The Minister of Food and Drug Safety, Kim Gang-rip, is giving a briefing on’CoVax-Pfizer’s special import approval for Corona 19 vaccine’ at the briefing room of the Ministry of Food and Drug Safety in Osong-eup, Cheongju-si, Chungbuk. News 1
On the 3rd, the Ministry of Food and Drug Safety approved the special import of’Cominati’, a corona 19 vaccine from Pfizer of the United States. First of all, it is limited to 117,000 doses (58,500 people) that will come in through the’COVAX facility’, a multinational vaccine supply organization in the middle of this month. As special income has been made, it is expected to be administered to the Corona 19 medical staff immediately after undergoing only the quality verification process.
Special income, a prerequisite for supplying COVAX
According to the Ministry of Food and Drug Safety and the Korean Disease Control Agency, the first supply of COVAX-Pfizer vaccine was announced from the World Vaccine Immunity Association (GAVI) earlier this year. It was 1 million doses (for 2 million people) in 12 countries, including Korea. In October of last year, the Korean government paid 85 billion won in advance to Kovacs and signed a supply contract for 10 million people. GAVI issued’special approval’ as a prerequisite at the first announcement. Since then, the Ministry of Food and Drug Safety and the Korean Disease Administration have undergone special import procedures, and it has become possible to secure some quantities (117,000 doses).
The special import system for pharmaceuticals is implemented during a public health crisis such as a pandemic of infectious diseases such as Corona 19. If a special case is requested by the Agency for Disease Control and Prevention, the Ministry of Food and Drug Safety will go through an expert advisory meeting to determine whether to approve it. When approval is decided, drugs that are not approved in Korea can be imported through the importer. It was used when introducing’Remdesivir’, a COVID-19 treatment by Gilead’s in the United States.
Characteristics of each vaccine type and inoculation institution. Graphic = Kim Eun-kyo [email protected]
Joint expert advisory meeting held on the 2nd
On the 2nd, the Ministry of Food and Drug Safety and Illness Administration held a joint expert advisory meeting. This is to receive expert advice on the necessity of special income. The advisory group consisted of 11 experts including infectious medicine specialists and vaccine and virology experts. Pfizer vaccine is the first product to utilize the’mRNA’ platform, so its safety and effectiveness have also been verified. Since it is an mRNA platform, distribution and storage at -70 degrees Celsius is required.
At the advisory meeting, the World Health Organization (WHO) approved the listing of the Pfizer vaccine on the emergency use list, the Korea Food and Drug Administration participated in the joint review of the WHO, reviewed non-clinical and clinical data in advance, and 28 regulatory agencies around the world. Based on the approval of use, etc., the validity of the special income was recognized.
Vaccination timing by target group. Graphic = Kim Eun-kyo [email protected]
95% preventive effect over 16 years old
In this process, attention was paid to the fact that the COVID-19 prevention effect was over the age of 16 and 95%, and an opinion was raised that it is reasonable to set the vaccination age to be 16 or older. The United States, the European Union, and the WHO have also approved vaccinations over the age of 16. Currently, the Korean government has not set up a vaccination plan for those under the age of 19. In the third quarter of this year for Pfizer’s preventive effect, adolescents aged 16-18 are also interested in getting the vaccine.
In response, Na Seong-woong, deputy chief of the Disease Administration, said at a briefing on the 3rd, “We will discuss ways to expand (inoculation age) according to the clinical approval of other vaccines. The worker is the target.”
Pfizer’s novel coronavirus infection, which was secured through the COVAX facility, an international project held at the briefing room of the Ministry of Food and Drug Safety in Cheongju City, Chungbuk on the afternoon of the afternoon of the 3rd. Corona 19) After the announcement of the results of the review of special vaccine imports, they are looking at the smartphone and talking before the reporters’ inquiries. yunhap news
At the advisory meeting, it was concluded that the Pfizer dose of 0.3 mL (based on dilution) was administered twice at least 21 days apart. However, as a precaution, it was recommended to’turn over gently without shaking’ when dilution of the vaccine. This is because the lipid nanoparticles (LNPs) that surround and protect the mRNA can be damaged.
The government has signed individual contracts with Pfizer other than Kovacs. It is 20 million doses (for 10 million people). Special income does not apply to this quantity. Separate domestic permit procedures must be followed.
“The government will make every effort to ensure that COVAX and Pfizer’s COVID-19 vaccine can be supplied without disruption to the vaccination implementation plan,” said Kang-lip Kim, head of the Food and Drug Administration. “After vaccination, we will thoroughly monitor and take appropriate and prompt measures. will be. Above all, we will make sure that the vaccine can be used safely.”
Reporter Minwook Kim [email protected]