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.
Objectives We estimated the overall and age-specific percentages of the Korean population
with presumed immunity against severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) as of April 2022 using the national registry.
Methods We used the national coronavirus disease 2019 (COVID-19) infection and vaccination
registry from South Korea, as described to define individuals with a previous history of
COVID-19 infection, vaccination, or both, as persons with presumed immunity.
Results Of a total of 53,304,627 observed persons, 24.4% had vaccination and infection, 58.1%
had vaccination and no infection, 7.6% had infection and no vaccination, and 9.9% had no
immunity. The SARS-CoV-2 Omicron variant emerged at a time when the presumed population
immunity ranged from 80% to 85%; however, nearly half of the children were presumed to
have no immunity.
Conclusion We report a gap in population immunity, with lower presumed protection in
children than in adults. The approach presented in this work can provide valuable informed
tools to assist vaccine policy-making at a national level.
The initial case of coronavirus disease 2019 (COVID-19) in India was reported on January 30, 2020, and subsequently, the number of COVID-19-infected patients surged during the first wave of April 2020 and the second wave in the same month of 2021. The government of India imposed a strict nationwide lockdown in April 2020 and extended it until May 2020. The second wave of COVID-19 in India overwhelmed the country’s health facilities and exhausted its medical and paramedical workforce. This narrative review was conducted with the aim of summarizing the evidence drawn from policy documents of governmental and non-governmental organizations, as well as capturing India's COVID-19 vaccination efforts. The findings from this review cover the Indian government's vaccination initiatives, which ranged from steps taken to combat vaccine hesitancy to vaccination roadmaps, deployment plans, the use of digital health technology, vaccination monitoring, adverse effects, and innovative strategies such as Har Ghar Dastak and Jan Bhagidari Andolan (people’s participation). These efforts collectively culminated in the successful administration of more than 1.8 billion doses of COVID-19 vaccines in India. This review also provides insights into other countries’ responses to COVID-19 and guidance for future pandemics.
Objectives This study aimed to disseminate information on coronavirus disease 2019 (COVID-19) vaccine safety among adolescents aged 12 to 17 years in the Republic of Korea. Methods: Two databases were used to assess COVID-19 vaccine safety in adolescents aged 12 to 17 years who completed the primary Pfizer-BioNTech vaccination series. Adverse events reported to the web-based COVID-19 vaccination management system (CVMS) and collected in the text message-based system were analyzed. Results: From March 5, 2021 to February 13, 2022, 12,216 adverse events among 12- to 17-yearolds were reported to the CVMS, of which 97.1% were non-serious adverse events and 2.9% were serious adverse events, including 85 suspected cases of anaphylaxis, 74 suspected cases of myocarditis and/or pericarditis, and 2 deaths. From December 13, 2021 to January 26, 2022, 10,389 adolescents responded to a text message survey, and local/systemic adverse events were more common after dose 2 than after dose 1. The most commonly reported events following either vaccine dose were pain at the injection site, headache, fatigue/tiredness, and myalgia. Conclusion: The overall results are consistent with previous findings; the great majority of adverse events were non-serious, and serious adverse events were rare among adolescents aged 12 to 17 years following Pfizer-BioNTech COVID-19 vaccination.
Citations
Citations to this article as recorded by
COVID-19 Vaccination in Korea: Past, Present, and the Way Forward Eliel Nham, Joon Young Song, Ji Yun Noh, Hee Jin Cheong, Woo Joo Kim Journal of Korean Medical Science.2022;[Epub] CrossRef
The coronavirus disease 2019 (COVID-19) pandemic rapidly spread globally. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which causes COVID-19, is a positive-sense single-stranded RNA virus with a reported fatality rate ranging from 1% to 7%, and people with immune-compromised conditions, children, and older adults are particularly vulnerable. Respiratory failure and cytokine storm-induced multiple organ failure are the major causes of death. This article highlights the innate and adaptive immune mechanisms of host cells activated in response to SARS-CoV-2 infection and possible therapeutic approaches against COVID-19. Some potential drugs proven to be effective for other viral diseases are under clinical trials now for use against COVID-19. Examples include inhibitors of RNA-dependent RNA polymerase (remdesivir, favipiravir, ribavirin), viral protein synthesis (ivermectin, lopinavir/ ritonavir), and fusion of the viral membrane with host cells (chloroquine, hydroxychloroquine, nitazoxanide, and umifenovir). This article also presents the intellectual groundwork for the ongoing development of vaccines in preclinical and clinical trials, explaining potential candidates (live attenuated-whole virus vaccines, inactivated vaccines, subunit vaccines, DNAbased vaccines, protein-based vaccines, nanoparticle-based vaccines, virus-like particles and mRNA-based vaccines). Designing and developing an effective vaccine (both prophylactic and therapeutic) would be a long-term solution and the most effective way to eliminate the COVID-19 pandemic.
