- Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years
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Seontae Kim, Yeseul Heo, Soon-Young Seo, Do Sang Lim, Enhi Cho, Yeon-Kyeng Lee
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Osong Public Health Res Perspect. 2022;13(5):382-390. Published online October 14, 2022
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DOI: https://doi.org/10.24171/j.phrp.2022.0233
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Abstract
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- Objectives
This study aimed to identify potential safety signals and adverse events following the primary Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccination series among children and adolescents aged 5 to 17 years in the Republic of Korea. Methods: Adverse events reported through the COVID-19 vaccination management system (CVMS, a web-based passive vaccine safety surveillance system) and adverse events and health conditions collected from a text message-based survey were analyzed. Results: A total of 14,786 adverse events among 5 to 17-year-old children and adolescents were reported in the CVMS; 14,334 (96.9%) were non-serious and 452 (3.1%) were serious, including 125 suspected cases of acute cardiovascular injury and 101 suspected cases of anaphylaxis. The overall reporting rate was lower in 5 to 11-year-old children (64.5 per 100,000 doses) than in 12 to 17-year-old adolescents (300.5 per 100,000 doses). The text message survey identified that local and systemic adverse events after either dose were reported less frequently in 5 to 11-year-old children than in 12 to 17-year-old adolescents (p<0.001). The most commonly reported adverse events were pain at the injection site, myalgia, headache, and fatigue/tiredness. Conclusion: The overall results are consistent with the results of controlled trials; serious adverse events were extremely rare among 5 to 17-year-old children and adolescents following Pfizer-BioNTech COVID-19 vaccination. Adverse events were less frequent in children aged 5 to 11 years than in adolescents aged 12 to 17 years.
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- The descriptive epidemiology of adverse events following two doses of mRNA COVID-19 vaccination in Curaçao, the Caribbean
Jonathan Lambo, Sirving Keli, Shaheen Khan Kaplan, Temiloluwa Njideaka-Kevin, Sireesha Bala Arja, Alaa Khedir Omer Altahir, Itunu Olonade, Rohit Kumar Infectious Diseases.2024; : 1. CrossRef - Myocarditis and Pericarditis are Temporally Associated with BNT162b2 COVID-19 Vaccine in Adolescents: A Systematic Review and Meta-analysis
Yongyeon Choi, Jue Seong Lee, Young June Choe, Hyeran Lee, Yoonsun Yoon, Seung Hwan Shin, Myung-Jae Hwang, HyoSug Choi, Sara Na, Jong Hee Kim, Hyun Mi Kang, Bin Ahn, Kyoungsan Seo, Sangshin Park Pediatric Cardiology.2024;[Epub] CrossRef - Safety monitoring of COVID-19 vaccines: February 26, 2021, To June 4, 2022, Republic of Korea
Yeon-Kyeng Lee, Yunhyung Kwon, Yesul Heo, Eun Kyoung Kim, Seung Yun Kim, Hoon Cho, Seontae Kim, Mijeong Ko, Dosang Lim, Soon-Young Seo, Enhi Cho Clinical and Experimental Pediatrics.2023; 66(10): 415. CrossRef - Effectiveness of the BNT162b2 vaccine in preventing morbidity and mortality associated with COVID-19 in children aged 5 to 11 years: A systematic review and meta-analysis
Sumayyah Ebrahim, Ntombifuthi Blose, Natasha Gloeck, Ameer Hohlfeld, Yusentha Balakrishna, Rudzani Muloiwa, Andy Gray, Andy Parrish, Karen Cohen, Ruth Lancaster, Tamara Kredo, Julia Robinson PLOS Global Public Health.2023; 3(12): e0002676. CrossRef
- Safety of the bivalent COVID-19 mRNA booster vaccination among persons aged over 18 years in the Republic of Korea
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Seok-Kyoung Choi, Seontae Kim, Mijeong Ko, Yeseul Heo, Tae Eun Kim, Yeonkyeong Lee, Juyeon Jang, Eunok Bahng
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Received July 8, 2024 Accepted September 5, 2024 Published online October 17, 2024
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DOI: https://doi.org/10.24171/j.phrp.2024.0194
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Abstract
- Objectives
The aim of this study was to disseminate information about the safety of bivalent coronavirus disease 2019 (COVID-19) mRNA booster vaccines administered to adults in the Republic of Korea.
Methods Two databases were used to assess the safety of COVID-19 booster doses of Pfizer BA.1, BA.4/5, Moderna BA.1, and BA.4/5 for adults 18 and older. Adverse events were analyzed using data reported to the web-based COVID-19 vaccination management system (CVMS) and a text-based active surveillance system.
Results Between October 11, 2022 and March 30, 2023, the CVMS received reports of 2,369 (93.7%) non-serious adverse events from vaccinated adults, along with 158 (6.3%) serious adverse events, which included 5 cases of anaphylaxis and 33 deaths. From October 11, 2022 to January 27, 2023, 40,022 people aged 18 and older responded to a survey conducted via text message. The booster doses were associated with fewer local and systemic adverse events compared to the original vaccines. After receiving the bivalent vaccine, the most commonly reported adverse events were pain at the injection site, headache, fatigue, and muscle pain.
Conclusion Overall, bivalent vaccines exhibited fewer adverse reactions compared to the original vaccines. The majority of adverse events were non-serious, and serious adverse events were rare among adults aged 18 years and older following vaccination with the Pfizer and Moderna bivalent vaccines.
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