COVID-19 vaccination and menstrual cycle characteristics: A prospective cohort study

We prospectively examined the association between COVID-19 vaccination and menstrual cycle characteristics in an internet-based prospective cohort study. We included a sample of 1,137 participants who enrolled in Pregnancy Study Online (PRESTO), a preconception cohort study of couples trying to conceive, during January 2021-August 2022. Eligible participants were aged 21–45 years, United States or Canadian residents, and trying to conceive without fertility treatment. At baseline and every 8 weeks for up to 12 months, participants completed questionnaires on which they provided information on COVID-19 vaccination and menstrual cycle characteristics, including cycle regularity, cycle length, bleed length, heaviness of bleed, and menstrual pain. We fit generalized estimating equation (GEE) models with a log link function and Poisson distribution to estimate the adjusted risk ratio (RR) for irregular cycles associated with COVID-19 vaccination. We used linear regression with GEE to estimate adjusted mean differences in menstrual cycle length associated with COVID-19 vaccination. We adjusted for sociodemographic, lifestyle, medical and reproductive factors. Participants had 1.1 day longer menstrual cycles after receiving the first dose of COVID-19 vaccine (95 % CI: 0.4, 1.9) and 1.3 day longer cycles after receiving the second dose (95 % CI: 0.2, 2.5). Associations were attenuated at the second cycle post-vaccination. We did not observe strong associations between COVID-19 vaccination and cycle regularity, bleed length, heaviness of bleed, or menstrual pain. In conclusion, COVID-19 vaccination was associated with a ∼1 day temporary increase in menstrual cycle length, but was not appreciably associated with other menstrual cycle characteristics.     

Strategy to identify priority groups for COVID-19 vaccination: A population based cohort study

BackgroundEvidence from COVID-19 outbreak shows that individuals with specific chronic diseases are at higher risk of severe prognosis after infection. Public health authorities are developing vaccination programmes with priorities that minimize the risk of mortality and severe events in individuals and communities. We propose an evidence-based strategy that targets the frailest subjects whose timely vaccination is likely to minimize future deaths and preserve the resilience of the health service by preventing infections.MethodsThe cohort includes 146,087 cases with COVID-19 diagnosed in 2020 in Milan (3.49 million inhabitants). Individual level data on 42 chronic diseases and vital status updated as of January 21, 2021, were available in administrative data. Analyses were performed in three sub-cohorts of age (16–64, 65–79 and 80+ years) and comorbidities affecting mortality were selected by means of LASSO cross-validated conditional logistic regression. Simplified models based on previous results identified high-risk categories worth targeting with highest priority. Results adjusted by age and gender, were reported in terms of odds ratios and 95%CI.ResultsThe final models include as predictors of mortality (7,667 deaths, 5.2%) 10, 12, and 5 chronic diseases, respectively. The older age categories shared, as risk factors, chronic renal failure, chronic heart failure, cerebrovascular disease, Parkinson disease and psychiatric diseases. In the younger age category, predictors included neoplasm, organ transplantation and psychiatric conditions. Results were consistent with those obtained on mortality at 60 days from diagnosis (6,968 deaths).ConclusionThis approach defines a two-level stratification for priorities in the vaccination that can easily be applied by health authorities, eventually adapted to local results in terms of number and types of comorbidities, and rapidly updated with current data. After the early phase of vaccination, data on effectiveness and safety will give the opportunity to revise prioritization and discuss the future approach in the remaining population.     

No significant increase in Guillain-Barré syndrome after COVID-19 vaccination in adults: A vaccine adverse event reporting system study

ObjectiveTo investigate the association between Guillain-Barré syndrome (GBS) and COVID-19 vaccination.BackgroundOn July 13, 2021, the US Food and Drug Administration (FDA) released a new warning that Johnson & Johnson COVID-19 vaccine could increase the risk of developing GBS.MethodsThe reporting rate of adult GBS after COVID-19 vaccination, ascertained with Brighton criteria, was compared with the reporting rate after other vaccinations during the same time period, and also compared with the reporting rate during control periods. Statistical methods such as proportion tests, and Pearson’s chi-squared test were utilized to identify significant relationships. Self-controlled and case centered analyses were conducted. A machine learning model was utilized to identify the factors associated with a worse outcome defined as emergency room (ER) or doctor visits, hospitalizations, and deaths.ResultsThe reporting rate of GBS after COVID-19 vaccination was significantly higher than after influenza and other vaccinations (49.7, 0.19, 0.16 per 10 million, p < 0.0001). However, the reporting rate was within the incidence range of GBS in the general population. Using self-controlled and case centered analyses, there was a significant difference in the reporting rate of GBS after COVID-19 vaccination between the risk period and control period (p < 0.0001). There was an estimated 0.7–1.7 per million excess reports of GBS within 6 weeks of COVID-19 vaccination. Machine learning model demonstrated that female gender and age between 18 and 44 are associated with worse outcome. No association was found between the onset interval of GBS and its prognosis.ConclusionsAlthough the reporting rate of GBS after COVID-19 vaccination was not statistically different than that of the general population, the increased reporting of GBS within the first 6 weeks after COVID-19 vaccination, more so than with other vaccinations, suggests that some cases of GBS are temporally associated with COVID-19 vaccination. However, there is a reduction in the reporting rate of GBS after other vaccines, compared to reporting rates pre-COVID-19, highlighting limitations inherent in any passive surveillance system. These findings warrant continuous analysis of GBS after COVID-19 vaccination. Further improvement of the machine learning model is needed for clinical use.     

