Pfizer-Bioentech’s COVID-19 vaccine is being vaccinated in the United States. Provided by AFP/Yonhap News
The Ministry of Food and Drug Safety’s new coronavirus infection (COVID-19, Corona 19) vaccine safety and effectiveness verification advisory group judged that the US Pfizer vaccine’Cominati’ had “sufficient preventive effect”. It was found that there was sufficient preventive effect in the age group, including adolescents aged 16-17 and older people aged 65 or older. Based on this, the advisory group made a reasonable opinion that it is appropriate to permit Pfizer vaccinations over the age of 16.
The Ministry of Food and Drug Safety announced on the 23rd that it had reached this conclusion with a’verification advisory group’ meeting for official approval of Pfizer’s Corona 19 vaccine.
The Ministry of Food and Drug Safety has set up an expert verification team to review the approval of the Corona 19 vaccine and treatment, and the verification advisory group corresponds to step 1 of the 3 tests. Experts focused on infectious medicine will participate in the advisory group. After that, consultation is conducted in the order of the Central Pharmacy Review Committee and the Final Inspection Committee.
Seven people including infectious medicine specialists, vaccine specialists, and clinical statistics specialists participated in this advisory group. They evaluated safety and effectiveness through phases 1, 2, and 3 of multinational clinical trials conducted in six countries including the United States, Brazil, and Germany. The clinical subjects were 43,448, with an average age of 50 years old, women 21,324 (49%), patients with underlying diseases such as lung disease 8978 (20.7%), obesity 15,063 (34.7%), and 10,000 over 55 years of age. 7846 (41.1%) were included.
The advisory group analyzed the preventive effect of the Pfizer vaccine on these clinical subjects, and found that the effect was 95%. Regardless of age or underlying disease, more than 94% of the preventive effects were found. The prevention effect was 95.1% for those aged 18-64 and 94.7% for those over 65 years old. The prevention effect was 95.3% in cases with underlying disease and 94.7% in cases without.
In all those who received the vaccine, the’binding antibody’ corresponding to the corona 19 virus antigen increased more than four times compared to before administration. All’neutralizing antibodies’, which neutralize viral infectivity and induce preventive effects, also increased more than four times.
Regarding the prevention of severe Corona 19, when the vaccine was given, one case of severe manifestation, such as a decrease in oxygen saturation, occurred, while three cases occurred in the control group who did not receive the vaccine. However, the advisory group said, “There is a tendency to prevent severe Corona 19, but the number of occurrences was small, so there was no statistical significance.”
As for the vaccine side effects, there were four’significant drug adverse reactions’ that could not be excluded from vaccination, including shoulder wounds and ventricular arrhythmias. In addition, most of the predicted local and systemic reactions were mild to moderate and disappeared within 1 to 2 days after onset. In the vaccine group, one drug-related hypersensitivity reaction, hives, occurred, and an acute severe allergic reaction,’anaphylaxis’, was not reported during the clinical trial.
Regarding the abnormal case, the advisory group said, “In clinical trials, the safety trend is judged to be acceptable, but if you have a history of anaphylaxis, careful monitoring after vaccination is necessary.”
The advisory group also advised that the Pfizer vaccination is appropriate for those aged 16-17. The advisory group said, “The clinical trial was designed to confirm safety and effectiveness in subjects over 16 years of age, and the preventive effect was confirmed, and it is judged that the immune response of adolescents aged 16-17 will not be different from that of adults.” · Considering the fact that many countries such as the UK and Japan have allowed them to be 16 years of age or older, it is reasonable to give permission to those aged 16 or older.”
The Ministry of Food and Drug Safety synthesizes the results of the Pfizer vaccine quality data review and verification advisory group meeting, receives consultation from the Central Pharmacy Review Committee on the 25th, and discloses the results on the 26th.