Novavax, Inc. 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.”