MFDS Approves Special Import of COVAX Pfizer Vaccine (Update)

Special Import Approval Quantity of 117,000 Doses... Introduction After Mid-Month

[Image source=Yonhap News]

[Asia Economy Reporter Kim Ji-hee] The Ministry of Food and Drug Safety approved the special import of Pfizer's COVID-19 vaccine 'Comirnaty' supplied through the COVAX Facility on the 3rd. The approved quantity for special import is 117,000 doses, which are expected to be imported into the country after mid-month.

This quantity is directly supplied from the COVAX COVID-19 vaccines, which the World Health Organization (WHO) has reviewed for safety and efficacy and approved for inclusion in the Emergency Use Listing, and is separate from the quantity scheduled to be imported through Pfizer Korea. The special import approval means authorization for the import and customs clearance of a specific quantity. Since it is separate from product approval, the review of the COVID-19 vaccine product approval applied for by Pfizer Korea will proceed as planned.

On the 2nd, the Ministry of Food and Drug Safety and the Korea Disease Control and Prevention Agency held a joint expert advisory meeting to receive advice from experts on safety, efficacy, and the necessity of special import. The joint expert advisory meeting consisted of a total of 11 members, including 10 infectious disease specialists, vaccine and virology experts from the Ministry of Food and Drug Safety’s verification advisory group and the Disease Control Agency’s expert advisory group, and one expert recommended by the Korean Medical Association.

The joint expert advisory meeting unanimously recognized the validity of the special import, considering ▲ the WHO’s approval for inclusion in the Emergency Use Listing ▲ the Korean Ministry of Food and Drug Safety’s participation in WHO’s joint review of non-clinical and clinical data ▲ approval for use by 28 regulatory agencies worldwide and ongoing use in multiple countries.

In particular, the meeting also consulted on whether it is appropriate to set the usage age at 16 years and older, given the limited efficacy in those aged 16 to 17. As a result, considering ▲ the clinical trial plan included subjects aged 16 and older with efficacy analyzed ▲ the overall preventive effect of 95% including all subjects ▲ and that all countries approving the vaccine such as the US, EU, and WHO include those aged 16 and older, the consensus was that setting the age at 16 and older is appropriate.

The recommended dose is 0.3 mL after dilution, with two doses administered at a minimum interval of 21 days, which was deemed appropriate.

Furthermore, the vaccine consists of mRNA and lipid nanoparticles (LNP), and since these two substances are chemically safe but not tightly bound, the structure can be easily broken down by physical force. Therefore, the Disease Control Agency’s COVID-19 vaccination management guidelines recommend sufficient caution such as ‘gently invert, do not shake.’

The Ministry of Food and Drug Safety stated, "In order to ensure public safety through vaccination, we decided on this special approval by comprehensively considering the opinions of the joint expert advisory meeting and overseas vaccination cases. Regarding the quality of the vaccine, once the quantity is confirmed after special approval and test reports for that quantity are obtained, we plan to consult with the Disease Control Agency on quality verification methods."

This content was produced with the assistance of AI translation services.