Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies
- Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune responses against Omicron (B.1.1.529) and other variants
- Third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold ACE2 inhibition increase after booster dose
- Immune responses in adolescents were 2- to 4-fold higher than adults against broad array of variants of interest and variants of concern
- Development of Omicron-specific vaccine on track for initiation of GMP manufacturing in early January
- Company to host investor conference call today from 4:30 - 5:00 pm ET
GAITHERSBURG, Md., Dec. 22, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well as additional data from its ongoing Phase 2 boost study. New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.
Immune responses included the following:
- Anti-spike IgG titers after Dose 3 increased 5.4-fold (prototype) to 9.3-fold (Omicron) from peak responses seen after 2-dose primary vaccination.
- This represents a 61.1-fold (prototype) and a 73.5-fold (Omicron) increase from prior to the Dose 3 boost.
- ACE2-inhibition titers increased 6-fold (prototype) to 19.9-fold (Omicron) compared to peak responses following 2-dose primary series, representing a 54.4-fold (prototype), a 24.4-fold (Delta) and a 36.3-fold (Omicron) increase from prior to the booster.
- Wild-type neutralization responses were observed after 2 doses for prototype, Delta and Omicron. Significant increases were observed after boosting, with titers for Delta and Omicron comparable to levels associated with protection in U.S. and Mexico and U.K. Phase 3 studies.
- After 2 doses, Omicron wild-type neutralization was <4-fold lower than prototype, suggesting that both a booster dose as well as an Omicron-specific vaccine may be beneficial.
Further, data from the pediatric expansion of Novavax' PREVENT-19 Phase 3 trial in the U.S. and Mexico showed robust immune responses in adolescents, including increased IgG and receptor inhibition titers against a wide array of variants, including Omicron, following a 2-dose series. Responses in adolescents were 2- to 4-fold higher than adults against all evaluated variants.
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