Reactogenicity following two doses of the BNT162b2 mRNA COVID-19 vaccine: Real-world evidence from healthcare workers in Japan

As the first authorized COVID-19 vaccine in Japan, the BNT162b2 mRNA COVID-19 vaccine is utilized for mass vaccination. Although efficacy has been proved, real-world evidence on reactogenicity in Japanese personnel is needed to prepare the public. Healthcare workers in a large academic hospital in Japan received two doses of the Pfizer-BioNTech vaccine from March 17 to May 19, 2021. Online questionnaires were distributed to registered recipients following each dose, from day 0 through day 8. Primary outcomes are the frequency of reactogenicity including local and systemic reactions. Length of absence from work was also analyzed. Most recipients self-reported reactogenicity after the first dose (97.3%; n = 3254; mean age [36.4]) and after the second dose (97.2%; n = 3165; mean age [36.5]). Systemic reactions following the second dose were substantially higher than the first dose, especially for fever (OR, 27.38; 95% CI, [22.00–34.06]; p < 0.001), chills (OR, 16.49; 95% CI, [13.53–20.11]; p < 0.001), joint pain (OR, 8.49; 95% CI, [7.21–9.99]; p < 0.001), fatigue (OR, 7.18; 95% CI, [6.43–8.02]; p < 0.001) and headache (OR, 5.43; 95% CI, [4.80–6.14]; p < 0.001). Reactogenicity was more commonly seen in young, female groups. 19.3% of participants took days off from work after the second dose (2.2% after the first dose), with 4.7% absent for more than two days. Although most participants reported reactogenicity, severe cases were limited. This study provides real-world evidence for the general population and organizations to prepare for BNT162b2 mRNA COVID-19 vaccination in Japan and other countries in the region.     

Adverse events after BNT162b2 mRNA COVID-19 vaccination in health care workers and medical students in Japan

To control the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the promotion of vaccination is important. However, adverse reactions following vaccination remain a concern. To investigate adverse events in the vaccinated Japanese population, we conducted a survey-based study among health care workers, including medical doctors and nurses; other medical staff; and medical university faculty, staff, and students in a single medical school and affiliated hospital in Japan. In addition, we analyzed the association of different adverse events with individual factors (e.g., age, sex) by performing network analysis. While young age and female sex are often considered risk factors for more severe adverse events, the regression models showed neither age nor sex was associated with local injection-site reactions after the second dose in this study. In contrast to local reactions, systemic adverse events were associated with young age and female sex. However, myalgia was unique in that it was not associated with younger age even though the network analysis showed that myalgia was consistently related to arthralgia and belonged to the group of systemic events after both the first and second vaccine doses. Further study is needed to ensure safe and effective vaccination to aid in controlling the COVID-19 pandemic.     

Adverse reactions to the BNT162b2 and mRNA-1273 mRNA COVID-19 vaccines in Japan

IntroductionThe BNT162b2 and mRNA-1273 COVID-19 vaccines are the main vaccines that have been used for mass vaccination in Japan. Information on adverse reactions to COVID-19 vaccines in the Japanese population is limited.MethodsWe conducted an online survey on self-reported adverse reactions in individuals who had received two doses of the BNT162b2 or mRNA-1273 vaccine. The incidence of adverse events after each dose of vaccine was investigated. Propensity score matching was used to compare the incidence of adverse reactions after the second dose of the BNT162b2 and mRNA-1273 vaccines.ResultsAfter the first and second doses of the BNT162b2 vaccine, and the first and second doses of the mRNA-1273 vaccine, 890, 853, 6401, and 3965 individuals, respectively, provided complete responses. Systemic reactions, including fever, fatigue, headache, muscle/joint pain, and nausea were significantly more common in females, individuals aged <50 years, and after the second dose. The incidence of injection site pain did not differ significantly according to the dose. The incidence of delayed injection site reactions after the first dose of mRNA-1273 vaccine was 3.9% and 0.8% among females and males, respectively, and 10.6% among females aged 40–69 years. Local and systemic reactions after the second dose, including fever, fatigue, headache, muscle/joint pain, nausea, and skin rash were more common in individuals who had received the mRNA-1273 vaccine.ConclusionsAdverse reactions were more frequently reported in females, younger individuals, and after the mRNA-1273 vaccine.     

