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Pfizer-Bioentech Corona vaccine 19. Provided by AFP / Yonhap News
The new coronavirus infectious disease (COVID-19, Corona 19) vaccine ‘Cominatiju’ developed by Pfizer and Bio & Tech received a national product license subject to the submission of a report on the final results of the clinical trial. Although it has been approved for vaccines over the age of 16, the Korean Centers for Disease Control and Prevention should deliberate on including vaccination targets for young people.
The Ministry of Food and Pharmaceutical Safety announced that it held a final inspection committee on the 5th and made the decision to approve the national product for Comati. The Ministry of Food and Drug Safety said: “Safety and efficacy have been recognized by comprehensively reviewing the data required for clinical trials and permitting examination, and by comprehensively reviewing quality control and manufacturing standards assessments (GMP )”, He said.
The Pfizer vaccine has been inoculated in Korea for medical personnel and others since the 27th. At 0 o’clock on the 5th, all 3,909 Pfizer vaccines were administered. This quantity was brought into Korea through ‘Covax Facility’, an international project for the joint purchase of vaccines, and was approved for special importation. Special importation is a system in which drugs that are not nationally approved are imported from abroad to deal with public health crises, such as an infectious disease pandemic. Remdesivir, a treatment for Corona 19, has also been approved for special import. This approval is a decision to approve the number of Pfizer vaccines that will come through a direct contract with Pfizer scheduled for the end of this month.
The final inspection committee considered that the majority of the adverse events reported in relation to safety were anticipated adverse events related to the administration of the vaccine and, in general, they were good. More than 1% of abnormal cases that occurred were injection site pain, fever, fatigue, chills, headache, and muscle pain, and most symptoms were mild to moderate and recovered within days after vaccination.
According to the Ministry of Food and Drug Safety, of the 43,448 subjects registered in the clinical trial, 126 people in the vaccine group and 111 people in the control group reported serious abnormalities. Among them, 4 serious cases of drugs that could not be excluded from the administration of the vaccine were shoulder injuries, lymphadenopathy, ventricular arrhythmia, low back pain and pain in both lower extremities.
The final inspection committee said: “However, for those with a history of hypersensitivity, including anaphylaxis, close monitoring is required after clearance, and we plan to further reflect abnormal cases to be reported in the future.”
The final inspection committee considered that the preventive effect was sufficient in terms of effectiveness. The final inspection committee said: “There were 8 vaccine groups and 162 control groups, respectively, and they showed a preventive effect of around 95%.”
In addition, the goal of vaccination was also determined to be 16 years of age or older, in the same way as the recommendations of the two consultative meetings. The final inspection committee said: “The clinical trial was designed to confirm the safety and efficacy in subjects over 16 years of age, and the preventive effect was confirmed, and it is estimated that the immune response of adolescents over 16 years of age will not be different. to that of adults. ” Countries such as the United States, Europe, the United Kingdom and Japan were also considered to have allowed them to be 16 years old or older.
However, adolescents over 16 years of age are not immediately included in the vaccination target. It must go through the deliberation of the Specialized Committee on Immunization of the Korea Centers for Disease Control and Prevention.
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