Novavax’s respiratory disease vaccine fails in phase 3 trial

In the Resolve phase 3 trial of 11,856 older adults (60 years of age and older), the vaccine did not meet its efficacy goals, including the primary objective related to prevention of moderate-severe lower respiratory tract disease.

The drug also did not meet its secondary efficacy goal in the phase 3 trial. The vaccine was well-tolerated.

Novavax president of research and development Gregory Glenn said: “We are both surprised and disappointed by the outcome of the Resolve trial, which we recently unblinded. Our initial analyses and review of the key aspects of the trial do not indicate issues with trial execution, data collection, data integrity, or drug product quality.

“We expect to have preliminary immunogenicity data in the coming weeks to further our understanding of the trial results.”

In a separate phase 2 rollover trial, Novavax observed absence of efficacy of a single immunization, but said it did observe that a second season immunization could offer efficacy.

The randomized, observer-blinded, placebo-controlled phase 2 rollover trial enrolled 1,329 older adults from the prior phase 2 study, undertaken at the same 10 sites in the US.

It showed immunogenicity in all active vaccine recipients. There was a 6-fold increase in anti-F IgG in the Placebo-Vaccine arm, consistent with the phase 2 efficacy trial.

Novavax said there was higher anti-F IgG at baseline in the Vaccine-Vaccine arm compared to the Placebo-Vaccine arm.

The Vaccine-Vaccine arm demonstrated a greater than 2-fold increase in anti-F IgG from the higher baseline.