Samsung Biologics Initiates Production of Moderna’s COVID-19 Vaccine

Samsung Biologics has hit the play button on manufacturing Moderna’s COVID-19 vaccines. Production of the mRNA vaccines comes less than half a year after the Korean CDMO giant sealed a contract manufacturing deal with the US vaccine developer.

After completing test production of Moderna’s vaccine, production has commenced despite not receiving GMP approval from the country’s Ministry of Food and Drug Safety. However, the company said it has filed an application for certification in September. Meanwhile, Minister of Food and Drug Safety Kim Kang-lip has said: “We are expecting that the GMP will be approved for Samsung Biologics facilities within this month.”

It is clear South Korea is anxious to mass-produce mRNA vaccines at home. Before Samsung Biologics began production, the country had to import all its mRNA vaccines from overseas, which was subject to chronic vaccine shortages and shipment delays.

The Korea Times reported on Thursday that government sources revealed Moderna has given its nod to Samsung Biologics to produce its mRNA vaccines.

“Samsung Biologics will distribute 2.8 million doses of Moderna vaccines currently being stored at its domestic storage house once the Ministry of Food and Drug safety completes qualification tests,” one source said.

As of Thursday, 61.6% of the population in South Korea has been fully vaccinated.

AstraZeneca Vaccines Already Produced at Home

Another Korean biopharma, SK Bioscience, is producing AstraZeneca and Novavax vaccines at its Andong facility. The company secured the contract manufacturing agreement with AstraZeneca last July and went on to seal the deal with Novavax a month later. Both vaccines use non-infectious viral spike proteins to trigger the immune response.

SK Bioscience has even chipped in $132 million to expand its production capacities at Andong to make more vaccines. Notably, it will equip the plant with the ability to produce mRNA vaccines.

The Andong plant itself is already doing well. In May, the facility won EU-GMP certification, allowing SK Bioscience to ship its shots to EU member countries. The approval is a hurdle Samsung Biologics will have to overcome if it wants to distribute the vaccines it produces to Europe.

Finally, mentions of Pfizer’s mRNA vaccines (co-founded with BioNTech) have been noticeably absent. That’s because no Korean manufacturer has secured the contract from the drug developer to date. In May, Pfizer and Samsung Biologics had to shoot down a report which claimed the companies were collaborating to produce the US drugmaker’s vaccines in South Korea. In a one-line filing to the Korean Exchange, Samsung Biologics said the report was “not factual.”

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Joy Lin

Without knowledge, there is no imagination. Without imagination, knowledge is meaningless