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

US to Submit Additional Clinical Data by April... Vaccination Priority Decided by KDCA

[Image source=Yonhap News]

[Asia Economy Reporter Seo So-jeong] 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, on the condition that the results of the ongoing Phase 3 clinical trials in the United States and other countries are submitted later.

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

The MFDS has requested AstraZeneca to submit interim and final reports of the clinical trials currently underway in the United States. Commissioner Kim Gang-lip explained at a briefing, "The clinical trial in the U.S. involves 30,000 participants, including about 7,500 elderly individuals. We have imposed the condition that the interim results be submitted by the end of April."

The final review committee, consistent with the advisory opinions from the verification advisory group and the Central Pharmaceutical Affairs Deliberation Committee, approved the vaccine for those aged 18 and over, including those 65 and older. However, since some countries in Europe and elsewhere have raised concerns about the vaccine’s efficacy in the elderly, it was finally decided to include a precaution in the usage instructions stating, "Use in elderly persons aged 65 years and older should be decided with caution."

MFDS: "No grounds found to exclude elderly from vaccination"
Doctors to assess patient condition and decide on vaccination

[Image source=Yonhap News]

The final review committee explained, "There are no safety or immune response issues for elderly persons aged 65 and over, but since only 660 elderly participants (7.4%) were involved in the clinical trials to confirm preventive efficacy, additional data is needed for statistical verification. This means that doctors should fully assess the benefits of vaccination based on the patient’s condition and make decisions accordingly."

Commissioner Kim said, "Decisions on which patients to vaccinate first, how to prioritize, and when vaccination for these patient groups will take place will be made by the Korea Disease Control and Prevention Agency, reflecting today’s approval results and considering vaccine supply status, after consultation with the Vaccination Committee and others."

The final review committee judged that "No serious adverse drug reactions 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. Overall, the vaccine’s safety is favorable."

However, they noted that monitoring for neurological adverse events, including transverse myelitis, is necessary after approval, and any future reported adverse events will be reflected in the product labeling and other relevant documents.

Use in pregnant and breastfeeding women is possible if the benefits outweigh the risks, but preventive vaccination during pregnancy is not recommended. For breastfeeding women, the usage precautions will state, "It is unknown whether this drug is excreted in breast milk."

Commissioner Kim admitted that approving the AstraZeneca vaccine was a difficult decision.

He said, "We made efforts to conduct the review process faster than for any other vaccine reviewed by the MFDS so far, and during the review, experts engaged in diverse and serious discussions and provided advisory opinions on various issues. We hope that the first COVID-19 vaccine approved domestically will invigorate future responses to COVID-19."

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. The national batch release approval process for the AstraZeneca vaccine is currently underway and is expected to be completed next week.

The AstraZeneca vaccine is a viral vector vaccine that inserts the gene for the COVID-19 virus surface antigen into a chimpanzee adenovirus that infects only chimpanzees, which is then cultured and delivered into human cells. It is administered as two intramuscular injections of 0.5 mL each, given 4 to 12 weeks apart.

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