The company recently submitted its data to the federal regulatory authorities for an Emergency Use Authorization of its COVID-19 vaccine, NVX-CoV2373. As it's time to think about this potential vaccine being available in the US, clinicians offer some insights and perspective on it.
Last week, Novavax announced they had submitted a request to the Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for its COVID-19 vaccine, NVX-CoV2373, for people 18 years of age and older.
The company submitted their EUA based off of 2 phase 3 clinical trials they conducted with 1 using nearly 30,000 participants that were randomized between December 27, 2020 and February 18, 2021, and the other using nearly 15,000 participants who were randomized between September 28, 2020 to November 28, 2020.
Both studies’ results were published in the New England Journal of Medicine.
In the former, which was name the PREVENT-19 trial, they had participants in the US and Mexico and the latter had people from the United Kingdom participating.
“Coming out of the US and the Mexico [PREVENT] trials they were looking at an efficacy of 90%,” Donald Alcendor, PhD, assistant professor of Cancer Biology Meharry Medical College, adjunct associate professor of Pathology, Microbiology and Immunology, Vanderbilt University School of Medicine, said. “Their efficacy in preventing COVID-19 with severe disease including hospitalizations and deaths, were clearly on par with the m-RNA vaccines.”
Meharry and Alcendor were involved with the Novavax clinical trials.
After it had initially looked like the company was going to file for the EUA last year, they were delayed due to production concerns. “They had a lot of manufacturing issues that put them on pause,” Alcendor explained. With these production challenges now seemingly behind them, Novavax is now ready to move forward with offering the vaccine in the US.
The company has already been applying for authorization in a number of countries including Canada, Israel, Australia, New Zealand, United Kingdom, India, Indonesia, and South Korea. The company is also pursuing a strategy of developing contracts to distribute the vaccine in the authorized countries.
Although there has been no timeline developed for the FDA’s review of the Novavax vaccine, if recent history has been any indicator, the federal regulators will likely move quickly in determining authorization. Therefore, it could happen in a matter of weeks.
As the US prepares for a fourth potential COVID-19 vaccine, it may be helpful to review how this vaccine differs from the m-RNA vaccines (Moderna, Pfizer-BioNTech) and the Johnson & Johnson vaccine, including some potential benefits.
The Novavax vaccine is a protein-based vaccine, engineered from the SARS-CoV-2 virus that caused COVID-19. Novavax used its recombinant nanoparticle technology to generate antigen derived from the COVID-19 spike protein. NVX-CoV2373 is formulated with Novavax’s saponin-bases adjuvant to enhance immune response and induce high levels of COVID-19-neutralizing antibodies.
“When you look at the 5 major vaccines, Pfizer-BioNTech, Moderna, J&J, Astra Zeneca, and Novavax, what you see is that Novavax is unique among all of them…what makes Novavax new and different is it gets rid of trying to teach your body how to make that protein; Novavax gives you the actual protein,” Alcendor stated.
Along with Novavax’s high efficacy demonstrated during its vaccine clinical trials, both Alcendor and William Schaffner, MD, medical director of the National Foundation for Infectious Diseases (NFID) make the distinction that the Novavax vaccine can still help in preventing severe COVID-19 even in the midst of dealing with the Omicron variant. And they both agree the Novavax vaccine may be an alternative for people concerned about the very rare risk of vaccine-induced immune thrombotic thrombocytopenia in other COVID-19 vaccines, if people have any allergies associated with the m-RNA vaccines or potential myocarditis risks in young males.
In addition, having more vaccines available can help the greater population here in the US and internationally, especially if we have to deal with future viruses. "If we have more manufacturers producing very effective vaccines going into the future—having those resources available is always reassuring,” Schaffner, said. “No telling what we are up against down the road. There may be new variants for which we might need to develop new vaccines.”
And in thinking about developing countries, the Novavax vaccine does not have the special cold storage requirements that are associated with the m-RNA vaccines, so the distribution and storage will be easier. “One good thing that makes this vaccine travel better than the other vaccines is that it lasts for 9 months at refrigerated temperatures,” Alcendor said.
Contagion spoke to Schaffner recently about the Novavax platform, some of its benefits, and how even with diminished efficacy in vaccines that they help in avoiding the progression to severe COVID-19.