Knowledge, attitudes, and intentions regarding COVID-19 vaccination in the general population and the effect of different framing messages for a brief video on intentions to get vaccinated among unvaccinated individuals in the United States during July 2021.

OBJECTIVE: To identify knowledge, attitudes, and beliefs (KABs) associated with COVID-19 vaccination intentions and assess the impact of vaccine-promoting messages on vaccination intentions. METHODS: Our nationally representative survey measured KABs of COVID-19 vaccination and incorporated a randomized experiment to assess the impact of different framing messages for a video encouraging vaccination intentions among unvaccinated adults in the US. Multivariable multinomial logistic regression models were fitted to investigate the relationships of KABs, trust in public health authorities (PHAs), and vaccine confidence with vaccination intentions. Difference-in-difference estimation was conducted to assess the impact of framing messages for a video on unvaccinated individuals' vaccination intentions. RESULTS: We observed that people with increasingly favorable vaccine KABs, trust in PHAs, and vaccine confidence were more likely to be vaccinated or intend to get vaccinated against COVID-19. Difference-in-difference estimates indicated a positive impact of exposure to the video on vaccination intentions while framing messages in some cases appeared to lower vaccination intentions. Associations between the video and vaccination intentions were more pronounced among Black/African American and Hispanic/Latinx populations and Democrats; however, associations did not vary by trust in PHAs or vaccine confidence. CONCLUSION: Videos that encourage people to get vaccinated may provide an efficient approach to nudge vaccine-hesitant individuals towards getting vaccinated. However, framing messages may negatively impact vaccination intentions and need to be developed carefully. PRACTICE IMPLICATIONS: This study provides solid experimental evidence for the importance of tailoring message framing to the characteristics and experience of the audience, while cautioning potential negative impacts of framing that does not match its intended audience. Our findings are applicable to health communication strategies on the population level, such as mass media campaigns, and the use of framing for messages to encourage vaccination but may also be informative for healthcare professionals consulting hesitant individuals about COVID-19 vaccinations.

Changes in vaccine attitudes and recommendations among US Healthcare Personnel during the COVID-19 pandemic.

A recommendation from healthcare personnel (HCP) is a strong predictor of vaccination. This study aimed to measure how HCP vaccine attitudes and recommendations changed during the COVID-19 pandemic. HCP were surveyed in January 2023 using a double opt-in network panel. Survey responses were summarized and stratified by HCP type and COVID-19 booster status. Multivariable logistic regression models were fitted. Comparisons were made to a September 2021 survey, with differences tested for significance (p < 0.05) using Pearson's χ2 Test. Nearly 82% of the 1207 HCP surveyed had received a COVID-19 booster, most commonly pediatricians (94%), followed by family medicine doctors (87%), pharmacists (74%), and nurses (73%) (p < 0.01). HCP with high trust in the Centers for Disease Control and Prevention (CDC) had nearly 6 times the odds (OR: 5.5; 95%CI: 3.9-7.7) of being boosted compared to HCP with low trust. From September 2021 to January 2023, the proportion of HCP recommending vaccines (COVID-19 and routine) to their patients decreased substantially for nearly all vaccines and patient populations specified. Trust in CDC also decreased (from 79 to 73%, p < 0.01), as did support for HCP COVID-19 vaccine mandates (from 65 to 46%, p < 0.01). HCP interest in additional online resources to improve their vaccine discussions with patients increased from 46 to 66% (p < 0.01). Additional regularly updated online resources from trusted medical sources that clarify progressing science and address dynamic public concerns are needed to improve vaccine confidence among HCP and help them support their patients' decision-making.

Benefit-Risk Assessment of mRNA COVID-19 Vaccines in Children Aged 6 Months to 4 Years in the Omicron Era.

