Long-awaited Novavax's COVID-19 Vaccine Results Hit 90% Efficacy In Pivotal US Trial, 100% Efficacy Against Moderate, Severe Infection

Novavax Inc NVAX has finally completed its U.S. Phase 3 trial for its protein-based COVID-19 vaccine candidate.
Overall efficacy in the study hit 90.3% across nearly 30,000 patients in the U.S. and Mexico, with a total of 77 cases observed.
In the placebo arm, researchers saw 63 cases of COVID-19 compared to 14 in the vaccine group.
Novavax reiterated its plans to file for emergency use with the FDA in the third quarter.
The company added the vaccine was 100% effective against moderate and severe disease based on ten moderate cases and four severe cases, all in the placebo group.
In addition to the topline data, Novavax also said the study hit 93.2% efficacy against variants of concern or interest.
The company had sequencing data available for 54 of the 77 cases, with 44 of those turning out to be such variants.
Among these participants, 38 cases were seen in the placebo arm compared to six in the vaccine group.
The remaining ten sequenced cases were “other variants,” Novavax said.
Among high-risk individuals, it hit 91% efficacy. 62 cases among those older than 65 or younger than 65 but with comorbidities were reported, compared to 13 in the vaccine arm.
Today’s results come in similar to those data, which Novavax previously said had been 96% effective against the original SARS-CoV-2 virus and 86% effective against the Alpha variant first identified in the U.K.
Efficacy plunged to 50% in the Beta variant, which first emerged in South Africa.
The company also announced promising data on its COVID-19 vaccine candidate, NVX-CoV2373, directed against the Beta (B.1.351) variant.
Price Action: NVAX shares are up 7.78% at $226 during the premarket session on the last check Monday.

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