Novavax launches phase III trial on COVID-19 vaccine in the US and Mexico

Novavax launches phase III trial on COVID-19 vaccine in the US and Mexico

The American biotech firm Novavax has initiated a phase III study of its COVID-19 vaccine candidate, NVX-CoV2373, in the US and Mexico.

NVX-CoV2373 is a full-length, prefusion spike protein, that was created using Novavax’s recombinant nanoparticle technology along with its proprietary saponin-based Matrix-M adjuvant.A single vaccine dose of NVX-CoV2373 contains 5mcg of protein and 50mcg of adjuvant.

The vaccine is stable at 2-8°C and can be transported in a ready-to-use liquid formulation that allows supply with the help of standard vaccine supply chain channels.

The phase III PRE-fusion protein subunit Vaccine Efficacy Novavax Trial COVID-19 (PREVENT-19) was initiated after data from phase I/II studies showed that the vaccine triggered a robust immune response, produced highly neutralising antibodies against the virus, and was well-tolerated.

PREVENT-19, conducted by Operation Warp Speed partners, is an observer-blinded, placebo-controlled, randomised study to analyse the effectiveness, safety and immunogenicity of NVX-CoV2373 with Matrix-M versus placebo.

The trial will have around 30,000 adult participants who will be randomised in a 2:1 ratio to receive two intramuscular injections of NVX-CoV2373—administered 21 days apart—or placebo.

The primary and secondary endpoint of the trial will be the prevention of PCR-confirmed, symptomatic COVID-19 and moderate or severe disease, respectively. Analysis of both the endpoints will be conducted at least seven days after the second dose.

Currently, Novavax is conducting a phase III trial of the vaccine candidate in the UK, a phase IIb safety and efficacy study in South Africa, and a phase I/II trial in the US and Australia.

The company anticipates data from these trials to be available by the first quarter of 2021.