BACKGROUND: There is no risk and benefit assessment of COVID-19 vaccination for children younger than 5 years using a single health outcomes scale. The objective of this study is to compare the expected risk and benefits of the mRNA primary series of COVID-19 vaccines for children aged 6 months to 4 years in the United States using a single health outcome scale in the Omicron era. METHODS: The expected benefits and risks of the primary two-dose series of mRNA COVID-19 vaccines for children aged 6 months to 4 years were stratified by sex, the presence of underlying medical conditions, the presence of infection-induced immunity, and the type of mRNA vaccine (BNT162b2 or mRNA-1273). A scoping literature review was conducted to identify the indicators in the decision tree model. The benefit-risk ratio was the outcome of interest. RESULTS: The benefit-risk ratios ranged from 200.4 in BNT162b2 for males aged 6-11 months with underlying medical conditions and without infection-induced immunity to 3.2 in mRNA-1273 for females aged 1-4 years without underlying medical conditions and with infection-induced immunity. CONCLUSIONS: The expected benefit of receiving the primary series of mRNA vaccines outweighed the risk among children ages 6 months to 4 years regardless of sex, presence of underlying medical conditions, presence of infection-induced immunity, or type of mRNA vaccines. However, the continuous monitoring of the COVID-19 epidemiology as well as vaccine effectiveness and safety is important.

Attitudes toward COVID-19 and Other Vaccines: Comparing Parents to Other Adults, September 2022.

Few analyses of COVID-19 vaccine attitudes also cover routine vaccines or focus on parents. In this cross-sectional study, we surveyed US adults in September 2022, immediately following the authorization of updated bivalent COVID-19 boosters for adults but before their authorization for children. The vaccine attitudes of parents were compared to other adults. Fewer parents were up-to-date on COVID-19 vaccines than other adults (54% vs. 67%), even after adjusting for age, education, and race/ethnicity (Adjusted Odds Ratio: 0.58; 95% Confidence Interval: 0.45-0.76). More parents had concerns about COVID-19 vaccines' safety in children (67% vs. 58%; aOR: 1.59; 95%CI: 1.23-2.06) and vaccine ingredients (52% vs. 45%; aOR: 1.41; 95%CI: 1.09-1.81), and more parents perceived COVID-19 in children to be no worse than a cold or the flu (51% vs. 38%; aOR: 1.56; 95%CI: 1.22-2.01). Fewer parents supported COVID-19 vaccine school requirements (52% vs. 57%; aOR: 0.75; 95%CI: 0.58-0.97) and perceived high vaccine coverage among their friends (51% vs. 61%; aOR: 0.60; 95%CI: 0.46-0.78). However, three-quarters of parents intended their child to receive all routinely recommended vaccines, whereas only half of adults intended to receive all routinely recommended vaccines themselves. To improve parental informed vaccine decision-making, public health must ensure pediatric providers have updated resources to support their discussions of vaccine risks and benefits with their patients' parents.

Corrigendum: LetsTalkShots: personalized vaccine risk communication.

[This corrects the article DOI: 10.3389/fpubh.2023.1195751.].

COVID-19 vaccination attitudes, values, intentions: US parents for their children, September 2021.

OBJECTIVES: To compare vaccine-related attitudes and values of parents of children 2-17 years old to other adults, examine intentions to vaccinate their children, and identify factors associated with intending to vaccinate children. METHODS: A nationally representative survey was conducted in September 2021 (just before the EUA for children 5-11 years old) using Ipsos KnowledgePanel, a probability-based web panel. The survey measured COVID-19 vaccination status, intentions, attitudes, values, and trust in public health authorities among US adults. Scale response options to survey items were dichotomized, and cross-tabulations and logistic regressions were performed. RESULTS: Parents had lower odds of reporting being vaccinated against COVID-19 than other adults even after adjusting for associated sociodemographic characteristics such as age (aOR: 0.66; 95 %CI: 0.50-0.87). The most prevalent parental concerns about COVID-19 vaccines included the speed of their development (88 %), potential side effects (78 %), suspicion of government (77 %), and suspicion of pharmaceutical companies (72 %). Fewer than half (42 %) of parents intended to vaccinate their children 5-11 years old, while 38 % were uncertain and 20 % were unlikely to ever vaccinate their children. Vaccinated parents had higher odds than unvaccinated parents of intending to vaccinate their children (OR: 675.51; 95 %CI: 106.46-4286.12). Discussions with healthcare providers who encouraged COVID-19 vaccination were positively associated with intent to vaccinate children (OR: 11.29; 95 %CI: 2.60-49.02). CONCLUSIONS: We found parental vaccination and conversations with providers were positively associated with intent to vaccinate children. Decisions about childhood vaccination need to be supported by healthcare providers and a public health system that makes vaccine access and related information equitable and accessible. Vaccination-related decision making should be guided by healthcare providers and provide information about safety and risk to children.