A case of encephalitis following COVID-19 vaccine

We describe the first case of encephalitis following coronavirus disease 2019 (COVID-19) vaccination. Our patient was a 46-year-old Japanese woman who presented with acute onset diplopia. Subsequent magnetic resonance imaging revealed brain stem encephalitis that was rapidly responsive to high dosage steroid therapy and completely improved. Although the occurrence of encephalitis after vaccination could have just been a casual temporal association, her symptoms were temporally correlated with two vaccinations. Our case suggests caution and indicates treatment and prognosis, despite no evidence of a causal relationship. Nonetheless, this report emphasizes the enormous benefits of vaccination, which should not be undermined.     

Antibody responses and SARS-CoV-2 infection after BNT162b2 mRNA booster vaccination among healthcare workers in Japan

IntroductionVaccine effectiveness against SARS-CoV-2 infections decreases due to waning immunity, and booster vaccination was therefore introduced. We estimated the anti-spike antibody (AS-ab) recovery by booster vaccination and analyzed the risk factors for SARS-CoV-2 infections.MethodsThe subjects were health care workers (HCWs) in a Chiba University Hospital vaccination cohort. They had received two doses of vaccine (BNT162b2) and a booster vaccine (BNT162b2). We retrospectively analyzed AS-ab titers and watched out for SARS-CoV-2 infection for 90 days following booster vaccination.ResultsAS-ab titer eight months after two-dose vaccinations had decreased to as low as 587 U/mL (median, IQR (interquartile range) 360–896). AS-ab titer had then increased to 22471 U/mL (15761–32622) three weeks after booster vaccination. There were no significant differences among age groups.A total of 1708 HCWs were analyzed for SARS-CoV-2 infection, and 48 of them proved positive. SARS-CoV-2 infections in the booster-vaccinated and non-booster groups were 1.8% and 4.0%, respectively, and were not significant. However, when restricted to those 20–29 years old, SARS-CoV-2 infections in the booster-vaccinated and non-booster groups were 2.9% and 13.6%, respectively (p = 0.04). After multivariate logistic regression, COVID-19 wards (adjusted odds ratio (aOR):2.9, 95% confidence interval (CI) 1.5–5.6) and those aged 20–49 years (aOR:9.7, 95%CI 1.3–71.2) were risk factors for SARS-CoV-2 infection.ConclusionsBooster vaccination induced the recovery of AS-ab titers. Risk factors for SARS-CoV-2 infection were HCWs of COVID-19 wards and those aged 20–49 years. Increased vaccination coverage, together with implementing infection control, remains the primary means of preventing HCWs from SARS-CoV-2 infection.     

Validation of COVID-19 serologic tests and large scale screening of asymptomatic healthcare workers

