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Stories from the NFCCA Newsletter, the “Northwood News” |
Northwood News ♦ February 2021
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.)
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. ■
© 2021 NFCCA [Source: https://nfcca.org/news/nn202102a.html]