Novavax's stock pops after WHO grants its COVID-19 vaccine emergency-use listing

By Ciara Linnane

Move means all 194 WHO member nations can now offer Novavax's protein-based vaccine

Novavax Inc.'s stock rose 2% early Tuesday, after the company said its protein-based COVID-19 vaccine has been granted emergency-use listing by the World Health Organization.

The move means that all 194 of the agency's member states can use the Novavax vaccine to protect against COVID in individuals 12 and older. The vaccine is already allowed in the U.S. under a similar emergency-use authorization.

"Rural or hard-to-reach areas can benefit from our vaccine's ease of transport and storage profile," Novavax Chief Executive John C. Jacobs said in a statement. "As part of a diversified vaccine portfolio, our vaccine can play an important role in helping to protect people around the globe against the latest variants."

The vaccine can be stored at temperatures between 35.6 and 46.4 degrees Fahrenheit (2 and 8 degrees Celsius) and has a 12-month shelf life. When it was first allowed, there were hopes its more conventional vaccine approach would help persuade skeptics of the mRNA-based vaccines developed by Pfizer Inc. (PFE) and German partner BioNTech SE (BNTX) and Moderna Inc. (MRNA) to get their shots.

The WHO decision was based on non-clinical data that shows the Novavax vaccine induced immune responses against the XBB.1.5, XBB.1.16 and XBB.2.3 variants.

XBB.1.5 and XBB.1.15 are currently designated as variants of interest, while XBB.2.3 is a variant under monitoring, which is a lesser WHO designation.

See also: Novavax shares rise as third-quarter results top expectations

The vaccine also produced neutralizing antibodies for subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6, the statement said.

"These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants," said the company.

Like other vaccine makers, Novavax is also working on combination shots with the hope that they'll improve uptake of the COVID vaccine. Novavax said it expects to launch a late-stage trial of its experimental COVID and flu combination shot next year, with the potential for accelerated approval and launch in 2026. The company made that statement when it reported quarterly earnings in early November.

Novavax's stock (NVAX) has fallen 47% in the year to date, while the S&P 500 has gained 18.5%.

-Ciara Linnane

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11-28-23 0801ET

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