▲ Corona 19 vaccine developed by AstraZeneca (above) and Corona 19 vaccine developed by Pfizer (Reuters Yonhap News)
The domestic vaccination of the new coronavirus infection (Corona 19) vaccine has entered the countdown. As the initial volume of vaccines developed by multinational pharmaceuticals is expected to enter Korea in early February, the government’s vaccination speed battle is expected to begin in earnest.
According to the industry on the 22nd, Pfizer is preparing to apply for a formal item license for the Corona 19 vaccine. Currently, the Ministry of Food and Drug Safety is undergoing a preliminary review of the Pfizer vaccine for rapid approval.
So far, AstraZeneca is the only multinational pharmaceutical company that has applied for a mental product license for the Corona 19 vaccine. AstraZeneca issued an item permission on the 4th after a preliminary review, and the Ministry of Food and Drug Safety completed an actual condition investigation on SK Bioscience, a manufacturing facility. In addition, after receiving additional data, they reviewed the preventive effect, validity of use and dosage, safety, etc., and entered into a quality review.
Unlike general pharmaceuticals, vaccines must go through the national shipment approval procedure after product approval. National shipment approval is a system in which the government once again checks quality for each manufacturing unit prior to marketing. The Ministry of Food and Drug Safety has shortened the time it takes to obtain a permit to a maximum of 40 days, and has also sought a way to simultaneously carry out the permit work and the national shipment approval procedure to speed up.
The government has planned the start of vaccination at the end of February, but it is drawing a plan as it seems that it will be possible to introduce the initial quantity sooner than expected from Cobax Facility. The number of vaccines that Korea has secured through Kovacs Facility is 10 million, of which 50,000 are likely to arrive in early February. It is predicted that the vaccine will be the first approved Pfizer vaccine in the world.
However, even if Pfizer applies for an item permit in January, the gap with AstraZenekawa will widen for about 20 days. In fact, inoculation in February is difficult. Therefore, in order to inoculate Pfizer vaccine before AstraZeneca vaccine, special import procedures for pharmaceuticals must be followed.
The special import of medicines is a system in which the head of the Ministry of Food and Drug Safety imports drugs that are not approved in Korea at the request of the relevant department heads in order to cope with public health crisis situations such as an infectious disease pandemic. Previously, Gilead Science’s Corona 19 treatment’Remdesivir’ was used in Korea through this system.
The government has secured a total of 56 million vaccines through Cobax Facility, AstraZeneca, Pfizer, Modena and Janssen, and is negotiating with NovaVax to add 20 million more. The amount of AstraZeneca vaccine produced by SK Bioscience is expected to be introduced in February. For smooth vaccination, 10,000 consigned medical institutions and 250 vaccination centers were designated and operated.
The Ministry of Food and Drug Safety will hold a meeting of the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ meeting on the 31st of the AstraZeneca vaccine in which external experts participate, and the results will be disclosed on the 1st of the following month. After that, it is decided whether or not to obtain permission after consulting the Central Pharmacy Review Committee and the Final Inspection Committee.