Special authorization requested for COVAX-Pfizer vaccine

KDCA submits application to MFDS on Feb. 2

Pfizer supply and UNICEF shipping contracts and customs clearance to be processed swiftly

The South Korean disease control authority is requesting the health authority to grant a special approval on 117,000 doses of Pfizer vaccines to be supplied to the country by COVAX Facility.

 

Under the supply agreement with COVAX Facility, the vaccines would be promptly introduced to South Korea for inoculation starting from this month.

 

On February 2, Korea Disease Control and Prevention Agency (KDCA) announced it applied for a special import authorization to the Ministry of Food and Drug Safety (MFDS) for the vaccines.

 

The action is based on the results of the COVID-19 Vaccine Expert Council meeting convened by MFDS and KDCA and the Article 85 of the Pharmaceutical Affairs Act.

 

In accordance to the Pharmaceutical Affairs Act, manufacturing and importing preventive drug or treatments without market authorization in South Korea may be possible as requested by a head of related ministry and agency amid pandemic or state emergency.

 

Previously at the council meeting, the experts agreed on the need of special import authorization of COVAX Facility-supplied Pfizer vaccine considering WHO and the U.S.

 

Food and Drug Administration (FDA) have approved of it and also as South Korea’s MFDS has participated in the collaborative review by WHO safety, efficacy and quality evaluation.

 

MFDS accepted KDCA’s special import authorization application on Feb.

 

2, so the agency could ink the supply contract with Pfizer to immediately bring in the vaccine as soon as the ministry’s authorization is granted.

 

Also the administrative procedure related to UNICEF shipping contract and customs clearance would be processed promptly as well.

 

KDCA official said, “We would fully prepare all processes to initiate the inoculation as soon as the vaccines arrive in South Korea.”