Will COVID-19 vaccine by SK be released first?

The lot release of vaccines for domestic manufacture is fast

Among AstraZeneca's COVID-19 vaccines that have been applied for approval from the MFDS, it is highly likely that the vaccine that SK Bioscience is consigning and producing will be distributed for the first time in Korea.

 

Recently, the MFDS has reported that item approval and lot release can be reviewed in duplicate to speed up the market.

 

The industry analyzes that it will be possible to review vaccines previously produced by SK Bioscience for approval.

 

The health authorities said through a briefing that they are in consultation with AstraZeneca to ensure that the vaccine that is distributed for the first time in Korea will be produced by SK Bioscience.

 

On the 14th, an official from the MFDS said, "There is an exaggerated part of the press report that item approval and lot release are reviewed.

 

Some overlapping periods can occur." Item approval and lot release are different.

 

In the case of vaccines, after item approval, a lot release review is conducted for the products sold in Korea.

 

Therefore, in order for item approval review and national lot release review to overlap, a commercial vaccine must be secured first.

 

The MFDS is required to produce three commercially available lot numbers in advance and submit them as item approval review data according to the regulations on drug safety.

 

Items produced for approval can be used for lot release screening.

 

It is more likely to proceed with lot release for domestically manufactured vaccines rather than imported vaccines that take time due to customs procedures.

 

The MFDS explained in a press release on the 11th that it plans to conduct an on-site survey on SK Bioscience for manufacturing and quality control evaluation during this month.

 

This survey also includes production data for three lots numbers produced in advance.

 

If the GMP (manufacturing and quality control standard) investigation is completed and the feasibility of the clinical trial is secured, it will be possible to review the lot release of commercial vaccines even before approval.

 

The MFDS plans to shorten the period of item approval to a maximum of 40 days (currently more than 180 days) and lot release within a maximum of 20 days (currently 2 to 3 months).

 

In order to start vaccination at the end of February, as announced by the government, lot release must also be carried out during the permit review period.

 

AstraZeneca's COVID-19 vaccine was applied to the MFDS on the 4th.

 

If item approval and lot release are up to 60 days, lot release should also be made during the approval review period.

 

It is said that the health authorities are discussing it, but the vaccine that will be distributed for the first time in Korea is most likely a vaccine produced by SK Bioscience.

 

When asked if the vaccine to be applied for the initial lot release screening is from SK Bioscience, the MFDS responded that it cannot be informed because the item is under review.

 

The imported vaccine that AstraZeneca applied is known to be a product produced in Italy.