Novavax vaccine claims 90% efficacy against most Wuhan virus variants
15 Jun 2021
Novavax Inc today announced that NVX-CoV2373, its recombinant nanoparticle protein-based vaccine against the Wuhan virus (SARS-CoV-2), demonstrated 100 per cent protection against moderate and severe disease, and 90.4 per cent efficacy overall, as evidenced in its pivotal Phase 3 trial.
The announcement comes at the end of a study that enrolled 29,960 participants across 119 sites in the US and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.
"These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe Covid-19 infection," Novavax CEO and president Stanley C Erck said.
The company said it "intends to file for regulatory authorisations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements."
"Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021" it said.
"PREVENT-19 confirms that NVX-CoV2373 offers a reassuring tolerability and safety profile," said Gregory M Glenn, MD, president of research and development, Novavax.
"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 US government," Glenn said.
Novavax SARS-CoV vaccine, which is also made by Serum Institute of India, has been found to be 90 pr cent effective against the various Wuhan virus variants.
NVX-CoV2373 also showed success among "high-risk" populations (defined as over age 65, under age 65 with certain comorbidities or having life circumstances with frequent Coronavirus exposure): vaccine efficacy was 91.0 per cent (95 per cent CI: 83.6, 95.0), with 62 SARS-CoV-2 cases in the placebo group and 13 SARS-CoV-2 cases in the vaccine group, the company said.
Novavax said the primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) SARS-CoV-2 with the onset at least 7 days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline.
Novavax expects to share further details of the PREVENT-19 trial results as additional data become available. Further analyses of the trial are ongoing and will be shared via preprint servers as well as submitted to peer-review journals for publication.
The company said the placebo-controlled portion of PREVENT-19 continues in adolescents from 12 to less than 18 years of age, completed recently with enrollment of 2,248 participants.
Novava intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.