Novavax Inc, Rockville, Md, has received US Food and Drug Administration (FDA) clearance to go ahead with its phase 1 clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing, and controls (CMC). The FDA’s questions have been resolved.
Preclinical studies of Novavax’s vaccine candidate were conducted on 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 virus.
Source: Novavax Inc