Infectious Disease

The final analysis shows that the Novavax COVID-19 vaccine provides 100% protection against serious illness

March 12, 2021

2 min read

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A final analysis found that Novavax’s COVID-19 vaccine was 96.4% effective against mild, moderate or severe diseases caused by wild SARS-CoV-2 in a Phase 3 study in the UK.

The company also announced the results of a final analysis of its Phase 2b study in South Africa, in which the vaccine, called NVX-CoV2373, was found to be effective in HIV-negative subjects in an area that caused the highest number of cases 55.4% had the B.1.351 variant of SARS-CoV-2, which raises concerns about its ability to bypass vaccines.

In both studies, the vaccine was 100% protected against serious illness, including hospitalization and death.

Originally, data from a preliminary analysis of the studies was published in January.

“We are very encouraged by the data showing that NVX-CoV2373 not only provides complete protection against the most severe forms of disease, but also dramatically reduces mild and moderate disease in both studies,” said Novavax President and CEO Stanley C. Erck said in a statement. “It is important that both studies confirmed the effectiveness against the variant strains.”

The UK phase 3 study enrolled more than 15,000 participants between the ages of 18 and 84, including 27% over 65 years of age. There were 106 cases among study participants – 10 in the vaccine group and 96 in the placebo group.

The effectiveness against the wild-type strain was 96.4% (95% CI, 73.8-99.5). Compared to variant B.1.1.7 it was 86.3% (95% CI, 71.3-93.5). The vaccine showed an overall effectiveness of 89.7% (95% CI, 80.2-94.6). The effectiveness was 83.4% (95% CI, 73.6-89.5) 14 days after the first dose.

The Phase 2b study was a randomized, observer-blind, placebo-controlled study among 2,665 healthy adults and 240 medically stable HIV-positive adults in South Africa. The overall effectiveness was calculated to be 48.6% (95% CI, 28.4-63.1) against predominantly variant strains, with 147 confirmed cases among the participants – 51 in the vaccine group and 96 in the placebo. Among HIV-negative participants, the effectiveness was 55.4% (95% CI, 35.9-68.9).

According to a full analysis of the data, the researchers reported that the vaccine-induced protection began 14 days after the initial dose (42.7%; 95% CI, 25-56.3) and increased efficacy 7 days after the second dose of the Vaccine occurred.

Recently Executive Vice President of Novavax John Trizzino told Congress that the company was ready to ship 100 million doses of the vaccine to the US by the end of June, pending approval.

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Amesh A. Adalja, MD

Amesh A. Adalja

The Novavax data is very positive and, like other vaccines, shows that they are very effective and especially where it matters – serious illness, hospitalization and death. The effectiveness against the problematic South African variant is still close to 50%, which I also find remarkable. It is to be hoped that this data will lead to regulatory approval and the inclusion of this vaccine in our armory.

Amesh A. Adalja, MD

Senior Scholar

Johns Hopkins Center for Health Safety

Disclosure: Adalja does not report any relevant financial information.

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