Simultaneous administration of mRNA COVID-19 bivalent booster and influenza vaccines.

The U.S. Food and Drug Administration authorized use of mRNA COVID-19 bivalent booster vaccines on August 31, 2022. Currently, CDC's clinical guidance states that COVID-19 and other vaccines may be administered simultaneously. At time of authorization and recommendations, limited data existed describing simultaneous administration of COVID-19 bivalent booster and other vaccines. We describe simultaneous influenza and mRNA COVID-19 bivalent booster vaccine administration between August 31-December 31, 2022, among persons aged ≥6 months in the Vaccine Safety Datalink (VSD) by COVID-19 bivalent booster vaccine type, influenza vaccine type, age group, sex, and race and ethnicity. Of 2,301,876 persons who received a COVID-19 bivalent booster vaccine, 737,992 (32.1%) received simultaneous influenza vaccine, majority were female (53.1%), aged ≥18 years (91.4%), and non-Hispanic White (55.7%). These findings can inform future VSD studies on simultaneous influenza and COVID-19 bivalent booster vaccine safety and coverage, which may have implications for immunization service delivery.

Lessons learned about post-secondary institution tobacco policy change by Tobacco-Free Generation Campus Initiative Grantees, 2018-2020.

OBJECTIVE: The Tobacco-Free Generation Campus Initiative (TFGCI) granted funding to U.S. post-secondary institutions to assist with creating 100% smoke- and tobacco-free campus policies to prevent young adult tobacco use. This study assessed grantee experiences working on campus tobacco policy change. Participants: Sixty U.S. post-secondary institutions completing TFGCI funded work between 2018 and 2020. Methods: An online survey assessment was completed by each institution at the end of their 18-month grant period to share facilitators and barriers to policy change, lessons learned, and advice for future efforts. Results: Many institutions faced challenges of time and capital constraints and pushback from campus constituents. Collaboration, diverse constituent engagement, and educational efforts throughout the advocacy process were important facilitators of policy change. Conclusions: Adopting and implementing comprehensive tobacco policy on college campuses is challenging. Regardless of institution type, commitment to the long-term goal and diverse stakeholder support guided movement toward 100% smoke- and tobacco-free campus policies.Supplemental data for this article can be accessed online at https://doi.org/10.1080/07448481.2021.1953032 .

Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system.

BACKGROUND: Studies combining data from digital surveys and electronic health records (EHR) can be used to conduct comprehensive assessments on COVID-19 vaccine safety. METHODS: We conducted an observational study using data from a digital survey and EHR of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 mRNA vaccine across Kaiser Permanente Southern California during November 4, 2021-February 28, 2022. Parents/guardians who enrolled their children were sent a 14-day survey on reactions. Survey results were combined with EHR, and medical encounters were described for children whose parents or guardians indicated seeking medical care for vaccine-related symptoms. This study describes self-reported reactions (local and systemic) and additional symptoms (chest pain, tachycardia, and pre-syncope). RESULTS: The study recruited 7,077 participants aged 5-11 years who received the Pfizer-BioNTech COVID-19 mRNA vaccine. Of 6,247 participants with survey responses after dose 1, 2,176 (35 %) reported at least one systemic reaction, and 1,076 (32 %) of 3,401 respondents following dose 2 reported at least one systemic reaction. Local reactions were reported less frequently following dose 2 (1,113, 33 %) than dose 1 (3,140, 50 %). The most frequently reported reactions after dose 1 were pain at the injection site (48 %), fatigue (20 %), headache (12 %), myalgia (9 %) and fever (5 %). The most frequently reported symptoms after dose 2 were also pain at the injection site (30 %), fatigue (19 %), headache (13 %), myalgia (10 %) and fever (9 %). Post-vaccination reactions occurred most frequently-one day following vaccination. Chest pain or tachycardia were reported infrequently (1 %). EHR demonstrated that parents rarely sought care for post-vaccination symptoms, and among those seeking care, the most common symptoms documented in EHR were fever and nausea, comprising <0.5 % of children. No encounters were related to myocarditis. CONCLUSION: While post-vaccination reactions to the Pfizer-BioNTech COVID-19 mRNA vaccine were common in children aged 5-11 years, our data showed that in most cases they were transient and did not require medical care.

Student tobacco use, secondhand smoke exposure, and policy beliefs before and after implementation of a tobacco-free campus policy: Analysis of five U.S. college and university campuses.

