AstraZeneca Vaccine "Cautious Vaccination for Those Aged 65 and Over"... Further Decision by KDCA

MFDS to Conclude Final Review Soon... Reconsideration of Elderly Vaccination at Vaccination Expert Committee

[Asia Economy reporters Seo So-jeong and Lee Chun-hee] The Ministry of Food and Drug Safety's Central Pharmaceutical Affairs Deliberation Committee has decided to grant product approval for the AstraZeneca vaccine, which has sparked controversy over its use in the elderly, on the condition that ongoing clinical trial results be submitted.

In particular, regarding vaccination for those aged 65 and older, which has been a subject of debate, it was agreed that further discussion will take place at the upcoming Korea Disease Control and Prevention Agency's Vaccination Expert Committee.

On the 5th, the Ministry of Food and Drug Safety stated that at the Central Pharmaceutical Affairs Deliberation Committee meeting held the previous day to consult on the safety and efficacy of the Korea AstraZeneca vaccine, the efficacy and effectiveness would be the same as in Europe for those aged 18 and older. However, the usage precautions will include the statement, "Vaccination for those aged 65 and older should be decided cautiously as there is insufficient data on effectiveness."

They also recommended submitting analysis data from upcoming U.S. clinical trial results. Recently, as various European countries have postponed vaccination for the elderly, a cautious approach has gained weight.

On the 1st, the Ministry of Food and Drug Safety's "COVID-19 Vaccine Safety and Effectiveness Verification Advisory Group" meeting expressed the opinion that "although clinical data is limited, vaccination cannot be excluded," allowing vaccination for the elderly aged 65 and older. While the Central Pharmaceutical Affairs Deliberation Committee meeting held the previous day leaned toward product approval in broad terms, the condition of submitting clinical results marked a noticeably different atmosphere.

Unlike the first verification advisory meeting, where many supported approval for the elderly, opinions among committee members were divided over the vaccine's effectiveness in the elderly during the second verification stage at the Central Pharmaceutical Affairs Deliberation Committee.

[Image source=Yonhap News]

Recently, Germany, Sweden, France, and Norway decided to administer the AstraZeneca vaccine only to those under 65, and Switzerland refused approval citing "no clear results on effectiveness in the elderly," which changed the atmosphere. Even within the committee, opinions emerged that "more in-depth discussion is necessary."

The Ministry of Food and Drug Safety initially planned to announce the advisory results at 5 p.m. on the day of the Central Pharmaceutical Affairs Deliberation Committee meeting. However, as the meeting lasted longer than expected and ended late in the evening, the announcement was postponed by a day. There were repeated last-minute struggles before the final decision was made.

Regarding the AstraZeneca vaccine, it is known that intense debates occurred among committee members over safety and efficacy, as it is scheduled to be the first vaccine administered to the elderly in Korea this month alongside Pfizer. If vaccination is restricted to those under 65, as in Germany and France, the plan to vaccinate 750,000 elderly residents of nursing hospitals starting in February would be disrupted.

A Ministry of Food and Drug Safety official said, "Based on expert opinions and efficacy and effectiveness obtained through the first verification advisory group and the second Central Pharmaceutical Affairs Deliberation Committee, a 'Final Review Committee' will be held soon to make the final decision on the approval of the AstraZeneca vaccine."

The Korea Disease Control and Prevention Agency added, "After the Ministry of Food and Drug Safety's final approval and review, reflecting those results, and after review by the COVID-19 vaccine expert advisory group and deliberation by the Vaccination Expert Committee, the vaccination plan for seniors aged 65 and older will be finalized."