[Asia Economy Reporter Lee Chun-hee] The Ministry of Food and Drug Safety has approved Moderna's messenger ribonucleic acid (mRNA) vaccine developed to respond to the Omicron COVID-19 variant.
On the 8th, the Ministry announced that it approved the import item of the COVID-19 vaccine 'Moderna Spikevax 2-dose (ingredient names Elasomeran, Imelasomeran)' applied for approval by Moderna Korea, on the condition that long-term storage test data for setting the expiration date be submitted after approval. This vaccine is a bivalent vaccine 'mRNA-1273.214' developed by combining 'mRNA-1273.529,' which targets the Omicron BA.1 variant, with the original vaccine 'Spikevax (mRNA-1273)' developed to target the initial COVID-19 virus, the Wuhan virus.
The efficacy and effectiveness are for the prevention of COVID-19 in individuals aged 18 and older. The dosage and administration are 'an additional dose of 0.5 mL (50 μg) at least 3 months after completing the primary or booster vaccination.' It is currently conditionally approved and authorized for booster doses in the European Union (EU), the United Kingdom, Switzerland, Australia, Canada, and other countries.
For approval, the Ministry reviewed clinical trial results and quality data conducted in the United States involving 814 adults aged 18 and older. Regarding safety, local adverse events appeared similarly in the existing vaccine group (377 people) and the bivalent vaccine group (437 people). The most common local adverse event was 'injection site pain,' and the most common systemic adverse event was 'fatigue.' Injection site pain occurred in 77.3% of the bivalent vaccine group and 76.6% of the existing vaccine group, while fatigue occurred in 54.9% of the bivalent vaccine group and 51.4% of the existing vaccine group, showing similar incidence rates.
Most adverse events were mild or moderate and were temporary reactions. No serious adverse drug reactions related to vaccine administration were observed.
Regarding effectiveness, among 594 individuals who had received a second booster dose and were not infected with COVID-19 (334 in the bivalent vaccine group and 260 in the existing vaccine group), immune response was compared using virus-specific neutralizing antibody titers four weeks after the additional dose. The bivalent vaccine showed higher levels than the existing vaccine: 1.75 times higher for BA.1 and 1.22 times higher for the Wuhan strain.
The Ministry's approval underwent consultation with the 'COVID-19 Therapeutics and Vaccines Safety and Effectiveness Verification Advisory Committee,' composed of vaccine experts and infectious disease specialists, regarding overall effectiveness and safety. The advisory committee stated, "Adverse events after the bivalent vaccine booster were similar to those of the existing vaccine, and superiority was confirmed in neutralizing antibody immune response compared to the existing vaccine," concluding that "the effectiveness and safety for approval are acceptable."
Spikevax 2-dose is not a vaccine developed to target other Omicron subvariants BA.4 and BA.5. Moderna's vaccine targeting BA.4 and BA.5 received approval from the U.S. Food and Drug Administration (FDA) on the 31st of last month (local time), but it has not yet been introduced domestically.
However, Moderna explains that even though Spikevax 2-dose was developed targeting BA.1, it also has efficacy against BA.4 and BA.5 variants. Moderna reported that after administering a 50 μg fourth dose of Spikevax 2-dose to participants who had completed the third dose, neutralizing antibody responses measured one month later showed a 6.3-fold preventive effect against BA.4 and BA.5 compared to those who had only received three doses.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
