NEWS: Novavax Announces #COVID19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination ir.novavax.com/2021-08-05-Nov…
Following the primary vaccination series (21 days apart), a single booster dose at 6 months of NVX-CoV2373 induced a robust increase in anti-Spike antibody levels - up ~4.6-fold vs the response seen after the primary series.
The increased antibody response was consistent for both younger and older adults.
Our #clinicaltrials in the UK and US/Mexico (PREVENT-19) showed high levels of vaccine efficacy. After a 3rd booster dose, antibody responses were ~4x greater than observed in those Phase 3 studies.
We also report boosted microneutralization responses that were ~5x greater than those observed in Phase 3 studies.
A 3rd dose boost increased functional hACE2 inhibition responses against variants. Response vs Delta (B.1.617.2) variant was >6x higher than after the primary series, >10x for Beta (B.1.351) & >8x for Alpha (B.1.17)
This post-boost consistency suggests a maturation of the immune response.
A third dose was generally well tolerated. Local & systemic symptoms showed a favorable, consistent reactogenicity profile. 90% of symptoms rated as mild or moderate after the third dose.
Adverse events were balanced between vaccine and placebo groups, with low rates of severe and adverse events.
Further, immune responses were not significantly changed when both #COVID and #flu vaccines were given, suggesting they can be used together in an annual vaccination campaign.
Together, this new data support the use of our NVX-CoV2373 vaccine in a boosting campaign. See the full presentation and learn more: ir.novavax.com/image/Q2-2021-…
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TODAY: Don't miss the Novavax team at @vaccinenation's World Vaccine Congress 2024. #WVCDC
Our Chief Medical Officer, Dr. Bob Walker, will be featured in this morning's keynote panel, titled "The future of COVID-19 vaccinations. Should we be developing broadly protective antigens or combinational vaccines?" #WVCDC
Dr. Raburn Mallory, SVP of Clinical Development, will be giving a presentation titled "Safety and Immunogenicity of the Novavax XBB.1.5 SARS-CoV-2 Vaccine in Previously mRNA Vaccinated Participants" about new data and developments. #WVCDC
ICYMI: We recently announced results that expand our knowledge of NVX-CoV2373 and its ability to help protect from COVID19 over a longer period of time. Let's talk about what it means. Thread:
Our new data build on findings from our #UK Phase 3 #clinicaltrial (randomized, placebo-controlled, double-blind, with crossover), where we examined vaccine performance in 15K adults. Publication: nejm.org/doi/full/10.10…
There, we found an overall vaccine efficacy of 89.7%. A median of 55 days of surveillance was used for the final analysis. The Alpha (B.1.1.7) strain predominated during this time, with 86.3% efficacy vs Alpha.
Our new data build on findings from our #UK Phase 3 #clinicaltrial (randomized, placebo-controlled, double-blind, with crossover), where we examined vaccine performance in 15K adults. Publication: nejm.org/doi/full/10.10…
There, we found an overall vaccine efficacy of 89.7%. A median of 55 days of surveillance was used for the final analysis. The Alpha (B.1.1.7) strain predominated during this time, with 86.3% efficacy vs Alpha.
Now, we're sharing data from an extended efficacy collection window from the UK Ph3 study: the 6-month period of 10 Nov 2020 - 10 May 2021, with a median of 101 days of surveillance. Alpha continued to dominate.
Today we're thrilled to announce results of our PREVENT-19 Phase 3 pediatric expansion to adolescents (ages 12 through 17). Let's talk about the data and what they mean. Thread:
Today's results build on findings from the adult main study, investigating the safety & efficacy of NVX-CoV2373 in the United States and Mexico amidst an evolving #COVID19 pandemic: nejm.org/doi/full/10.10…#clinicaltrials
The pediatric expansion randomized adolescents age 12 through 17, in the U.S., in a 2:1 ratio to receive 2x 5μg doses of NVX-CoV2373, our investigational #vaccine candidate, or placebo, 21 days apart. Protocol: novavax.com/sites/default/…
We're thrilled to announce that PREVENT-19 (US/Mex Phase 3) results were submitted for publication. The manuscript is now available as a pre-print. Let's dive into what we found. Thread: medrxiv.org/content/10.110…
PREVENT-19 builds on observations from other/ongoing #clinicaltrials, investigating the safety & efficacy of NVX-CoV2373 in the United States and Mexico amidst an evolving #COVID19 pandemic. ir.novavax.com/2021-08-05-Nov…
The trial randomized adults age 18+ in a 2:1 ratio to receive 2x 5μg doses of NVX-CoV2373, our investigational #vaccine candidate, or placebo, 21 days apart. novavax.com/sites/default/…
According to @CDC, “on average, about 8% of the U.S. population gets sick from #flu each season.” There is an urgent need for improved flu #vaccines, particularly for older adults (>age 65), who bear higher disease burden. cdc.gov/flu/about/keyf…
Coverage of existing flu vaccines is >60% in the US, but recent flu seasons have shown vaccine effectiveness may be just 10-13% for one virus strain (A/H3N2) in older adults. ncbi.nlm.nih.gov/pmc/articles/P…