Gaithersburg-based Novavax in phase 3 of coronavirus vaccine trials

There is hope on the horizon, and it's coming from a local drug developer.

Novavax, which is based in Gaithersburg, is now the 5th company to start phase three vaccine trials in the U.S. 

READ MORE: Maryland-based company gets $1.6B from government to develop coronavirus vaccine

The company said they were delayed due to issues in scaling up the manufacturing process.  

Novavax is starting to enroll upwards of 30,000 people across 115 sites across the country and Mexico. 

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FOX 5's Shirin Rajaee spoke with Dr. Gregory Glenn, the President of research and development at Novavax about how their vaccine is significantly different from Modernas' and Pfizers', starting with the fact that it's not an MRNA model vaccine. 

"MRNA is kind of a genetic immunization-- they take a part of a gene and that is injected into the human cells, and the humans getting that are getting that, make the protein and you get an immune response to the protein-- well  we make the protein, so we're a much more traditional vaccine, that's how vaccines have been created for years... we know they're safe," said Dr. Glenn. 

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He adds, "the way we make the vaccine-- is we make the spike protein itself, we inject the protein, we get an immune response to it. and that  immune response puts a cork on the spike's very effective."  

Dr. Glenn says they had very good results from their Phase 1 and 2 trials. 

They did not have any allergic reactions among their trial participant groups in the U.K and South Africa.  

He says vaccine symptoms have been mild-- some soreness at the injection site, some headaches-- but all symptoms have been short lived.

Now in this phase 3 trial in the U.S., two thirds of the participants will actually get the vaccine--it will be two shots administered 21 days apart.

He says diversity in participants  will be critical for Novavax.  

"It's designed to have 25% participants over 65, 15% African American, at least 20% Latinx and a smaller group of Native Americans. But that creates a really nice profile in terms of representing the populations that are at risk for covid disease, and giving them confidence that they can use it safely," said Dr. Glenn. 

Dr. Glenn also addressed the new variant strain of coronavirus found in the U.K. 

"We kind of expected this as covid viruses evolve... Our vaccine immunizes in a way where we're not susceptible to these small mutations, which can escape natural immunity but it shouldn't escape our vaccine immunity," he said. 

Novavax already has trials going on right now in the U.K. It's a phase three trial-- with about 15-thousand participants and a trial in South Africa with about four thousand people.
Safety and efficacy data from these trials are expected in just weeks.
Dr. Glenn says they may be able to get FDA approval as early as January-- with the data out out of the U.K and South Africa-- two areas where the virus runs rampant.  

But if not-- the expected timeline for Phase 3 trials to end in the U.S. is about March/April. 

Also, unlike how Pfizer's vaccine must be transported and stored at extremely low temperatures and even Moderna's,  Novavax's vaccine will not require that-- just regular refrigeration.