AZ vaccine’s import authorization still under review

GMP data has not been submitted…current supply depends on the SK Bioscience manufactured product

Pfizer, Janssen, Moderna vaccines all imported products… local manufacturing required to procure stable supply

Analysists expect Moderna to manufacture vaccines after establishing a subsidiary in Korea

Attention has been rising on the reason for the delayed approval of the imported AstraZeneca’s COVID-19 vaccine, which was the first vaccine to submit its application in Korea.

 

Although the Ministry of Food and Drug Safety (MFDS) had shortened the review period to 40 days, 3 months have passed and no news on the approval of the imported product has been heard to date.

 

This means that Korea’s procurement of AstraZeneca vaccines depends solely on the local supply produced by SK Bioscience.

 

On January 4th, AstraZeneca had submitted two applications for its vaccine; one for the manufacture and marketing authorization of its products manufactured by its CMO SK Bioscience, and the other for the import authorization of products manufactured outside of Korea, including those from Italy.

 

The ‘Korea AstraZeneca’s COVID-19 Vaccine Inj.’ which is manufactured under a CMO deal by SK Bioscience was been approved on February 10th and became the first COVID-19 vaccine to receive marketing authorization in Korea.

 

The approval process took only 40 days through a rolling review by MFDS.

 

However, the application for the imported product that was submitted the same day is still under review.

 

Regarding the matter, an MFDS official explained, “The GMP site data is known to be insufficient.

 

It seems that the submission of supplementary data by the company is being delayed due to the global use of the vaccine.” However, he added that the review process will not take long.

 

Among the AstraZeneca vaccines in use, 1.57 million doses (for 780,000 people) that were secured via independent contracts were approved for national lot release on February 17th.

 

However, due to the limited supply, authorities are having trouble speeding up the vaccination process.

 

Fortunately, an additional 7 million doses are expected to be introduced from May to June to be used for vaccination of those aged 65 or older However, regrets remain as the approval of the imported vaccine would have made procurement much easier.

 

3 types of vaccines – Pfizer and Janssen’s vaccines in addition to the AstraZeneca vaccine produced by SK bioscience – are currently approved in Korea.

 

On the 12th, GC Pharma, which is responsible for the domestic distribution of the Moderna vaccine, applied for approval.

 

All vaccines other than the AstraZeneca vaccine are imported products.

 

The prevailing opinion is that we need more locally manufactured vaccines for better procurement.

 

In the same line, the possibility of Moderna establishing a subsidiary in Korea for local production of vaccines has been raised.

 

In the ‘Moderna plans to establish a subsidiary in Korea’ report, Byung-Gook Park, a researcher at NH Investment & Securities stated that “Moderna had mentioned the possibility of establishing a subsidiary in Korea in its second Moderna Vaccines Day held on the 15th.

 

It plans to strengthen its vaccine capability by establishing subsidiaries in Korea, Japan, and Australia this year.” For a locally manufactured Moderna vaccine to be introduced to the market, the company would need to submit an additional marketing authorization application for the drug to MFDS.