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

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