Adverse Events and Safety Profile of the COVID-19 Vaccines in Adolescents: Safety Monitoring for Adverse Events Using Real-World Data

Lee, Chae Won; Sa, Soonok; Hong, Myunghee; Kim, Jihyun; Shim, Sung Ryul; Han, Hyun Wook

doi:10.3390/vaccines10050744

Cited by 15 publications

(14 citation statements)

References 44 publications

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“…Fifth, people under the age of 20 were excluded from the study because they were not eligible for the booster dose at the time of the study. There are only a few studies on young people; further study is needed to provide more data [ 24 , 25 , 26 ]. Sixth, our result only included short-term AE in the whole population.…”

Section: Discussionmentioning

confidence: 99%

Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose

Chen

et al. 2022

Vaccines

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With the spread of the new SARS-CoV-2 variants, many countries have begun COVID-19 vaccine booster programs with the mix-and-match strategy. However, research on the adverse events (AE) of booster doses is still scarce. The aim of our study was to analyze the reported incidence rate (IR), and factors associated with AE, including short-term serious adverse events (SAE) and short-term non-serious adverse events (NSAE), among different vaccine products through the hospital-based Vaccine Adverse Event Reporting System (VAERS). A total of 7432 records were collected during the three-month study period. While more than half of the responses (52.2%) reported the presence of AE after receiving a booster dose, only a few AE were considered SAE (2.4%). AE were significantly higher among women and people of younger age, and the brand of vaccines is the strongest factor associated with post-booster dose AE. The incidence of AE in mRNA1273 is higher than in BNT162b2 and MVC-COV1901 (IRR mRNA1273 vs. BNT162b2: 1.22, 95% CI: 1.11–1.34; BNT162b2 vs. MVC-COV1901: 2.77, 95% CI: 2.27–3.39). The IR of different groups were calculated to support the decision making of the booster vaccine. Although AE were not uncommon for booster vaccines, almost all AE were not serious and predictable using estimated IR. This result can be used to optimize booster vaccine decision making.

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Section: Discussionmentioning

confidence: 99%

Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose

Chen

et al. 2022

Vaccines

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“…The literature search screened 1296 studies of which 102 were reviewed in full text (Figure 1). A total of 43 studies were included in the meta-analyses, of which reported 16,978 cases of myocarditis [7,8, , 28,451 cases of myocardial infarction [8,19,20,43,47,50,[52][53][54][55][56][57][58] and 96,269 cases of cardiac arrhythmia [8,19,21,22,24,43,44] (Table S1). Overall risk of bias in these studies were rated as moderate to high quality (Tables S2 and S3).…”

Section: Search Results and Characteristics Of Included Studiesmentioning

confidence: 99%

cardiovascular safety of COVID-19 vaccines in real-world studies: a systematic review and meta-analysis

Chang

Liu

et al. 2022

Preprint

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AimsTo assess the association between COVID-19 vaccines and the risk of major adverse cardiovascular events (MACE) in the real world and to provide a reliable evidence-based basis for the cardiovascular safety of COVID-19 vaccines.MethodsWe conducted a comprehensive search in databases from January 1, 2020 to June 15, 2022 for observational studies, that included reporting of MACE and COVID-19 vaccines were included. Random-effects or fixed-effects models were used to estimate the pooled incidence rate and risk ratio of MACE after vaccination. Meta-regression, subgroup analyses, publication bias, sensitivity analyses were performed to evaluate the process and quality of meta-analysis.ResultsThe analyses included data from 43 studies reporting of 16,978 cases, 28,451 cases, and 96,269 cases of myocarditis, myocardial infarction, and cardiac arrhythmia, respectively. The overall incidence rate was 14.8 events per million persons of myocarditis, and 1.73 and 9.6 events per 10,000 persons of myocardial infarction and cardiac arrhythmia after COVID-19 vaccination, respectively. Overall and subgroup analyses showed the increased risks of myocarditis associated with second dose (RR, 2.09; 95%CI: 1.59-2.58), third dose (RR, 2.02; 95%CI: 1.40-2.91), mRNA-1273 (RR, 3.13; 95%CI: 2.11-4.14), or BNT162b2 (RR, 1.57; 95%CI: 1.30-1.85) vaccination. The risk ratios of myocarditis events were more frequently in males than in females (3.44, 2.61-4.54), in younger than in older (2.20, 1.06-4.55). No significant increase risk of myocardial infarction (RR, 0.96; 95%CI: 0.84-1.08) or cardiac arrhythmia (RR, 0.98; 95%CI: 0.84-1.12) events was observed following vaccination. The risk of cardiovascular events (myocarditis, RR, 8.53; myocardial infarction, RR, 2.59; cardiac arrhythmia, RR, 4.47) after SARS-CoV-2 infection was much higher than after vaccination.ConclusionAlthough there is a risk of cardiovascular events following vaccination, the risk was much lower than that following SARS-CoV-2 infection. The benefits of COVID-19 vaccination to the population outweigh the risks in terms of cardiovascular safety assessment.

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“…However, the AE patterns of adolescents differed from those of the adults. Lee et al 81 analyzed data from the Korean vaccine AE reporting system to compare the risk and types of AEs in adolescents (aged 12–15) with those in adults. Compared to adults, adolescents had a higher incidence of encephalitis/myelitis, convulsions, GBS, myocarditis/pericarditis, lymphadenopathy, lymphopenia, and multisystem inflammatory syndrome.…”

Section: Adverse Events Of Covid-19 Vaccines In Koreamentioning

confidence: 99%

COVID-19 Vaccination in Korea: Past, Present, and the Way Forward

et al. 2022

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Since its first emergence in late 2019, severe acute respiratory syndrome coronavirus-2 has claimed more than 6.5 million lives worldwide and continues to infect hundreds of thousands of people daily. To combat this once-in-a-century disaster, several vaccines have been developed at unprecedented speeds. Novel vaccine platforms (messenger ribonucleic acid vaccines and adenoviral vector vaccines) have played a major role in the current pandemic. In Korea, six vaccines, including a domestically developed recombinant vaccine, have been approved. As in other countries, vaccines have been proven to be safe and highly effective in Korea. However, rare serious adverse events and breakthrough infections have undermined public trust in the vaccines, even while the benefits of vaccination far outweigh the risks. The rise of the omicron variant and the subsequent increase in excess mortality demonstrated that while vaccines are a key component of the pandemic response, it alone can fail without non-pharmaceutical interventions like masking and social distancing. The pandemic of coronavirus disease has revealed both the strengths and weaknesses of our healthcare system and pandemic preparedness. When the next pandemic arrives, improved risk communication and vaccine development should be prioritized. To enable timely vaccine development, it is essential to make strategic and sufficient investments in vaccine research and development.

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Adverse Events and Safety Profile of the COVID-19 Vaccines in Adolescents: Safety Monitoring for Adverse Events Using Real-World Data

Cited by 15 publications

References 44 publications

Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose

Risk Factors and Incidence Rates of Self-Reported Short-Term Adverse Events of COVID-19 Vaccine Booster Dose

cardiovascular safety of COVID-19 vaccines in real-world studies: a systematic review and meta-analysis

COVID-19 Vaccination in Korea: Past, Present, and the Way Forward

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