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Background: Pregnant women were excluded from investigational trials of COVID-19 vaccines. Limited data are available to inform pregnant and postpartum women on their decisions to receive a COVID-19 vaccine.Methods: The goal of this observational, prospective cohort study is to evaluate the immunogenicity and safety of various Emergency Use Authorization (EUA) or licensed COVID-19 vaccines administered to pregnant or lactating women and describe the transplacental antibody transfer and kinetics of antibodies in mothers and infants. The study is adaptive, allowing additional groups to be added as new vaccines or vaccine regimens are authorized. Up to 20 clinical research institutions in the United States (U.S.) will be included. Approximately 200 pregnant women and 65 postpartum women will be enrolled per EUA or licensed COVID-19 vaccine formulation in the U.S. This study will include pregnant and postpartum women of all ages with and without chronic medical conditions. Their infants will be enrolled and followed beginning at birth in the pregnant cohort and beginning at the earliest possible time point in the postpartum cohort. Blood samples will be collected for immunogenicity outcomes and pregnancy and birth outcomes assessed among women and infants. Primary analyses will be descriptive and done by vaccine type and/or platform.Discussion: Given the long-standing and legitimate challenges of enrolling pregnant individuals into clinical trials early in the vaccine development pipeline, this study protocol describes our current study and provides a template to inform the collection of data for pregnant individuals receiving COVID-19 or other vaccines.Trial Registration: NCT05031468 . [ABSTRACT FROM AUTHOR]

The development of effective vaccines to combat infectious diseases is a complex multi-year and multi-stakeholder process. To accelerate the development of vaccines for coronavirus disease 2019 (COVID-19), a novel pathogen emerging in late 2019 and spreading globally by early 2020, the United States government (USG) mounted an operation bridging public and private sector expertise and infrastructure. The success of the endeavor can be seen in the rapid advanced development of multiple vaccine candidates, with several demonstrating efficacy and now being administered around the globe. Here, we review the milestones enabling the USG-led effort, the methods utilized, and ensuing outcomes. We discuss the current status of COVID-19 vaccine development and provide a perspective for how partnership and preparedness can be better utilized in response to future public-health pandemic emergencies. [ABSTRACT FROM AUTHOR]

The article discusses recommendations from the National Vaccine Advisory Committee on overcoming barriers and identifying opportunities for developing maternal immunizations. Topics mentioned include the risk of influenza hospitalization in infants less than six months of age, maternal immunization with the tetanus, diphtheria, and pertussis vaccine, and indirect benefits of influenza vaccination during pregnancy.

Background Vaccine purchasing groups (VPGs) may help reduce the upfront cost of vaccines. The objective of this study was to describe key business practices of VPGs in the United States. Methods Semi-structured, qualitative telephone interviews were conducted with representatives from 11 VPGs, based on a sampling frame of 53 VPGs. Interviews were transcribed and summarized by topic. Results Characteristics of the 11 VPGs interviewed reflect the broader VPG population: 64% national vs 36% regional; 8% charge a membership fee; membership ranging from 40 to over 300,000 sites. VPGs establish agreements with vaccine manufacturers, typically with either GlaxoSmithKline or Merck and Sanofi Pasteur; 1 VPG reported a single-product (Trumenba) agreement with Pfizer. VPG agreements specify “product loyalty” benchmarks (proportion of that manufacturer’s product line) that the VPG and its members must meet to receive discounted vaccine pricing. The amount of discount is considered proprietary. Practices may actively participate with only one VPG; the member discount is automatically applied by the manufacturer at the time of ordering. Vaccine manufacturers monitor sales data to ensure compliance with product loyalty terms; practices that do not meet benchmarks may be removed from the VPG. VPGs are paid administration fees by the manufacturers. VPGs use these fees to cover their operating expenses and often rebate a portion of these fees back to their members. All 11 VPGs offer additional services to members, ranging from immunization-focused education and technical assistance to discounts on a broad range of medical and business supplies. Conclusions VPGs can facilitate access to reduced purchase prices for most vaccines routinely recommended in the United States. Data on the magnitude of the price reductions were not publicly available. VPG members must balance loyalty-based price reductions against considerations of having a wider choice of vaccine products. [ABSTRACT FROM AUTHOR]

Given the increased risk of pandemics driven by emerging and reemerging infectious diseases, it is imperative that the United States and global scientific community be better prepared for future threats by prioritizing and launching key research programs and strategies. In December 2021, the National Institute of Allergy and Infectious Diseases (NIAID) published its pandemic preparedness plan, which focuses on the prototype pathogen approach for medical countermeasure development. The plan was introduced before its release at a NIAID-hosted workshop in November 2021 that featured scientific experts from the extramural community, government, and the private sector and focused on selection of prototype pathogens from 10 viral families with pandemic risk and moderate resources. This article will serve as an introduction to this special issue and will briefly define the prototype pathogen approach, describe the workshop goals and process for outcomes, and provide an outline of the viral working group articles to follow and future directions for NIAID., Competing Interests: Potential conflicts of interest. All authors: No reported conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (Published by Oxford University Press on behalf of Infectious Diseases Society of America 2023.)

