key: cord-0936155-4i5xiea9 authors: Izumo, Takehiro; Kuse, Naoyuki; Awano, Nobuyasu; Tone, Mari; Sakamoto, Keita; Takada, Kohei; Muto, Yutaka; Fujimoto, Kazushi; Saiki, Ayae; Ito, Yu; Matsumoto, Haruko; Inomata, Minoru title: Side effects and antibody titer transition of the BNT162b2 messenger ribonucleic acid coronavirus disease 2019 vaccine in Japan date: 2021-06-19 journal: Respir Investig DOI: 10.1016/j.resinv.2021.06.003 sha: 223ba03ae3c6e810aa3ac1a63f247220865f639b doc_id: 936155 cord_uid: 4i5xiea9 BACKGROUND: The coronavirus disease (COVID-19) has afflicted large populations worldwide. Although vaccines aroused great expectations, their side effects on Japanese people and the antibody titer transition after vaccination are unclear. METHODS: The side effects of the BNT162b2 mRNA COVID-19 vaccine in participants who received vaccination at our center were investigated. Some participants were also surveyed for the antibody titer transition. RESULTS: In this study, 983 and 798 Japanese participants responded to the first and second doses, respectively. Side effects occurred in 757 (77.0%) and 715 participants (90.0%) after the first and second doses, respectively. No Grade 4 side effects occurred. The second dose had significantly more side effects than the first dose (p < 0.001). Side effects occurred after the second dose in 571 female (92.1%) and 178 male participants (80.1%). Female participants had a higher incidence of side effects than the male participants (p < 0.001). A comparison among the age groups showed significant differences (p = 0.018), and the frequency of side effects decreased with age. Twenty-three individuals participated in the survey of antibody titer transition. After the second vaccine dose, the median antibody titers for IgG and IgM were 3.76 and 0.07 AU/mL, respectively. Both IgG and IgM titers showed a significant increase over the study period (p < 0.001). CONCLUSIONS: The BNT162b2 mRNA COVID-19 vaccine might be safe for Japanese people, and the antibody titer increased with two doses of vaccination. Larger nationwide studies are warranted to verify these findings. vaccination at our center were investigated. Some participants were also surveyed for the antibody titer 23 transition. Results: In this study, 983 and 798 Japanese participants responded to the first and second doses, 25 respectively. Side effects occurred in 757 (77.0%) and 715 participants (90.0%) after the first and second 26 doses, respectively. No Grade 4 side effects occurred. The second dose had significantly more side effects 27 than the first dose (p < 0.001). Side effects occurred after the second dose in 571 female (92.1%) and 178 28 male participants (80.1%). Female participants had a higher incidence of side effects than the male 29 participants (p < 0.001). A comparison among the age groups showed significant differences (p = 0.018), (SARS-CoV-2) and continues to spread worldwide [1] . In Japan, the number of cases has also been 42 increasing rapidly since the national and local governments declared a state of emergency. Elderly people, 43 patients with comorbidities, and healthcare workers are at high risk of SARS-CoV-2 infection [2] . Furthermore, reports have suggested that it can also prevent severe diseases [6] . Regarding the safety 55 profile, the frequency of pain following the administration of the BNT162b2 vaccine was found to be as However, vaccination against SARS-CoV-2 for healthcare professionals and a few elderly individuals has 59 just initiated in Japan, and no side effects have been reported. Regarding vaccination, details such as the 60 difference in side effects between the first and second vaccinations, sex-, and age-related differences are 61 unknown in Japan. Additionally, the antibody titer transition after SARS-CoV-2 vaccination has not been reported in Japan, and reports about dynamic changes and the prevalence of SARS-CoV-2 antibodies are few worldwide [7] . Therefore, the present prospective cohort study aimed to investigate the side effects of SARS-CoV-2 65 vaccination and survey the antibody titer transition after vaccination in Japanese healthcare workers. Data are presented as numbers (percentages). Differences between the groups were compared using 103 Fisher exact tests for categorical variables. The associations between the groups were presented as odds 104 ratios (ODs) and 95% confidence intervals (CIs). The Friedman test for paired data was used to evaluate 105 the significance of the differences in antibody titers at baseline and after the first and second doses of the 106 time course of the COVID-19 vaccination. The correlation between antibody titer and age was analyzed 107 using Spearman's rank correlation. All the reported P values were two-sided, and P values < 0.05 were 108 considered indicative of statistical significance. All statistical analyses were performed using EZR The demographic characteristics are shown in Table 1 (Table 3) . A comparison between female and male participants showed that female participants 144 had a significantly higher incidence of side effects than the male participants (p < 0.001; OD, 1.88; 95% (Table 4) . A comparison between the female and male participants showed that the female 162 participants had a significantly higher incidence of side effects than the male participants (p < 0.001; OD, The side effects after the second dose of vaccine were examined and compared according to age 181 ( . PEG is also used in shampoo and toothpaste and often in cosmetics; therefore, females 244 might be more prone to anaphylaxis as they generally use more cosmetics than males. Although 245 anaphylaxis did not occur in any of the participants in this study, this idea might apply to all side reactions. Significantly more female participants had Grade 3 side effects than the male participants. General fatigue 247 and joint pain were more common in women than men; therefore, caution is required. A rest day might be 248 necessary after the second vaccination. We also examined the side effects of age-based vaccination. As shown in Table 5 , the incidence of 250 side effects was significantly higher in the young participants than in the elderly participants. Additionally, 251 the incidence of Grade 3 side effects was higher in the young participants than in the elderly participants. age. This indicated that older people had lower antibody titers than younger people, which may be related 267 to the fact that older adults have a lower incidence of side effects owing to being vaccinated in this study. However, in this study, the correlation between antibody titer and side effects could not be investigated Data are presented as numbers (percentages). Differences between the groups were compared using Fisher exact tests. Differences between the groups were compared using Fisher exact tests. Differences between the groups were compared using Fisher exact tests. Differences between the groups were compared using Fisher exact tests. The impact of ethnicity on 310 clinical outcomes in COVID-19: A systematic review Clinical characteristics of 41 patients 312 with pneumonia due to 2019 novel coronavirus disease (COVID-19) in Jilin Safety and 315 Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults Safety and Efficacy 318 of the BNT162b2 mRNA Covid-19 Vaccine Review of COVID-19 mRNA Vaccines: BNT162b2 and mRNA-1273 Vaccine in a Nationwide Mass Vaccination Setting Dynamic changes and prevalence of 324 SARS-CoV-2 IgG/IgM antibodies: multiple factors-based analysis Back to normal SARS-CoV-2-Specific Antibodies Investigation of the freely available easy-to-use software 'EZR' for medical statistics Interim findings from 332 first-dose mass COVID-19 vaccination roll-out and COVID-19 hospital admissions in Scotland: 333 a national prospective cohort study Others: hypertension, oropharyngeal pain, dizziness, lymph node swelling, and drowsiness 378 Data are presented as numbers (percentages) Differences between the groups were compared using Fisher exact tests COVID-19, coronavirus disease All authors are required to disclose any COI within 3 calendar years preceding the current year, prior to the submission of any manuscript in the subject matter of which any company, entity, or organization has an interest. 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