SII, Novavax get WHO EUL for Covovax

Gaithersburg: Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, have 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.

The EUL pertains to vaccine 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 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.

"The 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." "It is very welcome news that the world now has a new weapon in its arsenal of tools to fight COVID-19," said Dr Richard Hatchett, Chief Executive Officer, Coalition for Epidemic Preparedness Innovations (CEPI).

"CEPI's investments to accelerate the clinical development and manufacturing of Novavax' vaccine have been critical to enabling equitable access to the vaccine through COVAX." "We welcome the news that the COVOVAX vaccine has received WHO Emergency Use Listing, providing the world – and COVAX participants – with another promising class of vaccine as well as yet another tool in the battle against COVID-19," said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. "With data on safety and efficacy against several variants, strong potential in mix and match and booster regimens, and standard storage temperatures, this vaccine will provide countries with another critical option in the quest to help protect their populations."

The grant of EUL was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants in the U.S. and Mexico, the results of which were published December 15, 2021 in the New England Journal of Medicine (NEJM); and a trial that evaluated the vaccine in more than 14,000 participants in the U.K., the results of which were published June 30, 2021 in NEJM.

In both trials, NVX-CoV2373 demonstrated high efficacy and a reassuring safety and tolerability profile.

"Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed," the release siad.

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.

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