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MFDS promotes RWD analysis of COVID-19 vaccines & txs

By Lee, Hye-Kyung | translator Choi HeeYoung

22.05.16 17:04:23

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The MFDS (Director Kim Kang-rip) will push for a benefit and risk assessment study from May this year based on data actually used in medical sites after the COVID-19 vaccine and PO treatment were introduced in Korea. This study was prepared to analyze safety information such as the incidence of side effects, vaccine defense effects, and hospitalization/death change rates by using RWD and RWE of COVID-19 vaccines and eating treatments.

The results of practical data studies will be used to examine the benefits and risks of drugs along with the results of clinical trials, and will be used to verify the causality of major adverse reactions or to establish a safety information monitoring system in the future

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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