The adoption of comprehensive tobacco policies by colleges and universities may help reduce student tobacco use. To this end, The American Cancer Society's Tobacco-Free Generation Campus Initiative (TFGCI) awarded grants to 106 higher learning institutions to adopt 100% tobacco-free campus policies. This study measured changes in student tobacco use, reported exposure to secondhand smoke, and support for types of tobacco policies among five TFGCI grantee institutions who implemented 100% tobacco-free policies. Students at five U.S. TFGCI grantee institutions completed two independent cross-sectional online surveys regarding tobacco use, exposure to secondhand smoke, and policy attitudes, once before (n = 2499) and once after (n = 1667) their campuses adopted a tobacco-free policy. Students were less likely to report current cigarette smoking (aOR: 0.73, 95% C.I.: 0.63, 0.85) and exposure to secondhand smoke on campus (aOR: 0.42, 95% C.I.: 0.23, 0.76) following the policy change. In contrast, students were more likely to report past 30-day use of electronic nicotine delivery systems (ENDS) (aOR: 2.16, C.I.: 1.77, 2.63) following the policy change, despite the policy's inclusion of all tobacco and nicotine products. Tobacco-free campus policies can be associated with decreases in tobacco product use and environmental smoke exposure. The extent of their effectiveness may vary by product and the inclusion of tailored messaging, cessation support, and enforcement approaches. To discourage use of these products among students, colleges and universities should adopt 100% tobacco-free policies, monitor product use trends, offer cessation support and messaging customized for specific groups and products, and utilize a comprehensive enforcement strategy.

U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines.

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.

Anxiety-Related Adverse Event Clusters After Janssen COVID-19 Vaccination - Five U.S. Mass Vaccination Sites, April 2021.

On April 7, 2021, after 5 weeks' use of the Janssen COVID-19 vaccine under the Food and Drug Administration (FDA) Emergency Use Authorization (EUA), CDC received reports of clusters of anxiety-related events after administration of Janssen COVID-19 vaccine from five mass vaccination sites, all in different states. To further investigate these cases, CDC interviewed vaccination site staff members to gather additional information about the reported events and vaccination site practices. Four of the five sites temporarily closed while an investigation took place. Overall, 64 anxiety-related events, including 17 reports of syncope (fainting), an anxiety-related event, among 8,624 Janssen COVID-19 vaccine recipients, were reported from these sites for vaccines administered during April 7-9. As a follow-up to these interviews, CDC analyzed reports of syncope shortly after receipt of Janssen COVID-19 vaccine to the Vaccine Adverse Event Reporting System (VAERS), the vaccine safety monitoring program managed by CDC and FDA. To compare the occurrence of these events with those reported after receipt of other vaccines, reports of syncopal events after influenza vaccine administered in the 2019-20 influenza season were also reviewed. Syncope after Janssen COVID-19 vaccination was reported to VAERS (8.2 episodes per 100,000 doses). By comparison, after influenza vaccination, the reporting rate of syncope was 0.05 episodes per 100,000 doses. Anxiety-related events can occur after any vaccination. It is important that vaccination providers are aware that anxiety-related adverse events might be reported more frequently after receipt of the Janssen COVID-19 vaccine than after influenza vaccination and observe all COVID-19 vaccine recipients for any adverse reactions for at least 15 minutes after vaccine administration.

First Month of COVID-19 Vaccine Safety Monitoring - United States, December 14, 2020-January 13, 2021.

Two coronavirus disease 2019 (COVID-19) vaccines are currently authorized for use in the United States. The Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine on December 11, 2020, and for the Moderna COVID-19 vaccine on December 18, 2020; each is administered as a 2-dose series. The Advisory Committee on Immunization Practices issued interim recommendations for Pfizer-BioNTech and Moderna COVID-19 vaccines on December 12, 2020 (1), and December 19, 2020 (2), respectively; initial doses were recommended for health care personnel and long-term care facility (LTCF) residents (3). Safety monitoring for these vaccines has been the most intense and comprehensive in U.S. history, using the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, and v-safe,* an active surveillance system, during the initial implementation phases of the COVID-19 national vaccination program (4). CDC conducted descriptive analyses of safety data from the first month of vaccination (December 14, 2020-January 13, 2021). During this period, 13,794,904 vaccine doses were administered, and VAERS received and processed† 6,994 reports of adverse events after vaccination, including 6,354 (90.8%) that were classified as nonserious and 640 (9.2%) as serious.§ The symptoms most frequently reported to VAERS were headache (22.4%), fatigue (16.5%), and dizziness (16.5%). A total of 113 deaths were reported to VAERS, including 78 (65%) among LTCF residents; available information from death certificates, autopsy reports, medical records, and clinical descriptions from VAERS reports and health care providers did not suggest any causal relationship between COVID-19 vaccination and death. Rare cases of anaphylaxis after receipt of both vaccines were reported (4.5 reported cases per million doses administered). Among persons who received Pfizer-BioNTech vaccine, reactions reported to the v-safe system were more frequent after receipt of the second dose than after the first. The initial postauthorization safety profiles of the two COVID-19 vaccines in current use did not indicate evidence of unexpected serious adverse events. These data provide reassurance and helpful information regarding what health care providers and vaccine recipients might expect after vaccination.

Worldviews and trust of sources for health information on electronic nicotine delivery systems: Effects on risk perceptions and use.

