Side effects and antibody titer transition of the BNT162b2 messenger ribonucleic acid coronavirus disease 2019 vaccine in Japan

Izumo, Takehiro; Kuse, Naoyuki; Awano, Nobuyasu; Tone, Mari; Sakamoto, Keita; Takada, Kohei; Muto, Yutaka; Fujimoto, Kazushi; Saiki, Ayae; Ito, Yu; Matsumoto, Haruko; Inomata, Minoru

doi:10.1016/j.resinv.2021.06.003

Cited by 31 publications

(38 citation statements)

References 12 publications

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“…In this study, the female gender was also associated with development of moderate and severe post-vaccinal adverse effects, showing a positive correlation of gender to the severity of the post-vaccinal side effects. This finding also agrees with other findings and confirms that the development of post-vaccinal side effects were significantly higher in females than in males (23,24,29). However, it disagrees with a recent study (30) that reported that males TABLE 4 | Comparison between the post vaccine adverse effects after vaccination with BNT162b2 and ChAdOx1 as well as those after the first and the second doses of BNT162b2.…”

Section: Discussionsupporting

confidence: 84%

BNT162b2 and ChAdOx1 SARS-CoV-2 Post-vaccination Side-Effects Among Saudi Vaccinees

et al. 2021

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Background: Vaccination against SARS-CoV-2 is important for reducing hospitalization and mortalities. Both Pfizer-BioNTech (BNT162b2) and the Oxford-AstraZeneca (ChAdOx1 nCoV-19) vaccines are used in Saudi Arabia and in many parts of the world. Post-vaccinal side effects were recorded, so we aimed to screen different complaints after vaccination among vaccinees in Saudi Arabia.Methods: An online questionnaire was designed to screen the local, systemic, and allergic post vaccination reactions for vaccinees who received either one or two doses of the BNT162b2 vaccine or one dose of the ChAdOx1 vaccine. The number and percentage were recorded for each response and analyzed using cross-tab and Chi square tests. The degree of the severity of post vaccination reactions were analyzed using Roc curve. The cofactors that may affect the severity of post-vaccinal reactions including previous COVID-19 infection, age, sex, body mass index, and comorbidities were investigated.Results: During our study, 4,170 individuals reported their responses: 2,601 received one dose of BNT162b2, of whom 456 completed the second dose, and 1,569 received a single dose of ChAdOx1. The side effects were reported in 85.6% of BNT162b2 vaccinees and 96.05% of ChAdOx1 vaccinees who voluntarily responded to a survey about post-vaccination side effects. The side effects were more severe in BNT162b2 than ChAdOx1. ChAdOx1 vaccinees reported mild, moderate, severe and critical side effects in 30.13, 28.62, 29.73, and 1.53%, respectively. In contrast, mild side effects were recorded among the majority of BNT162b2 vaccinees (63.92%) while moderate, severe, and critical side effects were 27.67, 7.68, and 0.72%, respectively. Both local and systemic side effects were recorded more frequently in ChAdOx1 in comparison to BNT162b2 vaccinees. Palpitation was among the new systemic side effects reported in the current study in high frequency. Abnormal menstrual cycle (delaying/increase hemorrhages or pain) was also reported in 0.98% (18/1846) of Pfizer-BioNTech and 0.68% (7/1028) of ChAdOx1 vaccinees, while deep vein thrombosis was only reported in a single case vaccinated with BNT162b2 vaccine.Conclusion: Both vaccines induced post-vaccinal side effects; however, ChAdOx1 induces a higher frequency of post-vaccinal systemic side effects than BNT162b2.

