Novavax Submits Final Round Of Data For COVID-19 Vaccine's EUA Application
BALTIMORE (WJZ) -- Novavax on Friday announced it has handed over the final round of data on its COVID-19 vaccine as it seeks emergency use authorization from the U.S. Food and Drug Administration.
The Maryland-based biotechnology company said it anticipates it will submit a request to the FDA for EUA in a month.
The company has developed a protein-based vaccine, which was engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19.
"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," Novavax president and CEO Stanley Erck said.
The two-dose vaccine regimen is intended to "enhance the immune response and stimulate high levels of neutralizing antibodies," the company said Friday.
According to Novavax, it already has manufacturing and distribution partnerships in place to produce the vaccine if it receives emergency use authorization.
