(LEAD) S. Korea approves Novavax COVID-19 vaccine

(ATTN: UPDATES with more info throughout)
By Kim Han-joo

SEOUL, Jan. 12 (Yonhap) -- South Korea's drug safety agency on Wednesday authorized the use of U.S.-based biotechnology company Novavax Inc.'s COVID-19 vaccine.

The protein-based vaccine, Nuvaxovid, marks the fifth COVID-19 vaccine to get approval for use here, following the ones by British-Swedish pharmaceutical giant AstraZeneca and Oxford University, Pfizer Inc., Johnson & Johnson and Moderna Inc.

The Ministry of Food and Drug Safety convened a panel of experts from both inside and outside to review the safety and efficacy of the two-dose regimen, after reviewing two sets of studies.

The approved vaccines will be distributed by SK Bioscience Co., a unit of South Korea's SK Group, after being manufactured at its local plant.

The ministry said it will streamline the shipment process and the Novavax vaccine is expected to be used for inoculation as early as next month.

Nuvaxovid will be used for first and second shots, and there is the possibility of authorizing the use for booster shots following further review, the ministry said.

The vaccine will be administered to people aged 18 or older, and a second injection will be administered 21 days after the first, the ministry said.

The first study, conducted in Mexico and the United States, found a 90.4-percent reduction in the number of symptomatic COVID-19 cases.

The second study, conducted in Britain, also showed a similar reduction in the number of symptomatic COVID-19 cases, with a vaccine efficacy of 89.7 percent.

The side effects observed in the studies were usually mild or moderate, and cleared within a couple of days after the inoculation, the ministry said.

A total of five serious side effects were reported globally, including one in Britain and four in the U.S., but most of the patients had fully recovered or were in the process of recovery at the time of authorization submission.

The ministry said the Novavax vaccine can be stored at a refrigerator temperature of between two and eight Celsius for up to five months.

Existing vaccine supply channels with more traditional cold chain capabilities will be used to store the products, the ministry said.

SK Bioscience has reserved manufacturing capacity at its plant in Andong, about 270 kilometers south of Seoul, for the production of Nuvaxovid through 2022.

The Seoul government and SK Bioscience have so far agreed to provide 40 million doses of Nuvaxovid in the country.

The ministry, however, said it has yet to determine whether Nuvaxovid is effective against the newly emerging omicron variant.

Novavax earlier said its data from its booster and adolescent studies showed Nuvaxovid creating immune response to omicron.

Nuvaxovid is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19.

The vaccine has so far gotten authorizations from European Union regulators, the World Health Organization, as well as several Asian countries. The company has said it will also submit a request to the U.S. Food and Drug Administration.

khj@yna.co.kr
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