MFDS Begins Preliminary Review of Moderna Bivalent Vaccine for Omicron Response

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Young-won] The Ministry of Food and Drug Safety announced on the 20th that it has begun a preliminary review of Moderna's bivalent COVID-19 vaccine developed to respond to the Omicron variant.

This follows Moderna Korea's application to the Ministry of Food and Drug Safety on the same day for a preliminary review of non-clinical and clinical trial data for 'Moderna Spikevax 2-Week'. Preliminary reviews of this vaccine are also underway in countries such as Europe.

This vaccine is an mRNA-based multivalent vaccine developed to express antigens of both the original Wuhan strain of the COVID-19 virus and the BA.1 Omicron variant. It was developed for use as a booster shot following the primary vaccination with existing vaccines.

The Ministry of Food and Drug Safety plans to promptly and thoroughly review the submitted non-clinical and clinical data.

Additionally, the Ministry stated that if Moderna Korea submits additional quality-related data and applies for product approval, it will conduct a swift and thorough review and consult experts regarding the safety and efficacy of the vaccine.

Earlier, Son Ji-young, CEO of Moderna Korea, said at a press conference held on the 19th, "We have secured the supply quantity to be able to provide the vaccine immediately upon approval according to the review schedule of the Ministry of Food and Drug Safety," adding, "Samsung Biologics has started vaccine production."

According to Moderna Korea, although this vaccine was developed targeting BA.1, it showed 6.3 times the preventive effect against BA.4 and BA.5 compared to those who received the third dose.

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