[전남인터넷신문]The Ministry of Food and Drug Safety held a meeting of the’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group’ (hereinafter referred to as Verification Advisory Group) on the results of the clinical trials of Pfizer Korea Co., Ltd. on February 22 (Mon).
2 Clinical trial results
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* USA, Argentina, Brazil, Germany, South Africa, Turkey ** Immunogenicity assessment: conducted in phases 1 and 2 conducted in Germany and the United States
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(Preventive effect) 36,523 people (18,198 people in the vaccine group, 18,325 people in the control group) who had not been infected with Corona 19 before 7 days after the vaccine or control drug* were administered twice were evaluated.
* Placebo: 0.9% physiological saline ** Including 21.9% (8,018 people) of the elderly over 65
The preventive effect is a comparison and analysis of the proportion of patients infected with COVID-19 that occurred in each group from the 7th day after the vaccine or control drug was administered twice. One or more clinical symptoms1) such as fever and cough were expressed, and the COVID-19 virus test was performed. 2) If the result is positive, the infection was defined as confirmed.
1) Fever, cough, shortness of breath, chills, muscle pain, loss of smell and taste, sore throat, diarrhea, vomiting 2) RT-PCR (Reverse Transcription Polymerase Chain Reaction) or NAAT (Nucleic Acid Amplification Test) , Nucleic acid amplification test)
As a result of the evaluation, the number of confirmed COVID-19 patients was 8 vaccine group and 162 control group, which had a preventive effect of about 95%, and showed a preventive effect of 94% or more regardless of age1) and underlying disease2).
※ Prevention rate (%) = 100 x (1-(Confirmation rate among vaccination group) / (Confirmation rate among placebo group)) 1) (Elderly) 95.1% aged 18-64, 94.7% over 65 years 2) ( Underlying disease) underlying disease (yes) 95.3%, underlying disease (no) 94.7%
In addition, as for the severe COVID-19 prevention, one case of severe manifestation, such as a decrease in oxygen saturation, occurred in the vaccine group, whereas three cases occurred in the control group, showing a tendency to prevent, but there were no statistical significance due to the small number of occurrences.
* Severe COVID-19 outbreak after at least one dose: vaccine group (1 case), control group (9 cases)
(Immunogenicity evaluation) As an indirect indicator that can predict the vaccine effect, the immune response, such as the type and amount of antibodies produced in the body after vaccine administration, was evaluated.
In the case of the’binding antibody’ that binds to the Corona 19 virus antigen, the’antibody value’* increased by more than four times in all subjects compared to before administration, resulting in a’serum conversion rate’* of 100%.
* Antibody titer: The titer of the corresponding antibody against a certain antigen (measured value) ** Serum conversion rate: The proportion of subjects whose antibody titer increases more than 4 times compared to before vaccination
Even in the case of’neutralizing antibodies’ that bind to the surface of virus particles and induce a preventive effect by neutralizing the infectivity of the virus, the’antibody value’ increases by more than 4 times in all subjects after the vaccine was administered twice, resulting in a’serum conversion rate’ of 100%. Was.
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A total of 8,183 patients (vaccine group: 4,093 patients, control group: 4,090 patients) were investigated for 1 week after vaccination.
* (Local) Redness, swelling, injection site pain (whole body) Fever, fatigue, headache, chills, nausea, diarrhea, muscle pain, joint pain * Predicted abnormal cases: Abnormalities caused by the vaccine at the beginning of vaccination (within 1 week) Actively investigated through an electronic diary with cases
Local reactions were mild to moderate in injection site pain (84.1%), edema (10.5%), and redness (9.5%), and disappeared within 1 to 2 days after onset.
Systemic reactions were mostly mild to moderate in order of fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%). It started within 3 days and disappeared within 1 day.
Most of the systemic reactions were incidence and severity higher in the younger age group than in the older age group, and overall incidence and severity increased after the second administration than the first dose.