Novavax "Phase 3 Clinical Trial COVID-19 Vaccine Efficacy 96.4%" (Summary)

Phase 3 Clinical Trial Results Announced... 100% Prevention Effect for Severe Cases
86% and 55% Effectiveness Against UK and South Africa Variants, Respectively

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kim Suhwan] The COVID-19 vaccine developed by the U.S. pharmaceutical company Novavax has been found to have a preventive efficacy of 96.4%.

Novavax announced this on the 11th (local time) when releasing the results of its Phase 3 clinical trial conducted in the United Kingdom. The vaccine showed 100% efficacy in preventing severe cases. A Novavax official stated, "The vaccine's preventive efficacy is remarkably high, which is very encouraging," and added, "We expect this to bring us one step closer to ending the COVID-19 pandemic."

Novavax's clinical trials were conducted in the UK and South Africa, where variant viruses are widespread. Currently, Phase 3 trials in the UK and Phase 2 trials in South Africa have been completed.

According to Novavax, the Phase 3 clinical trial results in the UK showed an 86% preventive efficacy against the UK variant. Adults aged 18 to 84 participated in the clinical trial, with those aged 65 and older accounting for 27% of all participants. Among participants aged 65 and older, 10 COVID-19 cases occurred, 9 of which were in the placebo group. Additionally, 5 severe cases emerged during the trial, all of which were also from the placebo group.

In the Phase 2 clinical trial conducted in South Africa, the preventive efficacy against the South African variant was found to be 55.4%. Novavax previously stated in a mid-January interim report that even in cases where antibodies were formed after COVID-19 infection, the preventive efficacy against the South African variant was expected to be limited.

Furthermore, the trial confirmed that the vaccine's preventive efficacy began to appear from the 14th day after the first dose, and increased from the 7th day after the second dose, according to Novavax.

Meanwhile, these clinical results are similar to the interim report released in January. At that time, Novavax announced that its vaccine showed preventive efficacies of 96% against COVID-19 and 86% against the UK variant.

Based on the Phase 3 results in the UK, Novavax plans to apply for approval in various countries, including the United States. Regarding the application to the U.S. Food and Drug Administration (FDA), major foreign media reported, "Since the U.S. may require completion of domestic clinical trials, it is uncertain when Novavax will apply to the FDA."

This content was produced with the assistance of AI translation services.