Novavax (NVAX) Provides Updates on Global Pathways to Licensure for ResVax

June 10, 2019 7:09 AM EDT

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Novavax, Inc. (NASDAQ: NVAX) a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced updates on the pursuit of global licensure for ResVax™ following the Prepare™ Phase 3 clinical trial.

  • The U.S. Food & Drug Administration (FDA) has recommended that Novavax conduct an additional Phase 3 clinical trial to confirm efficacy against medically significant RSV disease in infants born to mothers vaccinated with ResVax.
  • Novavax has recently held meetings with several European national regulatory agencies to solicit input on the Prepare trial and possible pathways to licensure in Europe. The next step will be to seek formal scientific advice this fall from the European Medicines Authority (EMA), the agency responsible for licensing vaccines for the European Union.
  • Bill & Melinda Gates Foundation, which provided an $89.1 million grant in support of the Prepare trial, continues to work with Novavax on a path to introduce ResVax to low and middle income countries.

“We remain encouraged by the ResVax efficacy observed with more severe RSV disease and hospitalizations. These data, coupled with the favorable safety profile of ResVax, demonstrate a positive public health benefit that warrants continued development to address the global unmet medical need in preventing serious RSV disease,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We aim to identify pathways to licensure that allow pregnant women globally to be vaccinated, so that their babies are protected from the serious short- and long-term consequences of RSV disease.”

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