Three AEs in particular-myocarditis, Guillain-Barré syndrome (GBS), and thrombosis-have been highlighted in the news and by regulatory agencies as potential side effects of one or more of the three FDA-authorized COVID-19 vaccines ( ). Since their authorization in the United States and other countries, these COVID-19 vaccines have greatly helped to mitigate the spread and severity of COVID-19 around the world.Īlthough COVID-19 vaccines are generally safe, they have been associated with various adverse events.
Food and Drug Administration (FDA), while a third, Pfizer-BioNTech’s Comirnaty, had been fully approved by the FDA for public use. As of 31 December 2021, two COVID-19 vaccines, Moderna’s mRNA-1273 and Johnson and Johnson’s Janssen vaccine, were authorized for emergency use by the U.S. The emergence of coronavirus disease 2019 (COVID-19), the disease caused by the SARS-CoV-2 virus, has led to the development of vaccines immunizing against SARS-CoV-2. Notably, severe COVID-19 vaccine AEs (including myocarditis, GBS, and TTS) rarely occur in comparison to the large number of COVID-19 vaccinations administered in the United States, affirming the overall safety of these COVID-19 vaccines. To support standard AE representation and study, we have also modeled and classified the newly identified thrombosis with thrombocytopenia syndrome (TTS) AE and its subclasses in the OAE by incorporating the Brighton Collaboration definition. The Pfizer vaccine was found to have a closer association with myocarditis than the other two COVID-19 vaccines in VAERS, while the Janssen vaccine was more likely to be associated with thrombosis and GBS AEs. Further statistical comparison between different ages, doses, and sexes was also performed for three notable AEs: myocarditis, GBS, and thrombosis. Using the Ontology of Adverse Event (OAE), these 96 adverse events were classified to different categories such as behavioral and neurological AEs, cardiovascular AEs, female reproductive system AEs, and immune system AEs. Females appeared to have a higher case report frequency for top adverse events compared to males. The Janssen COVID-19 vaccine had a higher crude reporting rate of AEs compared to the Moderna and Pfizer COVID-19 vaccines. Using VAERS data as of 31 December 2021, 96 AEs were found to be statistically significantly associated with the Pfizer-BioNTech, Moderna, and/or Janssen COVID-19 vaccines. An ontology-based classification and literature review were conducted for these enriched AEs. In this study, data from the Vaccine Adverse Event Reporting System (VAERS) was queried and analyzed via the Cov19VaxKB vaccine safety statistical analysis tool to identify statistically significant (i.e., enriched) AEs for the three currently FDA-authorized or approved COVID-19 vaccines. These vaccines have been effective in reducing the rate and severity of COVID-19 infection but also have been associated with various adverse events (AEs).
Since the beginning of the COVID-19 pandemic, vaccines have been developed to mitigate the spread of SARS-CoV-2, the virus that causes COVID-19.
10Center of Computational Medicine and Bioinformatics, University of Michigan Medical School, Ann Arbor, MI, United States.9Department of Microbiology and Immunology, University of Michigan Medical School, Ann Arbor, MI, United States.8Unit for Laboratory Animal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States.7Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, United States.6Advanced Institute of Information Technology, Peking University, Hangzhou, China.5Department of Medicine, Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, China.4National Institute of Health Data Science, Peking University, Beijing, China.3Chongqing Engineering Research Center of Medical Electronics and Information Technology, School of Bioinformatics, Chongqing University of Posts and Telecommunications, Chongqing, China.2Department of Cell Biology and Neuroscience, Rutgers University, New Brunswick, NJ, United States.1College of Literature, Science and the Arts, University of Michigan, Ann Arbor, MI, United States.Wenxin Guo 1 †, Jessica Deguise 1 †, Yujia Tian 2 †, Philip Chi-En Huang 1 †, Rohit Goru 1 †, Qiuyue Yang 3, Suyuan Peng 4, Luxia Zhang 4,5,6, Lili Zhao 7, Jiangan Xie 3* and Yongqun He 8,9,10*
0 kommentar(er)
