Gaithersburg-based Novavax, about two weeks away from formally applying for FDA approval for emergency use authorization for its COVID-19 vaccine in the US, has received approval to use the vaccine in South Korea.
Gaithersburg, Maryland-based Novavax, about two weeks away from formally filing Food and Drug Administration approval for emergency use approval for its COVID-19 vaccine in the U.S., has received approval to use the vaccine 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 provide 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 final requirement in the emergency authorization application process. It must wait a month after that submission to formally apply for an EUA, in accordance with the submission guidelines.
The FDA filing comes about six months after Novavax originally planned to file an application.
In December, Novavax received approval for its vaccine in India and in the European Union. The 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 in 2020 for the federal government to develop and manufacture a COVID vaccine, part of Operation Warp Speed.
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