Novavax Global Commercial Operations and COVID-19 Vaccine Update
Study met co-primary endpoints for homologous
booster indication
Pediatric expansion in adolescents 12-17 years of age
PREVENT-19
PRE-fusion Protein Subunit Vaccine Efficacy Novavax Trial | COVID-19
Neutralizing antibodies
Geometric Mean Titer (GMT)
(95% CI)
Geometric Mean Fold Ratio (GMFR)
(95% CI)
(3,658.0, 5,374.5)
14 Days after Primary Series
(N = 53)
4,434.0
28 Days after Booster Dose
(N = 53)
11,824.4
(8,993.1, 15,546.9)
2.7
(2.0, 3.5)
Seroconversion Rate (SCR) Relative to
100
100
Day 0
(95% CI)
(93.3, 100)
(93.3,100)
Difference in SCR
0
(95% CI)
(-6.8, 6.8)
Non-inferiority of booster dose vs. Day 35 response for GMFR demonstrated as LB of 95% CI >0.67 and point estimate >0.83,
superiority was demonstrated as LB of 95% CI for GMFR ratio is > 1
Non-inferiority of booster dose vs. Day 35 response for SCRs demonstrated as LB of 95% CI for difference of SCR is > -10%
novavax Validated Wild-Type neutralization assay performed at 360Bio Labs
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