Novavax's COVID-19 vaccine demonstrates 90% efficacy

Novavax (NSDQ:NVAX) announced today that its COVID-19 vaccine demonstrated 90.4% efficacy in protecting against COVID-19.

Gaithersburg, Md.–based Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine demonstrated 100% protection against moderate and severe disease, with 90.4% efficacy overall as it met the primary endpoint in the Prevent-19 pivotal Phase 3 trial.

According to a news release, the study enrolled 29,960 participants across 119 locations in the U.S. and Mexico to evaluate the efficacy, safety and immunogenicity of the NVX-CoV2373 vaccine. The primary endpoint was the first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline.

Preliminary safety data demonstrated that the vaccine was generally well-tolerated, with severe adverse events low in number and balanced between vaccine and placebo groups. No single adverse event term was reported by more than 1% of participants.

Further information from Prevent-19 is set to become available in the future. The company is conducting a placebo-controlled portion of the trial in 2,248 adolescents from 12 to less than 18.

“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” Novavax president & CEO Stanley C. Erck said in the release. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”

In the trial for NVX-CoV2373, 77 COVID-19 cases were observed, with 63 coming in the placebo group and 14 in the vaccine group. All cases in the vaccine group were defined as mild by protocol, with 10 moderate and four severe cases all observed in the placebo group.

Prevent-19 also met its key secondary endpoint, Novavax said, by demonstrating 100% efficacy against variants not considered to be “variants of concern (VoC)” or “variants of interest (VoI).” Of the sequenced cases, 35 (65%) were VoC, 9 (17%) were VoI, and 10 (19%) were other variants. Against VoC/VoI, the vaccine efficacy registered at 93.2%.

The vaccine proved successful within “high-risk” populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent COVID-19 exposure). Efficacy there was 91%, with 62 COVID-19 cases in the placebo group and 13 cases in the vaccine group.

Novavax said it plans to file for regulatory authorizations in the third quarter upon completing the final phases of process qualification and assay validation needed. Following authorization, the company said it remains on track to reach a manufacturing capacity of 100 million doses per month by the end of the third quarter, then 150 million doses per month by the end of the fourth quarter of 2021.

“PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile,” Novavax president of R&D Dr. Gregory M. Glenn said. “These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus. 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 U.S. government.”