ObjectivesSerologic testing for SARS-CoV-2 is an important element in the fight to slow the COVID-19 pandemic. This study aimed to validate two serologic tests for total (IgM, IgG, IgA) SARS-CoV-2 antibodies, (i) the Ortho-Clinical Diagnostics Anti-SARS-CoV-2 Total Antibody assay for the Vitros 5600 analyzers and (ii) a manual laboratory developed ELISA (FDA EUA pending), for use in parallel orthogonal testing of asymptomatic healthcare workers and affiliates of the University of Maryland Medical System.Design and MethodsValidation and verification of the two tests was performed using samples from hospitalized patients that were found to be PCR positive for SARS-CoV-2, samples pre-COVID-19, and samples from individuals with current/previous infections with other viruses. Healthcare workers and affiliates from across the University of Maryland Health System were provided testing free of charge and their results were reported as reactive or non-reactive if the two tests were concordance, or indeterminate if the results were discordant.ResultsValidation testing found the Ortho Vitros test to be 100% (73/73) sensitive, and 99.3% (152/153) specific, while the UMMC ELISA was found to be 97.6% (204/209) sensitive and 100% (288/288) specific. Real world testing among 8399 healthcare workers found that 2.9% (247/8399) of healthcare workers were positive for anti- SARS-CoV-2 antibodies by both tests. An indeterminate rate of 1.1% (91/8399), in which one test reported reactive results, and one as non-reactive was also seen.ConclusionsParallel orthogonal testing improves the positive and negative predictive value of serologic testing in populations with low prevalence. The use of an indeterminate result from parallel orthogonal testing allows for the follow-up and re-testing, which helps resolve discrepancies between assays.     

新冠肺炎疫情对医务工作者心理健康的影响

医务人员在新冠肺炎疫情中不仅仅是逆行的抗疫者，更多的是较普通人群面临更高的感染风险和更大的压力与挑战，需要承受长时间和超负荷工作，经历身心的疲惫和耗竭。本文复习国内外相关研究，围绕医务人员在疫情期间的心理健康问题，提出可从管理流程、心理/社会支持、心理承受力，以及作息和情绪管理等方面综合干预和预防，促进医务人员的身心健康。     

COVID-19 and gastroenteric manifestations

Coronavirus disease 2019 (COVID-19), caused by the infection of a novel coronavirus [severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)], has become a pandemic. The infection has resulted in about one hundred million COVID-19 cases and millions of deaths. Although SARS-CoV-2 mainly spreads through the air and impairs the function of the respiratory system, it also attacks the gastrointestinal epithelial cells through the same receptor, angiotensin converting enzyme 2 receptor, which results in gastroenteric symptoms and potential fecal-oral transmission. Besides the infection of SARS-CoV-2, the treatments of COVID-19 also contribute to the gastroenteric manifestations due to the adverse drug reactions of anti-COVID-19 drugs. In this review, we update the clinical features, basic studies, and clinical practices of COVID-19-associated gastroenteric manifestations.     

Ischemic colitis after receiving the second dose of a COVID-19 inactivated vaccine: A case report

BACKGROUNDThe outbreak of the coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 has been the most important clinical challenge worldwide since January 2020. COVID-19 inactivated vaccines play a crucial role in reducing the rates of morbidity and mortality.CASE SUMMARYWe presented a 48-year-old woman from Haidian District, Beijing, China who developed ischemic colitis after receiving the second dose of COVID-19 inactivated vaccine. Computed tomography of the abdomen showed edema and bowel wall thickening with hypodensity in the sigmoid colon and descending colon. Colonoscopy revealed hyperemia, edema and erosion of the mucosa with superficial ulceration and a yellow-white coating at the descending colon and sigmoid colon. The symptoms were relieved after 1 wk of receiving pinaverium bromide (50 mg, tid) and aspirin enteric-coated tablets (0.1 g, qd).CONCLUSIONThe possible occurrence of ischemic colitis should be considered after administration of the COVID-19 inactivated vaccines.     

Immunogenicity of a new gorilla adenovirus vaccine candidate for COVID-19

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Antibody responses induced by the BNT162b2 mRNA COVID-19 vaccine in healthcare workers in a single community hospital in Japan