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Section: Discussionsupporting

confidence: 84%

BNT162b2 and ChAdOx1 SARS-CoV-2 Post-vaccination Side-Effects Among Saudi Vaccinees

et al. 2021

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“…In addition, we did not include specific questions about anaphylaxis or myocarditis in the questionnaire. However, this study is relatively large compared to previous studies conducted in Japan [ 6 , 7 ] and is the first study in Japan to compare the adverse reactions to the two mRNA-based vaccines.…”

Section: Discussionmentioning

confidence: 97%

“…Therefore, continued monitoring of adverse reactions to COVID-19 vaccines under programmatic conditions, especially in young age groups, may provide relevant information to the public and contribute to people's acceptance of COVID-19 vaccines. However, programmatic evidence on the reactogenicity of COVID-19 vaccines in the Japanese population is limited [ 6 , 7 ]. In addition, there is a lack of evidence on the comparative side effects of different COVID-19 vaccines.…”

Section: Introductionmentioning

confidence: 99%

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

Kitagawa

Kaiki

Sugiyama

et al. 2022

Journal of Infection and Chemotherapy

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Introduction The 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. Methods We conducted an online survey on self-reported adverse reactions in individuals who had received two doses of the BNT162b2 mRNA 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 mRNA and mRNA-1273 vaccines. Results After 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 30–69 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. Conclusions Adverse reactions were more frequently reported in females, younger individuals, and after the mRNA-1273 vaccine.

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“…The vaccine helps to prevent not only the onset [ 1 ] but also the progression of COVID-19. However, some people hesitate in getting vaccinated due to fear of relatively common adverse effects that occur shortly after vaccination with the BNT162b2 vaccine [ 2 , 3 , 4 ].…”

Section: Introductionmentioning

confidence: 99%

Systemic Adverse Effects Induced by the BNT162b2 Vaccine Are Associated with Higher Antibody Titers from 3 to 6 Months after Vaccination

et al. 2022

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Objective: We aimed to determine the relationship between vaccine-related adverse effects and antibody (Ab) titers from 3 to 6 months after the second dose of the BNT162b2 coronavirus disease 2019 (COVID-19) mRNA vaccine (Pfizer/BioNTech) in Japan. Methods: We enrolled 378 healthcare workers (255 women and 123 men) whose Ab titers were analyzed 3 and 6 months after the second dose in our previous study and whose characteristics and adverse effects were collected previously by using a structured self-report questionnaire. Results: The workers’ median age was 44 years. Although injection-site symptoms occurred with almost equal frequency between the first and second doses, systemic adverse effects, such as general fatigue and fever, were significantly more frequent after the second dose than after the first dose. Multivariate analysis showed that fever was significantly correlated with female participants for the second dose (odds ratio (OR), 2.139; 95% confidence interval (95% CI), 1.185–3.859), older age for the first dose (OR, 0.962; 95% CI, 0.931–0.994) and second dose (OR, 0.957; 95% CI, 0.936–0.979), and dyslipidemia for the first dose (OR, 8.750; 95% CI, 1.814–42.20). Age-adjusted Ab titers at 3 months after vaccination were 23.7% and 23.4% higher in patients with a fever than in those without a fever after the first and second dose, respectively. In addition, age-adjusted Ab titers at 3 and 6 months after the second dose were, respectively, 21.7% and 19.3% higher in the group in which an anti-inflammatory agent was used than in the group without the use of an anti-inflammatory agent. Conclusion: Participants with systemic adverse effects tend to have higher Ab titers from 3 to 6 months after the second dose of the BNT162b2 vaccine. Our results may encourage vaccination, even among people with vaccine hesitancy related to relatively common systemic adverse effects.

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Side effects and antibody titer transition of the BNT162b2 messenger ribonucleic acid coronavirus disease 2019 vaccine in Japan

Cited by 31 publications

References 12 publications

BNT162b2 and ChAdOx1 SARS-CoV-2 Post-vaccination Side-Effects Among Saudi Vaccinees

BNT162b2 and ChAdOx1 SARS-CoV-2 Post-vaccination Side-Effects Among Saudi Vaccinees

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

Systemic Adverse Effects Induced by the BNT162b2 Vaccine Are Associated with Higher Antibody Titers from 3 to 6 Months after Vaccination

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