Novavax is participating in a stage of the COVID-19 Vaccine Schedule Combinations (Com-COV) program initiated by the University of Oxford and supported by the UK Vaccine Taskforce and the National Institute for Health and Care Research. Novavax' protein-based COVID-19 vaccine, NVX-CoV2373, is one of two COVID-19 vaccines that will be studied as a third dose booster in adolescents aged 12 through 15 years to evaluate the potential use of vaccines from different manufacturers to achieve immune protection against COVID-19.
“NVX-CoV2373 has already shown strong immune responses against COVID-19 and its variants, and we look forward to further examining its role as a booster as we continue to explore how best to manage the continuing evolution of the coronavirus,” said Matthew Snape, Professor in Paediatrics and Vaccinology at the University of Oxford, and Chief Investigator of the trial.
This stage of the investigator-initiated Phase 2 single-blind, randomized clinical trial will analyze reactogenicity and immune system responses to new combinations of vaccines in approximately 380 participants. All participants will have completed a two-dose schedule of the Pfizer-BioNTech vaccine at least three months before joining the trial. A third dose of either NVX-CoV2373 or the Pfizer-BioNTech vaccine will be administered as part of the trial.
Authorization in the U.S.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. and the trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration (FDA). The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee will review the Novavax COVID-19 vaccine for active immunization against SARS-CoV-2 during a meeting scheduled for June 7, 2022.