Benefits v. risks of COVID-19 vaccination: an examination of vaccination policy impact on the occurrence of myocarditis and pericarditis.

Studies of myocarditis/pericarditis following mRNA COVID-19 vaccines in Hong Kong have been published. Data are consistent with data from other active surveillance or healthcare databases. The mRNA COVID-19 vaccines have been shown to rarely increase risk of myocarditis, with the highest risk among males aged 12-17 after the second dose. An increased risk of pericarditis has also been shown after the second dose, though less common than myocarditis and more evenly distributed among different sex and age groups. Because of the increased risk of post-vaccine myocarditis, Hong Kong implemented a single dose mRNA COVID-19 vaccine policy on September 15, 2021 for adolescents (age 12-17 years). Post-policy, there were no cases of carditis. 40,167 first dose patients did not receive a second dose. This policy was highly successful in the reduction of carditis, but the trade-off is the potential risk of disease and cost to population-level immunity. This commentary brings forward some important global policy considerations.

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.

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.

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.

Impact of vaccine pause due to Thrombosis with thrombocytopenia syndrome (TTS) following vaccination with the Ad26.COV2.S vaccine manufactured by Janssen/Johnson & Johnson on vaccine hesitancy and acceptance among the unvaccinated population.

BACKGROUND: In response to reports of thrombosis with thrombocytopenia syndrome (TTS) post-vaccination, the Johnson & Johnson (J&J) vaccine was paused and then restarted in April 2021. Our objective was to assess whether this pause adversely impacted vaccine confidence. METHODS: Two large internet-based surveys were conducted in the US among adults to measure knowledge, attitudes and perceptions of the J&J vaccine pause and rates of vaccine hesitancy among unvaccinated persons before, during and after the pause. RESULTS: Among 66% of respondents aware of the pause, 44% identified blood clots as the reason for the pause without prompting. The impact of the pause on vaccine behavior among unvaccinated persons and perception of the vaccine safety system was mixed and modified by trust in the public health authorities. Those who were less willing to get vaccinated because of the pause were less inclined for all vaccines, not only the J&J product. Moreover, a notable proportion (22.1%) of the small number of persons (n = 30) vaccinated with the J&J vaccine after the pause reported not receiving information about the risk of TTS. The proportion of unvaccinated persons who were hesitant was increasing before and during the pause and then leveled off after the pause. CONCLUSIONS: The J&J vaccine pause is unlikely to be a major barrier to vaccine uptake. Public attitudes about vaccines may be more resilient than appreciated, especially when safety issues are investigated with transparent communication. This paper has important implications for messaging and program administration with future vaccine-specific adverse events. Efforts may be warranted to ensure all persons being offered the J&J vaccine are made aware of the risk of TTS.

Use of Random Domain Intercept Technology to Track COVID-19 Vaccination Rates in Real Time Across the United States: Survey Study.

BACKGROUND: Accurate and timely COVID-19 vaccination coverage data are vital for informing targeted, effective messaging and outreach and identifying barriers to equitable health service access. However, gathering vaccination rate data is challenging, and efforts often result in information that is either limited in scope (eg, limited to administrative data) or delayed (impeding the ability to rapidly respond). The evaluation of innovative technologies and approaches that can assist in addressing these limitations globally are needed. OBJECTIVE: The objective of this survey study was to assess the validity of Random Domain Intercept Technology (RDIT; RIWI Corp) for tracking self-reported vaccination rates in real time at the US national and state levels. RDIT-a form of online intercept sampling-has the potential to address the limitations of current vaccination tracking systems by allowing for the measurement of additional data (eg, attitudinal data) and real-time, rapid data collection anywhere there is web access. METHODS: We used RDIT from June 30 to July 26, 2021, to reach a broad sample of US adult (aged ≥18 years) web users and asked questions related to COVID-19 vaccination. Self-reported vaccination status was used as the focus of this validation exercise. National- and state-level RDIT-based vaccination rates were compared to Centers for Disease Control and Prevention (CDC)-reported national and state vaccination rates. Johns Hopkins University's and Emory University's institutional review boards designated this project as public health practice to inform message development (not human subjects research). RESULTS: By using RDIT, 63,853 adult web users reported their vaccination status (6.2% of the entire 1,026,850 American web-using population that was exposed to the survey). At the national level, the RDIT-based estimate of adult COVID-19 vaccine coverage was slightly higher (44,524/63,853, 69.7%; 95% CI 69.4%-70.1%) than the CDC-reported estimate (67.9%) on July 15, 2021 (ie, midway through data collection; t63,852=10.06; P<.001). The RDIT-based and CDC-reported state-level estimates were strongly and positively correlated (r=0.90; P<.001). RDIT-based estimates were within 5 percentage points of the CDC's estimates for 29 states. CONCLUSIONS: This broad-reaching, real-time data stream may provide unique advantages for tracking the use of a range of vaccines and for the timely evaluation of vaccination interventions. Moreover, RDIT could be harnessed to rapidly assess demographic, attitudinal, and behavioral constructs that are not available in administrative data, which could allow for deeper insights into the real-time predictors of vaccine uptake-enabling targeted and timely interventions.