Public health agencies, the news media, and the tobacco/vapor industry have issued contradictory statements about the health effects of electronic nicotine delivery systems (ENDS). We investigated the levels of trust that consumers place in different information sources and how trust is associated with cultural worldviews, risk perceptions, ENDS use, and sociodemographic characteristics using a nationally representative sample of 6051 U.S. adults in 2015. Seventeen percent of adults were uncertain about their trust for one or more potential sources. Among the rest, the Centers for Disease Control and Prevention (CDC), health experts, and the Food & Drug Administration (FDA) elicited the highest levels of trust. In contrast, tobacco and vapor manufacturers, vape shop employees, and, to a lesser extent, the news media were distrusted. Adults who had higher incomes and more education or espoused egalitarian and communitarian worldviews expressed more trust in health sources and the FDA, whereas those identifying as non-Hispanic Black or multiracial reported less trust. Current smokers, those who identified as non-Hispanic Black or other race, had lower incomes, and espoused hierarchy and individualism worldviews expressed less distrust toward the tobacco and vapor industry. Greater trust (or less distrust) toward the tobacco and vapor industry and an individualism worldview were associated with perceptions of lower risk of premature death from daily ENDS use, greater uncertainty about those risks, and greater odds of using ENDS. Public health and the FDA should consider consumer trust and worldviews in the design and regulation of public education campaigns regarding the potential health risks and benefits of ENDS.

Cost-benefit comparison of two proposed overseas programs for reducing chronic Hepatitis B infection among refugees: is screening essential?

BACKGROUND: Refugees are at an increased risk of chronic Hepatitis B virus (HBV) infection because many of their countries of origin, as well as host countries, have intermediate-to-high prevalence rates. Refugees arriving to the US are also at risk of serious sequelae from chronic HBV infection because they are not routinely screened for the virus overseas or in domestic post-arrival exams, and may live in the US for years without awareness of their infection status. METHODS: A cohort of 26,548 refugees who arrived in Minnesota and Georgia during 2005-2010 was evaluated to determine the prevalence of chronic HBV infection. This prevalence information was then used in a cost-benefit analysis comparing two variations of a proposed overseas program to prevent or ameliorate the effects of HBV infection, titled 'Screen, then vaccinate or initiate management' (SVIM) and 'Vaccinate only' (VO). The analyses were performed in 2013. All values were converted to US 2012 dollars. RESULTS: The estimated six year period-prevalence of chronic HBV infection was 6.8% in the overall refugee population arriving to Minnesota and Georgia and 7.1% in those ≥6 years of age. The SVIM program variation was more cost beneficial than VO. While the up-front costs of SVIM were higher than VO ($154,084 vs. $73,758; n=58,538 refugees), the SVIM proposal displayed a positive net benefit, ranging from $24 million to $130 million after only 5 years since program initiation, depending on domestic post-arrival screening rates in the VO proposal. CONCLUSIONS: Chronic HBV infection remains an important health problem in refugees resettling to the United States. An overseas screening policy for chronic HBV infection is more cost-beneficial than a 'Vaccination only' policy. The major benefit drivers for the screening policy are earlier medical management of chronic HBV infection and averted lost societal contributions from premature death.

Intronic cis-regulatory modules mediate tissue-specific and microbial control of angptl4/fiaf transcription.

The intestinal microbiota enhances dietary energy harvest leading to increased fat storage in adipose tissues. This effect is caused in part by the microbial suppression of intestinal epithelial expression of a circulating inhibitor of lipoprotein lipase called Angiopoietin-like 4 (Angptl4/Fiaf). To define the cis-regulatory mechanisms underlying intestine-specific and microbial control of Angptl4 transcription, we utilized the zebrafish system in which host regulatory DNA can be rapidly analyzed in a live, transparent, and gnotobiotic vertebrate. We found that zebrafish angptl4 is transcribed in multiple tissues including the liver, pancreatic islet, and intestinal epithelium, which is similar to its mammalian homologs. Zebrafish angptl4 is also specifically suppressed in the intestinal epithelium upon colonization with a microbiota. In vivo transgenic reporter assays identified discrete tissue-specific regulatory modules within angptl4 intron 3 sufficient to drive expression in the liver, pancreatic islet ß-cells, or intestinal enterocytes. Comparative sequence analyses and heterologous functional assays of angptl4 intron 3 sequences from 12 teleost fish species revealed differential evolution of the islet and intestinal regulatory modules. High-resolution functional mapping and site-directed mutagenesis defined the minimal set of regulatory sequences required for intestinal activity. Strikingly, the microbiota suppressed the transcriptional activity of the intestine-specific regulatory module similar to the endogenous angptl4 gene. These results suggest that the microbiota might regulate host intestinal Angptl4 protein expression and peripheral fat storage by suppressing the activity of an intestine-specific transcriptional enhancer. This study provides a useful paradigm for understanding how microbial signals interact with tissue-specific regulatory networks to control the activity and evolution of host gene transcription.