A second expert opinion came out that Pfizer’s Corona 19 vaccine’Cominatiju’ could be licensed for use by the age of 16 or older.
The Ministry of Food and Drug Safety said this conclusion was reached at a meeting of the’Central Pharmacy Review Committee’, the second expert advisory procedure for formal approval of Pfizer vaccine.
The day before, the Ministry of Food and Drug Safety held a Central Pharmacy Conference at the headquarters of the Ministry of Food and Drug Safety in Osong, Chungcheongbuk-do.
As with the conclusion of the first expert meeting, the’Verification Advisory Group’, the Central Pharmaceutical Affairs Commission recommended a formal product approval, saying that the vaccine’s preventive effect is sufficient with about 95%.
It was also the opinion of the previous experts that this vaccine was appropriate not only to adults but also to adolescents aged 16-17.
This is because the immune response of adolescents over the age of 16 is not different from that of adults, so it is possible to use adult clinical trial data.
We judged that safety issues such as abnormal cases are acceptable.
The Ministry of Food and Drug Safety will open a final inspection committee to finally decide whether to approve or not after further reviewing the quality data of Pfizer vaccine by synthesizing expert opinions obtained from the verification advisory group and the Central Pharmaceutical Affairs Commission and the efficacy and effect data of Pfizer vaccine.
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