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

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.