Immunogenicity, safety and clinical outcomes of the SARS-CoV-2 BNT162b2 vaccine in adolescents with type 1 diabetes
IntroductionThe mRNA-based BNT162b2 (Pfizer-BioNTech) vaccine has been shown to elicit robust systemic immune response and confer substantial protection against the severe coronavirus disease (COVID-19), with a favorable safety profile in adolescents. However, no data exist regarding immunogenicity,...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-06-01
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| Series: | Frontiers in Pediatrics |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fped.2023.1191706/full |
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| author | Hamdi Cihan Emeksiz Merve Nur Hepokur Sibel Ergin Şahin Banu Nursoy Şirvan Burçin Çiçek Aşan Önder Metin Yıldız Derya Karaman Aksakal Aysun Bideci Hüsnü Fahri Ovalı Ferruh İşman |
| author_facet | Hamdi Cihan Emeksiz Merve Nur Hepokur Sibel Ergin Şahin Banu Nursoy Şirvan Burçin Çiçek Aşan Önder Metin Yıldız Derya Karaman Aksakal Aysun Bideci Hüsnü Fahri Ovalı Ferruh İşman |
| author_sort | Hamdi Cihan Emeksiz |
| collection | DOAJ |
| description | IntroductionThe mRNA-based BNT162b2 (Pfizer-BioNTech) vaccine has been shown to elicit robust systemic immune response and confer substantial protection against the severe coronavirus disease (COVID-19), with a favorable safety profile in adolescents. However, no data exist regarding immunogenicity, reactogenicity and clinical outcomes of COVID-19 vaccines in adolescents with type 1 diabetes (T1D). In this prospective observational cohort study, we examined the humoral immune responses and side effects induced by the BNT162b2 vaccine, as well as, the rate and symptomatology of laboratory-confirmed COVID-19 vaccine breakthrough infections after completion of dual-dose BNT162b2 vaccination in adolescents with T1D and compared their data with those of healthy control adolescents. The new data obtained after the vaccination of adolescents with T1D could guide their further COVID-19 vaccination schedule.MethodsA total of 132 adolescents with T1D and 71 controls were enrolled in the study, of whom 81 COVID-19 infection-naive adolescents with T1D (patient group) and 40 COVID-19 infection-naive controls (control group) were eligible for the final analysis. The response of participants to the BNT162b2 vaccine was assessed by measuring their serum IgG antibodies to the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 4–6 weeks after the receipt of first and second vaccine doses. Data about the adverse events of the vaccine was collected after the receipt of each vaccine dose. The rate of COVID-19 vaccine breakthrough infections was evaluated in the 6-month period following second vaccination.ResultsAfter vaccinations, adolescents with T1D and controls exhibited similar, highly robust increments in anti-SARS-CoV-2 IgG titers. All the participants in the patient and control groups developed anti-SARS-CoV-2 IgG titers over 1,050 AU/ml after the second vaccine dose which is associated with a neutralizing effect. None of the participants experienced severe adverse events. The rate of breakthrough infections in the patient group was similar to that in the control group. Clinical symptomatology was mild in all cases.ConclusionOur findings suggest that two-dose BNT162b2 vaccine administered to adolescents with T1D elicits robust humoral immune response, with a favorable safety profile and can provide protection against severe SARS-CoV-2 infection similar to that in healthy adolescents. |
| first_indexed | 2024-03-13T03:10:58Z |
| format | Article |
| id | doaj.art-8d75d358961e4efcb462f4462436ebbc |
| institution | Directory Open Access Journal |
| issn | 2296-2360 |
| language | English |
| last_indexed | 2024-03-13T03:10:58Z |
| publishDate | 2023-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Pediatrics |
| spelling | doaj.art-8d75d358961e4efcb462f4462436ebbc2023-06-26T12:07:12ZengFrontiers Media S.A.Frontiers in Pediatrics2296-23602023-06-011110.3389/fped.2023.11917061191706Immunogenicity, safety and clinical outcomes of the SARS-CoV-2 BNT162b2 vaccine in adolescents with type 1 diabetesHamdi Cihan Emeksiz0Merve Nur Hepokur1Sibel Ergin Şahin2Banu Nursoy Şirvan3Burçin Çiçek4Aşan Önder5Metin Yıldız6Derya Karaman Aksakal7Aysun Bideci8Hüsnü Fahri Ovalı9Ferruh İşman10Department of Pediatric Endocrinology, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Pediatric Endocrinology, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Pediatric Endocrinology, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Pediatric