Objectives We descriptively reviewed a coronavirus disease 2019 (COVID-19) outbreak at a nursing hospital in Gyeonggi Province (South Korea) and assessed the effectiveness of the first dose of the Oxford-AstraZeneca vaccine in a real-world population. Methods: The general process of the epidemiological investigation included a public health intervention. The relative risk (RR) of vaccinated and unvaccinated groups was calculated and compared to confirm the risk of severe acute respiratory syndrome coronavirus-2 (SARSCoV-2) infection, and vaccine effectiveness was evaluated based on the calculated RR. Results: The population at risk was confined to ward E among 8 wards of Hospital X, where the outbreak occurred. This population comprised 55 people, including 39 patients, 12 nurses, and 4 caregivers, and 19 cases were identified. The RR between the vaccinated and unvaccinated groups was 0.04, resulting in a vaccine effectiveness of 95.3%. The vaccination rate of the nonpatients in ward E was the lowest in the entire hospital, whereas the overall vaccination rate of the combined patient and non-patient groups in ward E was the third lowest. Conclusion: The first dose of the Oxford-AstraZeneca vaccine (ChAdOx1-S) was effective in preventing SARS-CoV-2 infection. To prevent COVID-19 outbreaks in medical facilities, it is important to prioritize the vaccination of healthcare providers.
Citations
Citations to this article as recorded by
COVID-19 Vaccination in Korea: Past, Present, and the Way Forward Eliel Nham, Joon Young Song, Ji Yun Noh, Hee Jin Cheong, Woo Joo Kim Journal of Korean Medical Science.2022;[Epub] CrossRef
Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.
Objectives This study aimed to present data on reported adverse events following coronavirus disease 2019 (COVID-19) vaccination in Republic of Korea from February 26 to October 31, 2021, and to determine whether any significant patterns emerged from an analysis of the characteristics of suspected adverse event cases for each type of vaccine.
Methods Adverse events following COVID-19 vaccination reported by medical doctors and forensic pathologists were analyzed. Cases of suspected anaphylaxis were classified using the Brighton Collaboration definition.
Results By October 31, 2021, a total of 353,535 (0.45%) adverse events were reported after 78,416,802 COVID-19 vaccine doses. Of the adverse events, 96.4% were non-serious and 3.6% were serious. The most frequently reported adverse events were headache, myalgia, and dizziness. Of the 835 reported deaths after COVID-19 vaccination, 2 vaccine-related deaths were confirmed. Suspected anaphylaxis was confirmed in 454 cases using the Brighton Collaboration definition.
Conclusion The commonly reported symptoms were similar to those described in clinical trials. Most reported adverse events were non-serious, and the reporting rate of adverse events following COVID-19 vaccination was higher in women than in men (581 vs. 315 per 100,000 vaccinations). Confirmed anaphylaxis was reported in 5.8 cases per 1,000,000 vaccinations.
Citations
Citations to this article as recorded by
Allergic Reactions to COVID-19 Vaccines: Risk Factors, Frequency, Mechanisms and Management Nicoletta Luxi, Alexia Giovanazzi, Alessandra Arcolaci, Patrizia Bonadonna, Maria Angiola Crivellaro, Paola Maria Cutroneo, Carmen Ferrajolo, Fabiana Furci, Lucia Guidolin, Ugo Moretti, Elisa Olivieri, Giuliana Petrelli, Giovanna Zanoni, Gianenrico Senna, BioDrugs.2022; 36(4): 443. CrossRef
Safety monitoring of COVID-19 vaccination among adolescents aged 12 to 17 years old in the Republic of Korea Seontae Kim, Insob Hwang, Mijeong Ko, Yunhyung Kwon, Yeon-Kyeng Lee Osong Public Health and Research Perspectives.2022; 13(3): 230. CrossRef
Incidence and Characteristics of Adverse Events after COVID-19 Vaccination in a Population-Based Programme Laura Bonzano, Olivera Djuric, Pamela Mancuso, Lidia Fares, Raffaele Brancaccio, Marta Ottone, Eufemia Bisaccia, Massimo Vicentini, Alessia Cocconcelli, Alfonso Motolese, Rostyslav Boyko, Paolo Giorgi Rossi, Alberico Motolese Vaccines.2022; 10(7): 1111. CrossRef
Global Predictors of COVID-19 Vaccine Hesitancy: A Systematic Review Carla Pires Vaccines.2022; 10(8): 1349. CrossRef
Anaphylaxis and Related Events Following COVID‐19 Vaccination: A Systematic Review Pradipta Paul, Emmad Janjua, Mai AlSubaie, Vinutha Ramadorai, Beshr Mushannen, Ahamed Lazim Vattoth, Wafa Khan, Khalifa Bshesh, Areej Nauman, Ibrahim Mohammed, Imane Bouhali, Mohammed Khalid, Dalia Zakaria The Journal of Clinical Pharmacology.2022; 62(11): 1335. CrossRef
Adverse events of the Pfizer-BioNTech COVID-19 vaccine in Korean children and adolescents aged 5 to 17 years Seontae Kim, Yeseul Heo, Soon-Young Seo, Do Sang Lim, Enhi Cho, Yeon-Kyeng Lee Osong Public Health and Research Perspectives.2022; 13(5): 382. CrossRef
COVID-19 Vaccination in Korea: Past, Present, and the Way Forward Eliel Nham, Joon Young Song, Ji Yun Noh, Hee Jin Cheong, Woo Joo Kim Journal of Korean Medical Science.2022;[Epub] CrossRef
Objectives The coronavirus disease 2019 (COVID-19) pandemic has set a precedent for the fastest-produced vaccine as a result of global collaboration and outreach. This study explored Malaysians’ acceptance of the COVID-19 vaccine and its associated factors.
