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Background The rapid process of research and development and lack of follow-up time post-vaccination aroused great public concern about the safety profile of COVID-19 vaccine candidates. To provide comprehensive overview of the safety profile of COVID-19 vaccines by using meta-analysis technique. Methods English-language articles and results posted on PubMed, Embase, Web of Science, PMC, official regulatory websites, and post-authorization safety surveillance data were searched through June 12, 2021. Publications disclosing safety data of COVID-19 candidate vaccines in humans were included. A meta-analysis of proportions was performed to estimate the pooled incidence and the pooled rate ratio (RR) of safety outcomes of COVID-19 vaccines using different platforms. Results A total of 87 publications with safety data from clinical trials and post-authorization studies of 19 COVID-19 vaccines on 6 different platforms were included. The pooled rates of local and systemic reactions were significantly lower among inactivated vaccines (23.7%, 21.0%), protein subunit vaccines (33.0%, 22.3%), and DNA vaccines (39.5%, 29.3%), compared to RNA vaccines (89.4%, 83.3%), non-replicating vector vaccines (55.9%, 66.3%), and virus-like particle vaccines (100.0%, 78.9%). Solicited injection-site pain was the most common local reactions, and fatigue and headache were the most common systemic reactions. The frequency of vaccine-related serious adverse events was low (< 0.1%) and balanced between treatment groups. Vaccine platforms and age groups of vaccine recipients accounted for much of the heterogeneity in safety profiles between COVID-19 vaccines. Reporting rates of adverse events from post-authorization observational studies were similar to results from clinical trials. Crude reporting rates of adverse events from post-authorization safety monitoring (passive surveillance) were lower than in clinical trials and varied between countries. Conclusions Available evidence indicates that eligible COVID-19 vaccines have an acceptable short-term safety profile. Additional studies and long-term population-level surveillance are strongly encouraged to further define the safety profile of COVID-19 vaccines.

This Review updates the scientific evidence assessing possible causal associations of adverse events following immunisation (AEFI) compiled in the 2012 report from the Institute of Medicine and the 2014 report from the Agency for Healthcare Research and Quality. For 12 of 46 AEFI examined, a causal relationship has been established with at least one vaccine currently routinely recommended to the general USA population: anaphylaxis, arthralgia or arthritis (mild, acute, and transient, not chronic), deltoid bursitis (when vaccine is administered improperly), disseminated varicella infection (in immune deficient individuals for whom the varicella vaccine is contraindicated), encephalitis, febrile seizures, Guillain-Barré syndrome, hepatitis (in immune deficient individuals for whom the varicella vaccine is contraindicated), herpes zoster, immune thrombocytopenic purpura, meningitis, and syncope. Other than mild acute and transient arthralgia or arthritis, which is very common in adult women after rubella vaccine, these adverse reactions are rare or very rare. Vaccines have an excellent safety profile overall and provide protection against infectious diseases to individuals and the general population.

This is a Brighton Collaboration Case Definition of the term “Vaccine Associated Enhanced Disease” to be utilized in the evaluation of adverse events following immunization. The Case Definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for SARS-CoV-2 vaccines and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by selected Expert Reviewers prior to submission.

This is a Brighton Collaboration case definition of the term “Sensorineural Hearing Loss” to be utilized in the evaluation of adverse events following immunization. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of vaccines for Lassa Fever and other emerging pathogens. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and define levels of diagnostic certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network.

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 χ 2 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.

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).

Vaccine hesitancy reflects concerns about the decision to vaccinate oneself or one's children. There is a broad range of factors contributing to vaccine hesitancy, including the compulsory nature of vaccines, their coincidental temporal relationships to adverse health outcomes, unfamiliarity with vaccine-preventable diseases, and lack of trust in corporations and public health agencies. Although vaccination is a norm in the U.S. and the majority of parents vaccinate their children, many do so amid concerns. The proportion of parents claiming non-medical exemptions to school immunization requirements has been increasing over the past decade. Vaccine refusal has been associated with outbreaks of invasive Haemophilus influenzae type b disease, varicella, pneumococcal disease, measles, and pertussis, resulting in the unnecessary suffering of young children and waste of limited public health resources. Vaccine hesitancy is an extremely important issue that needs to be addressed because effective control of vaccine-preventable diseases generally requires indefinite maintenance of extremely high rates of timely vaccination. The multifactorial and complex causes of vaccine hesitancy require a broad range of approaches on the individual, provider, health system, and national levels. These include standardized measurement tools to quantify and locate clustering of vaccine hesitancy and better understand issues of trust; rapid, independent, and transparent review of an enhanced and appropriately funded vaccine safety system; adequate reimbursement for vaccine risk communication in doctors' offices; and individually tailored messages for parents who have vaccine concerns, especially first-time pregnant women. The potential of vaccines to prevent illness and save lives has never been greater. Yet, that potential is directly dependent on parental acceptance of vaccines, which requires confidence in vaccines, healthcare providers who recommend and administer vaccines, and the systems to make sure vaccines are safe.

Medical and public health professionals have cited vaccine hesitancy as a major threat to high vaccine coverage. The term may have different meanings for health care providers, public health professionals, government officials, media members, and various sectors of the public, all of whom see such concepts through different lenses. [...]Brewer and colleagues emphasize in their “Increasing Vaccination Model” social processes including social norms in the community and information sharing [8], and the “Tailoring Immunization Programmes” developed by WHO Regional Office of Europe Region focuses on barriers and motivators to vaccination in susceptible communities (i.e., hesitant communities); not only individual factors but also social, community and cultural factors [9,10]. [...]terms such as “community protection” or “community immunity” may be more agreeable and accurate when describing this concept for the public.

The US response to coronavirus disease 2019 (COVID-19) has been plagued with politics driving public health and messaging. As a result, COVID-19 vaccine rollout is occurring in an environment ill equipped to achieve broad acceptance of the vaccine. Addressing public concerns unlocks the potential for high vaccine coverage; this is best achieved when science and values, not politics, inform public health. A multifaceted and thorough engagement and communication plan that is responsive to the concerns and values of different groups must be swiftly yet carefully implemented in a coordinated manner by federal, state, and local governments. Effective communication will require rapid and rigorous science to promptly differentiate between adverse events following immunization that are causally related versus simply coincidental. Health care providers, in particular, will need support to process the otherwise potentially overwhelming amount of relevant information and effectively integrate it into discussions with their patients to support their decision making. An equitable COVID-19 immunization program could substantively reduce the disproportionate risks associated with this pandemic.