COVID-19 Vaccination Status, Attitudes, and Values among US Adults in September 2021.

BACKGROUND: The Delta COVID-19 variant caused a resurgence in cases and deaths during the summer of 2021, particularly among the unvaccinated, highlighting the need to increase vaccine coverage. We describe a survey conducted in September 2021, in the midst of the Delta variant surge, after the FDA fully approved Pfizer-BioNTech's vaccine for ages 16+ and issued an emergency use authorization for ages 12-15. METHODS AND FINDINGS: US adults were surveyed to measure COVID-19 vaccination status, intentions, attitudes, values, and trust in public health authorities. More than three-quarters (77%) reported receiving at least one dose of COVID-19 vaccination. Of the unvaccinated, 6% intended to vaccinate, 40% were unlikely to ever vaccinate, and 55% remained uncertain. Most of the unvaccinated were <45 years old (62%), without a bachelor's degree (83%), earning less than $85,000 annually (74%), and Republican/Independent (66%). Concerns among the unvaccinated-yet-still-uncertain included the vaccines' safety (86%), speed of development (86%), and suspicion of government (79%) and pharmaceutical companies (69%). Most (86%) of the unvaccinated reported they would not vaccinate if mandated by their employer. About one third (34%) of the unvaccinated reported facing at least one barrier to vaccination. CONCLUSION: More than half of unvaccinated adults remained uncertain about COVID-19 vaccination, indicating an opportunity to support their decision making. Public health must increase easy and equitable access to vaccination and renew efforts to provide unvaccinated populations access to information from trusted sources.

Masks, money, and mandates: A national survey on efforts to increase COVID-19 vaccination intentions in the United States.

Various efforts to increase COVID-19 vaccination rates have been employed in the United States. We sought to rapidly investigate public reactions to these efforts to increase vaccination, including self-reported responses to widespread reduced masking behavior, monetary incentive programs to get vaccinated, and work vaccination requirements. Using a unique method for data collection (Random Domain Intercept Technology), we captured a large (N = 14,152), broad-based sample of the United States Web-using population (data collected from June 30 -July 26, 2021). About 3/4 of respondents reported being vaccinated. The likelihood of vaccination and vaccination intention differed across various demographic indicators (e.g., gender, age, income, political leaning). We observed mixed reactions to efforts aimed at increasing vaccination rates among unvaccinated respondents. While some reported that specific efforts would increase their likelihood of getting vaccinated (between 16% and 32%), others reported that efforts would decrease their likelihood of getting vaccinated (between 17% and 42%). Reactions differed by general vaccination intention, as well as other demographic indicators (e.g., race, education). Our results highlight the need to fully understand reactions to policy changes, programs, and mandates before they are communicated to the public and employed. Moreover, the results emphasize the importance of understanding how reactions differ across groups, as this information can assist in targeting intervention efforts and minimizing potentially differential negative impact.

Healthcare Personnel (HCP) Attitudes About Coronavirus Disease 2019 (COVID-19) Vaccination After Emergency Use Authorization.

BACKGROUND: We previously reported on coronavirus disease 2019 (COVID-19) vaccination intent among healthcare personnel (HCP) before emergency use authorization. We found widespread hesitancy and a substantial proportion of HCP did not intend to vaccinate. METHODS: We conducted a cross-sectional survey of HCP, including clinical and nonclinical staff, researchers, and trainees between 21 February and 19 March 2021. The survey evaluated vaccine attitudes, beliefs, intent, and acceptance. RESULTS: Overall, 3981 (87.7%) of respondents had already received a COVID-19 vaccine or planned to get vaccinated. There were significant differences in vaccine acceptance by gender, age, race, and hospital role. Males (93.7%) were more likely than females (89.8%) to report vaccine acceptance (P < .001). Mean age was higher among those reporting vaccine acceptance (P < .001). Physicians and scientists showed the highest acceptance rate (97.3%), whereas staff in ancillary services showed the lowest acceptance rate (79.9%). Unvaccinated respondents were more likely to be females, to have refused vaccines in the past due to reasons other than illness or allergy, to care for COVID-19 patients, or to rely on themselves when making vaccination decision. Vaccine acceptance was more than twice previous intent among Black respondents, an increase from 30.8% to 73.8%, and across all hospital roles with all > 80% vaccine acceptance. CONCLUSIONS: The majority of HCP were vaccinated, much higher than reporting intent before vaccine was available. However, many HCP-particularly ancillary services-are still hesitant. Feasible and effective interventions to address the hesitant, including individually-tailored education strategies are needed, or vaccine can be mandated.

