Moderna Inc.’s COVID-19 vaccine first produced by Samsung Biologics Co. under a contract manufacturing organization (CMO) service will be available to South Koreans from this week.
Some 2.43 million doses of the US company’s messenger ribonucleic acid (mRNA)-based vaccine, fill-finished to vials, labeled and packaged at Samsung’s domestic plant, have been approved for use in Korea, the health authorities said on Tuesday.
The authorities said the Moderna vaccine will be administered for first and second shots as well as for booster shots for high-risk groups in the fourth quarter.
The approval marks the second time that COVID-19 vaccines manufactured in the country under CMO deals have been used for inoculating Koreans.
SK Bioscience Co. has also been approved to administer a COVID vaccine made by British-Swedish pharmaceutical giant AstraZeneca for Koreans.
The Korean government currently holds 6.88 million doses of Moderna vaccines, 8.13 million doses from Pfizer, 2.12 million doses from AstraZeneca and 195,000 doses from Janssen.
As of Tuesday, a total of 40.84 million people, or 79.5% of the country's 52 million population, have received their first shots of COVID-19 vaccines. The number of people with second shots reached 36.42 million, or 70.9%.
Moderna's COVID vaccine PART OF KOREA-US VACCINE PARTNERSHIP
In May, Samsung Biologics signed a drug product (DP) manufacturing deal with Moderna, a contract that involves putting vaccines into vials or syringes, sealing and packaging for shipping, but not making the drug substance (DS) of the vaccine.
There are only a few drugmakers including Switzerland’s Lonza Group with capabilities of the DS of mRNA vaccines.
Moderna’s drug substance is solely manufactured by Lonza, whereas it has many other DP suppliers across the world, including Catalent of the US, ROVI of Spain and Recipharm of Sweden.
Samsung’s contract with Moderna was signed during a South Korea-US vaccine partnership event held in Washington in May, with the attendance of Korean President Moon Jae-in.
To supply the Moderna vaccine in Korea, Samsung Biologics has obtained the Good Manufacturing Practices (GMP) certificate and product approval from the Ministry of Food and Drug Safety.
The contract drugmaker is currently installing substance production facilities at its third plant in Songdo, Incheon.
DS production is considered to be the most important and profitable part of the mass-scale vaccine production process.
Samsung Biologics’ headquarters and factories in Songdo, Incheon The company aims to get the GMP approval for the substance production by the first half of next year and start mass production afterward.
Other Korean biopharmaceutical companies such as Celltrion Inc., Eyegene Inc., Quratis Co. and ST Pharm Co. are also working on mRNA vaccines in line with the government’s plan to produce about 100 million doses of such vaccines from 2023.
The global mRNA vaccine and medicine market is expected to grow to $15.4 billion by 2026 from $9.4 billion this year, according to the bio industry.
The mRNA vaccine, employed by Pfizer and Moderna, is a type that uses a copy of a natural chemical called messenger RNA to produce an immune response.
Messenger RNA has been used to treat hepatosis and rare diseases, but given its relatively short period of time for development, the RNA molecule is now used not just for vaccines but for the treatment of cancer and other illnesses.
Write to Jae-young Han at jyhan@hankyung.com In-Soo Nam edited this article.
