Ministry of Food and Drug Safety Announces Results of Special Imports of Pfizer Vaccines in This Afternoon (Complementary)

On the morning of the 3rd, a simulation training for the new coronavirus infection (Corona 19) vaccine transport and unexpected situations is being conducted at the cargo terminal of Incheon International Airport in Jung-gu, Incheon. 2021.2.3/News1 © News1 Reporter Park Ji-hye

The Ministry of Food and Drug Safety announced on the 3rd that at 5 pm on the 3rd, it was announced on the day whether to import special domestic vaccines for the prevention of novel coronavirus infection (Corona 19). The special import target is Pfizer’s vaccine that comes through the COVAX facility, a global vaccine joint purchase alliance.

The announcement of this special income is the result of the Korea Centers for Disease Control and Prevention’s application for special income on the last 2 days to the Ministry of Food and Drug Safety for rapid vaccination of 117,000 doses of Pfizer vaccine (approximately 60,000 people) received through COVAX since mid-February.

Accordingly, the Ministry of Food and Drug Safety decided to review special imports based on the fact that the Pfizer vaccine received emergency approval from the World Health Organization (WHO) and the US Food and Drug Administration (FDA), and that the Korea Food and Drug Administration participated in the WHO emergency use approval review. .

Once the special import is decided, the vaccine can start immediately after introduction through administrative procedures such as customs and shipment confirmation as soon as the Pfizer vaccine arrives at the domestic airport. Pfizer vaccine is expected to be introduced for the first time in Korea in mid-February, and vaccination is expected immediately after the Lunar New Year holidays.

Apart from this special import, the Ministry of Food and Drug Safety is also undergoing a permit review for the Pfizer vaccine introduced after the third quarter. In this approval review, safety and effectiveness are confirmed based on the results of clinical trials and quality evaluations submitted by Pfizer directly to the Ministry of Food and Drug Safety.

In the case of the Ministry of Food and Drug Safety’s Corona 19 Rapid Permit Screening System, the maximum review period is 40 days, and after approval, it takes at least 20 days for national shipment approval for quality verification. In the case of special import, approval is possible within 7 days because only minimum safety is confirmed based on foreign cases.

Meanwhile, the Ministry of Food and Drug Safety allowed special importation of Gilead Science’s Corona 19 treatment’Remdesivir’ in June.

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