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8 "Vaccines"
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Brief Report
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
Received April 8, 2022  Accepted May 12, 2022  Published online June 10, 2022  
DOI: https://doi.org/10.24171/j.phrp.2022.0122    [Epub ahead of print]
  • 178 View
  • 11 Download
AbstractAbstract PDF
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-year-olds were reported to theCVMS, 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 safety data reported in the United States and a controlled trial and serious adverse.events were rare among adolescents aged 12 to 17 years following COVID-19 vaccination.
Review Article
Immune-related therapeutics: an update on antiviral drugs and vaccines to tackle the COVID-19 pandemic
Iqra Mir, Sania Aamir, Syed Rizwan Hussain Shah, Muhammad Shahid, Iram Amin, Samia Afzal, Amjad Nawaz, Muhammad Umer Khan, Muhammad Idrees
Osong Public Health Res Perspect. 2022;13(2):84-100.   Published online April 27, 2022
DOI: https://doi.org/10.24171/j.phrp.2022.0024
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  • 59 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDF
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.
Original Article
COVID-19 outbreak response at a nursing hospital in South Korea in the post-vaccination era, including an estimation of the effectiveness of the first shot of the Oxford-AstraZeneca COVID-19 vaccine (ChAdOx1-S)
Chanhee Kim, Geon Kang, Sun Gu Kang, Heeyoung Lee
Osong Public Health Res Perspect. 2022;13(2):114-122.   Published online April 26, 2022
DOI: https://doi.org/10.24171/j.phrp.2021.0262
  • 1,059 View
  • 51 Download
AbstractAbstract PDF
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.
Review Article
Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform
Jung Hun Ju, Naery Lee, Sun-hee Kim, Seokkee Chang, Misook Yang, Jihyun Shin, Eunjo Lee, Sunhwa Sung, Jung-Hwan Kim, Jin Tae Hong, Ho Jung Oh
Osong Public Health Res Perspect. 2022;13(1):4-14.   Published online February 8, 2022
DOI: https://doi.org/10.24171/j.phrp.2021.0311
  • 1,841 View
  • 112 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDF
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.
Brief Report
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 Res Perspect. 2021;12(6):396-402.   Published online December 21, 2021
DOI: https://doi.org/10.24171/j.phrp.2021.0310
  • 2,635 View
  • 122 Download
  • 1 Citations
Graphical AbstractGraphical Abstract AbstractAbstract PDFSupplementary Material
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.
Original Article
Factors influencing acceptance of the COVID-19 vaccine in Malaysia: a web-based survey
June Fei Wen Lau, Yuan Liang Woon, Chin Tho Leong, Hoon Shien Teh
Osong Public Health Res Perspect. 2021;12(6):361-373.   Published online November 25, 2021
DOI: https://doi.org/10.24171/j.phrp.2021.0085
  • 5,452 View
  • 364 Download
  • 4 Citations
AbstractAbstract PDFSupplementary Material
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.
Brief Reports
COVID-19 vaccine safety monitoring in the Republic of Korea: February 26, 2021 to April 30, 2021
Hyun-kyung Oh, Eun Kyeong Kim, Insob Hwang, Tae Eun Kim, Yeon-kyeong Lee, Eunju Lee, Yeon-Kyeng Lee
Osong Public Health Res Perspect. 2021;12(4):264-268.   Published online August 13, 2021
DOI: https://doi.org/10.24171/j.phrp.2021.0157
  • 2,435 View
  • 103 Download
  • 4 Citations
AbstractAbstract PDF
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.
The laboratory test procedure to confirm rotavirus vaccine infection in severe complex immunodeficiency patients
Su-Jin Chae, Seung-Rye Cho, Wooyoung Choi, Myung-Guk Han, Deog-Yong Lee
Osong Public Health Res Perspect. 2021;12(4):269-273.   Published online August 13, 2021
DOI: https://doi.org/10.24171/j.phrp.2021.0079
  • 1,793 View
  • 57 Download
AbstractAbstract PDF
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.

PHRP : Osong Public Health and Research Perspectives