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COVID-19 vaccines are the most important tool to stem the pandemic. They are being developed with unprecedented global collaboration and accelerated timelines to achieve WHO Emergency Use Listing, while using regulatory pathways through national regulatory authorities. Alongside preparations to ensure equitable access to the vaccines among people globally, preparations must be made within countries for COVID-19 vaccines safety surveillance on an urgent basis. Safety surveillance must be capable of investigating adverse events of special interest (AESI) and adverse events following immunization to determine a change in the benefit-risk profile of the vaccine, and to be able to anticipate coincidental events that might be attributed to the vaccine. Active surveillance systems should calculate the incidence of background rates of AESI prior to vaccine roll out. These background rates vary tremendously across regions, populations and case ascertainment methods. Active surveillance systems must be established or strengthened now, (including in LMIC), to calculate the background rates. Utilizing standardized case definitions and global standards for AESI will help in harmonization. Vaccine safety communication plans should be developed. Expanding the global vaccine safety system to meet the needs of COVID-19 and other emergency and routine use vaccines is a priority currently.

•Unvaccinated individuals put communities at risk of disease.•Parental vaccine refusal and hesitance is an emerging issue.•We conducted a systematic review for interventions to reduce refusal/hesitance.•We found limited evidence on effective strategies to guide policy makers.•There is a need for appropriately designed, executed and evaluated intervention studies. Unvaccinated individuals pose a public health threat to communities. Research has identified many factors associated with parental vaccine refusal and hesitancy toward childhood and adolescent immunizations. However, data on the effectiveness of interventions to address parental refusal are limited. We conducted a systematic review of four online databases to identify interventional studies. We used criteria recommended by the WHO's Strategic Advisory Group of Experts on immunization (SAGE) for the quality assessment of studies. Intervention categories and outcomes were evaluated for each body of evidence and confidence in overall estimates of effect was determined. There is limited evidence to guide implementation of effective strategies to deal with the emerging threat of parental vaccine refusal. There is a need for appropriately designed, executed and evaluated intervention studies to address this gap in knowledge.

There is widespread hesitancy towards COVID-19 vaccines in the United States, United Kingdom, and Australia. To identify predictors of willingness to vaccinate against COVID-19 in five cities with varying COVID-19 incidence in the US, UK, and Australia. Online, cross-sectional survey of adults from Dynata’s research panel in July-September 2020. Adults aged 18 and over in Sydney, Melbourne, London, New York City, or Phoenix. Willingness to receive a COVID-19 vaccine; reason for vaccine intention. To identify predictors of intention to receive a COVID-19 vaccine, we used Poisson regression with robust error estimation to produce prevalence ratios. The proportion willing to receive a COVID-19 vaccine was 70% in London, 71% NYC, 72% in Sydney, 76% in Phoenix, and 78% in Melbourne. Age was the only sociodemographic characteristic that predicted willingness to receive a COVID-19 vaccine in all five cities. In Sydney and Melbourne, participants with high confidence in their current government had greater willingness to receive the vaccine (PR = 1.24; 95% CI = 1.07–1.44 and PR = 1.38; 95% CI = 1.74–1.62), while participants with high confidence in their current government in NYC and Phoenix were less likely to be willing to receive the vaccine (PR = 0.78; 95% CI = 0.72–0.85 and PR = 0.85; 95% CI = 0.76–0.96). Consumer panels can be subject to bias and may not be representative of the general population. Success for COVID-19 vaccination programs requires high levels of vaccine acceptance. Our data suggests more than 25% of adults may not be willing to receive a COVID-19 vaccine, but many of them were not explicitly anti-vaccination and thus may become more willing to vaccinate over time. Among the three countries surveyed, there appears to be cultural differences, political influences, and differing experiences with COVID-19 that may affect willingness to receive a COVID-19 vaccine.

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.

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.

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.

The influenza A (H1N1) 2009 monovalent vaccination programme was the largest mass vaccination initiative in recent US history. Commensurate with the size and scope of the vaccination programme, a project to monitor vaccine adverse events was undertaken, the most comprehensive safety surveillance agenda in the USA to date. The adverse event monitoring project identified an increased risk of Guillain-Barré syndrome after vaccination; however, some individual variability in results was noted. Guillain-Barré syndrome is a rare but serious health disorder in which a person's own immune system damages their nerve cells, causing muscle weakness, sometimes paralysis, and infrequently death. We did a meta-analysis of data from the adverse event monitoring project to ascertain whether influenza A (H1N1) 2009 monovalent inactivated vaccines used in the USA increased the risk of Guillain-Barré syndrome. Data were obtained from six adverse event monitoring systems. About 23 million vaccinated people were included in the analysis. The primary analysis entailed calculation of incidence rate ratios and attributable risks of excess cases of Guillain-Barré syndrome per million vaccinations. We used a self-controlled risk-interval design. Influenza A (H1N1) 2009 monovalent inactivated vaccines were associated with a small increased risk of Guillain-Barré syndrome (incidence rate ratio 2·35, 95% CI 1·42–4·01, p=0·0003). This finding translated to about 1·6 excess cases of Guillain-Barré syndrome per million people vaccinated. The modest risk of Guillain-Barré syndrome attributed to vaccination is consistent with previous estimates of the disorder after seasonal influenza vaccination. A risk of this small magnitude would be difficult to capture during routine seasonal influenza vaccine programmes, which have extensive, but comparatively less, safety monitoring. In view of the morbidity and mortality caused by 2009 H1N1 influenza and the effectiveness of the vaccine, clinicians, policy makers, and those eligible for vaccination should be assured that the benefits of inactivated pandemic vaccines greatly outweigh the risks. US Federal Government.

•A large segment of the public is choosing to “Wait and Learn” about COVID-19 vaccine.•Values and lived experience are how communities decide about COVID-19 vaccine.•Pandemic conditions impact decision-making for those considering getting a vaccine. Safe and effective vaccines against Coronavirus Disease 2019 (COVID-19) provide the best opportunity to control the pandemic. Having safe and efficacious vaccines available is only half the equation; people must also take them. We describe a study to identify COVID-19 vaccine attitudes, values and intentions immediately preceding authorization of COVID-19 vaccines in the US. A national panel survey was conducted to measure intent to receive COVID-19 vaccines as well as disease and vaccine attitudes, values and trust in local, state and federal public health authorities. Greater than 80% of respondents reported confidence they could adhere to COVID recommendations such as mask wearing, social distancing and hand washing. The majority of respondents (70%) reported believing that current drugs were somewhat or very good at treating COVID-19 infection. Vaccine intent fell into three groups: Intenders (50%), Wait and Learn (40%), and Unlikelys (10%). Intent to get vaccinated was substantially lower among African American (32%), and higher among men (56%), those over 60 years of age (61%), those with a Bachelor’s degree or higher (63%), and Democrats (63%). The Wait and Learn group, compared to the Intenders, were less likely to report being diagnosed with a high risk condition for COVID-19, receiving an influenza vaccine in the past 12 months, discussing COVID-19 vaccine with their healthcare provider, perceiving COVID-19 as severe, considering a COVID-19 vaccine important to stop the spread of infection, and wering a mask usually or almost always. Only half of US adults intend to accept COVID-19 vaccines; most others (40%) are uncertain. Levels of immunity associated with community protection will not be achieved without reaching those who are currently uncertain. Characterizing COVID-19 vaccine attitudes and intentions and ascertaining values and trust in local, state, and federal public health authorities that impact vaccine decision-making are essential.

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.