Novavax remains ‘confident’ in rollout of updated COVID-19 vaccine in U.S.

Novavax said it remains confident in the ongoing rollout of its updated XBB protein-based non-mRNA COVID-19 vaccine in the U.S. Following arrival in pharmacies and healthcare provider offices, and first doses administered last week, Novavax’s vaccine is now widely available throughout the U.S. Novavax believes it is too soon to evaluate U.S. vaccination rates given that vaccinations will continue in the coming weeks. Novavax is encouraged by broad availability of its vaccine in the U.S. market and looks forward to gathering additional data as the season unfolds. In the European Union, Novavax continues to work in close partnership with the European Medicines Agency as they review the file for its updated COVID-19 vaccine for use in individuals aged 12 and older which is based on the global data package that has already supported U.S. Emergency Use Authorization. As part of the ongoing review process, Novavax has responded to additional questions from the EMA’s Committee for Medicinal Products for Human Use; CHMP has acknowledged receipt of this additional information and Novavax is currently awaiting feedback. Post-approval, Novavax expects to meet its full supply commitment for doses of its vaccine to European countries that have requested it through the Company’s advanced purchase agreement and is on track to provide these doses in line with the APA requirements. Novavax values EMA’s continued partnership and continues to work on the shared goal of bringing an updated protein-based non-mRNA COVID-19 vaccine to member states in the coming weeks. The company will provide an update on its upcoming Q3 earnings call in early November 2023.