Novavax gets its first emergency use nod

Nov. 1, 2021

Novavax and partner Serum Institute of India received emergency use authorization for their COVID-19 vaccine in Indonesia — making it the first authorization anywhere in the world for the Maryland-based vaccine-maker.

The National Agency of Drug and Food Control of the Republic of Indonesia has granted emergency use authorization (EUA) for Novavax's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. The Indonesia shot will be manufactured by Serum, the world's largest vaccine manufacturer, and sold under the Indian company's brand name, Covovax.

Novavax said it had also applied for emergency use for the vaccine in Canada and the European Medicines Agency. Back in September, the partners applied to the World Health Organization for an emergency use listing of the vaccine. Novavax has delayed filing for U.S. approval until the end of this year. Last month, a grim exclusive report from Politico said Novavax faced significant hurdles in proving it can manufacture its COVID-19 vaccine candidate to regulators’ quality standards — an issue that will delay production and result in a COVAX supply shortfall.

The Novavax shot was shown to be more than 90% effective — including against a variety of concerning variants in a large, late-stage U.S.-based clinical trial.