Final analysis shows Novavax COVID-19 vaccine 100% protective against severe disease
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A final analysis showed that Novavax’s COVID-19 vaccine was 96.4% efficacious against mild, moderate or severe disease caused by wild SARS-CoV-2 in a phase 3 trial in the United Kingdom, the company said.
Additionally, the company announced the results of a final analysis of its phase 2b trial in South Africa, where the vaccine, called NVX-CoV2373, was 55.4% efficacious among HIV-negative trial participants in a region where a majority of cases were caused by the B.1.351 variant of SARS-CoV-2, which has raised concerns over its ability to evade vaccines.
In both trials, the vaccine was 100% protective against severe disease, including hospitalization and death, the company said.
It originally released data from a preliminary analysis of the trials in January.
“We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease but also dramatically reduced mild and moderate disease across both trials,” Novavax President and CEO Stanley C. Erck said in a statement. “Importantly, both studies confirmed efficacy against the variant strains.”
The U.K. phase 3 trial enrolled more than 15,000 participants aged between 18 and 84 years, including 27% who were older than age 65 years. There were 106 cases among trial participants — 10 in the vaccine group and 96 in the placebo group.
Efficacy against the wild-type strain was 96.4% (95% CI, 73.8-99.5). It was 86.3% (95% CI, 71.3-93.5) against the B.1.1.7 variant. The vaccine demonstrated an overall efficacy of 89.7% (95% CI, 80.2-94.6). Efficacy was 83.4% (95% CI, 73.6-89.5) 14 days after the first dose.
The phase 2b trial was a randomized, observer-blind, placebo-controlled trial among 2,665 healthy adults and 240 medically stable HIV-positive adults in South Africa. The overall efficacy was calculated as 48.6% (95% CI, 28.4-63.1) against predominately variant strains, with 147 confirmed cases among participants — 51 in the vaccine group and 96 in the placebo. Among HIV-negative participants, the efficacy was 55.4% (95% CI, 35.9-68.9).
According to a complete analysis of the data, researchers reported that vaccine-induced protection began 14 days after the initial dose (42.7%; 95% CI, 25-56.3), and increased efficacy occurred 7 days after the second dose of the vaccine.
Recently, Novavax Executive Vice President John Trizzino told Congress that the company was prepared to deliver 100 million doses of the vaccine to the United States by the end of June, pending authorization.
Perspective
Back to TopAmesh A. Adalja, MD
The Novavax data are very positive and, like other vaccines, show it to be highly efficacious and especially where it counts — severe disease, hospitalization and death. The efficacy against the troublesome South African variant is still close to 50%, which I think is remarkable, as well. It is hoped that these data will lead to regulatory agency approval and the addition of this vaccine to our armamentarium.
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