Novavax files its COVID jab to WHO for emergency use listing

Novavax and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing for their COVID-19 vaccine, based on a conventional recombinant protein technology.

Getting a WHO emergency use listing (EUL) is a requirement for approvals by many national regulatory authorities, as well as for participation in the COVAX mechanism, which has been set up to procure COVID-19 vaccines for lower-income countries.

Novavax and Serum Institute have committed to provide more than 1.1 billion doses of the vaccine – codenamed NVX-CoV2373 – to COVAX, with 350 million doses coming from Novavax and 750 million from its Indian partner. The vaccine has also been submitted for approval in India, Indonesia and the Philippines.

One key advantage is that it can be stored at regular refrigeration temperatures, making it particularly well suited to distribution in countries with less sophisticated distribution systems.

The two companies have said they expect to be producing doses at a rate of 100 million a month very soon, and 150 million per month by year-end.

The Novavax shot is based on a full length recombinant spike protein in a nanoparticle adjuvant, and achieved an impressive 90% protective efficacy overall in phase 3 trials carried out in the US and Mexico, with 100% efficacy against moderate to severe COVID-19 disease.

The company is already running studies of NVX-CoV2373 as a booster shot, giving a third dose to people who received the shot in its phase 2 programme, and has said it generated antibody levels that were four- to six-times higher than were found to be protective in its other trials.

While the vaccine was developed based on the spike protein of the original Wuhan strain of SARS-CoV-2, cross protection also seems to be high against variants of concern, including the alpha, beta and delta strains, according to Novavax.

The company's head of R&D – Greg Glenn – told the HC Wainwright annual global investment conference earlier this month that he expects an annual booster will be necessary to maintain high-level, sustained antibody protection.

"Today's submission of our protein-based COVID-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world," said Novavax chief executive Stanley Erck.

"It represents another major milestone in Novavax' transformation into a commercial global vaccine company and reinforces the value of global collaboration and need for multiple approaches to help control the pandemic."