Early Adverse Effects after COVID-19 Vaccine in Children and Adolescents with Psychiatric Disorders

Öz

Objective: Vaccines for COVID-19 have reduced the severity of the infection and prevented deaths. Parents of children on psychopharmacological medications for psychiatric disorders were also referred to the hospital to learn whether the vaccine was safe for their children. It is not known until this period how chronic psychopharmacological drug use will interact with the vaccine. This study aimed to examine the early adverse effects of COVID-19 vaccines in children and adolescents aged 12-18 who have chronic psychiatric disorders and use psychopharmacological medications. Method: Post-vaccine short-term effects of 88 patients aged 12-18, who were followed up in the child and adolescent psychiatry clinic due to chronic psychiatric disorders and were using psychopharmacological medications, were monitored and compared with 88 vaccinated healthy controls. Results: Of the 88 patients, 80 (90.9%) were vaccinated with BNT162b2 (BioNTech) as the healthy control group; 8 (9.1%) were with Sinovac. Seventy-six (86.3%) of all patients were vaccinated with the second, and 21 (24%) were with the third dose. These were 83-second and 26-third doses for the control group. From all 45.4% of the patients were using antipsychotics. The cases were examined on the fourth and seventh days after vaccination. While the most frequently reported adverse effects after the first BNT162b2 dose in the patient group on the fourth day after vaccination were local pain (58.8%), fatigue (16.3%), redness (12.5%), and headache (11.3%), side affects first Sinovac dose in the patient group were local pain (75.0%), redness (25.0%), fatigue (25.0%). There was no significant difference between the patient and control groups receiving the BNT162b2 or Sinovac vaccine regarding adverse ffects on the fourth day. At the same time, in comparisons between patients diagnosed with psychiatric disorders, no statistical difference was found in terms of early adverse effects between the patients with and without antipsychotic use. Discussion: Our study shows that the vaccines mentioned in children and adolescents with psychiatric disorders are as safe and tolerable in terms of short-term side effects as in healthy individuals. This knowledge will be crucial in guiding evidence-based clinical decision-making and ensuring the safety of children and adolescents with psychiatric disorders.

Anahtar Kelimeler

• Adolescent
• Antipsychotic
• Child
• COVID-19
• Psychiatric disorder

Psikiyatrik Bozukluğu Olan Çocuk ve Ergenlerde COVID-19 Aşısı Sonrası Erken Yan Etkiler

Öz

Amaç: COVID-19 aşıları enfeksiyonun şiddetini azaltmada ve ölümleri önlemede büyük bir gelişme olmuştur. Psikiyatrik bozukluklar nedeniyle psikofarmakolojik ilaç kullanan çocukların ebeveynleri de bu öncelikten yararlanmak amacıyla hastaneye başvurmuş ve ilk olarak aşının çocukları için güvenli olup olmadığını merak etmişlerdir. Kronik psikofarmakolojik ilaç kullanımının aşı ile nasıl etkileşeceği bu döneme kadar bilinmemektedir. Bu araştırmada COVID-19 aşılarının 12-18 yaş arası kronik psikiyatrik bozukluğu olup psikofarmakolojik ilaç kullanan çocuk ve ergenlerde erken dönem yan etkilerinin incelenmesi amaçlanmıştır. Yöntem: Çocuk ve ergen psikiyatri kliniğinde kronik psikiyatrik bozukluk nedeniyle takip edilen ve psikofarmakolojik ilaç kullanan 12-18 yaş arası 88 hastanın aşı sonrası kısa dönem yan etkileri takip edilmiş ve aşı olan 88 sağlıklı kontrolle karşılaştırılmıştır. Bulgular: Çalışmaya alınan hastaların 80’i (%90,9) BNT162b2 (BioNTech) aşısı; 8’i (%9,1) Sinovac aşısı olmuştu. Tüm hastaların 76’sı (%86,3) ikinci doz, 21’i (%24) ise üçüncü dozla aşılanmıştı. Kontrol grubu için 83 kişi ikinci dozu ve 26 kişi ise üçüncü dozu olmuştu. Antipsikotik kullanımı hastaların %45,4’ünde mevcuttu. Aşılar sonrası dördüncü ve yedinci günde olguların muayeneleri yapıldı. Aşı sonrası dördüncü günde hasta grubunda birinci BNT162b2 dozundan sonra en sık bildirilen yan etkiler lokal ağrı (%58,8), yorgunluk (%16,3), kızarıklık (%12,5) ve baş ağrısı (%11,3) iken, birinci Sinovac dozundan sonra ise lokal ağrı (%75,0), kızarıklık (%25,0), yorgunluktu (%25,0). Dördüncü gündeki yan etkiler açısından BNT162b2 ya da Sinovac aşısı yapılan hasta ve kontrol grupları arasında anlamlı bir fark yoktu. Aynı zamanda psikiyatrik bozukluk tanısı konulan hastalar arasındaki karşılaştırmalarda erken dönem yan etkiler açısından antipsikotik kullanan ve kullanmayanlarda istatistiksel farklılık bulunmadı. Tartışma: Bu çalışmada incelenen COVID-19 aşılarının, psikofarmakolojik ilaç kullanan psikiyatrik bozukluğu olan ergenler için kısa vadede güvenli olduğu bulunmuştur. Bu bilgiler, kanıta dayalı klinik karar alma süreçlerine rehberlik etmede ve psikiyatrik bozukluğu olan çocuk ve ergenlerin güvenliğini ve refahını sağlamada kritik öneme sahip olacaktır.

