WASHINGTON (dpa-AFX) - Novavax Inc. (NVAX) and Serum Institute of India Pvt. Ltd. said that the Philippine Food and Drug Administration has granted emergency use authorization for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.
The vaccine will be manufactured and marketed in the Philippines by Serum Institute of India under the brand name COVOVAX.
The vaccine is stored with standard refrigeration at 2° to 8° Celsius.
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 COVID-19.
The Novavax/Serum Institute of India vaccine has recently received EUA in Indonesia and the companies have also filed for emergency authorization in India and for Emergency Use Listing 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.
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