Novavax might have an Omicron-specific COVID vaccine prepared by January

As drugmakers race to grasp how efficient present COVID-19 vaccines could also be in opposition to the newly emerged Omicron variant, Novavax has introduced it anticipates having the ability to start mass manufacturing an Omicron-specific vaccine as quickly as January subsequent yr.

Inside days of the Omicron variant being recognized, each Pfizer and Moderna introduced they have been engaged on new variations of their mRNA COVID-19 vaccines. BioNTech, the German mRNA firm working with Pfizer, rapidly identified how swiftly it might hypothetically replace its present vaccine.

It might take lower than 100 days to develop and begin transport a brand new variant-specific mRNA vaccine, stated BioNtech. In any case, the brilliance of mRNA vaccines is that each one it takes to provide a brand new COVID-19 vaccine is encoding mRNA molecules with the genetic blueprint of a brand new variant’s spike protein.

Novavax, however, is producing a completely completely different sort of vaccine. It’s making a protein subunit vaccine, which includes engineering host cells (on this case cells from a moth) to provide massive portions of the SARS-CoV-2 spike protein. These proteins are then harvested and formed right into a construction that resembles a coronavirus.

A current announcement from Novavax reveals it’s concurrently creating an Omicron-specific model of its vaccine whereas additionally testing whether or not antibodies generated by its present iteration can neutralize the brand new variant. In an announcement, the corporate signifies business manufacturing of a brand new variant-specific vaccine might start as quickly as subsequent month.

“The preliminary steps required to fabricate an Omicron-specific spike are underway and GMP manufacturing in a business facility is anticipated in January 2022,” the corporate assertion says. “Lab-based evaluation of a brand new strain-matched nanoparticle vaccine will start inside a number of weeks.”

Novavax additionally notes its medical trial information demonstrates the present iteration of the vaccine working very properly in opposition to all circulating variants of concern, together with Alpha, Beta and Delta. Whereas Omicron shows a group of distinctive mutations, it additionally shares numerous mutations with earlier variants so Novavax is optimistic its present vaccine will nonetheless be considerably efficient.

Over the past month Novavax has lastly began rolling out internationally after working by way of a sluggish medical trial course of and overcoming manufacturing hurdles. Early in November Indonesia grew to become the primary nation on this planet to grant emergency use authorization to the vaccine.

Authorization quickly adopted within the Philippines, with the corporate submitting purposes to regulatory our bodies all around the world. Because of the immense success of mRNA COVID-19 vaccines, Novavax beforehand indicated it might be prioritizing its preliminary regulatory submissions to international locations with extra pressing wants. Submission to the US Meals and Drug Administration is predicted earlier than the top of 2021.

Supply: Novavax

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