Moderna "Omicron-Targeted Vaccine Can Be Supplied Immediately Upon Korea Approval"

Son Ji-young, Moderna Korea CEO
"Production Started at Samsung Biologics"

First Omicron 'BA.1' Targeted Vaccine
Also Shows Effectiveness Against BA.4 and BA.5

On the 19th, Son Ji-young, CEO of Moderna Korea, is speaking at the Moderna Korea press conference held at JW Marriott Hotel Seoul in Seocho-gu, Seoul.
Photo by Lee Chun-hee

[Asia Economy Reporter Lee Chun-hee] Messenger ribonucleic acid (mRNA) vaccine developer Moderna's 'mRNA-1273.214' vaccine, developed to respond to the Omicron COVID-19 variant, is expected to be supplied domestically soon. Although global supply is anticipated by the end of next month, if domestic regulatory authorities grant approval quickly, domestic supply is likely to occur first.

Son Ji-young, CEO of Moderna Korea, stated at a press conference held on the morning of the 19th at JW Marriott Hotel Seoul in Seocho-gu, Seoul, "We have secured the quantity to supply immediately upon approval according to the schedule reviewed by the Ministry of Food and Drug Safety," adding, "Samsung Biologics has started production of the mRNA-1273.214 vaccine."

Moderna plans to soon apply for product approval of mRNA-1273.214 to the Ministry of Food and Drug Safety. Francesca Ceddia, Senior Vice President of Moderna Global Medical Affairs, said, "We are preparing the submission materials," and "We expect the application process to be completed within the next few days."

At the Moderna Korea press conference held on the 19th at JW Marriott Hotel Seoul in Seocho-gu, Seoul, Hee-Soo Kim, Vice President of Moderna Korea, Paul Burton, Chief Medical Officer (CMO) of Moderna Global, Ji-Young Son, CEO of Moderna Korea, and Francesca Ceddia, Senior Vice President of Moderna Global Medical Department (from left in the photo) are conducting a Q&A session. / Photo by Chunhee Lee

This schedule suggests that domestic supply could occur faster than the global supply date of "end of next month" announced by Vice President Ceddia on the same day. Ceddia stated, "We are collaborating with various global regulatory authorities, including Korea," and "While it depends on the approval dates of regulatory authorities, supply is planned by the end of August." However, since the quantity ready for immediate supply is already secured domestically, the schedule for supplying the Omicron-targeted variant vaccine in Korea depends on the Ministry of Food and Drug Safety's approval timeline.

However, regarding this secured quantity, Samsung Biologics' role is currently limited to the drug product (DP) manufacturing of Moderna vaccines, which it has been handling since last year. CEO Son explained, "The drug substance (DS) production part is not yet included in the contract." Nevertheless, she added, "Collaboration with Samsung Biologics is an important aspect," and "It is a long-term matter, and all possibilities remain open."

mRNA-1273.214 is a bivalent vaccine developed by combining 'Spikevax (mRNA-1273),' a vaccine targeting the original Wuhan strain of the COVID-19 virus, with 'mRNA-1273.529,' developed to target Omicron BA.1. Although developed to target BA.1, Moderna explains that it is also effective against the BA.4 and BA.5 variants currently dominant in Korea. According to results measuring neutralizing antibody responses one month after administering a 50μg dose of mRNA-1273.214 as a fourth dose to participants who had completed three doses of the vaccine, it showed 6.3 times the preventive effect against BA.4 and BA.5 compared to those who had received only three doses.