Novavax says that it has submitted the final round of data on its COVID-19 vaccine to the U.S. Food and Drug Administration (FDA) in anticipation of filing a request to the agency for emergency use authorization (EUA) in a month.
The final data is related to the vaccine’s manufacturing processes, and its submission is the final prerequisite for the EUA application.
The two-dose vaccine by Novavax, NVX-CoV2373, was engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes the disease COVID-19.
The vaccine is protein-based, which sets it apart from the COVID-19 vaccines currently available in the United States: the mRNA-based vaccines from Pfizer and Moderna and the non-replicating viral vector vaccine from Johnson & Johnson.
“NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies,” the Maryland-based biotechnology company said in a statement.
“NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.”
A phase 3 trial in the United States and Mexico with more than 25,000 participants “achieved [a 90.4 percent] efficacy overall,” according to Novavax.
The company stated that it has already established some partnerships to produce and distribute the vaccine should it receive the EUA.
The vaccine has received authorizations from EU regulators and the World Health Organization. It has also secured authorizations in India, Indonesia, and the Philippines, where it has partnered with the Serum Institute of India—one of the largest vaccine manufacturers in the world—to deliver its vaccines.
Novavax is also awaiting approval in Japan, where its vaccine would be manufactured and distributed by Takeda Pharmaceutical.
Reuters contributed to this report.