Novavax and Serum Institute of India announced that the World Health Organization (WHO) has granted Emergency Use Listing (EUL), for NVX-CoV2373, Novavax' recombinant nanoparticle protein-based Covid-19 vaccine with Matrix-M adjuvant, for active immunization of individuals 18 years of age and older for the prevention of coronavirus disease 2019 caused by SARS-CoV-2. Today's EUL pertains to vaccines manufactured and marketed by SII as Covovax, a novel recombinant, adjuvanted SARS-CoV-2 rS Vaccine, in India and licensed territories. An additional EUL filing is under review by the WHO for the vaccine to be marketed by Novavax under the brand name Nuvaxovid. 

The EUL prequalifies Novavax' Covid-19 vaccine as meeting the established WHO standards for quality, safety and efficacy. EUL is a prerequisite for exports to numerous countries, including those participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.

"Today's decision from the World Health Organization is vital to ensuring global access to a protein-based COVID-19 vaccine for hundreds of millions of people around the world," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank the World Health Organization for its thorough assessment. We believe this vaccine will help overcome barriers to vaccine access in many regions of the world by leveraging the traditional refrigeration used in existing vaccine supply channels, while also offering an option based on a familiar and well-understood technology."

"The EUL by the World Health Organization is a great encouragement towards making Covid-19 vaccines more accessible. Our partnership with Novavax has been successful in providing global public health leadership and ensuring that all countries have broad access to a viable vaccine," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "Covovax is the first protein-based Covid-19 vaccine option, with demonstrated efficacy and a well-tolerated safety profile, to be made available through the COVAX Facility. We thank the WHO and seek to help the world control the spread of the pandemic."

Novavax and SII recently received emergency use authorization (EUA) for Covovax in Indonesia and the Philippines.

The vaccine is also currently under review by multiple regulatory agencies worldwide. The company expects to submit its complete chemistry, manufacturing and controls (CMC) data package to the U.S. FDA by the end of the year.