The Food and Drug Administration’s independent Vaccines and Related Biological Products Advisory Committee recommended to the agency to grant an Emergency Use Authorization (EUA) to Novavax two-dose vaccine against COVID-19 for individuals 18 and older.
This recommendation has cleared another step on the path toward FDA’s authorization for the vaccine NVX-CoV2373, which is already authorized for use by the World Health Organization and more than 40 countries.
Called Nuvaxovid, it’s considered an alternative for people hesitant to get an mRNA vaccine since it is a protein-based vaccine platform engineered from the genetic sequence of the first strain of SARS-CoV-2.
It was created using Novavax’s recombinant nanoparticle technology to generate spike (S) protein-derived antigen from the coronavirus.
Novavax President and CEO Stanley C. Erck noted earlier this year that their vaccine offers a differentiated option built on a well-understood protein-based vaccine that can be an alternative to the portfolio of available COVID-19 vaccines.
Nuvaxovid is similar in design to a flu shot that’s available since 2013 and proved 100% effective at preventing moderate or severe infection in clinical trial participants and 90.4% efficacy at preventing mild, moderate, or severe infection with the early variants of SARS-CoV-2.
Although FDA is not required to follow the advisory committee’s recommendation, it usually does so it could decide as soon as this week whether to issue EUA for the two-dose vaccine for use in the US.
If cleared for use, Nuvaxovid will be the fourth FDA-approved COVID jab on the market. Along with Pfizer, Moderna, and Johnson & Johnson, which have already been cleared for use in adults in the US.
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