Novavax submits COVID vax for WHO emergency use listing

Sept. 24, 2021

Novavax and partner Serum Institute of India have applied to the World Health Organization for an emergency use listing of Novavax's COVID-19 vaccine.

A WHO listing would allow Maryland-based Novavax to ship vaccines to developing nations that rely on WHO guidance for their regulatory decisions, as well as enable Novavax to begin distributing shots through the COVAX facility.

Novavax’s shot has the potential to be the first protein subunit COVID-19 vaccine to win WHO approval. The technology trains the immune system to fight COVID-19 through a protein that contains part of the disease pathogen. Importantly, the Novavax vaccine, unlike mRNA vaccines, can be kept at normal refrigerated temperatures.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall.

Novavax and India's Serum Institute — the world's largest vaccine producer — have jointly committed to providing more than 1.1 billion doses to the COVAX facility.

Read the press release