Oilhwan Joongangyakshim Chairman: "Unvaccinated Over 65 Are at Greater Risk"

Conditional Approval for AstraZeneca Clinical Data Submission
Means Caution... Not a Vaccination Postponement
No Issues with Vaccine Safety
Consider Elderly in Nursing Hospitals
Final Review Committee Scheduled for the 10th

[Asia Economy Reporter Seo So-jeong] "It is not right to deprive those aged 65 and older of the right to be vaccinated when there are no safety issues with the AstraZeneca vaccine."

Oh Il-hwan, chairman of the Central Pharmaceutical Affairs Deliberation Committee (Central Pharmaceutical Committee) (photo), said in a phone interview with Asia Economy on the 8th, "The elderly aged 65 and over are the most urgent group for vaccination," adding, "Delaying vaccination for the elderly in nursing hospitals and the like will cause greater social harm."

Regarding the decision made at the Central Pharmaceutical Committee meeting held on the 4th to recommend product approval for the AstraZeneca vaccine on the condition of submitting further clinical trial result analysis data, Chairman Oh emphasized, "The accurate expression is that vaccination for those aged 65 and over should be done cautiously," and added, "It does not mean that vaccination has been deferred."

The Ministry of Food and Drug Safety plans to hold a final inspection committee meeting on the 10th to make the final decision on the approval of the AstraZeneca vaccine. The final inspection committee will conclude by synthesizing the first verification advisory group's opinion on 'approval for the elderly' and the second Central Pharmaceutical Committee's decision on 'cautious vaccination for the elderly.' Subsequently, the Vaccination Expert Committee under the Korea Disease Control and Prevention Agency will decide on specific matters such as the vaccination schedule for those aged 65 and over.

He explained, "Since the safety of the vaccine has already been confirmed, future discussions are not about whether to vaccinate the elderly or not," adding, "It means that it can be used for the elderly, and if safety and efficacy are clearly verified at the final inspection committee, the Vaccination Committee will determine specific enforcement ordinances such as vaccination implementation methods and priorities."

Verification with Additional Data from the UK
Switzerland’s Situation Differs Due to Smaller Population

In particular, Chairman Oh focused on the fact that the UK's independent regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA), released additional data on the 5th (local time) showing that the AstraZeneca vaccine is effective for those aged 65 and over. He said, "The data the committee members had at the Central Pharmaceutical Committee on the 4th was from early December last year," adding, "If we can receive and review the UK's additional data by the 10th, we will be able to make a more confident decision."

Regarding European countries' restrictions on the AstraZeneca vaccine for the elderly and Switzerland's refusal to approve the vaccine, Chairman Oh said, "Switzerland has easy access to Pfizer and Moderna vaccines and a population of only about 8.71 million," adding, "Korea is in a realistic situation where people cannot choose the vaccine they want to receive." He noted that it is unreasonable to make direct comparisons given the fierce global competition to secure vaccines.

He expressed concern, saying, "Analysis data on the US clinical trial results will come out no earlier than April or May," and added, "While it is true that statistical verification needs to be done, waiting idly until clinical trial data is released amid the rapid spread of variant viruses could lead to worse outcomes."

Chairman Oh further stated, "The elderly in nursing hospitals are the top priority to protect, and neglecting their vaccination could rather cause confusion in the quarantine system," and argued, "It is also not right from a national perspective."

He added, "It is correct to interpret that the door for approval was left open at the Central Pharmaceutical Committee, the second advisory stage, so that the Vaccination Committee can make the final adjustment," and said, "Since the risk of COVID-19 infection for the elderly is greater than the risk posed by vaccination, it is highly likely that approval will be granted in a broad sense."