SII, Novavax get emergency use nod for COVID vaccine in Philippines

Pune: Novavax, Inc. and Serum Institute of India Pvt. Ltd. (SII) have recently announced that the Philippine Food and Drug Administration (FDA) has granted 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.

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).

Read also: Novavax files for COVID vaccine EUL with 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.