Short-term mortality following COVID-19 vaccination in Bologna,Italy: a one-year study

The main objective of the study is to assess whether there is an increased risk of mortality in the days following the administration of COVID-19 vaccines in Bologna Health Authority in the first year of COVID-19 vaccination campaign. A secondary objective was to describe causes of deaths occurred in the days after vaccination. We conducted a retrospective observational study on all residents of Bologna Health Authority who received at least one COVID-19 vaccination dose from December 27, 2020 to December 31, 2021 and compared mortality in the 3, 7, 14 30 days after vaccination (risk interval) with the mortality in the period of the same length (3, 7, 14 and 30 days) beyond the 30th day after the last dose of vaccination (control interval). The cohort included 717,538 people. The mortality rate was 2.24 per 100 person-years during the 30 days risk interval vs 2.72 in the control interval with an adjusted incidence rate ratio equal to 0.76 (95% CI: 0.70–0.83, p < 0.001). The risk of mortality is significantly lower (p < 0.001) also in the 3, 7, 14 days risk intervals than in the control intervals. This study shows that there is no increase in mortality in the short-term period after COVID-19 vaccines.     

Safety,immunogenicity, and immune persistence of two inactivated COVID-19 vaccines replacement vaccination in China: An observational cohort study

BackgroundTo mitigate a national shortage of WIBP-CorV COVID-19 vaccine, China’s regulator approved administering BBIBP-CorV after WIBP-CorV for completion of a primary series. In a pragmatic observational study, we compared immunogenicity and safety of a primary series of WIBP-CorV followed by BBIBP-CorV with a primary series of two doses of BBIBP-CorV.MethodsWe invited healthy 18–59-years-old adults who had already received either WIBP-CorV or BBIBP-CorV as their first dose in a primary series to participate in this observational cohort study. Subjects who had received WIBP-CorV as their first dose became the observation group; subjects who had received BBIBP-CorV as their first dose became the control group. All participants received BBIBP-CorV as their second dose. We obtained sera 1, 2, and 6 months after second doses for nAb titer measurement by micro-neutralization cytopathic effect assay with SARS-CoV-2 strain HB01, standardized with WHO International Standard for anti-SARS-CoV-2 immunoglobulin. Safety was assessed for the 7 days after administration of second doses.ResultsBetween March and December 2021, 275 subjects were included in the observation group and 133 in the control group. Neutralizing seropositivity (≥1:4) rates were 98.91 % and 99.25 % at 1 month and 53.16 % and 70.69 % at 6 months. One-month geometric mean titers (GMTs) were 21.33 and 22.45; one-month geometric mean concentrations (GMCs) were 227.71 IU/mL and 273.27 IU/mL. One to two months after vaccination, observation group seropositivity rates and titers were not significantly different to the control group’s. Adverse reaction rates were 11.27 % and 18.80 %, all mild or moderate in severity.ConclusionsBoth primary series were immunogenic; immunogenicity of WIBP-CorV followed by BBIBP-CorV was not different than immunogenicity following two doses of BBIBP-CorV for two months after vaccination; safety profiles were acceptable for both regimens. BBIBP-CorV can be used to complete a primary series that started with WIBP-CorV.     

Evaluation of mortality risk after COVID-19 vaccination,Utah 2021

IntroductionIn order to evaluate trends in death after COVID-19 vaccination we analyzed the timing of death relative to vaccination date and the causes of death in vaccinated Utahns in 2021.MethodsWe matched people in the Utah immunization registry with documented COVID-19 vaccinations between December 18, 2020 and December 31, 2021 to Utah’s 2021 vital statistics death records. Vaccinated people were categorized as having one, two, or ≥ three COVID-19 vaccine doses in a time-updated metric. We examined crude mortality rates by dosing groups in two-week intervals for all deaths, and by COVID-19 versus non-COVID-19 causes, within the 44 weeks following receipt of the most recent vaccine.ResultsWe identified 2,072,908 individuals who received at least one dose of COVID-19 vaccine of whom 10,997 died in 2021. Only 17.5 % of the total vaccinated population was age 65+, while 80.9 % of those who died were over 65. In the four weeks following the first or second vaccination, all-cause mortality was low and then stabilized for the remainder of the evaluation period at a bi-weekly average of 33.0 and 39.0 deaths/100,000 people for one and two doses, respectively. Typical seasonal variation in death was observed among those with two doses. Small sample size precluded analysis of those with ≥ three doses, but trends were similar.ConclusionsMortality rates in the 44 weeks following the COVID-19 vaccination did not show trends suggesting an increase in mortality related to COVID-19 vaccination, reinforcing the safety of COVID-19 vaccines. This represents an accessible approach for local evaluation.     

