Abstract
While adult clinical trials of coronavirus disease 2019 (COVID-19) vaccines have moved quickly into phase 3 clinical trials, clinical trials have not started in children in the United ...States. The direct COVID-19 impact upon children is greater than that observed for a number of other pathogens for which we now have effective pediatric vaccines. Additionally, the role of children in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission has clearly been underappreciated. Carefully conducted phase 2 clinical trials can adequately address potential COVID-19 vaccine safety concerns. Delaying phase 2 vaccine clinical trials in children will delay our recovery from COVID-19 and unnecessarily prolong its impact upon children’s education, health, and emotional well-being, and equitable access to opportunities for development and social success. Given the potential direct and indirect benefits of pediatric vaccination, implementation of phase 2 clinical trials for COVID-19 vaccines should begin now.
While COVID-19 vaccines have moved quickly into adult Phase 3 clinical trials, clinical trials have not started in children in the US. Given potential direct and indirect benefits, implementation of pediatric COVID-19 Phase II vaccine clinical trials should begin now.
The Coronavirus Disease 2019 (COVID-19) pandemic has had a devastating impact on global health, and has resulted in an unprecedented, international collaborative effort to develop vaccines to control ...the outbreak, protect human lives, and avoid further social and economic disruption. Mass vaccination campaigns are underway in multiple countries and are expected worldwide once more vaccine becomes available. Some early candidate vaccines use novel platforms, such as mRNA encapsulated in lipid nanoparticles, and relatively new platforms, such as replication-deficient viral vectors. While these new vaccine platforms hold promise, limited safety data in humans are available. Serious health outcomes linked to vaccinations are rare, and some outcomes may occur incidentally in the vaccinated population. Knowledge of background incidence rates of these medical conditions is a critical component of vaccine safety monitoring to aid in the assessment of adverse events temporally associated with vaccination and to put these events into context with what would be expected due to chance alone. A list of 22 potential adverse events of special interest (AESI), including neurologic, autoimmune, and cardiovascular disorders, was compiled by subject matter experts at the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. The most recently available U.S. background rates for these medical conditions, overall and by age, sex, and race/ethnicity (when available), were sourced from reported statistics (data published by medical panels/ associations or federal government reports), and literature reviews in PubMed. This review provides estimates of background incidence rates for medical conditions that may be monitored or studied as AESI during safety surveillance and research for COVID-19 vaccines and other new vaccines.
Background
Febrile children 3–36 months old, who had a body temperature >39°C and white blood cell (WBC) count >15 000/mm3 were known to be at risk for occult pneumococcal bacteremia (OPB) in the ...pre‐pneumococcal conjugate vaccine (PCV) era. The positive predictive value of these criteria, however, decreased dramatically after the introduction of PCV, indicating a need for alternative criteria. A high rate of febrile seizures has been noted in children with OPB, suggesting that screening may still be practical in this population. We performed a retrospective analysis to evaluate factors that predict OPB in patients visiting the emergency department (ED) with febrile seizures.
Methods
Children 3–36 months old who visited the ED for febrile seizures and had blood cultures taken were included. Patients with underlying diseases were excluded from analysis. We performed statistical analyses comparing patient demographics according to the presence or absence of OPB.
Results
One thousand and eighty‐two patients visited the ED with febrile seizure, and blood cultures were taken in 397, of whom 87% had received more than three doses of PCV. Of the nine patients with OPB, eight (89%) met the risk criteria. In contrast, only 12% (48/388) of those without OPB met the criteria. In this population, those who fulfilled the risk criteria were more likely to have OPB than those who did not (14.3% vs 0.3%; likelihood ratio, 7.17).
Conclusions
High WBC count and fever may effectively predict OPB in pediatric patients with febrile seizure in the post‐PCV era.
Prenatal maternal immunization is an effective tool to protect mothers and infants from poor health outcomes due to infectious diseases. We provide an overview of the rationale for the use of ...prenatal vaccines, discuss the immunologic environment of the maternal-fetal interface including the impact of maternal vaccines prenatally and subsequently on the infant's immune response, and review vaccines currently recommended in pregnancy and landscape for the future of maternal vaccination. This review aims to provide an understanding of the recent history and progress made in the field and highlight the importance of continued research and development into new vaccines for pregnant populations.
