Effectiveness of Bivalent mRNA COVID-19 Vaccines in Preventing SARS-CoV-2 Infection in Children and Adolescents Aged 5 to 17 Years.

Importance: Bivalent mRNA COVID-19 vaccines were recommended in the US for children and adolescents aged 12 years or older on September 1, 2022, and for children aged 5 to 11 years on October 12, 2022; however, data demonstrating the effectiveness of bivalent COVID-19 vaccines are limited. Objective: To assess the effectiveness of bivalent COVID-19 vaccines against SARS-CoV-2 infection and symptomatic COVID-19 among children and adolescents. Design, Setting, and Participants: Data for the period September 4, 2022, to January 31, 2023, were combined from 3 prospective US cohort studies (6 sites total) and used to estimate COVID-19 vaccine effectiveness among children and adolescents aged 5 to 17 years. A total of 2959 participants completed periodic surveys (demographics, household characteristics, chronic medical conditions, and COVID-19 symptoms) and submitted weekly self-collected nasal swabs (irrespective of symptoms); participants submitted additional nasal swabs at the onset of any symptoms. Exposure: Vaccination status was captured from the periodic surveys and supplemented with data from state immunization information systems and electronic medical records. Main Outcome and Measures: Respiratory swabs were tested for the presence of the SARS-CoV-2 virus using reverse transcriptase-polymerase chain reaction. SARS-CoV-2 infection was defined as a positive test regardless of symptoms. Symptomatic COVID-19 was defined as a positive test and 2 or more COVID-19 symptoms within 7 days of specimen collection. Cox proportional hazards models were used to estimate hazard ratios for SARS-CoV-2 infection and symptomatic COVID-19 among participants who received a bivalent COVID-19 vaccine dose vs participants who received no vaccine or monovalent vaccine doses only. Models were adjusted for age, sex, race, ethnicity, underlying health conditions, prior SARS-CoV-2 infection status, geographic site, proportion of circulating variants by site, and local virus prevalence. Results: Of the 2959 participants (47.8% were female; median age, 10.6 years [IQR, 8.0-13.2 years]; 64.6% were non-Hispanic White) included in this analysis, 25.4% received a bivalent COVID-19 vaccine dose. During the study period, 426 participants (14.4%) had laboratory-confirmed SARS-CoV-2 infection. Among these 426 participants, 184 (43.2%) had symptomatic COVID-19, 383 (89.9%) were not vaccinated or had received only monovalent COVID-19 vaccine doses (1.38 SARS-CoV-2 infections per 1000 person-days), and 43 (10.1%) had received a bivalent COVID-19 vaccine dose (0.84 SARS-CoV-2 infections per 1000 person-days). Bivalent vaccine effectiveness against SARS-CoV-2 infection was 54.0% (95% CI, 36.6%-69.1%) and vaccine effectiveness against symptomatic COVID-19 was 49.4% (95% CI, 22.2%-70.7%). The median observation time after vaccination was 276 days (IQR, 142-350 days) for participants who received only monovalent COVID-19 vaccine doses vs 50 days (IQR, 27-74 days) for those who received a bivalent COVID-19 vaccine dose. Conclusion and Relevance: The bivalent COVID-19 vaccines protected children and adolescents against SARS-CoV-2 infection and symptomatic COVID-19. These data demonstrate the benefit of COVID-19 vaccine in children and adolescents. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations.

Longitudinal parental perception of COVID-19 vaccines for children in a multi-site, cohort study.

