Biotech firm Novavax has initiated a pivotal Phase III study of its Covid-19 vaccine candidate, NVX-CoV2373, in the US and Mexico.
A full-length, prefusion spike protein, NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology along with its proprietary saponin-based Matrix-M adjuvant.
A single vaccine dose contains 5mcg of protein and 50mcg of adjuvant.
The vaccine is stable at 2-8°C and is 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 trial (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.
Novavax president and CEO Stanley Erck said: “With the Covid-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population.”
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below formBy GlobalData
Being carried out with support from Operation Warp Speed partners, PREVENT-19 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 next year.