WHO grants emergency use listing for Novavax’s COVID-19 vaccine

The fight against COVID-19 earned another contender last week with the granting of an emergency use listing from the World Health Organization (WHO) to NVX-CoV2373, a vaccine created by Novavax and the first protein-based COVID-19 vaccine to earn that listing.

Better known as COVOVAX, as manufactured and marketed by the Serum Institute of India Pvt. Ltd. (SII), the vaccine is a recombinant nanoparticle protein-based vaccine meant for use on those at least 18 years old. It’s a recombinant, built from the genetic sequence of the original strain of SARS-CoV-2, and SII has rights to it in India and other licensed territories. However, an additional EUL filing is being reviewed by WHO that would allow Novavax to market the vaccine as Nuvaxovid. That will not be completed until a European Medicines Agency (EMA) review renders its own findings, though.

Nevertheless, this leaves Novavax COVID-19 vaccine prequalified under WHO established standards for quality, safety and efficacy. That is a prerequisite for export to many countries.

“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,” Stanley Erck, president and CEO of Novavax, said. “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 vaccine is already authorized for emergency use in Indonesia and the Philippines.

Novavax noted that the vaccine can be stored at temperatures above freezing, allowing use of existing vaccine supply and cold chain channels. For users, it is given in two doses issued 21 days apart. Its authorization was based on preclinical, manufacturing and clinical trial data, which demonstrated high efficacy, as well as acceptable safety and tolerability profiles.

“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,” Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance, said. “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.”