Omicron-compatible Moderna bivalent vaccine shipped…”Used in Korea in early October”

Spikebox 2-week booster vaccination, Omicron neutralizing antibody 8 times↑

Bivalent vaccine shipment [사진=모더나]
Moderna, a multinational pharmaceutical company, announced on the 21st that it has shipped ‘Spikebox 2 weeks’, a bivalent mRNA vaccine containing Omicron in Korea. It is expected to be used as a domestic booster vaccine from the beginning of next month after discussion with the Korea Centers for Disease Control and Prevention.

Previously, Moderna Spikebox 2 weeks (Elasomeran, Imelasomeran) was approved for use by the Ministry of Food and Drug Safety on the 8th as a vaccine to prevent COVID-19 caused by the corona-causing virus (SARS-CoV-2) in 18 years of age or older. .

This approval was based on phase 2 and 3 clinical data that evaluated the efficacy of 2 weeks of Spikebox. In the clinical trial, Spikebox 2 weeks included neutralizing antibody response against Omicron (BA.1) when compared with the efficacy of 50 μg booster dose of Spikebox in seronegative participants (participants who had never been infected with COVID-19). All key evaluation parameters were met, Moderna explained.

In the clinical trial results, the two-week booster vaccination with Spikebox increased the neutralizing antibody against Omicron approximately 8-fold in the group of participants who had no previous infection history.

In addition, when compared with the existing Spikebox strains, the newly approved Spikebox 2 strains elicited a strong neutralizing antibody response against Omicron sub-variants BA.4 and BA.5. Looking at the geometric mean fold increase (GMFR) for BA.4 and BA.5 mutations before and after inoculation, Spikebox 2 weeks showed a 6.3-fold increase in antibody compared to before inoculation. It appeared consistently regardless of previous COVID-19 infection.

Meanwhile, the Ministry of Food and Drug Safety is also reviewing licenses for Pfizer mRNA bivalent vaccines that correspond to BA.1, BA.4, and 5 sub-mutations of the Omicron. It is expected to introduce both Moderna and Pfizer, mRNA vaccines for booster vaccination, during the fourth quarter.

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