Clinical data for the elderly for the AZ vaccine are lacking

Sang-Bong Kim, Director of Bio-Pharmaceutical Bureau of the MFDS, explained at a briefing

The immunogenicity effect inference submitted to the EU is also examined and verified

The detailed schedule and plan for vaccination in Korea was announced, and a limited vaccination discussion continues overseas due to the lack of clinical data for AstraZeneca (AZ)'s COVID-19 vaccine, and the results of the review by licensing authorities are drawing attention later.

 

The MFDS will take all these into account and conduct a statistical review, but will review all the data inferring the effectiveness of the company to determine the final approval.

 

Sang-Bong Kim, Director of Bio-Pharmaceutical Bureau of the MFDS explained this through a regular briefing of COVID-19 during the day on the 28th.

 

Currently, the MFDS is in the process of reviewing as AZ applied for COVID-19 vaccine approval.

 

However, due to the lack of clinical data on the elderly, the company and Germany are also aware of this, and talks about vaccination plans for young people are also coming out.

 

When applying in Korea, AZ also submitted data stating that dose adjustments are not necessary for the young and the elderly, data from clinical trials in the UK and Brazil, and some of the data submitted to the EU licensing authority.

 

Director Sang-Bong Kim said, “The vaccine safety and effectiveness verification advisory group, the Central Pharmaceutical Affairs Review Committee, and the final review committee will thoroughly review when limiting clinical subjects to the elderly.

 

and in the currently submitted clinical results data, the number of elderly clinical investigators is insufficient, so a statistical review is necessary." The MFDS is planning to review and verify the effect inference as well as the immunogenicity data that AZ submitted at the time of EU approval application was submitted to the MFDS.

 

In the case of AZ products, the COVAX facility will collect the amount and timing of supply around the world and notify each country in the future, so the quarantine authorities plan to determine the inoculation plan by reflecting this schedule.