Anahtar Kelimeler

• Antipsikotik
• Aşı
• Çocuk
• COVID-19
• Ergen
• Psikiyatrik bozukluk

Teşekkür

We thank the participants, their parents/caregivers, and Mehmet Emin Seker, MSc, for his technical support.

Kaynakça

1. Anand, P., & Stahel, V. P. (2021). Review the safety of Covid-19 mRNA vaccines: a review. Patient Saf Surg, 15(1), 20. https://doi.org/10.1186/s13037-021-00291-9
2. Belfer, M. L., & Nurcombe, B. (2007). The epidemiology and burden of child and adolescent mental disorder. The mental health of children and adolescents: An area of global neglect, 27-42.
3. Bianco, A., Della Polla, G., Angelillo, S., Pelullo, C. P., Licata, F., & Angelillo, I. F. (2022). Parental COVID-19 vaccine hesitancy: a cross-sectional survey in Italy. Expert review of vaccines, 21(4), 541-547.
4. Cauchemez, S., Bosetti, P., Kiem, C. T., Mouro, V., Consoli, A., & Fontanet, A. (2021). Education and mental health: good reasons to vaccinate children. Lancet, 398(10298), 387. https://doi.org/10.1016/s0140-6736(21)01453-7
5. Chen, F., Cao, H., Baranova, A., Zhao, Q., & Zhang, F. (2023). Causal associations between COVID-19 and childhood mental disorders. BMC psychiatry, 23(1), 922.
6. Chen, G., Li, X., Sun, M., Zhou, Y., Yin, M., Zhao, B., & Li, X. (2021). COVID-19 mRNA Vaccines Are Generally Safe in the Short Term: A Vaccine Vigilance Real-World Study Says. Front Immunol, 12, 669010. https://doi.org/10.3389/fimmu.2021.669010
7. Control, Centers for Disease, & Prevention. (2022). Clinical considerations: Myocarditis and Pericarditis after Receipt of mRNA COVID-19 vaccines among Adolescents and Young Adults. Centers for Disease Control and Prevention. Retrieved August 12, 2022. In.
8. Copland, E., Patone, M., Saatci, D., Handunnetthi, L., Hirst, J., Hunt, D. P., Mills, N. L., Moss, P., Sheikh, A., & Coupland, C. A. (2024). Safety outcomes following COVID-19 vaccination and infection in 5.1 million children in England. Nature Communications, 15(1), 3822.