A Randomized Phase 2 Study to Evaluate Efficacy and Safety of AR36 for Prevention of Acute Mountain Sickness.

INTRODUCTION: AR36 is a pharmaceutical-grade plant extract used to support cardiovascular health in traditional Chinese medicine. Studies suggest that AR36 may prevent acute mountain sickness (AMS) during gradual ascent to high altitude. This randomized, placebo-controlled Phase 2 trial aimed to evaluate dosing regimens and assess efficacy and safety of AR36 for AMS prevention during rapid ascent. METHODS: Participants received placebo, low-dose AR36 (225 mg twice daily for 14 d prior and 5 d at altitude), or high-dose AR36 (12 d placebo, 300 mg twice daily for 2 d prior and 5 d at altitude). The primary efficacy outcome was 1993 Lake Louise Scoring System (LLSS) score on the morning after ascent. Safety was assessed through the proportion of treatment-emergent adverse events (TEAEs). RESULTS: One hundred thirty-two participants were randomized. Mean±SD age was 31.4±8.6 (range, 19-54) y. Baseline characteristics did not differ across groups. Lake Louise Scoring System scores on Day 16 in the placebo, low-dose, and high-dose groups were 4.03 (2.88), 4.42 (3.17), and 3.5 (2.31), respectively (placebo versus low-dose, P=0.462; placebo versus high-dose, P=0.574; n=110). The incidence of AMS on Day 16 was 66.7% in the placebo, 61.1% in the low-dose, and 55.3% in the high-dose group (P=0.66). The proportion of TEAEs in the placebo, low-dose, and high-dose groups was 38.4% (81), 28.4% (60), and 33.2% (70), respectively (P=0.205; n=127). There was no statistical difference between groups in LLSS, incidence of AMS, or TEAEs. CONCLUSIONS: AR36 did not improve LLSS or AMS incidence using the current regimens. AR36 was well tolerated.

Evaluation of online videos to engage viewers and support decision-making for COVID-19 vaccination: how narratives and race/ethnicity enhance viewer experiences.

Background: Vaccine hesitancy has hampered the control of COVID-19 and other vaccine-preventable diseases. Methods: We conducted a national internet-based, quasi-experimental study to evaluate COVID-19 vaccine informational videos. Participants received an informational animated video paired with the randomized assignment of (1) a credible source (differing race/ethnicity) and (2) sequencing of a personal narrative before or after the video addressing their primary vaccine concern. We examined viewing time and asked video evaluation questions to those who viewed the full video. Results: Among 14,235 participants, 2,422 (17.0%) viewed the full video. Those who viewed a personal story first (concern video second) were 10 times more likely to view the full video (p < 0.01). Respondent-provider race/ethnicity congruence was associated with increased odds of viewing the full video (aOR: 1.89, p < 0.01). Most viewers rated the informational video(s) to be helpful, easy to understand, trustworthy, and likely to impact others' vaccine decisions, with differences by demographics and also vaccine intentions and concerns. Conclusion: Using peer-delivered, personal narrative, and/or racially congruent credible sources to introduce and deliver vaccine safety information may improve the openness of vaccine message recipients to messages and engagement.

LetsTalkShots: personalized vaccine risk communication.

