CEPI’s biggest-ever award positions Novavax to scale up COVID-19 vaccine program

Novavax’s platform could offer a speedier alternative to traditional vaccine manufacturing

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With an eye on a global supply, Novavax is setting itself up to produce more than 1 billion doses of its COVID-19 vaccine in 2021 as well as complete Phase II testing with a new infusion of up to $384 million from CEPI.

The funding -- the largest Coalition for Epidemic Preparedness Innovations has awarded to date -- brings the total Novavax Inc. (NASDAQ:NVAX) has received from CEPI to $388 million.

CEPI has granted a total of $446 million across nine COVID-19 vaccine programs so far.

Novavax plans to scale up production of its Matrix-M adjuvant and vaccine antigen in multiple countries and manufacture 100 million doses of NVX-CoV2373, which will incorporate Matrix-M, by year-end.

NVX-CoV2373 is a stable, prefusion protein that induces anti-SARS-CoV-2 spike antibodies and is made with the company’s recombinant protein nanoparticle technology.

Novavax’s approach of using an insect cell baculovirus system to make protein vaccines could offer a speedier alternative to traditional influenza vaccine manufacturing, which requires a four-to-six month lead time to grow a virus in chicken eggs.

In March, the company reported pivotal data for NanoFlu, its flu vaccine, that provided validation for the platform (see “Novavax’s Flu Data Showcase Vaccine Platform’s Potential”).

It will use the new funding to complete Phase II testing of NVX-CoV2373. It expects to start the Phase I portion of a Phase I/II trial this month in Australia, with top-line data due in July. The Phase II portion will be run in multiple countries.

The partners plan to make the vaccine globally accessible as part of the Access to COVID-19 Tools (ACT) Accelerator, which launched in April. In addition to CEPI, ACT organizers include the Bill & Melinda Gates Foundation; Gavi, the Vaccine Alliance; Wellcome Trust; the WHO; and other international organizations (see “World Leaders Commit to Collaborate”).

Several COVID-19 vaccine developers are taking early steps to ramp up production, and Novavax, which is partnered with Emergent BioSolutions Inc. (NYSE:EBS) for manufacturing, is no exception (see “End of the Beginning”).

Others include Moderna Inc. (NASDAQ:MRNA), which secured mass manufacturing capacity for mRNA-1273 on May 1 through a deal with Lonza Group Ltd. (SIX:LONN) that will enable the company to produce 100 million 50 μg doses per year, and University of Oxford and Vaccitech Ltd., which have struck multiple manufacturing deals for their ChAdOx1 nCoV-19 vaccine (see “Lonza to Manufacture COVID-19 Vaccine”; “Oxford Adds to Surge of Pandemic Deals”).

Novavax closed up $5.77 (31%) to $24.50 Monday and gained an additional $9.90 (40%) in after-hours trading.

Prior to market close on Monday, a headline appeared on CEPI’s website revealing the extended partnership with Novavax. CEPI and the company formally announced the news after the close of the regular trading session.

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