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Maryland-Based Vaccine Manufacturer Developing COVID-19 Vaccine That Targets Omicron Variant

GAITHERSBURG, Md. (WJZ/AP) --  Novavax, a vaccine manufacturer based in Gaithersburg, Maryland, has started developing a new COVID-19 vaccine that targets the genetic sequence of the Omicron variant.

The Omicron strain — first discovered in South Africa — has more than 50 mutations and has alarmed health officials worldwide.

It is not yet clear how effective the vaccines are against it. "What we're seeing is a number of mutations to the spike protein so I think that's why there is a widened level of concern," Baltimore City Health Commissioner Dr. Letitia Dzirasa told WJZ on Monday. "We're still going to have to decipher what does that mean exactly. We're not sure yet if it makes this particular version more transmissible. That's what scientists are really racing around the clock to find out."

The Novavax two-dose shot is made with lab-grown copies of the spike protein that coats the coronavirus. That's very different than other widely used vaccines that deliver genetic instructions for the body to make its own spike protein. The company said its vaccine has shown efficacy against variants like Delta.

"Experience with our vaccine has demonstrated that it can protect and neutralize against disease-causing variants found in the real world, including broad responses observed in our clinical trials against variants such as Delta," the company said in a statement. "These data lead us to believe that our vaccine is likely to provide protection against new and emerging variants."

But the company said it will be ready to test a new treatment just for the Omicron variant.

"Specifically in response to the emerging Omicron coronavirus variant, Novavax has already initiated development of a new recombinant spike protein based on the known genetic sequence of B.1.1.529 and will have it ready to begin testing and manufacturing within the next few weeks," the company said.

Novavax and Serum Institute of India Pvt. Ltd. (SII) recently received Emergency Use Authorization (EUA) for the vaccine in Indonesia and the Philippines, and the companies have filed for EUA in India and for Emergency Use Listing (EUL) with the World Health Organization (WHO).

Novavax also announced regulatory filings for its vaccine in the United KingdomAustraliaNew ZealandCanada, the European Union and with the WHO. Additionally, Novavax and SK bioscience announced a Biologics License Application (BLA) submission to MFDS in South Korea.

Novavax expects to submit the complete package to the U.S. FDA by the end of the year.

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