Introduction: Vaccine hesitancy is a global health threat undermining control of many vaccine-preventable diseases. Patient-level education has largely been ineffective in reducing vaccine concerns and increasing vaccine uptake. We built and evaluated a personalized vaccine risk communication website called LetsTalkShots in English, Spanish and French (Canadian) for vaccines across the lifespan. LetsTalkShots tailors lived experiences, credible sources and informational animations to disseminate the right message from the right messenger to the right person, applying a broad range of behavioral theories. Methods: We used mixed-methods research to test our animation and some aspects of credible sources and personal narratives. We conducted 67 discussion groups (n = 325 persons), stratified by race/ethnicity (African American, Hispanic, and White people) and population (e.g., parents, pregnant women, adolescents, younger adults, and older adults). Using a large Ipsos survey among English-speaking respondents (n = 2,272), we tested animations aligned with vaccine concerns and specific to population (e.g., parents of children, parents of adolescents, younger adults, older adults). Results: Discussion groups provided robust feedback specific to each animation as well as areas for improvements across animations. Most respondents indicated that the information presented was interesting (85.5%), clear (96.0%), helpful (87.0%), and trustworthy (82.2%). Discussion: Tailored vaccine risk communication can assist decision makers as they consider vaccination for themselves, their families, and their communities. LetsTalkShots presents a model for personalized communication in other areas of medicine and public health.

Attitudes and Values of US Adults Not Yet Up-to-Date on COVID-19 Vaccines in September 2022.

(1) Background: Periodic resurgences in COVID-19 due to more contagious variants highlight the need to increase coverage of booster doses. (2) Methods: Our September 2022 nationally representative survey of US adults measured COVID-19 vaccination status, intentions, attitudes, values, and confidence in information sources. (3) Findings: Although 85% of the weighted sample reported receiving at least one dose of a COVID-19 vaccine, only 63% reported being up-to-date on COVID-19 vaccines (e.g., received a booster dose). Only 12% of those not yet up-to-date indicated they were likely to get up-to-date as soon as possible, whereas 42% were unlikely to ever get up-to-date, and 46% were still uncertain. Most of those not up-to-date on their COVID-19 vaccines were under 45 years of age (58%), without a bachelor's degree (76%), making under $75,000 annually (53%), and Republican or Independent (82%). Prevalent concerns about COVID-19 vaccines among those uncertain about getting up-to-date included: potential side effects that have not been figured out yet (88%), speed of development (77%), newness (75%), ingredients (69%), drug companies making money (67%), allergic reactions (65%), and experimenting on people (63%). (4) Conclusions: Nearly half of adults not yet up-to-date on COVID-19 vaccines were uncertain about doing so, indicating an opportunity to support their decision-making.

The Use of Narrative in Science and Health Communication: A Scoping Review.

BACKGROUND: Many people deny science and reject health recommendations despite widely distributed facts and statistics. Didactic science and health communication is often dry, and relies on the false assumption that people make purely evidence-based decisions. Stories can be a powerful teaching tool by capturing attention and evoking emotion. OBJECTIVE: We explore the impact and appeal of, and describe best practices for, using narrative (storytelling) versus didactic methods in science and health communication. PATIENT INVOLVEMENT: No patients were involved in the review process. METHODS: We searched PubMed and Web of Science for articles either: assessing effectiveness of narrative science/health communication; assessing acceptability of (or preference for) narrative science/health communication; giving advice on how best to use narrative; and/or providing science-based explanations for how/why narrative succeeds. RESULTS: Narrative science/health communication is effective and appealing for audiences across a variety of topics and mediums, with supporting evidence across fields such as epidemiology, neuroscience, and psychology. Whether narrative or didactic messaging is most effective depends on the topic, audience, and objective, as well as message quality. However, combining narrative with didactic methods is likely to be more effective than using either strategy alone. DISCUSSION: Narrative science/health communication merits wider implementation and further research. Narrative communication creates openness to information by delaying the formulation of counterarguments. PRACTICAL VALUE: Science and health communicators should collaborate with cultural and storytelling experts, work directly with their target audiences throughout the message development and testing processes, and rely on popular story elements (e.g., first-person point of view, relatable protagonists) to improve the comprehension, engagement, and thoughtful consideration of their intended audience. FUNDING: This work was funded by Thirty Meter Telescope, with which two authors (GKS and SD) were affiliated. Otherwise, the funding organization had no role in the study and/or submission.

Considerations for unblinding individual study participants during vaccine trials.

