<기사제목>MFDS Advisory Panel Recommends AZ Vaccine Approval... "Majority Opinion Supports Administration to Elderly" (Update)

"Final Clinical Report Must Be Submitted After Approval"

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The advisory panel for verification under the Ministry of Food and Drug Safety (MFDS) has issued an advisory result stating that conditional approval is possible for AstraZeneca's vaccine, expected to be the first COVID-19 vaccine in South Korea. Furthermore, the majority opinion was that the vaccine can be administered to the elderly without restrictions, despite ongoing controversies.

The MFDS announced on the 1st that following a meeting of the ‘COVID-19 Vaccine Safety and Effectiveness Verification Advisory Panel’ held on the 31st of last month to evaluate the efficacy and safety of AstraZeneca's COVID-19 vaccine, this proposal was made. Eight experts, including infectious disease specialists, vaccine experts, and clinical statistics experts, attended the meeting held the previous day. The advisory panel evaluated efficacy and safety based on a total of four submitted clinical trial data sets (two from the UK, one from Brazil, and one from South Africa).

The advisory panel stated, "Approval can be granted on the condition that the final clinical trial report for ongoing trials and interim analysis data from clinical trials conducted in the United States are submitted after approval."

Regarding the vaccine's efficacy in the elderly aged 65 and over, which had drawn significant attention, the panel reported, "Many experts expressed the opinion that vaccination of the elderly cannot be excluded solely because the number of elderly participants was small." The majority of the advisory panel cited reasons including ▲the clinical trial plan was designed to confirm efficacy and safety in subjects aged 18 and older ▲prevention effects were confirmed in the entire subject group including those aged 65 and over ▲immune responses after vaccination were similar to those in adults ▲and the safety profile was favorable.

Evaluation of prevention efficacy (660 subjects) and safety (2109 subjects) in the elderly aged 65 and over showed that one case of COVID-19 occurred in both the vaccine group and the control group. Neither group experienced hospitalization or severe illness. Immunogenicity evaluation results showed that binding antibodies and neutralizing antibodies were produced in elderly subjects who received the vaccine. Compared to the adult group aged 18 to 64, the seroconversion rate showed no significant difference. The incidence rates of predicted or unpredicted adverse events were also similar to or lower than those in the adult group.

[Image source=Yonhap News]

Kim Sang-bong, Director of the Bio-Pharmaceutical Division, stated at the briefing that "No conclusion or consensus has been reached regarding vaccination of the elderly, and since there are minority opinions, the Central Pharmaceutical Affairs Deliberation Committee will conduct a more comprehensive review to make a final decision." He added, "Although age restriction opinions have emerged in countries such as Germany and Italy, under the European Medicines Agency's (EMA) approval system, member states follow the EMA's approval conditions. The approval conditions themselves do not vary by member state, but advisory bodies of each country's health authorities may issue vaccination age recommendations."

The advisory panel's evaluation showed that AstraZeneca vaccine's prevention efficacy is approximately 62%, exceeding the 50% efficacy standard set by the World Health Organization (WHO) and other domestic and international criteria. Regarding dosage, the panel assessed that two doses at standard dosage with an interval of 4 to 12 weeks are appropriate. However, they recommended that when used in clinical practice after approval, specific guidelines on dosing intervals should be provided through expert consultation.

The MFDS plans to disclose the advisory results on the 4th after the second advisory procedure, the ‘Central Pharmaceutical Affairs Deliberation Committee’ meeting. Additionally, on the 5th, the final advisory procedure, the ‘Final Inspection Committee,’ will be held for Celltrion's COVID-19 treatment ‘Rekkironaju’ to make a final decision on approval and disclose the results on the same day.

This content was produced with the assistance of AI translation services.