Methods A cross-sectional anonymous web-based survey was disseminated to Malaysian adults aged ≥18 years old via social media platforms between July 10, 2020 and August 31, 2020.
Results In the analysis of 4,164 complete responses, 93.2% of participants indicated that they would accept the COVID-19 vaccine if it was offered for free by the Malaysian government. The median out-of-pocket cost that participants were willing to pay for a COVID-19 vaccine was Malaysian ringgit (MYR) 100 (interquartile range [IQR], 100) if it was readily available and MYR 150 (IQR, 200) if the supply was limited. Respondents with a low likelihood of vaccine hesitancy had 13 times higher odds of accepting the COVID-19 vaccine (95% confidence interval [CI], 8.69 to 19.13). High perceived risk and severity were also associated with willingness to be vaccinated, with adjusted odds ratios of 2.22 (95% CI, 1.44 to 3.41) and 2.76 (95% CI, 1.87 to 4.09), respectively. Age and ethnicity were the only independent demographic characteristics that predicted vaccine uptake.
Conclusion Public health strategies targeting perceived risk, perceived susceptibility and vaccine hesitancy could be effective in enhancing vaccine uptake.
Citations
Citations to this article as recorded by
Cross-sectional assessment of predictors for COVID-19 vaccine uptake: an online survey in Greece Petros Galanis, Irene Vraka, Olga Siskou, Olympia Konstantakopoulou, Aglaia Katsiroumpa, Ioannis Moisoglou, Daphne Kaitelidou Vacunas.2022; 23: S60. CrossRef
Key predictors of COVID-19 vaccine hesitancy in Malaysia: An integrated framework Jason Wei Jian Ng, Santha Vaithilingam, Mahendhiran Nair, Li-Ann Hwang, Kamarul Imran Musa, Anat Gesser-Edelsburg PLOS ONE.2022; 17(5): e0268926. CrossRef
Intention to receive a COVID-19 vaccine booster dose and associated factors in Malaysia Li Ping Wong, Haridah Alias, Yan-Li Siaw, Mustakiza Muslimin, Lee Lee Lai, Yulan Lin, Zhijian Hu Human Vaccines & Immunotherapeutics.2022;[Epub] CrossRef
Determinants of COVID-19 vaccine acceptance in Ethiopia: A systematic review and meta-analysis Ayenew Mose, Abebaw Wasie, Solomon Shitu, Kassahun Haile, Abebe Timerga, Tamirat Melis, Tadesse Sahle, Amare Zewdie, Dong Keon Yon PLOS ONE.2022; 17(6): e0269273. CrossRef
When do persuasive messages on vaccine safety steer COVID-19 vaccine acceptance and recommendations? Behavioural insights from a randomised controlled experiment in Malaysia Nicholas Yee Liang Hing, Yuan Liang Woon, Yew Kong Lee, Hyung Joon Kim, Nurhyikmah M Lothfi, Elizabeth Wong, Komathi Perialathan, Nor Haryati Ahmad Sanusi, Affendi Isa, Chin Tho Leong, Joan Costa-Font BMJ Global Health.2022; 7(7): e009250. CrossRef
COVID-19 vaccine acceptance rate and its predictors in Ethiopia: A systematic review and meta-analysis Getaneh Mulualem Belay, Tewodros Getaneh Alemu, Masresha Asmare Techane, Chalachew Adugna Wubneh, Nega Tezera Assimamaw, Tadesse Tarik Tamir, Addis Bilal Muhye, Destaye Guadie Kassie, Amare Wondim, Bewuketu Terefe, Bethlehem Tigabu Tarekegn, Mohammed Seid Human Vaccines & Immunotherapeutics.2022;[Epub] CrossRef
Cross-sectional assessment of predictors for COVID-19 vaccine uptake: an online survey in Greece Petros Galanis, Irene Vraka, Olga Siskou, Olympia Konstantakopoulou, Aglaia Katsiroumpa, Ioannis Moisoglou, Daphne Kaitelidou Vacunas (English Edition).2022; 23: S60. CrossRef
Objectives On February 26, 2021, coronavirus disease 2019 (COVID-19) vaccination was started for high-priority groups based on the recommendation of the Advisory Committee on Immunization Practices with 2 available COVID-19 vaccines (AstraZeneca and Pfizer-BioNTech) in Korea. This report provides a summary of adverse events following COVID-19 vaccination as of April 30, 2021.
