South Korea Approves EUA for Moderna’s COVID-19 Vaccine Produced by Samsung Biologics

On October 26, South Korea’s health ministry granted emergency use approval (EUA) for Moderna’s Covid-19 vaccine produced by Samsung Biologics. 

The approval was timely as the South Korean pharma giant only obtained Good Manufacturing Practice (GMP) certification earlier this week.

Deal with Moderna this May

In May, US President Joe Biden and his South Korean counterpart Moon Jae-In agreed to partner on COVID-19 vaccines between two countries. 

Following the discussion, Moderna and Samsung Biologics signed on a contract production deal, under which the latter will provide fill-finish manufacturing for Moderna’s COVID-19 vaccine, mRNA-1273.

Production of the vaccines began in August, during which Samsung Biologics waited for its third plant in Songdo to secure enough volume for the manufacturing service. The plant is awaiting approval from US and EU regulators to ship vaccines outside the country, said the company.

According to Korea’s health ministry, the Moderna vaccines manufactured by Samsung Biologics will be released by the end of this year, to be administered as booster shots for high-risk populations.

South Korea’s Second CMO Deal with COVID-19 Vaccine Developers

Samsung Biologics is the second Korean pharma to produce COVID-19 vaccine via contract manufacturing with global COVID-19 vaccine developers.

In 2020 July, SK Bioscience inked a contract with AstraZeneca to manufacture the COVID-19 vaccine in Korea domestically. According to official statistics, 72% of the Korean population has been fully vaccinated, and about 78.8% has received the first COVID-19 vaccine shot.

Author

Kathy Huang

We are, and will remain, perpetual newbies. - Kevin Kelly