Novavax Investor Relations – Press Releases and Statements
Novavax Statement on Second Quarter 2022 Financial Results and Operational Highlights
Today, Novavax adjusted its guidance for 2022 to account for several changing market dynamics. We remain confident in our vaccine as a strong additional choice. Its competitive product profile includes our vaccine’s efficacy, well-tolerated safety profile, durability of protection, and ability to address current and future variant strains.
In the third quarter, we are already making huge progress. We have shipped over 23 million doses since the beginning of July and, although in some cases the delivery time may be pushed back to 2023, we do not expect total contract demand to change under the majority of our advance purchase agreements.
Main commercial achievements
Above all, we have made significant progress since the beginning of the year. We have established a global presence with authorizations in 43 countries and an emergency use list with the World Health Organization. In the United States, we have successfully brought our vaccine to market under emergency use authorization and vaccinations are now underway in 47 states and growing. Beyond that, we are successfully expanding our COVID-19 vaccine label and expecting multiple depots globally for adolescents and the booster setting throughout the year. In markets where we have received favorable policy recommendations, we are seeing significant uptake of our vaccine. Finally, we have expanded our global footprint with a new European regional office in Switzerland and plan to add a location in Asia Pacific in the second half of this year. We believe these efforts will position us well for the transition to a commercial market in 2023.
Key Clinical Highlights
To support the expanded approvals, we advanced our robust clinical development program with additional trials initiated to evaluate our vaccine in homologous and heterologous booster and pediatric populations. We are also responding to the changing COVID landscape and are in the works with an Omicron clinical trial. The first results are expected towards the end of the third quarter of 2022 with plans to deposit a vaccine containing Omicron in the fourth quarter. At the same time, we remain confident in our prototype vaccine given its broad coverage against a range of circulating variants and are working urgently to meet customer demand.
Overall, we remain committed to developing new, first-in-class vaccine candidates with the potential to address today’s most pressing global health needs, including our combination COVID-19-influenza and a stand-alone influenza vaccine that should be in phase 3 soon. year. We are grateful to our employees and partners for their continued commitment; without them, all of our significant progress would not have been possible.