The American biotechnology company Novavax with its partner, Serum Institute of India, have announced the regulatory submission to the World Health Organization (WHO) for the list of emergency use of the vaccine candidate for a Covid-19 vaccine based on proteins of nanoparticles.
“Today’s submission of our protein-based Covid-19 vaccine to WHO for inclusion on the emergency use list is an important step on the road to accelerating access and more equitable distribution to countries most in need. from around the world, “said Stanley C. Erck, President and CEO of Novavax”
The concession by the WHO is a prerequisite for exports to many countries participating in the COVAX body, which was established to allocate and distribute vaccines equitably to participating countries and economies. In addition to the presentation to WHO, Novavax and its partner last month completed the presentation to regulatory agencies in India, Indonesia and the Philippines for the initiation of the vaccine review, including preclinical, clinical and chemical, manufacturing and controls.
How is the Novavax vaccine
Novavax’s Covid-19 vaccine is being evaluated in two pivotal phase 3 trials: a UK trial that demonstrated 96.4% efficacy against the parent virus strain, 86.3% against the variant Alpha and 89.7% overall effectiveness. And the PREVENT-19 trial in the US and Mexico that demonstrated 100% protection against moderate and severe diseases and an overall efficacy of 90.4%. Overall, it was well tolerated and elicited a strong antibody response.
This is a protein-based vaccine designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19 disease. Additionally, the vaccine was created using Novavax’s recombinant nanoparticle technology to generate antigen derived from coronavirus pico (S) protein and is formulated with Novavax’s proprietary saponin-based Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.
Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen requires two 0.5 ml doses (5 micrograms of antigen and 50 micrograms of Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored between 2 and 8 degrees Celsius, allowing the use of existing cold chain and vaccine supply channels.