AstraZeneca Vaccine Approval Granted... "Vaccination for Elderly Aged 65 and Over" (Update)

Submission Conditions for Clinical Trial Results in the US and Others... "Use in Elderly Should Be Decided Carefully"

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[Asia Economy Reporter Seo So-jung] The Ministry of Food and Drug Safety (MFDS) has approved the AstraZeneca vaccine as the first COVID-19 vaccine authorized in South Korea. It will also be administered to the elderly aged 65 and over, with the condition that the results of the ongoing Phase 3 clinical trials in the United States and other countries be submitted later.

The MFDS (Commissioner Kim Gang-lip) held a final review committee meeting at 10 a.m. on the 10th, composed of internal and external experts, and announced that it decided to approve the COVID-19 vaccine 'Korea AstraZeneca COVID-19 Vaccine' applied for approval by Korea AstraZeneca on the 4th, on the condition of submitting additional clinical trial results.

The final review committee approved the 'efficacy and effectiveness' for those aged 18 and over, including those aged 65 and above, consistent with the advisory results from the verification advisory group and the Central Pharmaceutical Affairs Deliberation Committee. However, since concerns about efficacy in the elderly have been raised in some countries such as Europe, it was finally decided to include in the precautions for use that 'use in elderly persons aged 65 and over should be carefully determined.'

Regarding this, the final review committee explained, "There are no safety or immune response issues for the elderly aged 65 and over, but since only 660 elderly participants (7.4%) were involved in the clinical trials to confirm preventive effects, additional data is needed for statistical verification," adding, "This means that doctors should make vaccination decisions based on a thorough assessment of the benefits according to the patient's condition."

The final review committee stated, "No serious adverse events related to the drug occurred in elderly persons aged 65 and over, and the incidence rates of expected or unexpected adverse events were similar to or lower than those in the adult group," concluding that "the overall safety of the vaccine is considered favorable."

However, it was noted that monitoring is necessary after approval for neurological adverse events, including transverse myelitis, and that any future reported adverse events will be additionally reflected in the approval details.

The Korea AstraZeneca COVID-19 Vaccine is manufactured by SK Bioscience, a domestic pharmaceutical company, under contract from Korea AstraZeneca, and is the first COVID-19 vaccine approved in South Korea. It has received conditional approval or emergency use authorization in 50 countries, including Europe (EMA) and the United Kingdom.

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