The Ministry of Food and Drug Safety has decided to approve the Pfizer vaccine’Cominati’ for the first time in Korea as an mRNA vaccine for those over the age of 16.
Kim Kang-rip, head of the Food and Drug Administration, held a briefing on the 5th and said, “The product approval was decided on the condition of submitting a report on the final results of clinical trials for’Cominatiju’, which was applied for permission from Pfizer Pharmaceutical Co., Ltd. in Korea.”
 ▲ Kang-rip Kim, Director of the Ministry of Food and Drug Safety. (Photo = Ministry of Food and Drug Safety) © |
The Ministry of Food and Drug Safety held a final inspection committee including external experts on this day and made this decision. This meeting was the final step in the COVID-19 vaccine approval process, attended by three external experts, including the chairman of the Central Pharmacy Review Committee Yoo-hwan, and five inside the Ministry of Food and Drug Safety.
Director Kim said, “The most reported adverse events related to safety were predicted adverse events related to vaccine administration, and was judged to be generally good.” After taking the results of the consultation, we decided to grant permission for those over the age of 16.”
However, for those with a history of hypersensitivity including anaphylaxis, close monitoring is required after permission, and future reports of abnormal cases will be additionally reflected in permission matters.
COMINATI is an mRNA vaccine, in which the corona 19 virus antigen gene is injected in the form of mRNA to synthesize an antigen protein in the body, and this protein induces the production of neutralizing antibodies, thereby neutralizing and removing the virus when the corona 19 virus enters the human body. do.
In particular, mRNA vaccines can be mass-produced within a short period of time due to a short manufacturing period, but since the main component of mRNA can be easily degraded by RNA degrading enzymes, a cryogenic frozen cold chain is required to maintain stability.
The efficacy and effect of this drug is to prevent COVID-19 from over 16 years of age. The usage and dose is to inoculate 0.3 ml of diluted vaccine twice every 3 weeks, and the storage conditions are at -60℃ to 90℃ for 6 months.
Meanwhile, as an mRNA vaccine, it is the first vaccine to be licensed in Korea, and it has received conditional approval or emergency use approval from 59 countries including Europe and the United States and WHO.
In order to enhance expertise and objectivity, the Ministry of Food and Drug Safety went through a triple consultation procedure of the verification advisory group, the central pharmacy review committee, and the final inspection committee. A final inspection committee was held.
“The final inspection committee has comprehensively reviewed the results of the KFDA review and the contents of the previous two consultations. We have decided to approve the item.”
“Generally, the most common abnormal cases were pain and fever at the injection site, and symptoms were mostly mild to moderate and recovered within a few days after vaccination.” “Based on these results, the final review committee said that the safety of the vaccine was generally good. I judged it.”
The preventive effect was evaluated on 36,523 people aged 16 years or older who were negative for the corona 19 virus, and in the vaccine group and the control group, 8 people in the vaccine group and 162 people in the control group, respectively, were diagnosed with Corona 19, representing about 95%.
Based on the results of these clinical trials, the Final Inspection Committee said that it decided that the vaccine had sufficient preventive effects and decided to permit it for those aged 16 or older.
 ▲ Progress of the permit review process. © |
This decision considered the fact that the clinical trial was designed to confirm the safety and effectiveness in subjects over 16 years of age, so that the preventive effect was confirmed, and that the immune response of adolescents over 16 years of age would not be different from that of adults.
In addition, it reflected the availability of clinical trial results for adults and the fact that many countries such as the United States, Japan, Europe, and the United Kingdom have approved them as 16 years of age or older.
In addition, with regard to the measures to secure safety after permission, the final inspection committee decided that the measures to ensure overall safety are appropriate, and after permission, through the risk management plan, continue to observe safety and collect and evaluate abnormal cases that may occur in the process of use after permission. .
“Even after this product is approved, we will do our best to strengthen the surveillance system for abnormal cases after vaccination in cooperation with the Korea Disease Control Agency, and to ensure that the public can receive the vaccine with confidence through thorough monitoring and prompt response.” Revealed.