MFDS beings rolling review of Pfizer’s multivalent vaccine

By Lee, Hye-Kyung | translator Alice Kang

22.08.05 17:16:04

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Consults with experts for advice on the safety and efficacy of the vaccine

The Ministry of Food and Drug Safety (Minister: Yu-Kyoung Oh) announced that it had started a rolling review on the clinical trial data that Pfizer Korea submitted on the 5th for its COVID-19 vaccine ‘Comirnaty2 Inj. 0.1mg/mL.'

Comirnaty2 Inj. 0.1mg/mL. is a multivalent mRNA vaccine that presents antigens for both the original COVID-19 virus (Wuhan strain) and its variant virus (Omicron strain, BA.1) that was developed as a booster vaccine to be received after primary vaccination.

The MFDS plans to promptly and closely review the submitted clinical data.

When the company applies for marketing authorization and additionally submits non-clinical data and quality data, the M

Lee, Hye-Kyung(hgrace7@dailypharm.com)

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