The Ministry of Food and Drug Safety (MFDS) said Wednesday that it has begun the preliminary review of the non-clinical and clinical trials results of Moderna’s Spikevax-2 mRNA Covid-19 vaccine submitted by Moderna Korea.

Moderna’s Spikevax-2 mRNA vaccine is undergoing a preliminary review of its non-clinical and clinical trials in Korea and Europe to be used as bivalent booster shots in September.
Moderna’s Spikevax-2 mRNA vaccine is undergoing a preliminary review of its non-clinical and clinical trials in Korea and Europe to be used as bivalent booster shots in September.

Moderna’s Spikevax-2 is a multi-vaccine containing mRNA that expresses the antigens of each of the initial coronavirus originating in Wuhan, China, together with the mutant viruses of Omicron and its subvariant, BA.1, developed as a booster dose after initial vaccinations.

According to recent data from the Korea Disease Control and Prevention Agency (KDCA), the BA.5, BA.2.3, and BA.2 omicron variants’ detection rates stand at 52 percent, 17.8 percent, and 8.7 percent, respectively. Therefore, additional vaccinations can reduce the risk of severe symptom progression by 95.4 percent compared to those without booster shots.

“We will conduct prompt and thorough examinations in consultation with infectious disease experts on the safety and effectiveness of the vaccine if quality data of materials is submitted together with the item permit application,” the ministry said.

The ministry added that it would swiftly finish the review of clinical and nonclinical data and supply safe and effective vaccines to the public.

Francesca Ceddia, Moderna’s senior vice president of global medicine, said, “Considering the procedures of health authorities, our new bivalent vaccine is expected to be available by October in Korea and Europe.”

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