Moderna’s Covid-19 vaccines manufactured by Samsung Biologics have been released for the Korean market for the first time.

The Ministry of Food and Drug Safety said on Thursday it granted lot release approval for Moderna’s Covid-19 vaccine Spikevax Inj. produced by Samsung Biologics.

Moderna’s Covid-19 vaccine manufactured by Samsung Biologics is distributed in the Korean market.
Moderna’s Covid-19 vaccine manufactured by Samsung Biologics is distributed in the Korean market.

On Monday, Moderna Korea won the marketing approval for Spikevax Inj., a Covid-19 mRNA vaccine made by Samsung Biologics.

Lot release approval allows the MFDS to re-confirm a biological product’s test results and manufacturing data to recheck the quality. It is the last step to distribute a vaccine in the local market.

The MFDS authorized the import of Moderna Covid-19 Vaccine Inj. in June. Still, the regulator has granted lot release approval for the locally produced Moderna vaccine is the first time.

“Spikevax is the first mRNA Covid-19 vaccine consigned to be manufactured in Korea among authorized Covid-19 vaccines,” the MFDS said.

The permit for Spikevax Inj. is expected to boost local vaccine distribution and vaccine exports. Samsung Biologics-manufactured Moderna Covid-19 vaccine recently won emergency use authorization in the Philippines and Colombia.

“The MFDS’ approval allows Moderna’s mRNA vaccine, manufactured by Samsung Biologics, to be sold in Korea and shipped overseas,” Moderna Korea said.

An industry official said the Korean regulator’s authorization could be used as a reference for regulatory agencies in other countries, just as FDA approval is referenced. “The approval is expected to increase vaccine exports to low-income countries, if not the entire world,” he said.

Investors’ anticipation for a rise of Samsung Biologics shares is growing. The company’s stock price has continued to pick up since the approval of Spikevax Inj. on Monday.

Shares of Samsung Biologics rose from 872,000 won ($736.8) on Monday to 904,000 won on Wednesday.

At noon on Thursday, the stock price was up by 4.76 percent to mark 947,000 won.

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