One of D.C. area’s largest biotech companies received one of the most important approvals from a government body for its COVID-19 vaccine.
Gaithersburg-based Novavax (NASDAQ: NVAX) is granted emergency use authorization from the European Medicines Agency (EMA). The organization conducts scientific evaluation on drugs to be authorized for marketing in the European Union and is equivalent to the Food and Drug Administration in the United States.
Being marketed as Nuvaxovid COVID-19 Vaccine, it is the first protein-based COVID-19 vaccine to be granted approval for use in Europe. It also marks the fifth COVID-19 vaccine recommended by the agency.
Novavax’s manufacturing partner, the Serum Institute of India (SII), will supply initial doses that will be distributed to EU countries.
"We welcome today's European Commission decision reflecting the first authorization of a protein-based COVID-19 vaccine for the people of the E.U.," said Stanley C. Erck, President and Chief Executive Officer, Novavax.
"We thank the European Medicines Agency, the Committee for Medicinal Products for Human Use reviewers and the European Commission for their thorough assessment as we look forward to playing a critical role in helping to address the continued threat of COVID-19. We also thank the thousands of clinical trial participants, our partners and Novavax employees worldwide who have contributed to this historic milestone."