Maryland-Based Novavax COVID-19 Vaccine Found Safe And Effective In UMMS Trial
BALTIMORE (WJZ/AP) -- A COVID-19 vaccine made by Gaithersburg-based manufacturer Novavax was found to be safe and effective in a Phase 3 trial by the University of Maryland School of Medicine.
The study found the company's vaccine 90% effective at preventing COVID-19 illness and 100% effective in preventing moderate and severe disease that required hospitalization.
The study was conducted in the first few months of the year with nearly 30,000 volunteers in the U.S. and Mexico. At the time, Alpha was the dominant COVID-19 strain, so the trial did not account for the Delta and Omicron variants.
"Our study results indicate that this vaccine is highly efficacious and very safe. In addition, this vaccine has many attractive features. It is made from a small piece of protein, like many currently licensed vaccines in the U.S. and has convenient refrigerator storage requirements, so it will be an important addition to the COVID-19 vaccine portfolio, in the U.S. and in countries where supply is lacking," said Dr. Karen Kotloff, a Co-Chair for the trial.
Novavax and the National Institute of Allergy and Infectious Disease provided some funding for the study.
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.
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 Kingdom, Australia, New Zealand, Canada, 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.
