NEWS: Novavax and Serum Institute of India Announce Submission to Regulatory Agencies in India, Indonesia, Philippines for Emergency Use Authorization of Novavax’ Recombinant Nanoparticle #COVID19 Vaccine ir.novavax.com/2021-08-05-Nov…
The submissions were made to the Drugs Controller General of India (DCGI) and regulatory agencies in Indonesia and the Philippines.
“Today’s submission of our recombinant nanoparticle COVID-19 vaccine, the first protein-based option filed with any regulatory agency, represents a major milestone in Novavax’ transformation into a commercial global vaccine company,” said Stanley C. Erck, President and CEO
“This important step toward access to millions of doses of a safe and effective vaccine for countries with an urgent need to control the pandemic was made possible through our strategic partnership with @SerumInstIndia, and it demonstrates the power of global collaboration.”
A submission to the @WHO for emergency use listing (EUL) based on the DCGI submission is expected to be filed in August.
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NEWS: Novavax Announces #COVID19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination ir.novavax.com/2021-08-05-Nov…
Following the primary vaccination series (21 days apart), a single booster dose at 6 months of NVX-CoV2373 induced a robust increase in anti-Spike antibody levels - up ~4.6-fold vs the response seen after the primary series.
The increased antibody response was consistent for both younger and older adults.
Novavax COVID-19 Vaccine Demonstrates 89.3% Efficacy in UK Phase 3 Trial bit.ly/2MyjKwC
First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants.
Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus.