SEOUL, Jan. 12 (BNA): South Korea’s Drug Safety Agency on Wednesday authorized the use of a COVID-19 vaccine for the US-based biotech company.
The protein-based vaccine, Nuvaxovid, is the fifth COVID-19 vaccine to gain approval for use here, after one by British-Swedish pharmaceutical giant AstraZeneca and Oxford University, Pfizer Inc. Johnson & Johnson and Moderna Inc.
The Ministry of Food and Drugs has formed a panel of experts from home and abroad to review the safety and effectiveness of the two-dose regimen after reviewing two sets of studies.
South Korea’s Yonhap News Agency reported that the approved vaccines will be distributed by SK Bioscience, a unit of South Korea’s SK Group, after being manufactured at its local factory.
The ministry said it will simplify the shipping process and the Novavax vaccine is expected to be used for vaccination early next month.
The ministry said that novaxovide will be used for the first and second doses, and there is a possibility to authorize the use of booster shots after further review.
The ministry said that the vaccine will be given to people aged 18 years or over, and a second injection will be given 21 days after the first.
The first study, conducted in Mexico and the United States, found a 90.4 percent decrease in the number of symptomatic COVID-19 cases.
The second study, conducted in Britain, showed a similar decrease in the number of cases of COVID-19 with symptoms, with the effectiveness of the vaccine reaching 89.7%.
The ministry said that the side effects observed in the studies were usually mild or moderate, and were cleared up within two days after the vaccination.
A total of five serious side effects have been reported globally, including one in Britain and four in the US, but most patients have fully recovered or are in recovery at the time the authorization was made.
The ministry said that the Novavax vaccine can be stored in the refrigerator at a temperature of between two and eight degrees Celsius for up to five months.
The ministry said that existing vaccine supply channels with traditional cold chain capabilities will be used to store products.
SK Bioscience has retained manufacturing capacity at its plant in Andong, about 270 kilometers south of Seoul, to produce Nuvaxovid until 2022.
The Seoul government and SK Bioscience have so far agreed to provide 40 million doses of Nuvaxovid in the country.
However, the ministry said it has not yet determined whether Nuvaxovid is effective against the newly emerging omicron variant.
Novavax said earlier that its data from its reinforcement and adolescence studies showed that novaxovid creates an 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 received clearances from regulators in the European Union, the World Health Organization, as well as several Asian countries. The company said it will also submit an application to the U.S. Food and Drug Administration.
HF