Endocrinology, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Pediatric Endocrinology, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Pediatric Endocrinology, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Pediatric Endocrinology, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Pediatric Endocrinology, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Pediatric Endocrinology, Gazi University Hospital, Ankara, TürkiyeDepartment of Pediatrics, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeDepartment of Biochemistry, Professor Doctor Süleyman Yalçın City Hospital, Istanbul Medeniyet University, Istanbul, TürkiyeIntroductionThe mRNA-based BNT162b2 (Pfizer-BioNTech) vaccine has been shown to elicit robust systemic immune response and confer substantial protection against the severe coronavirus disease (COVID-19), with a favorable safety profile in adolescents. However, no data exist regarding immunogenicity, reactogenicity and clinical outcomes of COVID-19 vaccines in adolescents with type 1 diabetes (T1D). In this prospective observational cohort study, we examined the humoral immune responses and side effects induced by the BNT162b2 vaccine, as well as, the rate and symptomatology of laboratory-confirmed COVID-19 vaccine breakthrough infections after completion of dual-dose BNT162b2 vaccination in adolescents with T1D and compared their data with those of healthy control adolescents. The new data obtained after the vaccination of adolescents with T1D could guide their further COVID-19 vaccination schedule.MethodsA total of 132 adolescents with T1D and 71 controls were enrolled in the study, of whom 81 COVID-19 infection-naive adolescents with T1D (patient group) and 40 COVID-19 infection-naive controls (control group) were eligible for the final analysis. The response of participants to the BNT162b2 vaccine was assessed by measuring their serum IgG antibodies to the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), 4–6 weeks after the receipt of first and second vaccine doses. Data about the adverse events of the vaccine was collected after the receipt of each vaccine dose. The rate of COVID-19 vaccine breakthrough infections was evaluated in the 6-month period following second vaccination.ResultsAfter vaccinations, adolescents with T1D and controls exhibited similar, highly robust increments in anti-SARS-CoV-2 IgG titers. All the participants in the patient and control groups developed anti-SARS-CoV-2 IgG titers over 1,050 AU/ml after the second vaccine dose which is associated with a neutralizing effect. None of the participants experienced severe adverse events. The rate of breakthrough infections in the patient group was similar to that in the control group. Clinical symptomatology was mild in all cases.ConclusionOur findings suggest that two-dose BNT162b2 vaccine administered to adolescents with T1D elicits robust humoral immune response, with a favorable safety profile and can provide protection against severe SARS-CoV-2 infection similar to that in healthy adolescents.https://www.frontiersin.org/articles/10.3389/fped.2023.1191706/fullBNT162b2 vaccineCOVID-19immunogenicitytype 1 diabetesadolescentsSARS-CoV-2 |
| spellingShingle | Hamdi Cihan Emeksiz Merve Nur Hepokur Sibel Ergin Şahin Banu Nursoy Şirvan Burçin Çiçek Aşan Önder Metin Yıldız Derya Karaman Aksakal Aysun Bideci Hüsnü Fahri Ovalı Ferruh İşman Immunogenicity, safety and clinical outcomes of the SARS-CoV-2 BNT162b2 vaccine in adolescents with type 1 diabetes Frontiers in Pediatrics BNT162b2 vaccine COVID-19 immunogenicity type 1 diabetes adolescents SARS-CoV-2 |
| title | Immunogenicity, safety and clinical outcomes of the SARS-CoV-2 BNT162b2 vaccine in adolescents with type 1 diabetes |
| title_full | Immunogenicity, safety and clinical outcomes of the SARS-CoV-2 BNT162b2 vaccine in adolescents with type 1 diabetes |
| title_fullStr | Immunogenicity, safety and clinical outcomes of the SARS-CoV-2 BNT162b2 vaccine in adolescents with type 1 diabetes |
| title_full_unstemmed | Immunogenicity, safety and clinical outcomes of the SARS-CoV-2 BNT162b2 vaccine in adolescents with type 1 diabetes |
| title_short | Immunogenicity, safety and clinical outcomes of the SARS-CoV-2 BNT162b2 vaccine in adolescents with type 1 diabetes |
| title_sort | immunogenicity safety and clinical outcomes of the sars cov 2 bnt162b2 vaccine in adolescents with type 1 diabetes |
| topic | BNT162b2 vaccine COVID-19 immunogenicity type 1 diabetes adolescents SARS-CoV-2 |
| url | https://www.frontiersin.org/articles/10.3389/fped.2023.1191706/full |
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