OBJECTIVES: Pediatric COVID-19 vaccine hesitancy and uptake is not well understood. Among parents of a prospective cohort of children aged 6 months-17 years, we assessed COVID-19 vaccine knowledge, attitudes, and practices (KAP), and uptake over 15 months. METHODS: The PROTECT study collected sociodemographic characteristics of children at enrollment and COVID-19 vaccination data and parental KAPs quarterly. Univariable and multivariable logistic regression models were used to test the effect of KAPs on vaccine uptake; McNemar's test for paired samples was used to evaluate KAP change over time. RESULTS: A total of 2,837 children were enrolled, with more than half (61 %) vaccinated by October 2022. Positive parental beliefs about vaccine safety and effectiveness strongly predicted vaccine uptake among children aged 5-11 years (aOR 13.1, 95 % CI 8.5-20.4 and aOR 6.4, 95 % CI 4.3-9.6, respectively) and children aged 12+ years (aOR 7.0, 95 % CI 3.8-13.0 and aOR 8.9, 95 % CI 4.4-18.0). Compared to enrollment, at follow-up parents (of vaccinated and unvaccinated children) reported higher self-assessed vaccine knowledge, but more negative beliefs towards vaccine safety, effectiveness, and trust in government. Parents unlikely to vaccinate their children at enrollment reported more positive beliefs on vaccine knowledge, safety, and effectiveness at follow-up. CONCLUSION: The PROTECT cohort allows for an examination of factors driving vaccine uptake and how beliefs about COVID-19 and the COVID-19 vaccines change over time. Findings of the current analysis suggest that these beliefs change over time and policies aiming to increase vaccine uptake should focus on vaccine safety and effectiveness.

Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study.

BACKGROUND: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2. OBJECTIVE: This report describes the objectives and methods for conducting the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study. PROTECT is a longitudinal prospective pediatric cohort study designed to estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) against infection among children aged 6 months to 17 years, as well as differences in SARS-CoV-2 infection and vaccine response between children and adolescents. METHODS: The PROTECT multisite network was initiated in July 2021, which aims to enroll approximately 2305 children across four US locations and collect data over a 2-year surveillance period. The enrollment target was based on prospective power calculations and accounts for expected attrition and nonresponse. Study sites recruit parents and legal guardians of age-eligible children participating in the existing Arizona Healthcare, Emergency Response, and Other Essential Workers Surveillance (HEROES)-Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) network as well as from surrounding communities. Child demographics, medical history, COVID-19 exposure, vaccination history, and parents/legal guardians' knowledge and attitudes about COVID-19 are collected at baseline and throughout the study. Mid-turbinate nasal specimens are self-collected or collected by parents/legal guardians weekly, regardless of symptoms, for SARS-CoV-2 and influenza testing via reverse transcription-polymerase chain reaction (RT-PCR) assay, and the presence of COVID-like illness (CLI) is reported. Children who test positive for SARS-CoV-2 or influenza, or report CLI are monitored weekly by online surveys to report exposure and medical utilization until no longer ill. Children, with permission of their parents/legal guardians, may elect to contribute blood at enrollment, following SARS-CoV-2 infection, following COVID-19 vaccination, and at the end of the study period. PROTECT uses electronic medical record (EMR) linkages where available, and verifies COVID-19 and influenza vaccinations through EMR or state vaccine registries. RESULTS: Data collection began in July 2021 and is expected to continue through the spring of 2023. As of April 13, 2022, 2371 children are enrolled in PROTECT. Enrollment is ongoing at all study sites. CONCLUSIONS: As COVID-19 vaccine products are authorized for use in pediatric populations, PROTECT study data will provide real-world estimates of VE in preventing infection. In addition, this prospective cohort provides a unique opportunity to further understand SARS-CoV-2 incidence, clinical course, and key knowledge gaps that may inform public health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/37929.

Effectiveness of 2-Dose BNT162b2 (Pfizer BioNTech) mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5-11 Years and Adolescents Aged 12-15 Years - PROTECT Cohort, July 2021-February 2022.

The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine was recommended by CDC's Advisory Committee on Immunization Practices for persons aged 12-15 years (referred to as adolescents in this report) on May 12, 2021, and for children aged 5-11 years on November 2, 2021 (1-4). Real-world data on vaccine effectiveness (VE) in these age groups are needed, especially because when the B.1.1.529 (Omicron) variant became predominant in the United States in December 2021, early investigations of VE demonstrated a decline in protection against symptomatic infection for adolescents aged 12-15 years and adults* (5). The PROTECT† prospective cohort of 1,364 children and adolescents aged 5-15 years was tested weekly for SARS-CoV-2, irrespective of symptoms, and upon COVID-19-associated illness during July 25, 2021-February 12, 2022. Among unvaccinated participants (i.e., those who had received no COVID-19 vaccine doses) with any laboratory-confirmed SARS-CoV-2 infection, those with B.1.617.2 (Delta) variant infections were more likely to report COVID-19 symptoms (66%) than were those with Omicron infections (49%). Among fully vaccinated children aged 5-11 years, VE against any symptomatic and asymptomatic Omicron infection 14-82 days (the longest interval after dose 2 in this age group) after receipt of dose 2 of the Pfizer-BioNTech vaccine was 31% (95% CI = 9%-48%), adjusted for sociodemographic characteristics, health information, frequency of social contact, mask use, location, and local virus circulation. Among adolescents aged 12-15 years, adjusted VE 14-149 days after dose 2 was 87% (95% CI = 49%-97%) against symptomatic and asymptomatic Delta infection and 59% (95% CI = 22%-79%) against Omicron infection. Fully vaccinated participants with Omicron infection spent an average of one half day less sick in bed than did unvaccinated participants with Omicron infection. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations.

