The vaccination date of AZ’s vaccine will be advanced

Kim Sang-bong, director of the MFDS, "approval/review up to 40 days, and lot release up to 20 days"

The MFDS announced that it will accelerate the marketing approval period as much as possible by approval/review process of AstraZeneca's COVID-19 vaccine, which was accepted for approval on the 4th, and the national lot release at same time.

 

The approval/review system takes up to 40 days and lot release takes up to 20 days, but it is technically the intention to work together to shorten the time of inoculation by cooperating between the departments.

 

On that day, Director of the MFDS Kim Sang-bong made this statement at the COVID-19 briefing at Central Disease Control Headquarters.

 

AstraZeneca submitted an application for COVID-19 vaccine approval to the MFDS, and the MFDS were continuing a briefing on approval of the vaccine with the KCDA.

 

Director Kim Sang-bong said some media reported that it took at least 60 days for AstraZeneca's vaccine to actually be marketed, but this was not true.

 

It is true that the approval/review process takes up to 40 days and lot release takes up to 20 days, but this can be shortened as much as the maximum period of the administrative procedure.

 

If the review of approval/review system data is completed within 20 days, it will be processed in 20 days instead of 40 days, and allow lot release as soon as it is confirmed.

 

It is explained that a plan is being devised to advance the time of vaccination for the people by simultaneously conducting review and lot release.

 

"The lot release usually takes 2-3 months, but we have built the infrastructure for the lot release of COVID-19 vaccine from last year.

 

The principle is that approval/review and lot release are not carried out at the same time, but Pfizer, Janssen, Moderna and others are also sharing the application for approval." He said, "Clinical data and review results will be released through the media.

 

However, at the time of completion of the approval, we will explain to the public in detail,and it was a measure to submit some of the experimental data." KDCA Commissioner Jung Eun Kyeong said that it has not been decided whether or not the overseas COVID-19 vaccine will be commissioned in Korea except for Astrazeneca’s vaccine.

 

She said she is doing her best to prepare for safe distribution and vaccination after the vaccine is marketed.

 

She advised not to use a combination of different types of COVID-19 vaccines.

 

This means that the drug should be administered according to the efficacy and safety and vaccination cycle confirmed in clinical trials.

 

She said, "Pfizer mRNA COVID-19 vaccine will be introduced in the third quarter.

 

We are discussing for an early supply.

 

It is difficult to say everything because there is confidential between institutions.

 

We plan to explain it to the people once it is confirmed." She said, "We are preparing to discuss and simulate the distribution plan of COVID-19 vaccine with cold chain that can be distributed at –70°C and –20°C.

 

It takes a lot of time to set up an inoculation center to prepare for vaccination.

 

It is not a rule to mix different types of vaccines, and the relatively identical vaccines should be administered at the same time."