[현장연결] Ministry of Food and Drug Safety “Pfizer Corona 19 Vaccine, Special Import Approval…Introduced in mid-month
The Ministry of Food and Drug Safety is announcing the results of a review of the special importation of Pfizer’s Corona 19 vaccine that comes through COVAX facility.
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The vaccine approved today is limited to the amount that Korea will receive directly according to the contract between the Korea Disease Administration and COVAX, and is different from the amount scheduled to be imported through Pfizer Korea.
Gabi, the World Association for Vaccine Immunization, announced that it plans to distribute and supply about 1 million doses of Covax Pfizer vaccine as the primary supply to 6 to 12 countries earlier this year, and the completion of procedures such as special approval within the country where the vaccine is to be introduced. As it was presented as a prerequisite for supply, the special import procedure was quickly promoted.
The Ministry of Food and Drug Safety and the Korea Disease Administration held a joint expert advisory meeting on February 2 to receive advice from experts on safety, effectiveness and the need for special imports.
The joint expert advisory meeting includes one expert recommended by the Korean Medical Association, including infectious diseases infectious medicine specialists and vaccine virology specialists, such as the Ministry of Food and Drug Safety’s COVID-19 treatment vaccine safety and effectiveness verification advisory group and the Korea Disease Administration’s COVID-19 expert advisory group. It consisted of 11 people in total.
Pfizer’s Corona 19 vaccine, which will be introduced and inoculated for the first time in Korea through COVAX, is the first vaccine developed using the mRNA vaccine platform.
This vaccine is the first vaccine to be listed on the emergency use list by the World Health Organization, and it has been approved for emergency use or conditionally licensed by 28 regulatory agencies around the world, including the United States, the European Union, and the United Kingdom. Vaccination is already being done in several countries, including Singapore and Israel.
The safety and effectiveness of the clinical trials submitted at the time of the preliminary review were evaluated in one case in Germany and one in multinational clinical trials such as the United States.
The clinical trial subjects included in the efficacy analysis totaled 36,523, who received two doses at 21-day intervals.
The preventive effect of cases of COVID-19 infection that occurred 7 days after administration of two vaccines was 95% of those over 65 years of age.
Safety was evaluated for a total of 21,744 subjects aged 16 or older who received the vaccine at least once in two clinical trials.
Adverse reactions were injection site pain, fatigue, headache, muscle pain, chills, joint pain and fever, and injection site swelling, usually mild or moderate, and resolved within days after vaccination.
In terms of safety, it was generally good with predicted adverse events associated with most vaccine administration.
At the joint expert advisory meeting, safety and efficacy were discussed in depth based on the feasibility of special importation for coma and clinical trial data.
As approval for domestic use is required as a prerequisite for receiving the first supply of supply from COVAX, we consulted on the feasibility of special imports in consideration of the situation where rapid vaccination is necessary to respond to the outbreak of infectious diseases in Korea.
The joint expert advisory meeting was first approved by the World Health Organization to be listed on the emergency use list, and second, the Korea Food and Drug Administration participated in the joint review of the World Health Organization to review non-clinical and clinical data, and 28 items around the world. Regulatory agencies have approved the use, and in consideration of the fact that many countries have already been vaccinated, all of the feasibility of special import was recognized.
We also consulted on views on how to use the COVAX Pfizer vaccine.
As for the age of use, we asked if it is appropriate to set the age to 16 years or older in situations where the effectiveness of the age group from 16 to 17 years is limited.
The joint expert advisory meeting is based on the first analysis of the effectiveness of the clinical trial plan, including subjects over 16 years of age, second, 95% prevention effect including all subjects, and third, all approved countries such as the United States, the European Union, and WHO. In consideration of the inclusion of those aged 16 and older, it was an opinion that it would be appropriate to be 16 or older.
Regarding the usage and dosage, we asked for advice on how to use 0.3 ml of intramuscular injection at least 21 days apart.
The joint expert advisory meeting stated that 0.3ml is the volume after dilution in terms of usage, and it was the opinion that it would be reasonable to set the dosing interval to at least 21 days.
In addition, the joint expert advisory meeting suggests that the proposed use plan for the precautions for use is appropriate, but the vaccine may be easily degraded by physical force during the dilution and administration of the drug. It is recommended to give sufficient caution, such as not shaking.
The Ministry of Food and Drug Safety decided to approve this special case by comprehensively considering the opinions of the joint expert advisory meeting and cases of overseas vaccinations in order to secure national security through vaccination.
As for the quality of the vaccine, we plan to discuss the quality verification method with the Agency for Disease Control and Prevention as soon as the quantity is confirmed after special approval and a test report is secured for that quantity.
In the future, the government will make every effort to ensure that the COVAX Pfizer Corona 19 vaccine can be supplied without any disruption to the vaccination implementation plan, and take appropriate and prompt measures through thorough monitoring of abnormal cases after vaccination, so that the vaccine can be used safely. I’ll do it.
Thank you.
Yonhap News TV article inquiries and reports: katok/line jebo23
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