Methods Adverse events following immunization are notifiable by medical doctors to the Korea Immunization Management System (KIMS) under the national surveillance system. We analyzed all adverse events reports following COVID-19 vaccination to the KIMS from February 26 to April 30, 2021.
Results In total, 16,196 adverse events following 3,586,814 administered doses of COVID-19 vaccines were reported in approximately 2 months (February 26 to April 30, 2021). Of these, 15,658 (96.7%) were non-serious adverse events, and 538 (3.3%) were serious adverse events, including 73 (0.5%) deaths. The majority of adverse events (n=13,063, 80.7%) were observed in women, and the most frequently reported adverse events were myalgia (52.2%), fever (44.9%), and headache (34.9%). Of the 73 deaths following the COVID-19 vaccination, none were related to the vaccines.
Conclusion By April 30, 3.6 million doses of the COVID 19 vaccine had been given in Korea, and the overwhelming majority of reports were for non-serious events. The Korea Disease Control and Prevention Agency continues to monitor the safety of COVID-19 vaccination.
Citations
Citations to this article as recorded by
Safety and effectiveness of BNT162b2 mRNA Covid-19 vaccine in adolescents Young June Choe, Seonju Yi, Insob Hwang, Jia Kim, Young-Joon Park, Eunhee Cho, Myoungyoun Jo, Hyunju Lee, Eun Hwa Choi Vaccine.2022; 40(5): 691. CrossRef
Direct and Indirect Associations of Media Use With COVID-19 Vaccine Hesitancy in South Korea: Cross-sectional Web-Based Survey Minjung Lee, Myoungsoon You Journal of Medical Internet Research.2022; 24(1): e32329. CrossRef
Self-Reported COVID-19 Vaccines’ Side Effects among Patients Treated with Biological Therapies in Saudi Arabia: A Multicenter Cross-Sectional Study Lama T AlMutairi, Wesal Y Alalayet, Sondus I Ata, Khalidah A Alenzi, Yazed AlRuthia Vaccines.2022; 10(6): 977. CrossRef
COVID-19 vaccine safety monitoring in Republic of Korea from February 26, 2021 to October 31, 2021 Insob Hwang, Kyeongeun Park, Tae Eun Kim, Yunhyung Kwon, Yeon-Kyeng Lee Osong Public Health and Research Perspectives.2021; 12(6): 396. CrossRef
The rotavirus vaccine is a live vaccine, and there is a possibility of infection by the virus strain used in the vaccine. We investigated the process of determining whether an infection was caused by the vaccine strain in a severe complex immunodeficiency (SCID) patient with rotavirus infection. The patient was vaccinated with RotaTeq prior to being diagnosed with SCID. The testing process was conducted in the following order: confirming rotavirus infection, determining its genotype, and confirming the vaccine strain. Rotavirus infection was confirmed through enzyme immunoassay and VP6 gene detection. G1 and P[8] were identified by multiplex polymerase chain reaction for the genotype, and G3 was further identified using a single primer. By detecting the fingerprint gene (WC3) of RotaTeq, it was confirmed that the detected virus was the vaccine strain. Genotypes G1 and P[8] were identified, and the infection was suspected of having been caused by rotavirus G1P[8]. G1P[8] is the most commonly detected genotype worldwide and is not included in the recombinant strains used in vaccines. Therefore, the infection was confirmed to have been caused by the vaccine strain by analyzing the genetic relationship between VP4 and VP7. Rotavirus infection by the vaccine strain can be identified through genotyping and fingerprint gene detection. However, genetic linkage analysis will also help to identify vaccine strains.