Novavax Announces Phase 3 Study for COVID-19 Vaccine Candidate

January 4, 2021
Gabrielle Ientile, Assistant Editor

With support from Operation Warp Speed and the National Institutes of Health, the study will evaluate the safety and efficacy of NVX-CoV2373.

Biotechnology company Novavax has announced the start of its phase 3 study evaluating a vaccine candidate for coronavirus disease 2019 (COVID-19).

“This trial underscores the importance of private/public partnerships in solving the need for globally available vaccines to interrupt the ongoing COVID-19 epidemic,” said Larry Corey, MD, virologist at the Fred Hutchinson Cancer Research Center and co-leader of the COVID-19 Prevention Network.

The study will follow research from phase 1/2 studies, which proved that the vaccine candidate, NVX-CoV2372, generated neutralizing antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and induced a strong immune response.

The PREVENT-19 study, with support from Operation Warp Speed (OWS) partners including the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID), aims to assess the efficacy, safety, and immunogenicity of NVX-CoV2373 in preventing COVID-19, according to a news release. The study will include a limit of 30,000 volunteers – 2-thirds of whom will receive active vaccine – from an estimated 115 sites across the United States and Mexico.

The randomized, placebo-controlled, observer-blinded study has been designed to align with other phase 3 trials taking place under OWS to facilitate data analysis amid the COVID-19 pandemic.

Novavax used its recombinant nanoparticle technology to create the spike (S) protein present in NVX-CoV2373, which is encoded by the genetic sequences of the SARS-CoV-2 S protein. The vaccine candidate cannot cause COVID-19 infection nor can it replicate, according to investigators.

With some Americans already vaccinated for COVID-19 and millions of more doses on the way, investigators are working to make sure that NVX-CoV2373 can be easily delivered to patients should it be considered for distribution. The vaccine candidate is stable at 2° C to 8° C, packaged in ready-to-use liquid formulation and able to be shipped to hospitals, pharmacies, and other vaccination locations.

“We are encouraged by the data generated to date on NVX-CoV2373 and are optimistic about our ability to positively build on the body of evidence with this trial,” said Gregory M. Glenn, MD, president of research and development, Novavax.

More information about the trial and how to enroll can be found here.

Reference

  1. Novavax Announces Initiation of PREVENT-19 Pivotal Phase 3 Efficacy Trial of COVID-19 Vaccine in the United States and Mexico. News Release. Novavax; December 28, 2020. Accessed January 4, 2020. https://ir.novavax.com/news-releases/news-release-details/novavax-announces-initiation-prevent-19-pivotal-phase-3-efficacy.