On the 5th, the Ministry of Food and Drug Safety held a final inspection committee and approved’Cominatiju’, a novel coronavirus infection (Corona 19) vaccine applied by Pfizer Korea.
The Final Inspection Committee decided on the approval of the item on the condition of submitting the final result report of the clinical trial of’Cominati Province’, which applied for the approval of the imported item on January 25th.
The approved item is a separate quantity from the Pfizer vaccine of’COVAX Facility’, an international vaccine joint purchase project by the government.
The final review committee’s judgment is that 95% of the preventive effect of’Cominatiju’ is sufficient as the result of expert consultation.
In addition, in multinational clinical trials conducted in the United States, there were 8 out of 18,198 vaccine groups and 162 out of 18,325 controls.
There was 1 case of drug-related hypersensitivity reaction after vaccine administration, and no reports of anifalaxis, acute and severe drug-related allergic reaction.
Serious adverse events were reported in 0.6% of the vaccine group and 0.5% of the control group, and all 4 cases of’significant adverse reactions’ that cannot be excluded from being related to vaccine administration were either recovered or were recovering.
In the same way as the recommendations of the two advisory meetings, the subjects of vaccination were selected as’adolescents aged 16-17 and adults’.
This is because it was judged that the immune response of adolescents would not be different from that of adults, and many countries such as the United States, Europe, the United Kingdom, and Japan also approved them as 16 years of age or older.
On the other hand, the quarantine authorities plan to exclude those under the age of 18 from being eligible for’Cominati’ vaccinations and pass the deliberation of the Vaccination Specialist Committee of the Korea Centers for Disease Control and Prevention to permit them.