The Annual American Men's Internet Survey of Behaviors of Men Who Have Sex With Men in the United States: Key Indicators Report 2018.

The American Men's Internet Survey (AMIS) is an annual web-based behavioral survey conducted in the United States of men who have sex with men (MSM). This rapid surveillance report describes the sixth cycle of data collection (September-December 2018; AMIS 2018). The key indicators were the same as those previously reported for past AMIS cycles. The AMIS methodology has not substantively changed since AMIS 2017. MSM were recruited from a variety of websites using banner advertisements and email blasts. In addition, participants from AMIS 2017 who agreed to be recontacted for future research were emailed a link to AMIS 2018. Men were eligible to participate if they were aged ≥15 years, resided in the United States, provided a valid US ZIP code, and reported ever having sex with a man or identified as gay or bisexual. The analysis was limited to those who reported having oral or anal sex with a male partner in the past 12 months. We examined demographic and recruitment characteristics using multivariable regression modeling (P<.05) stratified by the participants' self-reported HIV status. The AMIS 2018 round of data collection resulted in 10,129 completed surveys from MSM representing every US state, Puerto Rico, and Guam. Most participants were non-Hispanic White, aged between 15 and 24 years, living in urban areas in the southern United States, and recruited from general social networking websites. The plurality (4230/10,129, 41.76%) of participants was in the youngest age group, 15-24 years, followed by the 40 years and older age group (3088/10,129, 30.49%). The self-reported HIV prevalence was 6.08% (616/10,129). Compared with HIV-negative or unknown status participants, HIV-positive participants were more likely to have had anal sex without a condom with a male partner in the past 12 months (adjusted odds ratio [aOR] 2.02, 95% CI 1.63-2.50) and more likely to have had anal sex without a condom with a serodiscordant or an unknown status partner (aOR 3.90, 95% CI 3.27-4.66). The reported use of marijuana in the past 12 months was higher among HIV-positive participants than among HIV-negative or unknown status participants (aOR 1.39, 95% CI 1.15-1.68). The reported use of methamphetamines and other illicit substances in the past 12 months was higher among HIV-positive participants than among HIV-negative or unknown status participants (aOR 3.42, 95% CI 2.41-4.87 and aOR 1.90, 95% CI 1.56-2.32, respectively). Most HIV-negative or unknown status participants (6838/9513, 71.88%) reported ever taking an HIV test previously, and 52.51% (4995/9513) of the participants reported undergoing HIV testing in the past 12 months. HIV-positive participants were more likely to report testing and diagnosis of sexually transmitted infections than HIV-negative or unknown status participants (aOR 3.50, 95% CI 2.89-4.24 and aOR 2.61, 95% CI 2.10-3.25, respectively).

The Annual American Men's Internet Survey of Behaviors of Men Who Have Sex With Men in the United States: 2017 Key Indicators Report.

