Novavax, a Gaithersburg-based 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 National Agency of Drug and Food Control of the Republic of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. It will be manufactured by SII in India and marketed by SII in Indonesia under the brand name COVOVAX™.
“The first authorization of Novavax’ COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, which despite being the fourth most populous nation on earth, continues to work to procure sufficient vaccine for its population,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “This also marks the first regulatory authorization worldwide of a protein-based COVID-19 vaccine based on Phase 3 clinical data demonstrating efficacy and a favorable safety profile. This is a landmark moment for Novavax and our partner, Serum Institute of India, and it is the first of many authorizations that Novavax expects in the coming weeks and months for our vaccine globally.”