The advisory group is meeting on Tuesday to discuss the vaccine’s presenting data and a potential authorization.
The Food and Drug Administration ‘s (FDA) Vaccines and Related Biological Products and Advisory Committee (VRBPAC) is going to convene on Tuesday morning to discuss Novavax’s request for an Emergency Use Authorization (EUA) for its COVID-19 vaccine, NVX-CoV2373, for active immunization against SARS-CoV-2 in individuals 18 years of age and older.
The company submitted their request in January and the FDA committee’s meeting is scheduled to begin tomorrow at 8:30am EDT and run all day until 5pm.
Novavax’s filing comes from data it submitted to FDA earlier this year and is 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 named the PREVENT-19 trial, they had participants in the US and Mexico and the latter had people from the United Kingdom participating.
In the PREVENT-19 trial, the vaccine demonstrated an overall efficacy of 90.4%. In the UK study, the vaccine was found to be 89.7% effective against symptomatic Covid-19 caused by both B117 and non-B117 variants.
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.
The Novavax vaccine does not have the special cold storage requirements that are associated with the m-RNA vaccines. And 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.
Clinicians spoke about some of the potential benefits of the NVX-CoV2373 vaccine.
Check back tomorrow afternoon for any breaking news coming from the VRBPAC meeting.