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Novavax Announces Extended Durability of Protection Against Infection and Disease in United Kingdom COVID-19 Vaccine Phase 3 Clinical Trial

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Novavax Announces Extended Durability of Protection Against Infection and Disease in United Kingdom COVID-19 Vaccine Phase 3 Clinical Trial | Pharmtech Focus

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today shared extended analysis from its pivotal Phase 3 clinical trial conducted in the United Kingdom (UK), showing that a high level of efficacy for its protein-based COVID-19 vaccine, NVX-CoV2373, was maintained over a 6-month period of surveillance. Additionally, the analysis showed vaccine efficacy of 82.5% (95% CI: 75.0, 87.7) in protection against all COVID-19 infection – both symptomatic and asymptomatic – as measured by PCR+ or anti-N seroconversion.

“These data have two implications for NVX-CoV2373. Importantly, the vaccine offers protection against symptomatic and asymptomatic COVID-19 infection which may both interrupt virus transmission and prevent COVID-19 disease,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “Additionally, we are encouraged to see that our COVID-19 vaccine maintains a high level of durable efficacy and continues to exhibit a reassuring safety profile in this extended timeframe.”

The data build upon the final analysis of the UK Phase 3 trial, published in the New England Journal of Medicine in June 2021, which was used as part of Novavax’ regulatory submissions for NVX-CoV2373 around the world and demonstrated a vaccine efficacy of 89.7% (95% CI: 80.2, 94.6), with cases collected over three months (median of 55 days of surveillance).

In the expanded data collection window, vaccine efficacy was evaluated over a 6-month period from November 10, 2020, through May 10, 2021 (median of 101 days of surveillance). NVX-CoV2373 continued to show a reassuring safety profile during this window, with adverse events that were balanced between vaccine and placebo groups. Additionally, the trial demonstrated continued protection with an overall vaccine efficacy of 82.7% (95% CI: 73.3, 88.8). Vaccine efficacy against severe disease was 100% (95% CI: 17.9, 100) during the 6-month efficacy collection window, in line with the initial analysis.

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