Premature unblinding of individual participants is rarely reported in publications, but such unblinding can disrupt vaccine trials by causing worry and drop-out of other participants or "pseudo unblinding," in which participants or investigators over-interpret certain symptoms as being related to receiving an investigational product. This review summarizes appropriate reasons for unblinding in vaccine trials. Regulatory guidance could be improved by distinguishing guidance for vaccine trials from drug trials, with the recognition that unblinding individual participants in vaccine studies is rarely needed for management of adverse events following immunization.

Factors Affecting SARS-CoV-2 Vaccination Intent and Decision Making Among African American, Native American, and Hispanic Participants in a Qualitative Study.

Limited studies are available on how decisions and perceptions on SARS-CoV-2 vaccination have changed since the start of vaccination availability. We performed a qualitative study to identify factors critical to SARS-CoV-2 vaccination decision making and how perspectives evolved among African American/Black, Native American, and Hispanic communities disproportionately affected by COVID-19 and social and economic disadvantage. We conducted 16 virtual meetings, with 232 participants in wave 1 meetings (December 2020) and with 206 returning participants in wave 2 meetings (January and February 2021). Wave 1 vaccine concerns in all communities included information needs, vaccine safety, and speed of vaccine development. Lack of trust in government and the pharmaceutical industry was influential, particularly among African American/Black and Native American participants. Participants showed more willingness to get vaccinated at wave 2 than at wave 1, indicating that many of their information needs had been addressed. Hesitancy remained greater among African American/Black and Native American participants than among Hispanic participants. Participants in all groups indicated that conversations tailored to their community and with those most trustworthy to them would be helpful. To overcome vaccine hesitancy, we propose a model of fully considered SARS-CoV-2 vaccine decision making, whereby public health departments supply information, align with community values and recognize lived experiences, offer support for decision making, and make vaccination easy and convenient.

Risk and Benefit of mRNA COVID-19 Vaccines for the Omicron Variant by Age, Sex, and Presence of Comorbidity: A Quality-Adjusted Life Years Analysis.

The development of the mutant omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the coronavirus disease 2019 (COVID-19) pandemic raised the importance of reevaluating the risk and benefit of COVID-19 vaccines. With a decision tree model, we calculated the benefit-risk ratio and the benefit-risk difference of receiving monovalent messenger RNA (mRNA) COVID-19 vaccine (primary 2 doses, a third dose, and a fourth dose) in the 4-5 months after vaccination using quality-adjusted life years. The analysis was stratified by age, sex, and the presence of comorbidity. Evidence from peer-reviewed publications and gray literature was reviewed on September 16, 2022, to inform the study. Benefit-risk ratios for receipt of the BNT162b2 vaccine (Pfizer-BioNTech) ranged from 6.8 for males aged 12-17 years without comorbidity for the primary doses to 221.3 for females aged ≥65 years with comorbidity for the third dose. The benefit-risk ratios for receipt of the mRNA-1273 vaccine (Moderna) ranged from 7.2 for males aged 18-29 years without comorbidity for the primary doses to 101.4 for females aged ≥65 years with comorbidity for the third dose. In all scenarios of the one-way sensitivity analysis, the benefit-risk ratios were more than 1, irrespective of age, sex, comorbidity status, and type of vaccine, for both primary and booster doses. The benefits of mRNA COVID-19 vaccines in protecting against the omicron variant outweigh the risks, irrespective of age, sex, and comorbidity.

Vaccinomics: A scoping review.

