Government to Analyze Safety of COVID-19 Vaccines and Treatments Using 'Real-World Data'

On April 25, when the 4th COVID-19 booster vaccination for those aged 60 and over who made prior reservations began, a citizen is receiving the vaccine at Bumin Hospital in Gangseo-gu, Seoul. April 25, 2022 Photo by Joint Press Corps (Consent for portrait rights obtained)

[Asia Economy Reporter Chunhee Lee] The government is set to conduct a safety analysis based on real-world usage data of COVID-19 vaccines and oral treatments.

The Ministry of Food and Drug Safety announced on the 16th that it will begin a "benefit-risk assessment study" based on real-world data of COVID-19 vaccines and oral treatments starting this month.

This study will analyze safety information such as adverse event incidence rates and effectiveness indicators like vaccine protection effects and changes in hospitalization and mortality rates by utilizing real-world data (RWD) and real-world evidence (RWE) of COVID-19 vaccines and oral treatments.

RWD refers to various real-world usage data related to patients, health status, and healthcare delivery systems collected from diverse sources, while RWE is the clinical evidence confirmed through analysis of RWD regarding the usage status, potential benefits, and risks of pharmaceuticals, etc.

The study results will be used alongside clinical trial outcomes to review the benefits and risks of pharmaceuticals. Through this, the causality of major adverse reactions will be verified, and it will also be utilized to establish future safety information monitoring systems.

The main research contents include developing techniques to evaluate the epidemiological association between vaccination and adverse reactions for vaccines, as well as developing criteria to assess vaccine effectiveness and safety for specific groups such as children, the elderly, pregnant women, immunocompromised individuals, and organ transplant patients. For oral treatments, the study involves analyzing safety and efficacy information of domestic patients using real-world data.

According to the Ministry of Food and Drug Safety, agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are also conducting various studies on COVID-19 vaccines and treatments using real-world data.

The FDA, together with the Pilgrim Healthcare Foundation, is promoting strategic research using real-world data to perform drug role assessments related to COVID-19 treatments, while the EMA, in collaboration with the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance, is conducting studies on the incidence rates of major adverse reactions of interest by population groups related to COVID-19 vaccines, as well as major adverse reactions related to pregnancy outcomes in pregnant women and newborns.

Japan is also conducting prescription status investigations and benefit-risk assessment studies of COVID-19 treatments based on the "MID-NET" platform through the Pharmaceuticals and Medical Devices Agency (PMDA).

This content was produced with the assistance of AI translation services.