Gaithersburg, Maryland-based Novavax could file for Food and Drug Administration approval for its COVID-19 vaccine within weeks, after completing one of the final steps in the process.
Novavax said Friday it had completed submission of the final data package, including chemistry, manufacturing and the controls module to the FDA, the final prerequisite in the emergency use authorization application process.
Novavax now expects to submit a request for emergency use with the FDA in one month, in accordance with submission guidance for emergency use authorization vaccines.
“Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” said Novavax CEO Stanley Erck.
In late-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. It has authorizations pending in several other countries, including South Korea and Japan.
The Novavax vaccine differs from existing messenger RNA vaccines currently in use, and can be shipped and stored at much higher refrigeration temperatures, which could increase access in hard-to-reach areas.
Novavax received $1.6 billion from the federal government in 2020 to develop and manufacture its COVID vaccine, as part of Operation Warp Speed, the program intended to accelerate vaccine development.