster vaccine (RZV) vaccine prevents shingles and, therefore, may reduce the use of opioids and the negative health outcomes and costs associated with it. In this retrospective medical claims study, including patients between 2012 and 2017, we evaluated the receipt of pain medication including opioids in herpes zoster patients, and assessed factors associated with opioid prescription.

Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S.

Background: The Ad26.COV2.S vaccine was highly effective against severe-critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis.

Clinical and economic outcomes associated with respiratory syncytial virus vaccination in older adults in the United States.

Background: Respiratory syncytial virus (RSV) is an important cause of lower respiratory infections and hospitalizations among older adults. We aimed to estimate the potential clinical benefits and economic value of RSV vaccination of older adults in the United States (US).

Methods: We developed an economic model using a decision-tree framework to capture outcomes associated with RSV infections in US adults aged ≥ 60 years occurring during one RSV season for a hypothetical vaccine versus no vaccine.

Estimated Public Health Impact of the Recombinant Zoster Vaccine.

Objective: To investigate the potential public health impact of adult herpes zoster (HZ) vaccination with the adjuvanted recombinant zoster vaccine (RZV) in the United States in the first 15 years after launch.

Methods: We used a publicly available model accounting for national population characteristics and HZ epidemiological data, vaccine characteristics from clinical studies, and anticipated vaccine coverage with RZV after launch in 2018. Two scenarios were modeled: a scenario with RZV implemented with 65% coverage after 15 years and a scenario continuing with zoster vaccine live (ZVL) with coverage increasing 10% over the same period.

Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19.

Background: The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation.

Fighting against a protean enemy: immunosenescence, vaccines, and healthy aging.

The progressive increase of the aged population worldwide mandates new strategies to ensure sustained health and well-being with age. The development of better and/or new vaccines against pathogens that affect older adults is one pivotal intervention in approaching this goal. However, the functional decline of various physiological systems, including the immune system, requires novel approaches to counteract immunosenescence.

The epidemiology of medically attended respiratory syncytial virus in older adults in the United States: A systematic review.

Objective: This review was undertaken to assess the historical evidence of the disease incidence and burden of laboratory-confirmed respiratory syncytial virus (RSV) in medically attended older adults.

Design: A qualitative systematic literature review was performed; no statistical synthesis of the data was planned, in anticipation of expected heterogeneity across studies in this population.

Methods: A literature search of PubMed, Embase, and the Cochrane Library was conducted for studies of medically attended RSV in older adults (≥ 50 years) published in the last 15 years.

Immunogenicity and safety of a respiratory syncytial virus fusion protein (RSV F) nanoparticle vaccine in older adults.

Background: A preventative strategy for Respiratory Syncytial Virus (RSV) infection constitutes an under-recognized unmet medical need among older adults. Four formulations of a novel recombinant RSV F nanoparticle vaccine (60 or 90 μg RSV F protein, with or without aluminum phosphate adjuvant) administered concurrently with a licensed inactivated trivalent influenza vaccine (TIV) in older adult subjects were evaluated for safety and immunogenicity in this randomized, observer-blinded study.

Results: A total of 220 healthy males and females ≥ 60 years of age, without symptomatic cardiopulmonary disease, were vaccinated concurrently with TIV and RSV F vaccine or placebo.

Antipsychotic Adherence and Rehospitalization in Schizophrenia Patients Receiving Oral Versus Long-Acting Injectable Antipsychotics Following Hospital Discharge.

Background: Antipsychotic medications are a central component of effective treatment for schizophrenia, but nonadherence is a significant problem for the majority of patients. Long-acting injectable (LAI) antipsychotic medications are a recommended treatment option for nonadherent patients, but evidence regarding their potential advantages has been mixed. Observational data on newer, second-generation LAI antipsychotic medications have been limited given their more recent regulatory approval and availability.

Concurrent Oral Antipsychotic Drug Use Among Schizophrenia Patients Initiated on Long-Acting Injectable Antipsychotics Post-Hospital Discharge.

Pharmacological treatment is central to effective management of schizophrenia. Prescribing clinicians have an increasing array of options from which to choose, and oral antipsychotic polypharmacy is common in routine clinical practice. Practice guidelines recommend long-acting injectable (LAI) formulations, typically viewed as monotherapeutic alternatives, for patients with established nonadherence.

Use of a multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) for bacterial meningitis prevention.

Developing effective vaccines against Neisseria meningitidis serogroup B has been challenging for several reasons, including the fact that the capsular polysaccharide of N. meningitidis serogroup B is a poor antigen. Therefore, studies have focused on developing vaccines that target capsular protein meningococcal antigens using reverse vaccinology, a technique that predicts likely vaccine candidates using computational analysis of the whole bacterial genome.

A multi-component meningococcal serogroup B vaccine (4CMenB): the clinical development program.

