Novavax, SII receive emergency use authorisation for COVID-19 caccine in the Philippines

The vaccine will be manufactured and marketed in the Philippines by SII under the brand name COVOVAX

Novavax and Serum Institute of India (SII), announced that the Philippine Food and Drug Administration (FDA) has granted emergency use authorisation (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 immunised, 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 CEO, 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 the 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, CEO, 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 Emergency Use Listing (EUL) with the World Health Organization (WHO). Novavax also announced regulatory filings for its vaccine in the UK, 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.