Health: Novavax, after delays, files for US authorisation of Covid-19 vaccine – Gulf Digital News

Health: Novavax, after delays, files for US authorisation of Covid-19 vaccine – Gulf Digital News

Novavax Inc said on Monday it has filed for emergency use authorization of its Covid-19 vaccine for US adults, a long-awaited step for the company following months of struggles with development and manufacturing problems.

The filing is based on data provided to the U.S. Food and Drug Administration last month and results of two late-stage trials in the United States, Mexico and the UK that showed the protein-based vaccine had an overall efficacy of about 90%, the company said.

"We believe our vaccine offers a differentiated option... that can be an alternative to the portfolio of available vaccines to help fight the Covid-19 pandemic,” said Novavax Chief Executive Officer Stanley Erck in a statement.

Novavax's vaccine uses a different technology than the mRNA vaccines from Pfizer/BioNTech and Moderna or the Johnson and Johnson shot.

Novavax has had to delay its US submission multiple times due to development and manufacturing setbacks. A report earlier this year said the methods Novavax used to test the efficacy of its vaccine had fallen short of regulators' standards.

Data released in June from a late-stage U.S. trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta.

Early data published in late December