EPH99 Janssen COVID-19 Vaccine Safety in a Real-World Setting: A Pharmacovigilance Study
نویسندگان
چکیده
The development of COVID-19 vaccines is a global priority aiming to mitigate the spread SARS-CoV-2. Although vaccination has been proved be effective in reducing rate and severity COVID-19, it also associated with ocurrence serious adverse events (AEs). Jcovden, previously Janssen (Ad26.COV2.S) vaccine, have shown safe phase 3 trials. We aimed compare its safety Pfizer-BioNTech (BNT162b2) Oxford-AstraZeneca (ChAdOx1) real-world setting. Data about special interest following were obtained from EudraVigilance, large spontaneous-reporting database operated by European Medicines Agency (EMA). Analysis included all reports until 22nd August 2022. Vaccines compared means Proportional Reporting Ratios (PRRs) regarding selected AEs. PRR was calculated as ratio between proportion spontaneous specific AE for Jcovden same obtaind comparators. A >2 indicates possible association AE. found (PRR>2) vaccine different AEs interest. probability reporting Thrombosis thrombocytopenia syndrome, cerebral venus sinus thrombosis, myelitis transverse, Guillain Barret Syndrome, pulmonary embolism capillary leak syndrome 9 times greater (PRR value 9) vaccine. Also, myocartidis/pericarditis Syndrome 2.5 than ChAdOx1, respectively. Overall, most vaccine-associated occur very rarely. possibly some other covid-19 vaccines. real-word setting that not observed clinical trials reassure importance continuous monitoring safety.
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ژورنال
عنوان ژورنال: Value in Health
سال: 2023
ISSN: ['1098-3015', '1524-4733']
DOI: https://doi.org/10.1016/j.jval.2023.03.981