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 which showed induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement.
Novavax president and CEO Rahul Singhvi said that they are excited to advance their vaccine candidate for RSV into clinical testing.
"This is a significant accomplishment and represents the second major internally discovered vaccine program based on our core platform technologies," Singhvi said.