Pfizer Vaccine 'Special Import' Approved... 60,000 Doses to Arrive After Lunar New Year (Comprehensive)

"Measures According to COVAX Preconditions... Product Approval Is Separate"

[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 is 1.17 million doses, which are expected to be imported into the country after mid-February.

However, this quantity is part of the COVID-19 vaccines directly supplied by COVAX 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, while the product approval for the COVID-19 vaccine applied for by Pfizer Korea is being reviewed separately.

At a briefing on the same day, Kim Gang-lip, head of the Ministry of Food and Drug Safety, said, "Today's approval is an unavoidable measure taken under the condition that the vaccine must be available for domestic use before the Pfizer vaccine's approval process is completed in Korea in order to receive supply from COVAX." He added, "Regarding national lot release, once this procedure is completed and the domestic supply quantity is confirmed, test reports for that quantity will be obtained through COVAX, and discussions with the Korea Disease Control and Prevention Agency (KDCA) on quality verification methods will proceed accordingly."

He further explained, "Although the approval procedure and product authorization are clearly different, much of the content reviewed is similar to that examined during the authorization process. Opinions from the joint expert advisory meeting presented during this approval process will also be appropriately referenced in the authorization process."

On the 2nd, the Ministry of Food and Drug Safety and the KDCA held a joint expert advisory meeting to receive consultation from experts on safety, efficacy, and the necessity of special import. The joint expert advisory meeting consisted of 11 members, including infectious disease specialists, vaccine and virology experts from the Ministry of Food and Drug Safety's verification advisory group and the KDCA's expert advisory group, as well as one expert recommended by the Korean Medical Association.

The joint expert advisory meeting unanimously recognized the validity of the special import, considering ▲ the World Health Organization (WHO) approval for emergency use listing, ▲ the participation of the Korean Ministry of Food and Drug Safety in WHO's joint review of non-clinical and clinical data, and ▲ approval for use by 28 regulatory agencies worldwide with many countries currently using the vaccine.

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 16- to 17-year-olds. The conclusion was that setting the age at 16 and older is reasonable, considering ▲ clinical trial plans included subjects aged 16 and above with efficacy analyzed, ▲ the overall preventive efficacy of 95% including all subjects, and ▲ all countries that approved the vaccine, including the US, EU, and WHO, included those aged 16 and older.

Regarding this, the KDCA stated, "Unlike other vaccines, Pfizer's vaccine is authorized for use up to age 16." They added, "Since the vaccines entering under this special import are intended for healthcare workers and personnel responsible for COVID-19, this issue will not apply." They further noted, "However, since Korea conducts mass vaccinations for all vaccines simultaneously, the age will be set at 18 and above, and discussions will be held on expanding this based on clinical approvals of other vaccines."

The recommended dose is 0.3 mL after dilution, with two doses administered at least 21 days apart. Additionally, since the mRNA and lipid nanoparticles (LNP) that make up the vaccine are chemically safe but not tightly bound, the structure can be easily broken down by physical force. Therefore, the KDCA's COVID-19 vaccination management guidelines recommend giving sufficient caution such as "gently invert, do not shake."

The Ministry of Food and Drug Safety stated, "From the perspective of ensuring public safety through vaccination, the decision for this special approval was made after comprehensively considering the opinions of the joint expert advisory meeting and overseas vaccination cases." They added, "Regarding vaccine quality, once the quantity is confirmed after special approval and test reports for that quantity are obtained, we plan to consult with the KDCA on quality verification methods."

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