[속보]Ministry of Food and Drug Safety “Verification Advisory Group, Opinion Advantages on AZ Vaccine Administration for Elderly People”

Sangbong Kim, Director of the Bio-Pharmaceutical Bureau, Ministry of Food and Drug Safety./News1 © News1 Reporter Yongbin Kim

The Ministry of Food and Drug Safety announced the results of the verification advisory group meeting on February 1 that opinions were focused on whether it is possible to administer the AstraZeneca vaccine to the elderly over the age of 65. However, as the clinical data for the elderly are small, the policy is to disclose the results on the same day after receiving advice from the Central Pharmacy Review Committee, the second verification step on the 4th. The government plans to start vaccinating AstraZeneca from the end of February.

The Ministry of Food and Drug Safety is currently undergoing the verification process of a triple advisory meeting such as’Safety and Effectiveness Verification Advisory Group → Central Pharmacist Review Committee → Final Inspection Committee’ before obtaining the final approval for Corona 19 vaccine and treatment in Korea.

On February 1, the Ministry of Food and Drug Safety said, “As a result of consulting on whether the administration of the AstraZeneca vaccine is appropriate to the elderly, many experts commented that the administration to the elderly could not be ruled out just because the number of elderly people participated in the clinical trial was small.” Said.

This is because △The clinical trial was designed to confirm the efficacy and safety in subjects 18 years of age or older △The point that the prevention effect was confirmed in all subjects including 65 years of age or older △The immune response after vaccine administration was similar to that of adults △The safety profile This is the result of considering the good points.

On the other hand, a small number of experts in the advisory group expressed the opinion that the preventive effect was not proven due to insufficient data on the elderly, who are high-risk groups.

In addition, there is no difference in the seroconversion rate in immunogenicity for the elderly than for adults, but the antibody price is lower than for adults under 65 years of age, and the correlation between immunogenic response and preventive effect is not established. It was an opinion that it is desirable to do it.

The antibody titer refers to the amount of antibody that binds to the Corona 19 virus antigen, and the seroconversion rate refers to the increase in antibody titer by more than 4 times compared to before administration.

In addition, the advisory group determined that it was appropriate to administer twice the standard dose as in clinical trials. In addition, it was considered that the interval between administration of 4 to 12 weeks was appropriate.

Sang-Bong Kim, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, said, “On the 4th, the Ministry of Food and Drug Safety, the legal advisory body of the Ministry of Food and Drug Safety, will receive advice and discuss the results on the safety, effectiveness, and matters to be considered during approval. It is planned”.

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