[메디게이트뉴스 서민지 기자] Special imports for 117,000 doses of Pfizer’s Corona 19 vaccine’Cominati’ will be approved, and will be introduced into Korea as early as the middle of this month and will begin vaccination for medical staff working in the Corona 19 medical field.
Kang-rip Kim, Director of the Ministry of Food and Drug Safety, made this announcement on the 3rd through a briefing on COVAX FACILITY-Pfizer’s COVAX Vaccine Special Import Review.
COVAX is a global vaccine supply mechanism proposed by the Global Vaccine and Immunity Alliance (GAVI) for a sufficient and equitable distribution of the Corona 19 vaccine.
This special import approval is limited to the first supply volume of GAVI supplying 1 million doses to 12 countries, and the special import procedure was promoted by presenting special approval as a prerequisite for vaccine supply. In other words, it is a separate quantity from importing through the official approval process of the Ministry of Food and Drug Safety through Pfizer Korea.
The special import system is a system in which the Minister of Food and Drug Safety imports drugs that are not approved in Korea through the importer when the head of the relevant agency, such as the Commissioner of Diseases, requests a special case in order to appropriately cope with a public health crisis situation such as an infectious disease pandemic or a radiation emergency situation prescribed by the Pharmacist Act All. Special import approval is for the import and customs clearance of a specific quantity, and approval is made on a case-by-case basis each time it is imported.
“It is approved through a separate procedure called special import, but we plan to conduct quality verification such as national shipment approval by securing additional test reports,” said Kim Kang-rip, head of the Ministry of Food and Drug Safety. “It will be possible to receive full-fledged vaccination only after mid-February.”
Prior to the decision to import special cases, the Ministry of Food and Drug Safety and the Korean Disease Administration held a joint expert advisory meeting with the Ministry of Food and Drug Safety and Disease Administration on the 2nd to receive expert advice on safety, effectiveness, and the need for special imports.
The Ministry of Food and Drug Administration-Disease Administration’s joint expert advisory group consisted of 11 people, including the COVID-19 treatment and vaccine verification advisory group, 10 infectious medicine specialists and vaccine experts, and one recommended by the medical association.
Pfizer’s Corona 19 vaccine is the first vaccine developed using the mRNA vaccine platform, and the mRNA vaccine is a vaccine that induces an immune response by injecting an antigen gene into the human body in the form of RNA to produce an antigen protein in the body.
The manufacturing period is short and mass production is possible within a short period of time. However, because RNA, the main component, is easily degraded by RNA degrading enzyme (RNase), the stability is low, so a frozen (-20℃ or -75±15℃) cold chain is required.
Currently, the World Health Organization (WHO) has approved the EUL (Emergency Use Listing) listing for Pfizer’s Corona 19 vaccine, and it has received conditional approvals from the United States, the European Union, and the United Kingdom in the United States, Europe, Canada, Israel, and Singapore. The vaccination is taking place.
The advisory group evaluated safety and effectiveness based on data from phase 1 clinical trials in Germany and phases 1, 2, and 3 of multinational clinical trials such as the United States.
According to the corresponding clinical data, as a result of administering twice at 21-day intervals to 36,523 subjects in the clinical trial, the preventive effect was found to be 95% (8 cases in the vaccine group and 162 cases in the placebo group) in those aged 16 years or older. Safety was evaluated in 21,744 people 16 years of age or older, and most of them had predicted adverse events related to vaccine administration, but disappeared within a few days after vaccination.
All the advisory groups said, “Pfizer vaccine has been approved for listing on the emergency use list by the World Health Organization (WHO), and the Korean Food and Drug Administration participated in the joint review of the World Health Organization (WHO) to review non-clinical and clinical data. It has been approved for use by dogs regulatory agencies and is being used in a number of countries,” he admitted, “Considering this, the special import is reasonable.”
In addition, in relation to setting the age of use to 16 years or older in a situation where the effectiveness of the 16 to 17 years old is limited, “The effectiveness of the clinical trial plan was analyzed, including subjects over 16 years of age. Including the prevention effect is 95%. All approved countries also include those aged 16 years or older,” he said, “taking this into consideration, it is reasonable to be 16 years old or older.”
Kim said, “All of the imported special imports are for medical staff. Therefore, there are questions about the effectiveness of 16-17 years old, but there will be no age-related problems.”
In terms of usage, it was revealed that it is reasonable to specify that 0.3mL is the volume after dilution, and to set the inoculation interval to at least 21 days. Since it is composed of mRNA and lipid nanoparticles (LNP), it is recommended not to apply physical force.
“It’s a very unstable structure. It’s a very unstable structure. It’s very cold and cold in the distribution process, and I’m afraid that stability will be degraded if it shakes or shocks in handling.” Revealed.
With regard to follow-up measures such as management of abnormal cases and compensation for damages after the introduction of special cases, the’Management of Adverse Reactions after Corona 19 Vaccination’ of the Corona 19 Vaccination Guidelines of the Corona 19 Vaccination Promotion Team of all ministries will be applied mutatis mutandis.
Kim said, “In order to secure public safety through vaccination, we have decided to approve this special case by comprehensively considering the opinion of the joint expert advisory meeting and overseas vaccination cases,” he said. “Going forward, the government will be vaccinated against COVAX-Pfizer Corona 19 vaccine We will make every effort to ensure that the implementation plan is supplied without disruption, and we will take appropriate and prompt action if necessary through thorough monitoring of abnormal cases after vaccination.”
Meanwhile, Director Kim explained, “The general approval process, which is currently under way, proceeds differently from this special procedure, but the opinions of the advisory meeting received during this special procedure will be appropriately used in the product approval process.”