IntroductionThe effectiveness of several vaccines against coronavirus disease (COVID-19) has been reported in the real-world setting. However, it is still unknown how long antibodies persist following vaccination and whether or not the persistence of antibodies has a protective effect against COVID-19.MethodsHealthcare workers who had received two doses of the BNT162b2 mRNA COVID-19 vaccine were enrolled, and a single-center study was conducted at the National Hospital Organization Hakodate National Hospital. Serum samples from all participants were collected 13–21 weeks (median: 20 weeks) after the second dose of vaccination. The antibody titers were measured using an electrochemiluminescence immunoassay (Elecsys® Anti-SARS-CoV-2 S). Data on characteristics of the participants were gathered from patient records and interview sheets.ResultsA total of 401 participants, among whom 70.1% were women and the median age was 42 years, were evaluated in this study. None of the participants had a definite COVID-19 history, and all participants who received complete vaccination showed positive antibody titers. The antibody titer was observed to be higher in participants with younger age (p < 0.001) and those who were females (p = 0.028). Despite the higher risk of infection than that of the general public, no vaccinated staff developed breakthrough infections.ConclusionsThis study demonstrates the significant contribution of the BNT162b2 vaccine in the acquisition of anti-SARS-CoV-2S antibodies; therefore, the general population should benefit from these two vaccine doses, which are expected to be protective for at least five months.     

COVID-19 prevalence among healthcare workers in Jakarta and neighbouring areas in Indonesia during early 2020 pandemic

BackgroundThe COVID-19 disease has overwhelmed and disrupted healthcare services worldwide, particularly healthcare workers (HCW). HCW are essential workers performing any job in a healthcare setting who are potentially directly or indirectly exposed to infectious materials. Our retrospective cohort study aimed to determine the prevalence of COVID-19 infections among HCW in Jakarta and neighbouring areas during the first three months of the pandemic.MethodsNasopharyngeal/oropharyngeal swab specimens from HCW working at private and public hospitals in Jakarta and neighbouring areas were screened for SARS-CoV-2 between March and May 2020. Data on demography, clinical symptoms, contact history, and personal protective equipment (PPE) use were collected using standardised forms.ResultsAmong 1201 specimens, 7.9% were confirmed positive for SARS-CoV-2 with the majority coming from medical doctors (48.4%) and nurses (44.2%). 64.2% of the positive cases reported to have contact with suspect/confirmed COVID-19 cases, including 32 (52.2%) with patient and 3 (6.6%) with co-worker. The symptomatic HCW had a significantly lower median Ct value as compared to their asymptomatic counterpart (p < .001). Tendency to have a higher prevalence of pneumonia was observed in the age group of 40 – 49 and ≥50 years old.ConclusionOur findings highlighted the necessity to implement proper preventive and surveillance strategies for this high-risk population including adherence to strict PPE protocol and appropriate training.

Key Message

• Healthcare workers (HCW), defined as those handling any job in a healthcare setting, are at the frontline of risk of infection as SARS-CoV-2 is easily transmitted through airborne droplets and direct contact with contaminated surfaces. The aim of our study is to attain a more comprehensive and accurate picture of the impact of COVID-19 on HCW during the earlier phase of the outbreak in Indonesia to develop effective strategies that protect the health and safety of this workforce. Our findings highlighted that COVID-19 infections in HCW were mostly acquired in healthcare settings, with significant consequences of pneumonia and hospitalisation occurring across all age groups.

     

Features of antibody responses after SARS-COV-2 infection in healthcare workers in the first wave of COVID-19 pandemic in Mexico City

ObjectiveTo investigate the antibody response to SARS-CoV-2 and identify associated factors in frontline and second-line healthcare workers (HCWs) at a large hospital in Mexico City during the first wave of COVID-19 pandemic.MethodsThis was a cross-sectional study of HCWs returning to work following mandatory isolation after recovering from COVID-19. Immunoglobulin (Ig) M and IgG antibodies elicited by SARS-CoV-2 were semiquantitatively measured using densitometric analysis of band intensities in lateral flow assay (LFA) devices. The mean pixel intensity (dots-per-inch [dpi]) of each band on the LFA was considered a measure of antibody titre.ResultsOf the 111 HCWs involved in the study, antibody responses were detected in 73/111 (66%) participants. Severe COVID symptoms was associated with old age. No differences in IgM intensity were observed between men and women, but IgG intensity was significantly higher in men than in women. Second-line HCWs produced a higher IgG intensity than firstline HCWs. The IgG intensity was high in severe cases.ConclusionsFor HCWs who may acquire SARS-CoV-2 infection, it is necessary to establish a routine program for detection of the virus to avoid risk of infection and spread of COVID-19.     

