Novavax announces filing of regulatory submissions for EUA in PHL, Indonesia, India


THE Covid-19 vaccine NVX-Cov2373 developed by Novavax, a US biotechnology company, demonstrated a 92.6-percent efficacy against variants of concern and interest including the Delta variant. This was reported from ongoing analysis of the Phase III US/Mexico Clinical Trial on 30,000 participants. 

Regulatory filings for Emergency Use Application (EUA) in the Philippines, India, and Indonesia have been submitted and are under evaluation. Emergency Use Listing (EUL) with the World Health Organization (WHO) is set to be filed within the month of August along with filings in other countries, including those considered as Stringent Regulatory Authorities (SRAs).

This was confirmed by Faberco Life Sciences Inc., the local biopharmaceutical company that has the rights from Serum Institute of India (SII) to distribute the vaccine in the Philippines. Serum Institute is developing CovovaxTM in partnership with Novavax under a licensing agreement.

The 92.6-percent efficacy rate of COVOVAXTM against variants including the Delta variant is one of the highest among all vaccines, Novavax announced in their recent meeting. 

The US/Mexico Phase III clinical trials also confirmed 90-percent overall vaccine efficacy seven days after the second dose, and 100-percent efficacy against severe disease and hospitalization.

Positive data from a 6-month booster study for Novavax’ vaccine candidate NVX-CoV2373 supports the use in primary vaccination, and booster campaigns down the road.  A booster dose at 6 months after the first two doses, increases the immune response against Delta (6.6 times), Alpha (10.8 times), and Beta (8.1 times) variants.

Additionally, the Phase III UK study on 15,000 participants studied a combination of the NVX-Cov2373 vaccine with a quadrivalent influenza vaccine in 400 participants showed that it has a high safety profile, is very well-tolerated, and has an efficacy rate of 87.5 percent.

SII has committed supplies of 1.1 billion doses of the vaccine, primarily to the COVAX facility and with priority given to the Philippines and Indonesia.  It also recently finalized a supply agreement for 200 million doses with the European Commission to expand global reach among countries. Deliveries are scheduled to commence early October of this year. Novavax also has commitments to Japan, South Korea, Canada, UK, and Australia.

Faberco Life Sciences Inc. is a Philippine biopharmaceutical company aiming to be a leading provider of premium pharmaceutical products. In a statement on Saturday, Faberco said it partners with reputable international manufacturers at the forefront of innovative product platforms and therapeutic categories.

Image courtesy of AP/Alastair Grant

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