Novavax on track to deliver Operation Warp Speed promise

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Novavax is on track to deliver 100 million doses of COVID-19 vaccine NVX-CoV2373 to the U.S. by year-end, according to remarks made Tuesday by President of R&D Gregory Glenn.

Novavax Inc. (NASDAQ:NVAX) committed to the doses via its deal with Operation Warp Speed, which itself has committed to delivering 300 million doses of COVID-19 vaccines by year-end (see “Novavax Contract from Operation Warp Speed”; “Operation Warp Speeds Takes First Step”).

The company has a $1.6 billion contract from the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD) to develop the full-length recombinant spike protein nanoparticle vaccine. The deal was Operation Warp Speed’s second publicly disclosed and largest commitment to a vaccine developer. It also has received $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

Speaking at the Second International Society for Vaccines COVID-19 Vaccines Virtual Congress, Glenn said that the company’s Phase I trial of NVX-CoV2373 had completed and that the company expects to report neutralizing antibody titers and T cell responses by the end of the month. That would make Novavax the sixth vaccine front-runner to report those measures (see “Timelines for AZ/Oxford Vaccine”).

Novavax’s trial, which tested 5 µg or 25 µg doses, enrolled 131 participants age 18-59 and divided them into five groups. Two of the groups received two doses of the antigen plus two 50 µg doses of Matrix-M adjuvant, one group received two doses of the antigen without the adjuvant, and one group received a single dose of antigen only. The fifth group received placebo.

Glenn said he expects the vaccine to be effective at the lower 5 µg dose, which would facilitate scale-up of manufacturing in its many facilities across the globe, including a Czech facility acquired in May (see “Manufacturing Land Grab”).

Glenn did not say whether the 5 µg dose must prove effective for the company to reach 100 million doses by year-end.

Novavax plans to start a Phase III trial of the vaccine in October.

Also at the virtual meeting, partners Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) reiterated that a Phase IIb/III safety and efficacy study of BNT162b1 may begin as early as this month, with the potential for an Emergency Use Authoriziation (EUA) in 4Q20 (see “U.K. Secures Access”).

Johnson & Johnson (NYSE:JNJ) said Phase I/IIa results of Ad26 SARS-CoV-2 are anticipated in September and a Phase III study may start the same month, with the potential for an EUA in January 2021.

Novavax gained $2.46 to $140.69 Tuesday.

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