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According to industry sources on the 30th, the Ministry of Food and Drug Safety will hold a’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ meeting on the afternoon of the 31st, in which external experts participate in the clinical trial data of AstraZeneca Corona 19 Vaccine (AZD1222).
The results will be released on the 1st of next month.
In this meeting, clinical experts focused on infectious medicine will participate in the meeting to look into the safety and effectiveness of AstraZeneca Corona 19 vaccine, clinical significance, and the appropriateness of the target patient. The Ministry of Food and Drug Safety has prepared a procedure for consulting external experts in’triple’ for objective and transparent approval review for COVID-19 treatments and vaccines. Consultation is conducted in the order of verification advisory group, central pharmacy review committee, and final inspection committee
On the 4th, AstraZeneca applied for an item permission for the Corona 19 vaccine with the Ministry of Food and Drug Safety. Among the corona 19 vaccines to be introduced in Korea, it is the first product to apply for product permission. The government signed a contract with AstraZeneca to purchase 10 million vaccines.
Recently, as controversy about the efficacy of the AstraZeneca vaccine on the elderly over the age of 65 has risen, the authorities are known to thoroughly verify this part.
The Ministry of Food and Drug Safety is comparing and reviewing the vaccination group and the placebo group to see if there is any safety information that requires special attention from the elderly over 65 years of age.
An official from the Ministry of Food and Drug Safety said, “We will thoroughly verify the safety and effectiveness through a triple expert consultation procedure starting on the 31st,” and said, “There is no specific decision on the scope of the permit, since expert consultation has not yet started.”
Earlier, the European Union (EU) executive committee approved the conditional sale of AstraZeneca’s COVID-19 vaccine on the 29th (local time). Following the vaccine developed by Pfizer and Modena, it is the third COVID-19 vaccine approved by the EU for conditional use.
The European Medicines Agency (EMA) said that the AstraZeneca vaccine was found to be safe and effective in preventing COVID-19 in people over the age of 18 when the results of clinical trials conducted in the UK, Brazil and South Africa were combined.
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