Covid vaccine: Novavax completes process for WHO emergency use approval

New Delhi, Nov 05: Biotechnology firm Novavax Inc has reportedly completed the submission process for emergency use listing of its COVID-19 vaccine candidate with the World Health Organization.

A nod from WHO would set the stage for Novavax to begin shipping doses to the COVAX program that supplies shots to low-income countries.

"Today's submission reflects our continued focus on accelerating access and equitable distribution as we work to bring our vaccine to people in need around the globe," said Stanley C. Erck, President and Chief Executive Officer, Novavax.

"We continue to work with urgency to deliver our COVID-19 vaccine, built on a proven, well-understood vaccine platform, because no one is safe until everyone is safe," he said.

The submission also includes clinical data from PREVENT-19, a pivotal Phase 3 trial of 30,000 participants in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall.

Clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K. were also previously submitted to WHO, in which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall. In both trials, NVX-CoV2373 demonstrated a favorable safety and tolerability profile.

Novavax and SII have already filed for authorisation of Novavax' COVID-19 vaccine in India and the Philippines, as well as for emergency use listing (EUL) with the World Health Organization (WHO), the statement said.

Recently, Novavax also completed rolling submissions for authorisation of the Novavax vaccine with regulatory agencies in the UK, European Union, Canada and Australia, it added.

"Novavax expects to submit additional regulatory filings for its vaccine around the world as well as an additional supplemental filing for its vaccine for EUL with the WHO, shortly. Novavax expects to submit its complete package to the US FDA by the end of the year," the statement said.

Clinical trials of NVX-CoV2373 show, the vaccine is extremely effective and offers complete protection against both moderate and severe COVID-19 infection.

The Novavax vaccine can be stored in standard refrigerators, making it easier to distribute.

The vaccine was effective against several variants, including the one first detected in the UK that's dominant in the US, and in high-risk populations including the elderly and people with other health problems.

The company has committed to supplying 110 million doses to the US over the next year and a total of 1.1 billion doses to developing countries.

About the NVX-CoV2373 Phase 3 trials

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M^TM adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.