Mortality in the Islamic Republic of Iran, 1964-2004

OBJECTIVE: Reliable information on the pattern, level and trend of mortality is essential for evidence-based policy to improve health. Various sources of mortality data in the Islamic Republic of Iran have not been critically assessed. This paper aims to document and evaluate the completeness of the different data sources on mortality and to estimate the level and trends of mortality over the past 40 years according to various mortality indices such as child mortality, adult mortality and life expectancy. METHODS: We undertook a systematic review of all available studies on infant mortality from 1964 to 2004 and estimated the most probable trend in child mortality. Death registration data from between 1992 and 2004 were assessed for completeness to estimate the level of adult mortality. Life tables for 2004 were constructed for the Islamic Republic of Iran based on these data, corrected for under-registration of death. FINDINGS: Infant mortality decreased from an estimated 154 deaths per 1000 live births in 1964 to 26 in 2004. The risk of adult mortality in 2004 was estimated to be 0.124 and 0.175 for females and males respectively. According to adjusted death registration data, life expectancy at birth in 2004 was 71.2 for females and 68.7 for males. The average completeness of death registration for ages 5 years and older across all systems was 76% for the period 2001-2004. CONCLUSION: There has been a general decline in child mortality in the Islamic Republic of Iran over the past three decades. Adult mortality levels also have declined, but less substantially. Mortality information systems have improved, yet serious concerns remain regarding the completeness and quality of data.     

COVID-19 and seasonal flu vaccination hesitancy: Links to personality and general intelligence in a large,UK cohort

Vaccines are a powerful and relatively safe tool to protect against a range of serious diseases. Nonetheless, a sizeable minority of people express ‘vaccination hesitancy’. Accordingly, understanding the bases of this hesitancy represents a significant public health opportunity. In the present study we sought to examine the role of Big Five personality traits and general intelligence as predictors of vaccination hesitancy across two vaccination types in a large (N = 9667) sample of UK adults drawn from the Understanding Society longitudinal household study. We found that lower levels of general intelligence were associated with COVID-19 and seasonal flu vaccination hesitancy, and lower levels of neuroticism was associated with COVID-19 vaccination hesitancy. Although the self-reported reasons for being vaccine hesitant indicated a range of factors were important to people, lower general intelligence was associated with virtually all of these reasons. In contrast, Big Five personality traits showed more nuanced patterns of association.     

Over- and under-estimation of COVID-19 deaths

European Journal of Epidemiology - The ratio of COVID-19-attributable deaths versus “true” COVID-19 deaths depends on the synchronicity of the epidemic wave with population mortality;...     

Safety monitoring of COVID-19 vaccination among adolescents aged 12 to 17 years old in the Republic of Korea

ObjectivesThis study aimed to disseminate information on coronavirus disease 2019 (COVID-19) vaccine safety among adolescents aged 12 to 17 years in the Republic of Korea.Methods Two databases were used to assess COVID-19 vaccine safety in adolescents aged 12 to 17 years who completed the primary Pfizer-BioNTech vaccination series. Adverse events reported to the web-based COVID-19 vaccination management system (CVMS) and collected in the text message-based system were analyzed.Results From March 5, 2021 to February 13, 2022, 12,216 adverse events among 12- to 17-year-olds were reported to the CVMS, of which 97.1% were non-serious adverse events and 2.9% were serious adverse events, including 85 suspected cases of anaphylaxis, 74 suspected cases of myocarditis and/or pericarditis, and 2 deaths. From December 13, 2021 to January 26, 2022, 10,389 adolescents responded to a text message survey, and local/systemic adverse events were more common after dose 2 than after dose 1. The most commonly reported events following either vaccine dose were pain at the injection site, headache, fatigue/tiredness, and myalgia.ConclusionThe overall results are consistent with previous findings; the great majority of adverse events were non-serious, and serious adverse events were rare among adolescents aged 12 to 17 years following Pfizer-BioNTech COVID-19 vaccination.     

Management of COVID-19 and vaccination in Nepal: A qualitative study

Objective

The aim of this research is to investigate the perspective of citizens of Nepal on the management COVID-19, the roll-out of the vaccine, and to gain an understanding of attitudes towards the governments' handling of the COVID-19 pandemic.

