Ministry of Food and Drug Safety Advisory Group recommends conditional permits, although there are few clinical participants, the effect has been confirmed
About AstraZeneca’s COVID-19 vaccine, which has been controversial that it is not effective for the elderly, an expert advisory group of the Korean Food and Drug Administration presented an opinion that “the vaccination of the elderly cannot be excluded.”
On the 1st, the Ministry of Food and Drug Safety explained the status of AstraZeneca’s COVID-19 vaccine item approval and review, and on the 31st of last month, 8 people including infectious medicine specialists, vaccine experts and clinical statistics experts participated in the’Corona 19 vaccine safety and effectiveness. Verification Advisory Group (hereinafter referred to as Verification Advisory Group)’ meeting results were disclosed.
On that day, Sang-Bong Kim, director of the Bio-Pharmaceutical Bureau, said, “Based on the clinical trial data (submitted by AstraZeneca), the results of in-depth discussions on the dose, interval, and effects in the elderly, showed a preventive effect of about 62%. It was found that it satisfies the criteria (prevention effect of 50% or more). In particular, “a number of experts have suggested that administration to the elderly cannot be excluded.”
Although the data on the high-risk elderly group in the clinical trial were limited, the preventive 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, and the safety profile was good. This is because the administration of the elderly cannot be excluded just because the number of elderly participants is small.
However, according to the opinion of a few experts, the preventive effect was not proven due to lack of data on the elderly. The seroconversion rate in immunogenicity is not different from that of adults, but the antibody titer is lower than that of adults under 65 years of age, and the immunogenic response and prevention effect There was an opinion that the correlation of the drug should be reflected in the approval matters after confirming additional results such as clinical trials.
The clinical trial data submitted by AstraZeneca for the approval/examination of this product include 2 cases in the UK (Phase 1/2, Phase 2/3), 1 case in Brazil (Phase 3), and 1 case in South Africa (Phase 1/2). There are 4 cases in total. The effectiveness evaluation is the result of two clinical trials conducted in the UK (Phase 2/3) and Brazil (Phase 3), and the safety evaluation is the result of four clinical trials.
For the effectiveness analysis, 8,895 adults (4,440 in vaccine group and 4,455 in control group) with an average age of 42.2 years received two standard doses, and 37% (3,281) of those with underlying diseases such as obesity, cardiovascular system, and respiratory system. Persons), and 7.4% (660 persons) of the elderly over the age of 65 were included.
As a result of the evaluation, the number of people who were confirmed as Corona 19 were 27 in the vaccine group and 71 in the control group, showing a preventive effect of about 62%.
When analyzing the preventive effect according to the interval of administration, it showed 52.57% at 4-8 weeks, 68.89% at 9-12 weeks, and 60.86% at 4-12 weeks. The wider the interval, the greater the preventive effect and immune response. It is characterized by showing a tendency to do.
The Ministry of Food and Drug Safety has synthesized expert opinions, efficacy, effects (drafts), recommendations, and review results obtained through the’Verification Advisory Group’ advisory meeting, On February 4 (Thursday), the statutory advisory body of the Ministry of Food and Drug Safety, the’Central Pharmacy Deliberation Committee’, will be consulted on the effectiveness and matters to be considered when permitting, and the results will be disclosed the same day.
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