Novavax Provides Updates on the Global Pathways to Licensure for ResVax™
The U.S. Food & Drug Administration( FDA) has recommended that Novavaxconduct an additional Phase 3 clinical trial to confirm efficacy against medically significant RSV disease in infants born to mothers vaccinated with ResVax.
Novavaxhas 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 milliongrant in support of the Prepare trial, continues to work with Novavaxon 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
AboutRSV in Infants
Globally, RSV (respiratory syncytial virus) is the leading viral cause of severe lower respiratory tract disease in infants and young children. It is the second leading cause of death in children under one year of age. Estimated annual hospitalizations of 1.4 million and an estimated 27,300 in-hospital deaths were due to RSV acute lower respiratory infection in children under six months of age. RSV results in a total global economic burden of
In the U.S., RSV is the leading cause of hospitalization of infants, with estimated annual hospitalizations of up to 76,000. While RSV can impact all infants, babies under six months of age are among those at highest risk, as approximately 77% of all first-year RSV infections occur before six months. In the U.S., the total economic burden is
ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. ResVax is being evaluated in Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom received the vaccine, and their infants. Prepare is supported by an
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Source: Novavax, Inc.