Method

A qualitative methodology was used. In-depth interviews were conducted with 18 males and 23 females aged between 20 and 86 years old from one remote and one urban district of Nepal. Interviews were conducted in November and December 2021. A thematic approach was used to analyse the data, utilising NVivo 12 data management software.

Result

Three major themes were identified: (1) Peoples' perspective on the management of COVID-19, (2) people's perception of the management of COVID-19 vaccination and (3) management and dissemination of information. It was found that most participants had heard of COVID-19 and its mitigation measures, however, the majority had limited understanding and knowledge about the disease. Most participants expressed their disappointment concerning poor testing, quarantine, vaccination campaigns and poor accountability from the government towards the management of COVID-19. Misinformation and stigma were reported as the major factors contributing to the spread of COVID-19. People's knowledge and understanding were mainly shaped by the quality of the information they received from various sources of communication and social media. This heavily influenced their response to the pandemic, the preventive measures they followed and their attitude towards vaccination.

Conclusion

Our study concludes that the study participants' perception was that testing, quarantine centres and vaccination campaigns were poorly managed in both urban and rural settings in Nepal. Since people's knowledge and understanding of COVID-19 are heavily influenced by the quality of information they receive, we suggest providing contextualised correct information through a trusted channel regarding the pandemic, its preventive measures and vaccination. This study recommends that the government proactively involve grassroots-level volunteers like Female Community Health Volunteers to effectively prepare for future pandemics.

Patient and Public Contribution

This study was based on in-depth interviews with 41 people from diverse socioeconomic backgrounds. This study would not have been possible without their participation.     

Impact of misclassification on measures of cardiovascular disease mortality in the Islamic Republic of Iran: a cross-sectional study

OBJECTIVE: To assess the extent and pattern of misclassification of death from non-specific diagnoses emanating from the Iranian death registration system, and to correct the data for health policy and planning. METHODS: Detailed medical records for 1426 hospital deaths classified to seven ill-defined or vague causes of death were reviewed by trained physicians, who then completed standard death certificates. Underlying causes of death from the review were compared with the cause assigned in registration data. FINDINGS: The probable underlying pattern of causes of death in the Islamic Republic of Iran is substantially different to that suggested by the death registration system. About 88% of 582 cases with non-specific diagnoses at ages 15-69 years were reassigned to various specific causes including ischaemic heart disease (33%), stroke (13%) and injuries (10%). A similar pattern of misclassification is apparent for 738 deaths at older ages (70 years and over), with 46% being reassigned to ischaemic heart disease and stroke. CONCLUSION: A significant proportion of deaths in the Iranian death registration system are being classified to cause groups of little relevance to epidemiological research or health policy. Reassignment of these deaths would increase the proportion of deaths from ischaemic heart disease and cerebrovascular diseases each by 32%, diabetes mellitus by 68% and chronic lower respiratory diseases by 73%. Substantial changes to procedures for diagnosing causes of death are urgently required if registration data are to effectively guide health policies and programmes in the Islamic Republic of Iran.     

Let's talk about COVID-19 vaccination: Relevance of conversations about COVID-19 vaccination and information sources on vaccination intention in Switzerland

BackgroundCOVID-19 vaccine hesitancy is known to be more pronounced among young people. However, there are a lack of studies examining determinants of COVID-19 vaccination intention in the general population in this young age-group in Switzerland, and in particular, studies investigating the influence of information sources and social networks on vaccination intention are missing.MethodsThe cross-sectional study “COVIDisc – Discussion with young people about the corona pandemic” provided the opportunity to investigate COVID-19 vaccination intention in 893 individuals aged 15–34 years from the cantons of Zurich, Thurgau, and Ticino in Switzerland. An online survey was administered between 10 November 2020 and 5 January 2021. Associations of public information sources and conversations about COVID-19 with COVID-19 vaccination intention were analyzed with multivariable logistic regression and mediation analysis using generalized structural equation modeling.Results51.5% of the participants intended or probably intended to get vaccinated once the vaccine would be available. Using print or online news (AOR 1.50, 95% CI 1.09–2.07) as an information source and having conversations about the COVID-19 vaccine (AOR 2.09, 95% CI 1.52–2.87) increased participants' COVID-19 vaccination intention. The effects of female gender (b = −0.267, p = 0.039) and risk perception (b = 0.163, p = 0.028) were partially mediated by having conversations about the COVID-19 vaccine. The effects of age (b = −0.036, p = 0.016), secondary educational level (b = 0.541, p = 0.010) and tertiary educational level (b = 0.726, p = 0.006) were fully mediated via having conversations about the COVID-19 vaccine.ConclusionsConversations and campaigns should start even before vaccines become available. Our data support interventions for young women and less educated people using social norms and supporting information seeking with news. Trust and risk perceptions are essential foundations for vaccine intentions.