South Korea Ministry of Food and Drug Safety approves Novavax COVID-19 vaccine
pharmafile | January 12, 2022 | News story | Research and Development |
Biotechnology company Novavax, alongside SK bioscience, a vaccine business subsidiary of Korea-based SK Group, announced that South Korea’s Ministry of Food and Drug Safety (MFDS), has approved a Biologics License Application (BLA) for Nuvaxovid COVID-19 vaccine. This vaccine is for the active immunisation of individuals 18 years of age and older, for the prevention of COVID-19 caused by SARS-CoV-2.
Nuvaxovid, Novavax’s COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea, and will be manufactured and marketed in the country by SK bioscience.
SK bioscience has an advance purchase agreement with the South Korean government, to supply 40 million doses of Novavax’s vaccine,.
“Novavax is proud to bring our COVID-19 vaccine to South Korea at a critical time in the pandemic as both the Delta and Omicron variants have taken hold,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “We thank our partners at SK bioscience for their commitment to this public health challenge and the MFDS for its thorough assessment of our data as we look forward to helping address major obstacles to controlling the pandemic through the additional option of our protein-based vaccine.”
Novavax’s vaccine also recently received conditional marketing authorisation (CMA) in the EU, and emergency use listing (EUL) from WHO under the brand name Nuvaxovid. The vaccine is currently under review by multiple regulatory agencies worldwide, and the company anticipated receipt of additional worldwide authorisations in the first half of 2022.
Lina Adams