The American Men's Internet Survey (AMIS) is an annual Web-based behavioral survey of men who have sex with men (MSM) who live in the United States. This Rapid Surveillance Report describes the fifth cycle of data collection (July 2017 to November 2017: AMIS 2017). The key indicators are the same as those previously reported for past AMIS cycles (December 2013 to May 2014: AMIS 2013; November 2014 to April 2015: AMIS 2014; September 2015 to April 2016: AMIS 2015; and September 2016 to February 2017: AMIS 2016). The AMIS methodology has not substantively changed since AMIS 2016. The MSM were recruited from a variety of websites using banner advertisements and email blasts. Additionally, participants from AMIS 2016 who agreed to be recontacted for future research were emailed a link to AMIS 2017. Men were eligible to participate if they were aged ≥15 years, resided in the United States, provided a valid US zone improvement plan code, and reported ever having sex with a man or identified as gay or bisexual. The analysis was limited to those who reported having oral or anal sex with a male partner in the past 12 months. We examined demographic and recruitment characteristics using multivariable regression modeling (P<.05) stratified by the participants' self-reported HIV status. The AMIS 2017 round of data collection resulted in 10,049 completed surveys from MSM representing every US state, Puerto Rico, and Guam. Participants were mainly non-Hispanic white, over the age of 40 years, living in the Southern United States and urban areas, and recruited from geospatial social networking websites. The plurality (4485/10,049, 44.6%) of participants was in the 40 years and older age group, followed by the youngest age group, 15 to 24 years (2726/10,049, 27.1%). Self-reported HIV prevalence was 9.6% (964/10,049). Compared with HIV-negative or unknown-status participants, HIV-positive participants were more likely to have had anal sex without a condom with a male partner in the past 12 months (adjusted odds ratio [aOR] 2.21, 95% CI 1.86-2.63) and more likely to have had anal sex without a condom with a serodiscordant or an unknown-status partner (aOR 3.13, 95% CI 2.71-3.62). The reported use of marijuana in the past 12 months was higher among HIV-positive participants than HIV-negative or unknown status participants (aOR 1.29, 95% CI 1.09-1.51). The reported use of methamphetamines and other illicit substances in the past 12 months was higher among HIV-positive participants than HIV-negative or unknown status participants (aOR 5.57, 95% CI 4.38-7.09 and aOR 1.93, 95% CI 1.65-2.27, respectively). Most HIV-negative or unknown status participants (7330/9085, 80.7%) reported ever taking an HIV test previously, and 60.6% (5504/9085) reported undergoing HIV testing in the past 12 months. HIV-positive participants were more likely to report testing and diagnosis of sexually transmitted infections than HIV-negative or unknown status participants (aOR 2.85, 95% CI 2.46-3.31 and aOR 2.73, 95% CI 2.29-3.26, respectively).

Correction to: Complementary and Alternative Medicine Among Persons living with HIV in the Era of Combined Antiretroviral Treatment.

In the original publication of the article, the given and family name of the fourth author was not correct. The name has been corrected with this erratum.

Complementary and Alternative Medicine Among Persons living with HIV in the Era of Combined Antiretroviral Treatment.

Complementary and alternative medicine (CAM), often pursued independent of prescribing clinicians, may interact with traditional treatments, yet CAM use has not been well characterized among people living with HIV (PLWH) in the combined antiretroviral therapy (ART) era. We analyzed data from the Veterans Aging Cohort Study (October 2012-April 2015) to characterize CAM use in PLWH on ART. CAM users were more likely to have lived longer with HIV, report more bothersome symptoms, be prescribed more benzodiazepines and opioids, and consume less nicotine and alcohol. Given its high prevalence, clinicians should routinely assess for CAM use and its impact among PLWH.

Antihistamines and birth defects: a systematic review of the literature.

INTRODUCTION: Approximately 10 - 15% of women reportedly take an antihistamine during pregnancy for the relief of nausea and vomiting, allergy and asthma symptoms, or indigestion. Antihistamines include histamine H1-receptor and H2-receptor antagonists. AREAS COVERED: This is a systematic evaluation of the peer-reviewed epidemiologic literature published through February 2014 on the association between prenatal exposure to antihistamines and birth defects. Papers addressing histamine H1- or H2-receptor antagonists are included. Papers addressing pyridoxine plus doxylamine (Bendectin in the United States, Debendox in the United Kingdom, Diclectin in Canada, Lenotan and Merbental in other countries) prior to the year 2001 were excluded post hoc because of several previously published meta-analyses and commentaries on this medication. EXPERT OPINION: The literature on the safety of antihistamine use during pregnancy with respect to birth defects is generally reassuring though the positive findings from a few large studies warrant corroboration in other populations. The findings in the literature are considered in light of three critical methodological issues: i) selection of appropriate study population; ii) ascertainment of antihistamine exposures; and iii) ascertainment of birth defect outcomes. Selected antihistamines have been very well studied (e.g., loratadine); others, especially H2-receptor antagonists, require additional study before an assessment of safety with respect to birth defect risk could be made.