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From next week, the government will begin verification by external experts for approval of the Pfizer’s novel coronavirus infection (Corona 19) vaccine’Cominati’. It plans to complete the item approval process by the first week of next month.
The Ministry of Food and Drug Safety announced on the 18th that the vaccine will receive’triple’ external expert advice leading to the verification advisory group, the central pharmacy review committee, and the final inspection committee.
On January 25th, Pfizer Pharmaceutical Korea applied for approval of the Corona 19 vaccine to the Ministry of Food and Drug Safety.
Prior to this, the Ministry of Food and Drug Safety said that it would significantly shorten the period of approval for the Corona 19 vaccine from 6 months to 40 days, so if this schedule is met, the Pfizer vaccine item license is expected to be issued by the first week of March.
In fact, Kim Sang-bong, head of the Food and Drug Administration’s Bio-Pharmaceutical Bureau, also answered a question about the Pfizer vaccine product licensing schedule in a call with Yonhap News, saying, “It is scheduled for the first week of March.”
The Ministry of Food and Drug Safety approved the AstraZeneca vaccine on the 10th of this month, 37 days after the application for approval was received on January 4th of this year. It took ten days from the start of the expert verification to the final approval.
Of the 13 million vaccines contracted by the government with Pfizer, 500,000 will be pre-supplied to Korea at the end of next month. The vaccination starts in April when the food and drug approval and the national shipment approval process are completed without problems.
This is different from 58,000 people (117,000 doses) that will be supplied through the international project’COVAX facility’. The Ministry of Food and Drug Safety has approved special imports for this quantity, which is scheduled to arrive in late this month or early March.
Special import of medicines is a system that allows drugs that are not approved domestically to be imported from overseas to cope with the pandemic of infectious diseases, and is different from the official approval currently in progress.
Pfizer’s Corona 19 vaccine is a’nucleic acid vaccine’ developed using messenger ribonucleic acid (mRNA, messenger RNA) containing the genetic information of the virus, and this method was the first to commercialize the Corona 19 vaccine.
In clinical trials, the preventive effect against Corona 19 infection was 95% in people 16 years of age or older, and there were no unpredictable serious abnormal cases.
In Israel, where 27% of the population received the Pfizer vaccine twice, a study found that the number of symptoms of COVID-19 infection decreased by 94% in the double-vaccinated group compared to the unvaccinated group.
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