Controversy Over AstraZeneca Vaccine for Elderly... Second Advisory Result Announced at 11:30

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

[Asia Economy Reporter Chunhee Lee] Following the Pfizer vaccine, the first COVID-19 vaccine approved domestically, the advisory results from the Central Pharmaceutical Affairs Deliberation Committee for the approval of the AstraZeneca vaccine will be announced at 11:30 AM on the 5th.

The Ministry of Food and Drug Safety (MFDS) announced on the 5th that it will release the advisory results from the Central Pharmaceutical Affairs Deliberation Committee regarding the AstraZeneca vaccine, which was conducted on the 4th, according to this schedule. The MFDS conducts reviews through a three-layer advisory process before approving COVID-19 vaccines and treatments, involving a verification advisory group, the Central Pharmaceutical Affairs Deliberation Committee, and a final inspection committee.

Originally, the advisory results from the Central Pharmaceutical Affairs Deliberation Committee for the AstraZeneca vaccine were scheduled to be announced at 5 PM on the 4th, the day of the review. However, as the meeting extended past the scheduled time and continued late into the night, the announcement of the advisory results was postponed to the following day. It is reported that whether to vaccinate the elderly with the AstraZeneca vaccine was a key discussion point.

Currently, overseas, many countries are restricting vaccination with the AstraZeneca vaccine due to insufficient clinical data for the elderly. Germany, France, and Italy have excluded the elderly from the vaccination target group, and Switzerland has not approved the use of the vaccine itself, citing "lack of clear results."

Among the 8,895 clinical trial results used by the MFDS to analyze the effectiveness of the AstraZeneca vaccine, only 660 subjects, or 7.4%, were aged 65 or older. However, the earlier verification advisory group acknowledged the limited data for the elderly but issued a majority opinion stating that "exclusion of administration to the elderly solely due to the small number of elderly subjects is not justified," citing reasons such as ▲the study design confirming efficacy and safety in subjects aged 18 and older ▲the confirmed preventive effect in the entire target group including those aged 65 and older ▲and the immune response being similar to that of adults.