Novavax is finally submitting an Emergency Use Authorization request to the U.S. Food and Drug Administration for its COVID-19 vaccine candidate, NVX-CoV2373, a protein-based vaccine.
Novavax is submitting its protein-based vaccine application for emergency use. (STR/NurPhoto via Getty Images)
Gaithersburg, Maryland-based Novavax is finally submitting an Emergency Use Authorization request to the U.S. Food and Drug Administration for its protein-based vaccine candidate.
Initially, Novavax planned to request EUA by May 2021, but the company put off the request over several development and manufacturing roadblocks. Working together with its manufacturing partner, Serum Institute of India, Novavax got the vaccine authorized in several countries, including Europe. It is also listed for emergency use by the World Health Organization and is available in more than 170 countries.
The EUA submission is for people 18 years of age and older. In the two pivotal Phase III trials, the vaccine demonstrated an overall efficacy of about 90%. The PREVENT-19 trial enrolled about 30,000 people in the U.S. and Mexico. The second trial was in the U.K. and had about 15,000 participants. The U.K. trial achieved an overall efficacy of 89.7%. Overall, the PREVENT-19 trial demonstrated 90.4% efficacy. There were few severe adverse events between the protein-based vaccine and placebo cohorts.
What is a Protein-Based Vaccine?
NVX-CoV2373 is a protein-based vaccine. It was designed from the genetic sequence of the Wuhan strains of SARS-CoV-2. Novavax leveraged its recombinant nanoparticle technology to create antigen from the virus’s spike protein and is formulated with the company’s saponin-based Matrix-M adjuvant to boost the immune response.
The vaccine is stored at 2 to 8 degrees Celsius (about 35 to 46 degrees Fahrenheit), which is advantageous because it can utilize existing vaccine supply and cold chain channels. It also has a shelf life of approximately nine months. If the FDA grants it the EUA, the first 100 million doses are ready for delivery. Like the mRNA vaccines from Moderna and Pfizer-BioNTech, the Novavax vaccine requires two doses three weeks apart.
The PREVENT-19 study was run with support from the U.S. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority, and the National Institute of Allergy and Infectious Diseases. BARDA is giving up to $1.75 billion under a Department of Defense deal.
“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,” stated Stanley Erck, Novavax’s president and chief executive officer.
With more than 64% of the U.S. population fully vaccinated, there’s some doubt just how much traction the Novavax vaccine would get. However, it may have some applicability for a mix-and-match booster if it gets authorized for that. Almost 90% of U.S. adults have received at least one dose of one of the three available vaccines. In November 2021, Erck said, “In the U.S., the primary market I think in 2022 is going to be to supply a vaccine, our normal two-dose regimen, to a lot of people who have been hesitant to get other vaccines. And to provide a booster.”
In theory, people who have been reluctant to get vaccinated with mRNA vaccines because they claim the technology’s safety is unproven will be willing to get the Novavax shots, which use more traditional approaches. At a conference last year, Dr. Peter Marks, the FDA’s top vaccines official, stated, “There are some people in the United States who still will not take our mRNA vaccines and they are waiting for a protein-based vaccine. And for us, anything we can do to help get a larger portion of our population vaccinated is something that we need to do.”