Assessment of US Healthcare Personnel Attitudes Towards Coronavirus Disease 2019 (COVID-19) Vaccination in a Large University Healthcare System.

BACKGROUND: As a priority group, healthcare personnel (HCP) will be key to the success of coronavirus disease 2019 (COVID-19) vaccination programs. This study assessed HCP willingness to get vaccinated and identified specific concerns that would undermine vaccination efforts. METHODS: We conducted a cross-sectional survey of HCP, including clinical and nonclinical staff, researchers, and trainees, between 23 November and 5 December 2020. The survey evaluated attitudes, beliefs, and willingness to get vaccinated. RESULTS: There were 5287 respondents with a mean (SD) age of 42.5 (13.56) years; 72.8% were female (n = 3842). Overall, 57.5 % of individuals expressed intent to receive COVID-19 vaccine; 80.4% were physicians and scientists representing the largest group. 33.6% of registered nurses, 31.6% of allied health professionals, and 32% of master's level clinicians were unsure they would take the vaccine (P < .001). Respondents who were older, male, White, or Asian were more likely to get vaccinated than other groups. Vaccine safety, potential adverse events, efficacy, and speed of vaccine development dominated concerns listed by participants. Fewer (54.0%) providers of direct care versus non-care providers (62.4%) and 52.0% of those who had provided care for COVID-19 patients (vs 60.6% of those who had not) indicated they would take the vaccine if offered (P < .001). CONCLUSIONS: We observed that self-reported willingness to receive vaccination against COVID-19 differs by hospital roles, with physicians and research scientists showing the highest acceptance. These findings highlight important heterogeneity in personal attitudes among HCPs around COVID-19 vaccines and highlight a need for tailored communication strategies.

Promoting COVID-19 vaccine acceptance: recommendations from the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA.

Since the first case of COVID-19 was identified in the USA in January, 2020, over 46 million people in the country have tested positive for SARS-CoV-2 infection. Several COVID-19 vaccines have received emergency use authorisations from the US Food and Drug Administration, with the Pfizer-BioNTech vaccine receiving full approval on Aug 23, 2021. When paired with masking, physical distancing, and ventilation, COVID-19 vaccines are the best intervention to sustainably control the pandemic. However, surveys have consistently found that a sizeable minority of US residents do not plan to get a COVID-19 vaccine. The most severe consequence of an inadequate uptake of COVID-19 vaccines has been sustained community transmission (including of the delta [B.1.617.2] variant, a surge of which began in July, 2021). Exacerbating the direct impact of the virus, a low uptake of COVID-19 vaccines will prolong the social and economic repercussions of the pandemic on families and communities, especially low-income and minority ethnic groups, into 2022, or even longer. The scale and challenges of the COVID-19 vaccination campaign are unprecedented. Therefore, through a series of recommendations, we present a coordinated, evidence-based education, communication, and behavioural intervention strategy that is likely to improve the success of COVID-19 vaccine programmes across the USA.

Walking the Tightrope: Reevaluating science communication in the era of COVID-19 vaccines.

Scientists are trained to be skeptical and not overstate the existing evidence. This cautiousness is a valuable asset when working in scientific research, where the goal is the pursuit of knowledge and truth. It becomes a handicap when scientists are asked to communicate to the public about pressing topics such as COVID-19 vaccines. Often in such contexts, immediate recommendations are sought, and decisions must be made even when complete evidence is lacking. For scientists to be effective public communicators, they must adjust their mindset and embrace brevity, clarity, and other principles of effective communication. Focusing messages on what is known fosters public confidence in taking needed actions, whereas focusing on what is still unknown fosters inaction and seeds doubt. The implementation of principles of effective communication does not inherently conflict with maintaining scientific accuracy and acknowledging uncertainty, but it does require additional care, effort, and training.