Nuvaxovid, Novavax’ recombinant, adjuvanted Covid-19 vaccine, is the first protein-based Covid-19 shot to get regulatory approval in South Korea
Novavax, together with SK bioscience, has secured the South Korea’s Ministry of Food and Drug Safety (MFDS) approval for Nuvaxovid, its recombinant, adjuvanted Covid-19 vaccine.
Last month, the company has extended its collaboration and licence agreements with SK bioscience, the vaccines business unit of SK Group.
Under the extended partnership, SK bioscience will reserve additional manufacturing capacity to produce key components of NVX-CoV2373.
Also, it has acquired non-exclusive rights to sell doses of Novavax’s vaccine to the governments of Vietnam and Thailand, and additional doses in Korean market.
SK bioscience has submitted the Biologics License Application (BLA) for Nuvaxovid, and the company is also expected to manufacture and commercialise the vaccine in the country.
The company has secured advance purchase agreement with the South Korean government for the supply of 40 million doses of Nuvaxovid.
Also known as NVX-CoV2373, it is the first protein-based Covid-19 vaccine to receive regulatory approval in South Korea, said the Novavax.
Novavax president and chief executive officer Stanley C Erck said: “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.
“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 has created NVX-CoV2373 based on genetic sequence of SARS-CoV-2, using its recombinant nanoparticle technology, and saponin-based Matrix-M adjuvant.
The vaccine has received conditional marketing authorisation (CMA) in the EU, and the World Health Organization (WHO) emergency use listing (EUL).
Through its partner Serum Institute of India, Novavax has secured the emergency use authorization (EUA) for the vaccine in India, Indonesia and the Philippines.
Nuvaxovid is currently being reviewed by various regulatory agencies worldwide, and the company expects to receive additional global authorisations in the first half of 2022.
Furthermore, Novavax intends to seek FDA EUA for the vaccine in the next 30 days, as per the FDA guidance applicable for submission of EUA vaccines.