The Ministry of Food and Drug Safety’s’Corona 19 Vaccine Safety and Effectiveness Verification Advisory Group (hereinafter referred to as Verification Advisory Group)’ recommended that Pfizer’s novel coronavirus infection (Corona 19) vaccine,’Cominati’, be approved by persons 16 years of age or older.
Kim Sang-bong, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, announced the results of the verification advisory group for’Cominatiju’ through a briefing on the 23rd.
The verification advisory meeting was held on the 22nd with 7 people including infectious medicine specialists, vaccine experts, and clinical statistics experts. Based on data from the clinical trial of’Cominati’, the age, safety, and effectiveness of administration were in-depth. Discussed.
The submitted clinical trial data consisted of two cases, including one clinical trial conducted in Germany (Phase 1/2) and a multinational clinical trial (1 case) conducted in six countries (1/2/3) including the United States. In addition, safety and effectiveness were evaluated through multinational clinical trials conducted in the United States.
As a result of evaluating the effectiveness of two doses of’Cominati’ vaccination compared to placebo in 36,523 people who had not been confirmed to be infected with Corona 19 7 days before the start of the test,’Cominati’ showed about 95% of the preventive effect. And showed more than 94% preventive effect regardless of age and underlying disease.
Regarding the prevention of severe Corona 19, one case occurred in the vaccine group, such as a decrease in oxygen saturation, 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 cases.
As a result of evaluating the immunogenicity of’Cominati’ as an indirect indicator for predicting the vaccine effect, both the binding antibody and the neutralizing antibody increased four times in all subjects compared to before administration, and showed a 100% seroconversion rate.
After vaccination, a total of 8,183 patients were surveyed for 1 week after vaccination. As a result, local reactions were mostly injection site pain (84.1%), swelling (10.5%), and redness (9.5%). Mild to moderate symptoms disappeared within 1 to 2 days, and systemic reactions were fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2). %), mostly mild to moderate, started within 2-3 days after vaccination and disappeared within 1 day.
In addition, the incidence and severity of most systemic reactions were 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.
‘Unpredicted adverse events’ related to vaccine administration were investigated for 4 weeks after vaccine administration in a total of 37,586 people, and as a result, it was found that about 20.8% of the vaccine administration group. The main symptoms were injection site pain (11.2%), fever (6%), fatigue (5.3%), chills (5.3%), headache (4.8%), and muscle pain (4.7%).
One drug-related hypersensitivity reaction (urticaria) occurred in the vaccine-treated group, and no drug-related anaphylactic reaction was reported during the clinical trial period.
In addition, of all 43,448 registered subjects in the clinical trial, “significant adverse events” were reported in 0.6% (126 patients) in the vaccine group and 0.5% (111 patients) in the control group, but serious drug abnormalities that cannot be excluded from the vaccine administration. There were 4 reactions including shoulder wounds.
In particular, as a result of evaluating the preventive effect (107 people) and safety (283 people) of’Cominatiju’ for adolescents aged 16-17 years, there were no cases of Corona 19 infection in both the vaccine group and the control group.
Adverse events were also similar to those reported in other age groups (18 to 55 years old, over 56 years old), and there were no serious adverse drug reactions.
Based on this, the verification advisory group ▲The point that the clinical trial was designed to confirm safety and effectiveness in subjects over 16 years of age, and the preventive effect was confirmed ▲The point that it is judged that the immune response of adolescents aged 16-17 will not be different from that of adults ▲Adult Considering the availability of data from clinical trials in the United States, Europe, the United Kingdom, and Japan, they presented an opinion that it is reasonable to grant permission to those over the age of 16, considering the fact that many countries such as the United States, Europe, the United Kingdom, and Japan have permitted them to be 16 years of age or older.
In addition, the verification advisory group added, “In clinical trials, the safety profile is judged to be acceptable, but careful monitoring after vaccination is necessary for people with a history of anaphylaxis.”
Regarding the preventive effect of’Cominatiju’, the verification advisory group judged that “the effect was confirmed in the submitted data, and the immune response is also maintained higher than the antibody in the plasma of the cure during natural infection, so the preventive effect is sufficient.”
In addition, he added the opinion that it is reasonable to continuously monitor the safety of anaphylaxis and other abnormal cases that appeared during clinical trials through the’Risk Management Plan’ after approval, and to continuously collect and evaluate information.
The Ministry of Food and Drug Safety synthesizes the expert opinions and recommendations obtained through the verification advisory group meeting, as well as the review results, and should consider the safety, effectiveness, and approval of the applied item at the’Central Pharmacy Review Committee’, a legal advisory body of the Ministry of Food and Drug Safety on the 25th. We will receive advice on matters, etc., and the results will be disclosed on the 26th.