US trial data shows Novavax’s COVID-19 vaccine is 90% effective

New data from a trial conducted in the US and Mexico has showed that Novavax’s COVID-19 vaccine NVX-CoV2373 is 90% effective at preventing COVID-19.

The phase 3 PREVENT-19 trial enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373.

Overall, 63 COVID-18 cases were reported in the placebo group and 14 in the vaccine group, with all cases in the vaccinated group defined by trial protocol as mild. Meanwhile, ten moderate cases and four severe COVID-19 cases were observed in the placebo group.

As such, NVX-CoV2372 yielded a vaccine efficacy of 100% against moderate or severe COVID-19 infection.

In addition, the jab was found to provide protection against variants of concern (VoC) and variants of interest (VoI), with the B.1.17 variant – first discovered in the UK – becoming the predominant strain in the US during the accrual of the efficacy endpoints.

In a statement, Novavax said sequence data was available for 54 of the 77 COVID-19 cases observed in the trial.

The vaccine candidate was 93.2% effective against VoC/VoI, which represented 82% of the cases, hitting a key exploratory endpoint of the trial.

On top of that, NVX-CoV2372 was also successful at preventing COVID-19 in high-risk populations, defined as individuals aged over age 65, under age 65 with certain comorbidities or those who are frequently exposed to COVID-19.

The vaccine had an efficacy of 91% in these participants, with 62 COVID-19 cases in the placebo group and 13 in the vaccine group.

"PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile. [This] data show[s] consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus,” said Gregory M. Glenn, president of research and development, Novavax.

“Our vaccine will be a critical part of the solution to COVID-19 and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the US government,” he added.

Novavax is planning to file the vaccine for regulatory authorisations in Q3, with the company adding that it is on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter.

By the end of the fourth quarter of 2021, Novavax said it is also on track to manufacture 150 million doses per month.