It is important to understand real-world BNT162b2 COVID-19 vaccine effectiveness (VE), especially among racial and ethnic minority groups. We performed a test-negative case-control study to measure ...BNT162b2 COVID-19 VE in the prevention of COVID-19-associated acute respiratory illness (ARI) hospitalizations at two Atlanta hospitals from May 2021–January 2023 and adjusted for potential confounders by multivariate analysis. Among 5139 eligible adults with ARI, 2763 (53.8%) were enrolled, and 1571 (64.5%) were included in the BNT162b2 analysis. The median age was 58 years (IQR, 44–68), 889 (56.6%) were female, 1034 (65.8%) were African American, 359 (22.9%) were White, 56 (3.6%) were Hispanic ethnicity, 645 (41.1%) were SARS-CoV-2-positive, 412 (26.2%) were vaccinated with a primary series, and 273 (17.4%) had received ≥1 booster of BNT162b2. The overall adjusted VE of the BNT162b2 primary series was 58.5% (95% CI 46.0, 68.1), while the adjusted VE of ≥1 booster was 78.9% (95% CI 70.0, 85.1). The adjusted overall VE of primary series for African American/Black individuals was 64.0% (95% CI 49.9, 74.1) and 82.7% (95% CI 71.9, 89.4) in those who received ≥1 booster. When analysis was limited to the period of Omicron predominance, overall VE of the primary series decreased with widened confidence intervals (24.5%, 95% CI −4.5, 45.4%), while VE of ≥1 booster was maintained at 60.9% (95% CI 42.0, 73.6). BNT162b2 primary series and booster vaccination provided protection against COVID-19-associated ARI hospitalization among a predominantly African American population.
In Japan, immunization is regulated by the Immunization Law, enacted shortly after World War II ended. It has been subsequently revised in response to social changes; however, after public health ...conditions improved, adverse events following immunization have received more public attention than the effectiveness of vaccination. This kind of public opinion had a major impact on the immunization program, leading to a so-called "vaccine gap" around a decade ago, that is, the less availability of vaccines for routine vaccination as compared with other countries. However, in recent years, several vaccines have been approved and are being routinely administered with the same schedule as in other countries. National immunization programs are influenced by various factors, such as cultures, customs, habits and ideas. This paper summarizes the status of immunization schedule and practices in Japan, process of policymaking, and possible future issues.
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus that causes coronavirus disease 2019 (COVID-19), has caused substantial morbidity and mortality. Operation Warp ...Speed aims to accelerate the development of a safe and effective vaccine by early 2021. Multiple vaccine candidates with reassuring safety and efficacy profiles have advanced to phase 3 clinical trials in adults. The purpose of this review is to describe the burden of COVID-19 in children, to update pediatricians about adult COVID-19 vaccine clinical trials, to discuss the importance of COVID-19 vaccine trials in children and to instill confidence in the established vaccine development and licensure processes.
Children of all ages are at risk for SARS-CoV-2 infection and severe disease manifestations. Children are also susceptible to downstream effects of COVID-19, including social isolation and interruption in education. Developing a pediatric COVID-19 vaccine could prevent disease, mitigate downstream effects and enable children to re-engage in their world.
Children could benefit both directly and indirectly from vaccination. In light of the safety and immunogenicity results from recent adult COVID-19 vaccine clinical trials, children should have the opportunity to be included in clinical trials in parallel to ongoing adult phase 3 clinical trials in a manner that is careful, methodical and transparent.
Although immunization is essential for maintaining public health, adverse events following immunization (AEFI) occur at a certain rate. Therefore, it is extremely important to conduct ...postimmunization safety monitoring and relief systems to ensure the safe implementation of immunizations for the public. This article summarizes the monitoring system of AEFI and the unique compensation system (so-called relief system) in Japan. In addition, current problems and issues on the AEFI monitoring and relief system will be specified, and immunization-related systems planned to be built in the future in Japan will be introduced.
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