Today’s first expert advisory… EU approves conditional sale to all age groups over 18
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(London AFP = Yonhap News) The European Union (EU) executive committee officially approved the conditional sale of a novel coronavirus infection (Corona 19) vaccine jointly developed by multinational pharmaceutical company AstraZeneca and Oxford University in the UK on the 29th (local time). did. This vaccine is the third Corona 19 vaccine approved by the EU after the vaccine developed by Pfizer, Bioentech and Modena. The photo was taken last November of AstraZeneca and Oxford Corona 19 vaccine, syringe, and company logo. [email protected]
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(Seoul = Yonhap News) Reporter Jandi Kim = AstraZeneca’s novel coronavirus infection (Corona 19) vaccine, officially approved by the European Union (EU) executive committee for conditional sale, is an expert advisory procedure for approval review in Korea on the 31st. Step on
The Ministry of Food and Drug Safety will hold a meeting of the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ (hereinafter referred to as Verification Advisory Group) in which external experts participate in AstraZeneca’s Corona 19 vaccine.
The meeting will discuss the safety and effectiveness of the AstraZeneca Corona 19 vaccine, its clinical significance, and the appropriateness of the target patient.
With the government announced in February that it would introduce AstraZeneca’s Corona 19 vaccine to Korea, the product was recently engulfed in controversy over whether it would be effective for the elderly over the age of 65.
This is because some argued that the vaccine should be limited to the vaccination of the elderly, saying that sufficient clinical trials have not been conducted in people over 65 years of age.
Despite this controversy, on the 29th (local time), the European Medicines Agency (EMA) recommended conditional marketing approval of AstraZeneca vaccine to all age groups over the age of 18, and on the same day, the EU Commission decided to approve the conditional marketing.
EMA judges that the vaccine’s clinical trial results show that it has been shown to be safe and effective in preventing COVID-19 in people over the age of 18.
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 there is still an expert advisory procedure, there is no current decision or direction for vaccination for the elderly over 65 years old.
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 the approval through’triple’ expert advice leading to the Central Pharmacy Review Committee and the Final Inspection Committee.
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2021/01/31 06:01 sent
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