Novavax Starting Summer of 2021 with Positive COVID-19 Vaccine Data and a Visit from Governor Hogan
With a visit from Maryland Governor Larry Hogan at the location of their future Vaccines Innovation Campus and Global Headquarters In Gaithersburg, positive data on their COVID-19 Variant Strain Vaccine, and a Phase 3 Trial showing 90% Overall Efficacy/100% Protection Against Moderate and Severe Disease in PREVENT-19. Novavax had one of the most newsworthy weeks to kick off the Summer of 2021.
“Governor Larry Hogan today toured the site of the future Novavax headquarters in Gaithersburg and celebrated the unveiling of plans for the new campus. Novavax is a clinical stage vaccine company that works to deliver novel products to prevent a broad range of infectious diseases, including COVID-19.
The governor was joined by Novavax president and CEO Stan Erck, and former CDC director Dr. Robert Redfield, who serves the Hogan administration as a senior advisor for public health, along with members of the governor’s cabinet and local elected officials.”
Novavax Announces Positive Data from Three Complementary Studies of COVID-19 Beta (B.1.351) Variant Strain Vaccine
“These data suggest that not only could one booster dose of this variant-directed vaccine potentially provide a robust, protective immune boost after vaccination against the original SARS-CoV-2 virus, but also the potential to provide broad protection against various virus strains if used as a primary vaccine regimen,” said Gregory M. Glenn, M.D., President of Research and Development, Novavax. “This broad immune coverage is vital to controlling the pandemic as variants of concern continue to emerge worldwide that could jeopardize the protection created through ongoing COVID-19 vaccination efforts.”
Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial
“Today, Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines. These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Novavax continues to work with a sense of urgency to complete our regulatory submissions and deliver this vaccine, built on a well understood and proven platform, to a world that is still in great need of vaccines.”
The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements. Upon regulatory approvals, Novavax remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.
Even with the news of vaccinations reaching arms in the United States, the need for doses around the globe continues to be a priority. Variants of the Coronavirus have been and will be a topic of discussion as we begin thinking about the need for booster shots for continued protection during this pandemic. The dedicated research and development from Novavax and their peers within the BioHealth Capital Region will pay dividends to our collective health and future battles against infectious diseases.