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Monday, May 6, 2024

Novavax files for emergency use in PH, India and Indonesia

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The COVID-19 vaccine NVX-Cov2373 developed by Novavax, a US biotechnology company, demonstrated a 92.6% 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 Covovax in partnership with Novavax under a licensing agreement.

The 92.6% efficacy rate of COVOVAX against variants including the Delta variant is one of the highest amongst all vaccines. This was announced by Novavax in their recent meeting.  The US/Mexico Phase III clinical trials also confirmed 90% overall vaccine efficacy 7 days after the second dose, and 100% 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 2 doses, increases the immune response against Delta (6.6 times), Alpha (10.8 times), and Beta (8.1 times) variants.

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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%.

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 has also recently finalized a supply agreement for 200 million doses with the European Commission to expand global reach amongst countries. Deliveries are scheduled to commence early October of this year. Novavax also has commitments to Japan, South Korea, Canada, UK, and Australia.

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