Pregnant women are highly susceptible to Plasmodium falciparum malaria, leading to substantial maternal, perinatal, and infant mortality. While malaria vaccine development has made significant progress in recent years, no trials of malaria vaccines have ever been conducted in pregnant women. In December 2016, an expert meeting was convened at NIAID, NIH, in Rockville, Maryland to deliberate on the rationale and design of malaria vaccine trials in pregnant women. The discussions highlighted the progress made over recent years in the field of maternal immunization for other infectious diseases, and the evolving regulatory and ethical environment, all of which support a new emphasis on testing malaria vaccines that offer direct benefits to pregnant women. Initial safety and immunogenicity studies of malaria vaccines will be conducted in non-pregnant adult volunteers. Subsequently, efficacy trials involving pregnant women will likely be conducted in malaria-endemic and often resource-poor environments where sufficiently high malaria incidence will allow vaccine activity to be measured. Such trials will need to meet all international standards to ensure the safety of mother and offspring, under oversight of appropriate ethical and regulatory bodies. The convened experts drafted a clinical development plan to test a malaria vaccine product during pregnancy, using as a case study PfSPZ Vaccine being developed by Sanaria Inc. that is currently in phase 2 testing. Following the expert recommendations, a pregnancy registry has been initiated in Ouelessebougou, Mali, to provide baseline information on maternal and fetal outcomes as a context for evaluating PfSPZ Vaccine safety in the future, and new regimens are being assessed that will be suitable for evaluation in pregnant women., (Copyright © 2018.)

Antibody prevalence studies in laboratory mice indicate that murine norovirus (MNV) infections are common, but the natural history of these viruses has not been fully established. This study examined the extent of genetic diversity of murine noroviruses isolated from healthy laboratory mice housed in multiple animal facilities within a single, large research institute- the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID-NIH) in Bethesda, Maryland, U.S. Ten distinct murine norovirus strains were isolated from various tissues and feces of asymptomatic wild type sentinel mice as well as asymptomatic immunodeficient (RAG 2(-/-)) mice. The NIH MNV isolates showed little cytopathic effect in permissive RAW264.7 cells in early passages, but all isolates examined could be adapted to efficient growth in cell culture by serial passage. The viruses, although closely related in genome sequence, were distinguishable from each other according to facility location, likely due to the introduction of new viruses into each facility from separate sources or vendors at different times. Our study indicates that the murine noroviruses are widespread in these animal facilities, despite rigorous guidelines for animal care and maintenance.

Pathogenic caliciviruses of the genus Vesivirus circulate in oceanic ecosystems and spread to and among terrestrial mammals. Isolation of Vesivirus from natural and laboratory infections in humans led to this investigation of Vesivirus seroprevalence and viremia. Sera from four groups were tested for antibodies to Vesivirus as follows: blood donors whose units were cleared for donation, blood donors whose units were not accepted for donation solely because of elevated blood liver alanine aminotransferase (ALT) concentrations, patients with clinical hepatitis of unknown but suspected infectious cause, and patients with clinical hepatitis of unknown cause but associated with blood transfusion or dialysis. Additionally, sera were tested for Vesivirus genome by three methods: dot-blot and two reverse transcription-polymerase chain reaction (RT-PCR) methods. The calculated seroprevalence against Vesivirus virions within these groups (N = 765) was 12%, 21%, 29%, and 47%, respectively (P < 0.001 for group differences). Additionally, 11 (9.8%) of 112 sera tested yielded RT-PCR amplicons that by nucleotide sequence were distinct from each other and related to known Vesivirus. These data indicate that some blood donors in the population tested have serologic evidence of previous Vesivirus infection and some also have Vesivirus viremia. These results justify further investigation of an association between Vesivirus infection and illness in humans., (Copyright 2006 Wiley-Liss, Inc.)

Human calicivirus was the first recognized viral agent causing gastroenteritis in humans. Norovirus (NV) and Sapovirus (SV), two genera within the Caliciviridae family, cause epidemic and endemic acute gastroenteritis in children and adults. The role of these viruses as a cause of sporadic acute gastroenteritis in young children requiring hospitalization is not well established. The aim of this study was to assess the prevalence and genetic diversity of caliciviruses among children hospitalized with symptoms of acute gastroenteritis. Stool samples were collected over 2 years from symptomatic children (N=1840) up to 5 years of age at three pediatric hospitals in the US. Overall, 156 (8.5%) samples were CV-positive, 131 (7.1%) confirmed by sequencing to be NV and 25 (1.4%) confirmed to be SV. Sequences of RT-PCR-amplified polymerase gene segments were analyzed using distance, maximum likelihood and parsimony algorithms. Phylogenetic analysis of 97 NV sequences showed that seven strains were in genogroup I, 86 strains were in genogroup II and four strains were not in genogroup I, II, or III, likely representing three new NV genogroups IV, VI and VII. Genogroup I and genogroup II strains were in 12 new genetic clusters, three in genogroup I and nine in genogroup II. Within genogroups I and II, most (98%) NV strains were in genetic clusters with no known prototype in GenBank. Phylogenetic analysis of 24 SV strains showed that half grouped with the London/92 strain in one genogroup and the remainder in three other proposed genogroups, one novel. In conclusion, NV and SV were frequent causes of hospitalization for acute gastroenteritis in young children and infecting strains were highly diverse, including newly recognized genogroups and genetic clusters within known genogroups.