RSV vaccine's star falls further following FDA setback

Hopes for Novavax’ (Nasdaq: NVAX) once highly-anticipated respiratory syncytial virus (RSV) shot, ResVax, were dealt a new blow on Monday, as the US regulator said an additional Phase III trial would be needed.

With research funded by an $89.1 million grant from the Bill & Melinda Gates Foundation, Novavax has been in discussions with the US Food and Drug Administration in relation to data from the Phase III Prepare trial.

In February 2019, the firm’s share price plummeted after it said the trial did not meet its primary objective of prevention of medically significant RSV lower respiratory tract infection (LRTI).