Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today announced that the Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The vaccine will be manufactured and marketed in the Philippines by SII under the brand name COVOVAX™.
"With less than a third of the Philippine population fully immunized, we expect the option for a protein vaccine, built on a well-understood technology platform, to contribute substantially to increased vaccination rates," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Novavax looks forward to SII's delivery of the vaccine to the Philippines, and with additional authorizations expected elsewhere soon, to helping control the COVID-19 pandemic around the globe."
Because the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it may be transported and stored using existing vaccine supply chain, potentially increasing access in hard-to-reach areas.
"The approval of COVOVAX in the Philippines is another step forward in the global fight against the coronavirus," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to deliver the first protein-based COVID-19 vaccine to the Philippines."
The Novavax/SII vaccine has recently received EUA in Indonesia and the companies have also filed for emergency authorization in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, Canada and with the WHO, as well as the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) in South Korea. Novavax expects to submit the complete package to the U.S. FDA by the end of the year.
For additional information on COVOVAX, including the Summary of Product Characteristics, Prescribing Information and Important Safety Information, please visit the following websites:
Food and Drug Administration Philippines
Serum Institute of India
Authorized Use of Novavax' Covid-19 Vaccine in the Philippines
The Philippines Food and Drug Administration has issued Emergency Use Authorization (EUA) for Covovax /Recombinant Spike Protein of SARS-CoV-2 Virus 5 mcg for active immunization of individual 18 years of age and older for the prevention of coronavirus disease 2019 caused by SARS-CoV-2
Important Safety Information
COVOVAX is contraindicated in persons who have hypersensitivity to the active substance or to any of the excipients of this vaccine.
About the NVX-CoV2373 Phase 3 Trials
NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response. It is also being evaluated in a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall.
About NVX-CoV2373
NVX-CoV2373, Novavax' Covid-19 vaccine, is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M™ adjuva...
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