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Stories from the NFCCA Newsletter, the “Northwood News”

Northwood News ♦ February 2021

Local Biotech Company Now Developing a COVID-19 Vaccine

By Sharon Canavan

Novavax, a Gaithersburg-based biotechnology company, recently began a late-stage trial of its COVID-19 vaccine.  To speed research efforts and help fund clinical trials, the company received $1.6 billion in taxpayer funding under the U.S. government’s “Operation Warp Speed” program and up to an additional $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).  The company’s COVID-19 vaccine candidate has also been given Fast Track designation by the U.S. Food and Drug Administration (FDA).

At the end of 2020, Novavax began two large Phase 3 clinical trials in the United States and Mexico.  An active vaccine will be administered to two-thirds of the 30,000 volunteers enrolled in this study.  Anthony S. Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases, stated that, “The launch of this study — the fifth investigational COVID-19 vaccine candidate to be tested in a Phase 3 trial in the United States — demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines.”  Further information about the Novavax clinical trial is available on the National Institute of Health website at https://clinicaltrials.gov/ ct2/show/NCT04611802.

As reported in The New England Journal of Medicine, Novavax found that its Phase 1/2 studies demonstrated “that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.”  (See www.nejm.org/doi/full/10.1056/NEJMoa2026920.)


A Novavax scientist in Gaithersburg, Maryland, conducting vaccine development research under a laboratory hood.
Once FDA approval is secured, Novavax projects it will begin delivering vaccine doses as early as mid-year 2021.  Similar to other Covid-19 vaccines, the Novavax vaccine will require two doses.  One of the Novavax vaccine’s important advantages, however, is its stability; it can be stored, handled, and shipped at above-freezing temperatures (35 to 46 degrees Fahrenheit) rather than the sub-zero temperatures required by other Covid-19 vaccines.  This will make the Novavax vaccine more suitable for distribution to clinics that lack sub-zero freezer capacity, which is a challenge in rural areas in the U.S. and in countries with limited medical infrastructure.  Novavax has already negotiated vaccine purchase agreements with the U.S., Canada, and other countries in Europe, Australia, and Asia.

As is evident from the slow rollout of the existing Covid-19 vaccines, adequate manufacturing capacity and production is a major stumbling block to ramping up vaccination supplies.  Early on during its clinical testing stage, Novavax teamed up with another Maryland-based company, Emergent Biosolutions, which assisted with contract development and manufacturing organization.

Novavax is now building out its manufacturing production capacity.  In November 2020, the company purchased additional properties in Gaithersburg for additional laboratory and manufacturing space.  The company has also taken steps to build out its international production network to boost manufacturing and support for its global distribution efforts.   ■


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