AstraZeneca Vaccine Enters Final Approval Stage... The Key Issue Is Its Effectiveness in the Elderly

Central Pharmaceutical Review Committee Advisory Procedure Announced This Afternoon
Earlier, Advisory Group Stated 'Data Is Limited but Exclusion from Administration Is Not Possible'

Europe Sees Multiple Exclusions of Elderly Vaccinations... Switzerland Denies Approval
Government Vaccination Plan May Face Setbacks

AstraZeneca COVID-19 Vaccine [Image Source=AFP Yonhap News]

[Asia Economy Reporter Lee Chun-hee] As the Central Pharmaceutical Affairs Deliberation Committee convenes on the 4th to approve the AstraZeneca vaccine following the Pfizer vaccine, the first COVID-19 vaccine approved domestically, concerns about the effectiveness of the AstraZeneca vaccine in the elderly raise the possibility of disruptions to the vaccination plan.

On the 4th, the Ministry of Food and Drug Safety (MFDS) will conduct an advisory procedure with the Central Pharmaceutical Affairs Deliberation Committee regarding the AstraZeneca vaccine and will announce the results in the afternoon. Before approving COVID-19 vaccines and treatments, the MFDS undergoes a triple advisory process involving the Verification Advisory Group, the Central Pharmaceutical Affairs Deliberation Committee, and the Final Inspection Committee.

The key issue at the Pharmaceutical Affairs Deliberation Committee is undoubtedly whether to vaccinate the elderly. Previously, the Verification Advisory Group, while noting limited data on the elderly group, issued a majority opinion stating that "vaccination for the elderly cannot be excluded solely because of the small number of elderly participants," citing reasons such as ▲ the study design confirming efficacy and safety in subjects aged 18 and over ▲ confirmed preventive effects in the entire population including those aged 65 and over ▲ immune responses similar to adults.

In the clinical trial data used by the MFDS to analyze the effectiveness of the AstraZeneca vaccine, out of 8,895 cases, only 660 (7.4%) were elderly aged 65 and over. It is known that a minority opinion was also presented at the meeting based on this. Due to insufficient data on high-risk elderly groups and the lack of proven preventive effects, it was argued that vaccination for the elderly should be permitted only after additional clinical results are available.

Internationally, countries such as Germany, France, and Italy have excluded the elderly from AstraZeneca vaccination targets, and Switzerland has not approved the use of the vaccine at all. On the 3rd (local time), Swissmedic, the Swiss regulatory authority for medicines, stated, "There is no clear evidence of effectiveness in the elderly based on the data available so far."

Kim Sang-bong, Director of the Biologics and Herbal Medicine Bureau at the Ministry of Food and Drug Safety, is announcing the results of the AstraZeneca COVID-19 vaccine verification advisory committee meeting on the afternoon of the 1st at the briefing room of the Korea Disease Control and Prevention Agency in Cheongju, Chungbuk.
[Photo by Yonhap News]

In Korea, if the AstraZeneca vaccine is disallowed for elderly vaccination during the verification process, the government's vaccination plan may be completely reconsidered. The government plans to start vaccinating 750,000 people this month, including residents, inpatients, and workers at elderly nursing hospitals and facilities, as well as psychiatric nursing and rehabilitation facilities.

Considering that the Pfizer vaccine requires an ultra-cold chain for distribution, making vaccination within nursing facilities difficult, vaccination for these groups may only be possible after May when Janssen or Moderna vaccines arrive. Vaccination for about 8.5 million elderly people aged 65 and over, starting in the second quarter, may also be sequentially delayed due to supply issues.

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