BACKGROUND: This scoping review summarizes a key aspect of vaccinomics by collating known associations between heterogeneity in human genetics and vaccine immunogenicity and safety. METHODS: We searched PubMed for articles in English using terms covering vaccines routinely recommended to the general US population, their effects, and genetics/genomics. Included studies were controlled and demonstrated statistically significant associations with vaccine immunogenicity or safety. Studies of Pandemrix®, an influenza vaccine previously used in Europe, were also included, due to its widely publicized genetically mediated association with narcolepsy. FINDINGS: Of the 2,300 articles manually screened, 214 were included for data extraction. Six included articles examined genetic influences on vaccine safety; the rest examined vaccine immunogenicity. Hepatitis B vaccine immunogenicity was reported in 92 articles and associated with 277 genetic determinants across 117 genes. Thirty-three articles identified 291 genetic determinants across 118 genes associated with measles vaccine immunogenicity, 22 articles identified 311 genetic determinants across 110 genes associated with rubella vaccine immunogenicity, and 25 articles identified 48 genetic determinants across 34 genes associated with influenza vaccine immunogenicity. Other vaccines had fewer than 10 studies each identifying genetic determinants of their immunogenicity. Genetic associations were reported with 4 adverse events following influenza vaccination (narcolepsy, GBS, GCA/PMR, high temperature) and 2 adverse events following measles vaccination (fever, febrile seizure). CONCLUSION: This scoping review identified numerous genetic associations with vaccine immunogenicity and several genetic associations with vaccine safety. Most associations were only reported in one study. This illustrates both the potential of and need for investment in vaccinomics. Current research in this field is focused on systems and genetic-based studies designed to identify risk signatures for serious vaccine reactions or diminished vaccine immunogenicity. Such research could bolster our ability to develop safer and more effective vaccines.

COVID-19 vaccination among different types of US Healthcare Personnel.

BACKGROUND: Increasing vaccine coverage remains the best way to control the COVID-19 pandemic. Healthcare personnel (HCP) have long been the most credible and frequently used source of vaccine information for the public, and an HCP recommendation is a strong predictor of vaccination. METHODS: A survey of HCP was conducted in September 2021 via a double opt-in network panel. Responses to survey items were summarized and stratified by HCP type and adjusted logistic regression models were fitted. RESULTS: >94% of the 1074 HCP surveyed reported receiving at least one dose of COVID-19 vaccine or intending to soon, with vaccinating most common among pediatricians (98%), followed by family medicine doctors (96%), pharmacists (94%), and nurses/nurse practitioners/physician assistants (88%). HCP with high trust in the Centers for Disease Control and Prevention had 26 times the odds of vaccinating of HCP with low trust (95%CI: 9, 74). Nearly half of unvaccinated HCP (47%) were concerned about side effects, and one third of unvaccinated HCP (33%) were concerned the vaccine was developed too quickly. About three quarters of HCP reported strongly recommending the Pfizer-BioNTech (75%) and Moderna (70%) vaccines to their patients, compared to about one quarter (24%) strongly recommending Johnson & Johnson. CONCLUSIONS: Although most HCP are vaccinated against COVID-19 and strongly recommend vaccination to their patients, some harbor similar concerns to the public. Additional resources - regularly updated to explain the progressing scientific landscape and address ever evolving public concerns - are needed to further improve vaccine coverage among HCP and aid them in supporting the decision-making of their patients.

Characterization of parental intention to vaccinate elementary school aged children in the state of California.

In October 2021, Emergency Use Authorization of Coronavirus Disease 2019 (COVID-19) vaccines was granted for children aged 5-11. To ensure vaccine uptake in children upon approval, California will implement a state-wide executive order mandating COVID-19 vaccination for school children following full US FDA approval. This study uses survey data collected between November 6th, 2020 and December 14th, 2020 (n = 2091) to identify how sociodemographic characteristics and attitudes towards childhood vaccines among California parents were associated with their intentions to vaccinate their child against COVID-19. About one quarter (26 %) of surveyed California parents did not intend to vaccinate their child, suggesting skepticism towards the COVID-19 vaccine for children and the potential for pushback to a COVID-19 vaccine school-entry mandate. However, 17 % were unsure of their decision, suggesting the potential for public health messaging to make a positive impact on COVID-19 vaccine confidence and uptake. This study identifies characteristics of hesitant parents in California to prioritize for research and outreach. These data also provide a baseline for parental attitudes towards vaccinating children against COVID-19 in California, which will be useful for characterizing changes in attitudes towards childhood COVID-19 vaccination over time.

Economic impact of vaccine safety incident in Ukraine: The economic case for safety system investment.

