The company has submitted the chemistry, manufacturing and controls (CMC) data module, completing final data packages required for the EUA application

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Novavax to request FDA EUA for its Covid vaccine. (Credit: pearson0612 from Pixabay.)

Novavax has submitted the final data package to the US Food and Drug Administration (FDA) as a prerequisite to emergency use authorisation (EUA) application for its Covid-19 vaccine, NVX-CoV2373, with Matrix-M adjuvant.

The submission includes the complete chemistry, manufacturing and controls (CMC) module for the recombinant nanoparticle protein-based Covid-19 vaccine.

Novavax is planning to file an application with the US regulator in 30 days, seeking EUA for its vaccine, as per FDA guidance related to EUA applications for vaccines.

Also, the company intends to supplement the submission, with data from additional manufacturing sites across its global supply chain.

Novavax president and CEO Stanley Erck said: “Novavax is committed to delivering our protein-based vaccine in the United States, where the Covid-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting.

“We thank the US Government for its ongoing support of our Covid-19 vaccine program, as well as our clinical trial participants and those who have supported the development and manufacturing of our vaccine.”

Novavax is a biotechnology company focused on developing and marketing advanced vaccines for serious infectious diseases.

Its NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, using its recombinant nanoparticle technology.

The vaccine is formulated using the company’s patented saponin-based Matrix-M adjuvant for enhanced immune response and high neutralising antibodies.

NVX-CoV2373 is being evaluated in two Phase 3 trials, PREVENT-19 in the US and Mexico, and the other clinical trial in the UK.

The Phase 3 PREVENT-19 trial evaluated the efficacy, safety and immunogenicity of NVX-CoV2373 in 25,452 participants, and showed 90.4% overall efficacy for the vaccine.

The study has met both primary and key secondary endpoints, at least seven days after the second vaccination, said the company.

The UK clinical trial, designed as a randomised, placebo-controlled, observer-blinded study, enrolled 14,039 participants and achieved overall efficacy of 89.7%.

In August last year, Novavax entered into a manufacturing partnership with the Serum Institute of India (SII) to supply its Covid‑19 vaccine in India, and other countries.

Recently, Novavax and SII secured the Drugs Controller General of India (DCGI) emergency use authorisation for Covovax in India.