9. Frenck, R. W., Jr., Klein, N. P., Kitchin, N., Gurtman, A., Absalon, J., Lockhart, S., Perez, J. L., Walter, E. B., Senders, S., Bailey, R., Swanson, K. A., Ma, H., Xu, X., Koury, K., Kalina, W. V., Cooper, D., Jennings, T., Brandon, D. M., Thomas, S. J., Türeci, Ö., Tresnan, D. B., Mather, S., Dormitzer, P. R., Şahin, U., Jansen, K. U., & Gruber, W. C. (2021, Jul 15). Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents. N Engl J Med, 385(3), 239-250. https://doi.org/10.1056/NEJMoa2107456
10. Gao, P., Kang, L. Y., Liu, J., & Liu, M. (2023). Immunogenicity, effectiveness, and safety of COVID-19 vaccines among children and adolescents aged 2-18 years: an updated systematic review and meta-analysis. World J Pediatr, 1-14. https://doi.org/10.1007/s12519-022-00680-9
11. Gedik, M. S., Kilci, A. İ., Hakkoymaz, H., Küçük, Ö. F., Solak, Y., Basan, N. M., & Çıkrıkçı, Y. E. (2023). Evaluation of patients of vaccine side effects after the COVID-19 vaccine. Revista da Associacao Medica Brasileira (1992), 69(1), 147–152. https://doi.org/10.1590/1806-9282.20221035
12. Han, B., Song, Y., Li, C., Yang, W., Ma, Q., Jiang, Z., Li, M., Lian, X., Jiao, W., Wang, L., Shu, Q., Wu, Z., Zhao, Y., Li, Q., & Gao, Q. (2021). Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial. Lancet Infect Dis. https://doi.org/10.1016/1473-3099(21)00319-4
13. Hu, M., Wong, H. L., Feng, Y., Lloyd, P. C., Smith, E. R., Amend, K. L., Kline, A., Beachler, D. C., Gruber, J. F., & Mitra, M. (2023). Safety of the BNT162b2 COVID-19 vaccine in children aged 5 to 17 years. JAMA pediatrics, 177(7), 710-717.
14. Kamidani, S., Rostad, C. A., & Anderson, E. J. (2021). COVID-19 vaccine development: a pediatric perspective. Curr Opin Pediatr, 33(1), 144-151. https://doi.org/10.1097/MOP.0000000000000978
15. Lee, S. W., Yang, J. M., Moon, S. Y., Yoo, I. K., Ha, E. K., Kim, S. Y., Park, U. M., Choi, S., Lee, S.-H., & Ahn, Y. M. (2020). Association between mental illness and COVID-19 susceptibility and clinical outcomes in South Korea: a nationwide cohort study. The Lancet Psychiatry, 7(12), 1025-1031.
16. Mathioudakis, A. G., Ghrew, M., Ustianowski, A., Ahmad, S., Borrow, R., Papavasileiou, L. P., Petrakis, D., & Bakerly, N. D. (2021). Self-Reported Real-World Safety and Reactogenicity of COVID-19 Vaccines: A Vaccine Recipient Survey. Life (Basel), 11(3). https://doi.org/10.3390/life11030249
17. Mazereel, V., Van Assche, K., Detraux, J., & De Hert, M. (2021). COVID-19 vaccination for people with severe mental illness: why, what, and how? Lancet Psychiatry, 8(5), 444-450. https://doi.org/10.1016/S2215-0366(20)30564-2
18. Mulligan, M. J., Lyke, K. E., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., Neuzil, K., Raabe, V., Bailey, R., Swanson, K. A., Li, P., Koury, K., Kalina, W., Cooper, D., Fontes-Garfias, C., Shi, P.-Y., Türeci, Ö., Tompkins, K. R., Walsh, E. E., Frenck, R., Falsey, A. R., Dormitzer, P. R., Gruber, W. C., Şahin, U., & Jansen, K. U. (2020). Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.  Nature, 586(7830), 589-593. https://doi.org/10.1038/s41586-020-2639-4
19. Oliver, S. E., Gargano, J. W., Marin, M., Wallace, M., Curran, K. G., Chamberland, M., McClung, N., Campos-Outcalt, D., Morgan, R. L., Mbaeyi, S., Romero, J. R., Talbot, H. K., Lee, G. M., Bell, B. P., & Dooling, K. (2020). The Advisory Committee on Immunization Practices’ Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep, 69(50), 1922-1924. https://doi.org/10.15585/mmwr.mm6950e2
20. Ophinni, Y., Hasibuan, A. S., Widhani, A., Maria, S., Koesnoe, S., Yunihastuti, E., Karjadi, T. H., Rengganis, I., & Djauzi, S. (2020). COVID-19 Vaccines: Current Status and Implication for Use in Indonesia. Acta Med Indones, 52(4), 388-412. https://www.ncbi.nlm.nih.gov/pubmed/33377885
21. Pollmächer, T., Haack, M., Schuld, A., Kraus, T., & Hinze-Selch, D. (2000). Effects of antipsychotic drugs on cytokine networks. Journal of psychiatric research, 34(6), 369-382.
22. Sabu, J. M., Zahid, I., Jacob, N., Alele, F. O., & Malau-Aduli, B. S. (2022). Effectiveness of the BNT162b2 (Pfizer-BioNTech) Vaccine in Children and Adolescents: A Systematic Review and Meta-Analysis. Vaccines, 10(11), 1880. https://www.mdpi.com/2076-393X/10/11/1880
23. Tural Hesapçıoğlu, S., Hacıosmanoğlu, C. D., Okuyucu, M., & Ceylan, M. (2024). Çocuk ve Ergen Psikiyatrisi Yataklı Tedavi Kliniğinde İzlenen Hastalarda Psikiyatrik Bozukluklar. Türk Tıp Dergisi, 9(1), 1-7.
24. Veerman, S. R. T., Bogers, J. P. A. M., Cohen, D., & Schulte, P. F. J. (2022). COVID-19: Risks, Complications, and Monitoring in Patients on Clozapine. Pharmacopsychiatry, 55(1), 48–56. https://doi.org/10.1055/a-1562-2521
25. World Health Organization. (2021). Interim Recommendations for Use of the Pfizer–BioNTech COVID-19 Vaccine, BNT162b2, Under Emergency Use Listing: Interim Guidance, 8 January 2021. In: World Health Organization Geneva.
26. Xu, Y., Xu, D., Luo, L., Ma, F., Wang, P., Li, H., Li, Q., Wei, L., Diao, J., Liu, Y., Zhang, W., & Zheng, X. (2021). A Cross-Sectional Survey on COVID-19 Vaccine Hesitancy Among Parents From Shandong vs. Zhejiang. Frontiers in public health, 9, 779720. https://doi.org/10.3389/fpubh.2021.779720
27. Zhao, Y., Du, J., Li, Z., Xu, Z., Wu, Y., Duan, W., Wang, W., Zhang, T., Xu, J., & Wu, H. (2023). It is time to improve the acceptance of COVID‐19 vaccines among people with chronic diseases: A systematic review and meta‐analysis. Journal of Medical Virology, 95(2), e28509.