BACKGROUND: Vaccine confidence and coverage decreased following a death temporally but not causally related to measles vaccination in Ukraine in 2008. Large measles outbreaks including international exportations followed. Herein we characterize this experience including associated costs. METHODS: Mixed-methods were used to characterize this vaccine safety incident and quantify health and economic costs. Qualitative interviews illuminate the incident, social climate, and corruption that influenced vaccine confidence in Ukraine. A literature review explored attitudes toward vaccines in the USSR and post-independence Ukraine. Infectious disease incidence was examined before and after the vaccine safety incident. An economic analysis estimated associated healthcare costs, including prevention and outbreak control measures, additional vaccination activities due to failure of the 2008 campaign, treatment costs for new cases domestically and foreign exportation, and productivity loss from treatment time and mortality for new cases. FINDINGS: Vaccine hesitancy and distrust in government and public health programs due to corruption existed in Ukraine before the vaccine safety incident. The mishandling of the 2008 incident catalyzed the decline of vaccine confidence and prompted poor procurement decisions, leading to a drop in infant vaccination coverage, increased domestic measles cases, and exportation of measles. The estimated cost of this incident was approximately $140 million from 2008 to 2018. INTERPRETATION: Absent a rapid and credible vaccine safety response, a coincidental death following immunization resulted in major outbreaks of measles with substantial economic costs. Adequate investments in a post-licensure safety system may help avoid similar future incidents.

MomsTalkShots, tailored educational app, improves vaccine attitudes: a randomized controlled trial.

BACKGROUND: Many pregnant women and parents have concerns about vaccines. This analysis examined the impact of MomsTalkShots, an individually tailored educational application, on vaccine attitudes of pregnant women and mothers. METHODS: MomsTalkShots was the patient-level component of a multi-level intervention to improve maternal and infant vaccine uptake that also included provider- and practice-level interventions. The impact of these interventions was studied using a two-by-two factorial design, randomizing at both the patient- and the practice-level. Study staff recruited pregnant women from a diverse set of prenatal care practices in Colorado and Georgia between June 2017 and July 2018. All participants (n = 2087) received a baseline survey of maternal and infant vaccine intentions and attitudes, and two follow-up surveys at least 1 month and 1 year after their infant's birth, respectively. Half of participants (n = 1041) were randomly assigned to receive educational videos through MomsTalkShots, algorithmically tailored to their vaccine intentions, attitudes, and demographics. Since the practice/provider intervention did not appear impactful, this analysis focused on MomsTalkShots regardless of the practice/provider intervention. RESULTS: By 1 month post-birth, MomsTalkShots increased perceived risk of maternal influenza disease (61% among MomsTalkShots recipients vs 55% among controls; Odds Ratio: 1.61, 95% Confidence Interval: 1.23-2.09), confidence in influenza vaccine efficacy (73% vs 63%; OR: 1.97, 95%CI: 1.47-2.65), and perceived vaccine knowledge (55% vs 48%; OR: 1.39, 95%CI: 1.13-1.72). Among those intending not to vaccinate at baseline, MomsTalkShots increased perceived risk of maternal influenza disease (38% vs 32%; OR: 2.07, 95%CI: 1.15-3.71) and confidence in influenza vaccine efficacy (44% vs 28%; OR: 2.62, 95%CI: 1.46-4.69). By 1 year post-birth, MomsTalkShots increased perceived vaccine knowledge (62% vs 50%; OR: 1.74, 95%CI: 1.36-2.24) and trust in vaccine information from obstetricians and pediatricians (64% vs 55%; OR: 1.53, 95%CI: 1.17-2.00). Among those uncertain about vaccinating at baseline, MomsTalkShots increased perceived vaccine knowledge (47% vs 12%; OR: 6.89, 95%CI: 1.52-31.25) and reduced infant vaccine safety concerns (71% vs 91%; OR: 0.24, 95%CI: 0.06-0.98). CONCLUSIONS: MomsTalkShots improved pregnant women's and mothers' knowledge and perceptions of maternal and infant vaccines and the diseases they prevent, and offers a scalable tool to address vaccine hesitancy. TRIAL REGISTRATION: Registered at Clinicaltrials.gov on 13/09/2016 (registration number: NCT02898688).