As drugmakers race to understand how effective current COVID-19 vaccines may be against the newly emerged Omicron variant, Novavax has announced it anticipates being able to begin mass manufacturing an Omicron-specific vaccine as soon as January next year.
Within days of the Omicron variant being identified, both Pfizer and Moderna announced they were working on new versions of their mRNA COVID-19 vaccines. BioNTech, the German mRNA company working with Pfizer, quickly pointed out how swiftly it could hypothetically update its current vaccine.
It would take less than 100 days to develop and start shipping a new variant-specific mRNA vaccine, said BioNtech. After all, the brilliance of mRNA vaccines is that all it takes to produce a new COVID-19 vaccine is encoding mRNA molecules with the genetic blueprint of a new variant’s spike protein.
Novavax, on the other hand, is producing an entirely different kind of vaccine. It is making a protein subunit vaccine, which involves engineering host cells (in this case cells from a moth) to produce large quantities of the SARS-CoV-2 spike protein. These proteins are then harvested and shaped into a structure that resembles a coronavirus.
A recent announcement from Novavax reveals it is simultaneously developing an Omicron-specific version of its vaccine while also testing whether antibodies generated by its current iteration can neutralize the new variant. In a statement, the company indicates commercial manufacturing of a new variant-specific vaccine could begin as soon as next month.
“The initial steps required to manufacture an Omicron-specific spike are underway and GMP manufacturing in a commercial facility is anticipated in January 2022,” the company statement says. “Lab-based assessment of a new strain-matched nanoparticle vaccine will begin within a few weeks.”
Novavax also notes its clinical trial data demonstrates the current iteration of the vaccine working very well against all circulating variants of concern, including Alpha, Beta and Delta. While Omicron displays a collection of unique mutations, it also shares a number of mutations with previous variants so Novavax is optimistic its current vaccine will still be somewhat effective.
Over the last month Novavax has finally started rolling out across the world after working through a slow clinical trial process and overcoming manufacturing hurdles. Early in November Indonesia became the first country in the world to grant emergency use authorization to the vaccine.
Authorization soon followed in the Philippines, with the company submitting applications to regulatory bodies all over the world. Due to the immense success of mRNA COVID-19 vaccines, Novavax previously indicated it would be prioritizing its initial regulatory submissions to countries with more urgent needs. Submission to the US Food and Drug Administration is expected before the end of 2021.
Source: Novavax
Thanks Rich!