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MFDS has launched permission review for Pfizer Comirnaty 2

By Kim, Jung-Ju | translator Choi HeeYoung

22.08.29 17:56:11

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Pfizer's COVID-19 2-valent vaccine Comirnaty2 0.1mg/mL permission review has begun.

The Ministry of Food and Drug Safety (Director Oh Yoo-kyung) announced that Pfizer Korea has applied for permission today (29th) to import 0.1mg/mL of Comirnati 2, an mRNA-type bivalent vaccine that expresses the initial COVID-19 virus and mutant virus (Omicron periphery BA.1) antigens, respectively. Comirnaty 2 0.1 mg/mL shows the preventive efficacy of COVID-19 caused by the SARS-CoV-2 virus at the age of 12 and has been developed for use in additional vaccinations after basic vaccination.

The authorities will quickly and closely review the clinical, nonclinical, quality, and GMP data submitted when appl

Kim, Jung-Ju(jj0831@dailypharm.com)
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