Is There Life Left In The Novavax Clinical Program?

Novavax, Inc. NVAX announced positive data Monday for its Phase 2 safety and immunogenicity trial of RSV F Vaccine and identified a “path forward” for the efficacy study planned for 2018.

The stock was down about 6 percent at $1.42 a share at time of publication.

In the meantime, one biotech expert offered a critical analysis of the report. Adam Feuerstein, a reporter with STAT News, considered it deceptive, as the positive news pertained to safety rather than efficacy.

$NVAX “positive topline data” relate to safety and immunogenecity of RSV vaccine, not efficacy. Smoke, meet mirror.

— Adam Feuerstein (@adamfeuerstein) July 24, 2017

In September, the company reported missed primary endpoints in two other Phase 3 trials involving the drug, which prompted an 81 percent price drop. However, CEO Stan Erck and employees, based on proliferated insider buys, remained confident that the vaccine had potential.

"Over many years, we have consistently shown in well-accepted animal models that our vaccine stimulates protective immune responses in every way that we can measure,” Erck said at the time. “Further, over that same period, we have consistently shown in well-accepted animal models that our vaccine protects these animals when vaccinated and then challenged with RSV. In nine clinical trials in pediatrics, women of childbearing age, pregnant women, healthy adults, and in the older adult population, we have consistently shown robust immune responses by every measurement that we can make. Finally, in two trials in the older adult population, first in 1,600 older adults, and now in our rollover study arm that evaluated the impact of a second annual vaccination following an initial vaccination a year earlier, we have shown that our vaccine provides protection from Acute Respiratory Disease due to RSV infection."

Related Link:

After Phase 3 Novavax Trial Misses Endpoints, Piper Downgrades Despite Remaining Vaccine Efforts