FDA lifts hold on Novavax RSV vaccine trial

Shares of Novavax ($NVAX) surged this morning on the news that the FDA has lifted its clinical hold on a Phase I study of an experimental RSV vaccine. Back in November the biotech reported that it had received a question from the FDA regarding chemistry, manufacturing and controls which has now been resolved.

"We are excited to advance our vaccine candidate for RSV into clinical testing," said Dr. Rahul Singhvi, the CEO of the Rockville, MD-based vaccines company. "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."

The Phase I study follows the successful conclusion of the preclinical program for the vaccine in August. Its stock was up seven percent in early trading, according to Reuters.

- read the Novavax release
- here's the Reuters report

Suggested Articles

Novavax has inked a $60 million contract with the U.S. Department of Defense to help fund U.S.-based manufacturing of its COVID-19 vaccine candidate.

Since the Warp Speed selections went public, experts have been wondering why some drugmakers were left off.

A few years ago, one of our Fierce editors met a Big Pharma R&D chief for the first time. “You’re the ones with the scary name,” he joked.