Novavax secures grant to support RSV F vaccine development

Novavax expects to start the trial during the first quarter of next year. The grant will also support the company’s regulatory licensing initiatives for WHO prequalification.

After licensing, the company agreed to make the vaccine accessible to people in the developing world.

Data from a phase 2 clinical trial revealed that immunizing pregnant women with its RSV vaccine was effective in protecting infants when they are most at risk.

The trial tested the vaccine against a placebo in 50 healthy pregnant women in their third trimester. Women in the vaccinated group showed a geometric mean 14-fold increase in anti-F IgG, 29-fold rise in PCA, and 2-fold rise in microneutralization titers.

Novavax said women who received placebo demonstrated no significant change in their antibody levels.

Novavax president and CEO Stanley Erck said: "Along with today’s announcement of top-line data from the Phase 2 clinical trial of our RSV F Vaccine with the goal to protect infants via maternal immunization, we are very gratified to receive the support of the Bill & Melinda Gates Foundation to improve the health of infants throughout the world.

"Our groundbreaking Phase 2 results in both maternal and older adult target populations, underscore the promise of our RSV F Vaccine programs. We look forward to carrying our recent momentum into the fourth quarter as we prepare to initiate two pivotal Phase 3 trials of our RSV F Vaccine."

The company said respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children globally, with projected annual infection and mortality rates of 64 million and 160,000, respectively.