MFDS Begins Preliminary Review of Pfizer's Omicron Subvariant Bivalent Vaccine

[Asia Economy Reporter Lee Gwan-joo] Pfizer has applied to the Ministry of Food and Drug Safety for a preliminary review of its COVID-19 bivalent vaccine developed to respond to the Omicron subvariants BA.4 and BA.5.

The Ministry of Food and Drug Safety announced on the 7th that it has begun reviewing the submitted data after Korea Pfizer Pharmaceutical applied for a preliminary review of non-clinical and quality data for the COVID-19 vaccine 'Comirnaty 2-dose 0.1 mg/mL (BA.4-5 type)'.

This vaccine is a bivalent mRNA vaccine expressing antigens of the original COVID-19 virus and the variant virus (common parts of BA.4 and BA.5), developed for use as a booster following the primary vaccination with existing vaccines.

It received emergency use authorization in the United States on the 31st of last month, and review is ongoing in Europe. The Ministry of Food and Drug Safety stated, "We plan to review the submitted non-clinical and quality data promptly and thoroughly," and added, "We will continue to do our best to supply safe and effective vaccines to our people."

This content was produced with the assistance of AI translation services.