Recently approved in Europe and Australia, the multi-component meningococcal B vaccine, 4CMenB (Bexsero®, Novartis Vaccines and Diagnostics), contains three surface-exposed recombinant proteins (fHbp, NadA, and NHBA) and New Zealand strain outer membrane vesicles (NZ OMV) with PorA 1.4 antigenicity. This comprehensive review of the 4CMenB clinical development program covers pivotal phase I/IIb/III studies in over 7,000 adults, adolescents, and infants.

Clinically based surveillance of invasive meningococcal disease in young children admitted to selected US hospitals between January 2000 and June 2009: a retrospective cohort study.

Invasive meningococcal disease (IMD) is under-reported in countries that do not employ polymerase-chain reaction for surveillance because culture-negative cases are omitted. To evaluate a clinically based, case-finding method, we developed case definitions for "probable," "compatible with," and "possible, but unlikely" IMD, respectively, based on supportive documentation (e.g.

Effective influenza vaccines for children: a critical unmet medical need and a public health priority.

Seasonal influenza causes clinical illness and hospitalization in all age groups; however, conventional inactivated vaccines have only limited efficacy in young children. MF59(®), an oil-in-water emulsion adjuvant, has been used since the 1990s to enhance the immunogenicity of influenza vaccines in the elderly, a population with waning immune function due to immunosenescence. Clinical trials now provide information to support a favorable immunogenicity and safety profile of MF59-adjuvanted influenza vaccine in young children.

Critical appraisal of a quadrivalent CRM(197) conjugate vaccine against meningococcal serogroups A, C W-135 and Y (Menveo) in the context of treatment and prevention of invasive disease.

Worldwide, invasive meningococcal disease affects about 500,000 people annually. Case fatality in developed countries averages 10%, and higher rates are reported in less prosperous regions. According to the World Health Organization, the most important pathogenic serogroups are A, B, C, W-135, X, and Y.

Ensuring the optimal safety of licensed vaccines: a perspective of the vaccine research, development, and manufacturing companies.

Vaccine safety is increasingly a focus for the general public, health care providers, and vaccine manufacturers, because the efficacy of licensed vaccines is accepted as a given. Commitment to ensuring safety of all vaccines, including childhood vaccines, is addressed by the federal government, academia, and industry. Safety activities conducted by the vaccine research, development, and manufacturing companies occur at all stages of product development, from selection and formulation of candidate vaccines through postlicensure studies and surveillance of adverse-event reports.

Menveo®): a novel quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135 and Y.

Meningococcal disease remains a global public health concern despite the wide availability of polysaccharide and polysaccharide-protein conjugate vaccines. The latter often afford a greater duration and scope of protection compared with the former. A novel quadrivalent meningococcal conjugate vaccine, Menveo(®) (MenACWY-CRM; Novartis Vacines, Bellaria-Rosia, Italy) has recently been licensed in Europe, the USA, Canada and other countries to protect adolescents and adults against disease caused by serogroups A, C, W-135 and Y.

Optimizing protection against meningococcal disease.

Neisseria meningitidis is a leading cause of bacterial meningitis and septicemia in the United States. Vaccines directed against meningococcal disease must elicit high and persistent titers of bactericidal antibodies against prevalent meningococcal serogroups and be highly efficacious in preventing meningococcal infection. Currently, 2 quadrivalent (A, C, W-135, Y) vaccines-a polysaccharide meningococcal vaccine and a conjugate meningococcal vaccine-are licensed in the United States.

Universal immunization of infants against Neisseria meningitidis: addressing the remaining unmet medical need in the prevention of meningitis and septicemia.

Effective immunization policies have markedly decreased the incidence of many lethal infectious diseases of childhood, including diphtheria, pertussis, and poliomyelitis, among others. In industrialized countries, relatively recent success in combating meningitis and sepsis has come with the implementation of universal immunization of infants against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae. These universal immunization programs have reduced disease incidence and related deaths by more than 90%.

Effectiveness of school-based influenza vaccination.

Background: Vaccination of children in school is one strategy to reduce the spread of influenza in households and communities.

Methods: We identified 11 demographically similar clusters of elementary schools in four states, consisting of one school we assigned to participate in a vaccination program (intervention school) and one or two schools that did not participate (control schools). During a predicted week of peak influenza activity in each state, all households with children in intervention and control schools were surveyed regarding demographic characteristics, influenza vaccination, and outcomes of influenza-like illness during the previous 7 days.

A pilot study of the effectiveness of a school-based influenza vaccination program.

Objective: The objective of this study was to evaluate the feasibility of a school-based influenza immunization program.

Methods: Pupils and their families from 3 demographically similar elementary schools participated in this pilot, unblinded, controlled intervention study. Live attenuated influenza vaccine (FluMist) was made available to all eligible pupils in 1 target school during regular school hours.