Pre-pandemic mental and physical health as predictors of COVID-19 vaccine hesitancy: evidence from a UK-wide cohort study

BackgroundAlthough several predictors of COVID-19 vaccine hesitancy have been identified, the role of physical health and, particularly, mental health, is poorly understood.MethodsWe used individual-level data from a pandemic-focused investigation (COVID Survey), a prospective cohort study nested within the UK Understanding Society (Main Survey) project. In the week immediately following the announcement of successful testing of the first efficacious inoculation (Oxford University/AstraZeneca, November/December 2020), data on vaccine intentionality were collected in 12,035 individuals aged 16–95 years. Pre-pandemic, study members had responded to enquiries about diagnoses of mental and physical health, including the completion of the 12-item General Health Questionnaire for symptoms of psychological distress (anxiety and depression). Peri-pandemic, individuals indicated whether they or someone in their household was shielding; that is, people judged by the UK National Health Service as being particularly clinically vulnerable who were therefore requested to remain at home. Intention to take up vaccination for COVID-19 was also self-reported.ResultsIn an analytical sample of 11,955 people (6741 women), 15.4% indicated that they were vaccine-hesitant. Relative to their disease-free counterparts, shielding was associated with a 24% lower risk of being hesitant (odds ratio; 95% confidence interval: 0.76; 0.59, 0.96), after adjustment for a range of covariates which included age, education, and ethnicity. Corresponding results for cardiometabolic disease were 22% (0.78; 0.64, 0.95), and for respiratory disease were 26% (0.74; 0.59, 0.93). Having a pre-pandemic diagnosis of anxiety or depression, or a high score on the distress symptom scale, were all unrelated to the willingness to vaccine-hesitancy.ConclusionsPeople with a physical condition were more likely to take up the potential offer of a COVID-19 vaccination. These effects were not apparent for indices of mental health.

Key messages

• In understanding predictors of COVID-19 vaccine hesitancy, the role of physical and mental health has not been well-examined despite both groups seemingly experiencing an elevated risk of the disease.
• In a large UK cohort study, people with a pre-pandemic physical condition were more likely to take up the theoretical offer of vaccination.
• There were no apparent effects for indices of pre-pandemic mental health.

     

Understanding the effects of COVID-19 stigmatisation on job performance: a survey of frontline healthcare workers

The level of stigmatisation among health care providers has increased during the COVID-19 pandemic, and understanding the effect of COVID-19 stigmatisation on job performance has become increasingly important. The study explores the influence of COVID-19 stigmatisation on job performance among frontline health workers via the mediating role of anxiety. Furthermore, the moderating effect of resilience in the association between COVID-19 stigmatisation and anxiety is further examined. Participants were made up of 820 frontline health workers working in the epicentres of the Bono Ahafo, Western, Greater Accra, and Northern regions of Ghana. The hierarchical regression technique was employed in estimating the relationship between the variables. COVID-19 stigmatisation among frontline health workers directly affected anxiety and performance. In addition, the results showed that resilience moderated the relationship between COVID-19 stigmatisation and anxiety. The findings again demonstrated that anxiety partially mediated the association between concern for disclosure and public attitude and negative experience and job performance, whereas personalised stigma was insignificant. The study provides implications for establishing anti-stigma interventions and programs to enhance job performance among health workers.

Key messages

1. Many healthcare workers are subject to stigmatisation during the COVID-19 pandemic.
2. The study employs hierarchical regression methods to examine the impacts of COVID-19 stigmatisation on job performance among frontline health workers.
3. The health management team should strengthen interventions to control the stigma experienced by health workers during COVID-19 treatments.