Breaking: Novavax Submits EUA Request for COVID-19 Vaccine Candidate

NVX-CoV2373 is a protein-based COVID-19 vaccine for adults 18 years and older.

Novavax Inc has submitted their request to the FDA for an emergency use authorization (EUA) for their protein-based COVID-19 vaccine candidate, NVX-CoV2373, according to a company press release.1 If authorized, the vaccine would be available to adults 18 years and older.

The company’s EUA request was submitted based in part on the results of 2 “large pivotal clinical trials” that showed an overall efficacy of 90%, along with a “reassuring safety profile.” These trials included PREVENT-19 (NCT04611802), which included 30,000 participants from the United States and Mexico, and a second trial conducted in 15,000 participants in the UK. Results of both trials were published in the New England Journal of Medicine.2,3

Worldwide, numerous agencies—including the European Commission and the WHO—have granted conditional or emergency use listing of the Novavax vaccine.

NVX-CoV2373 is a protein-based vaccine candidate, engineered using the genetic sequence of the first SARS-CoV-2 strain. The vaccine was created using the company’s recombinant nanoparticle technology to “generate an antigen derived from the coronavirus spike (S) protein.” The vaccine is packaged as a ready-to-use liquid formulation in a vial containing 10 doses. Vaccination regimen is two 0.5 mL doses administered 21 days apart. NVX-CoV2373 is stored between 2 and 8 degrees Celsius, allowing for the use of preexisting vaccine supply and cold chain.

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said Stanley C. Erck, Novavax president and CEO, in the press release.1

References

  1. Novavax submits request to the US FDA for emergency use authorization of COVID-19 vaccine. Press release. Novavax. January 31, 2022. Accessed January 31, 2022. https://ir.novavax.com/2022-01-31-Novavax-Submits-Request-to-the-U-S-FDA-for-Emergency-Use-Authorization-of-COVID-19-Vaccine?sf159353148=1
  2. Dunkle LM, Kotloff KL, Gay CL, et al; for the 2019nCoV-301 Study Group. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. N Engl J Med. Published online December 15, 2021. Doi:10.1056/NEJMoa116185
  3. Heath PT, Galiza EP, Baxter DN, et al; for the 2019nCoV-302 Study Group. Safety and efficacy of NVX-CoV2373 Covid-19 vaccine. N Engl J Med. 2021;385(13):1172-1183. Doi:10.1056/NEJMoa2107659