FDA clears Novavax's Phase I clinical trial to evaluate new RSV vaccine candidate

Novavax, Inc. (Nasdaq: NVAX) announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold.  In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.

Preclinical studies of Novavax's vaccine candidate to prevent RSV infection were conducted in cotton rats, a well-accepted animal model of RSV infection and disease. Results showed induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement.  After the RSV challenge, no detection of disease was observed in any of the animals immunized with the vaccine candidate at any dose level tested.  Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus.  There is currently no approved vaccine to prevent RSV infection.

"We are excited to advance our vaccine candidate for RSV into clinical testing," said Dr. Rahul Singhvi, President and CEO of Novavax.  "This is a significant accomplishment and represents the second major internally discovered vaccine program based on our core platform technologies. RSV is the leading cause of viral death in infants and a common illness in elderly adults.  A safe and effective vaccine is especially needed in these populations since RSV infection does not provoke lasting immunity."