Gaithersburg, Maryland-based Novavax, still about two weeks away from formally filing for Food and Drug Administration approval for emergency use authorization for its COVID-19 vaccine in the U.S., has received approval for the vaccine’s use in South Korea.
The South Korean Ministry of Food and Drug Safety has approved the Novavax vaccine for use in individuals 18 years of age and older.
The Novavax vaccine will be manufactured and marketed by South Korea-based SK Group, a subsidiary of Novavax partner SK Bioscience. SK Group has an agreement to supply the South Korean government with an initial 40 million doses of the Novavax vaccine.
Earlier this month, Novavax completed submission of the final data package for FDA approval of its vaccine, the last prerequisite in the emergency use authorization application process. It must wait one month after that submission to formally apply for EUA, in accordance with submission guidance.
The FDA application will come about six months after Novavax had originally intended to file.
In December, Novavax received authorization for its vaccine in India, as well as the European Union. Its two-dose vaccine is already being distributed in Indonesia and the Philippines. Authorization is pending in other countries, including Japan.
Novavax received $1.6 billion for the federal government in 2020 to develop and manufacture a COVID vaccine, part of Operation Warp Speed.
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