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AstraZeneca Corona 19 vaccine approved for use in the EU▶ Click here to enlarge
AstraZeneca’s new coronavirus infection vaccine (Corona 19), officially approved by the executive committee of the European Union (EU) for conditional sale, is undergoing expert advisory procedures for license review in Korea on the 31st.
The Ministry of Food and Pharmaceutical Safety will hold a meeting of the ‘Corona 19 Vaccine Safety and Efficacy Verification Advisory Group’ (hereinafter Verification Advisory Group) in which external experts participate in the AstraZeneca Corona 19 vaccine .
The meeting will discuss the safety and efficacy of the AstraZeneca Corona 19 vaccine, its clinical significance, and the suitability of the target patient.
When the government announced in February that it would introduce AstraZeneca’s Corona 19 vaccine in Korea, the product was recently embroiled in controversy over whether it would be effective for people over 65.
This is because some argued that the vaccine should be limited to vaccinating the elderly, saying that not enough clinical trials have been conducted in people over 65.
Despite this controversy, on the 29th (local time), the European Medicines Agency (EMA) recommended conditional marketing approval for the AstraZeneca vaccine to all age groups over 18 years of age, and on the same day, the Commission of the EU decided to approve the conditional marketing.
The EMA believes that the results of the clinical trial of the vaccine show that it has been shown to be safe and effective in preventing COVID-19 in people over 18 years of age.
The Ministry of Food and Drug Safety has repeatedly emphasized that it will thoroughly verify the safety and effectiveness of AstraZeneca’s Corona 19 vaccine. In particular, the vaccination group and the placebo group are compared and reviewed to see if there is any safety information that requires special attention in the elderly over 65 years of age.
However, as an expert advice procedure still exists, currently it has not been decided or the direction has been decided on whether or not to immunize the elderly over 65 years.
The results of the verification advisory group meeting will be released on February 1. After the verification advisory group meeting, the Ministry of Food and Drug Safety will decide whether to approve or not after consulting a “triple” expert leading to the Central Pharmacy Review Committee and the Final Inspection Committee.
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