The US biotechnology firm Novavax Inc. announced on Friday the regulatory submission to the World Health Organization (WHO) for Emergency Use Listing (EUL) of Novavax recombinant nanoparticle protein-based Covid-19 vaccine candidate with Matrix-M™ adjuvant.
“[The] submission of our protein-based Covid-19 vaccine to WHO for emergency use listing is a significant step on the path to accelerating access and more equitable distribution to countries in great need around the world,” said Stanley C. Erck, president and chief executive officer, Novavax.
The submission was done together with its partner, Serum Institute of India Pvt. Ltd. (SII). The vaccine will carry the trademark COVOVAXTM in the Philippines where an Emergency Use Application (EUA) was already submitted to the Food and Drug Administration (FDA).
“With this development we hope to inch closer to FDA approval for COVOVAXTM in the Philippines,” said Dr. Luningning Villa of Faberco Life Sciences Inc., the local biopharmaceutical company that will have the local rights to distribute the Novavax-developed vaccine, COVOVAXTM in the Philippines.
The grant of EUL by WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.
Clinical trials for COVOVAX have shown the following results:
- 92.6 percent efficacy against variants of concern and interest including Delta
- 100 percent efficacy against severe illness that leads to hospitalization and death
- 91 percent efficacy on high-risk populations including seniors and those with comorbidities
- 90 percent overall efficacy including the original strain
Novavax has also previously announced that the vaccine has shown very high efficacy against all variants when given as a booster. Interim results from Phase 3 studies in adolescents aged 12 to 17 are also expected within the last of the year.
Faberco Life Sciences Inc. is a Philippine biopharmaceutical company marketing and distributing targeted premium pharmaceutical products for devastating and critical diseases. Faberco partners with reputable international manufacturers at the forefront of innovative product platforms and therapeutic categories.