FDA clears Novavax RSV vaccine candidate for early stage trial

Novavax resolves question about chemistry, manufacturing and controls

The US Food and Drug Administration (FDA) has given its clearance for a Phase I clinical trial to evaluate a new vaccine candidate from Novavax to prevent respiratory syncytial virus (RSV) infection.

In November, the FDA had put the trial on hold and asked Novavax to resolve a question about chemistry, manufacturing and controls (CMC), which has now been resolved.

Preclinical studies of Novavax's vaccine candidate to prevent RSV infection were conducted in cotton rats and results showed induction of neutralising 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 immunised with the vaccine candidate at any dose level tested.

‘This is a significant accomplishment and represents the second major internally discovered vaccine programme based on our core platform technologies,’ said Rahul Singhvi, president and chief executive of Novavax.

RSV is the most common cause of lower respiratory tract illnesses in infants and young children worldwide. More severe lower respiratory tract disease is also seen in adults over 65. It is estimated that RSV infects more than 8.5 million adults annually.

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