J&J Quits RSV Development With Two Rivals Already Poised For US Approval

The pharma, which has been de-emphasizing vaccines and infectious disease of late, will end its Phase III trial for an RSV vaccine with May approvals pending for both Pfizer’s and GSK’s candidates.

Janssen Pharmaceutica sign and logo
J&J steps away from RSV vaccine development • Source: Michael Vi / Shutterstock.com

Johnson & Johnson revealed on 29 March that it is ending development of its respiratory syncytial virus (RSV) vaccine candidate, effectively shuttering its 20,000-plus patient Phase III study mid-stream, due to the fact that competitors appear likely to beat them to the market. GSK plc and Pfizer Inc. have RSV candidates filed for approval at the US Food and Drug Administration with action dates in May. J&J said enrollment was ongoing at the time of its decision.

J&J was roughly a year behind its two peers in terms of reporting data from the pivotal EVERGREEN study. Its adult vaccine candidate is an adenovirus vector vaccine combined with a soluble protein. GSK’s candidate has a 3 May action date at FDA, while Pfizer’s candidate, filed for priority review on 7 December, also is due for an FDA decision in May

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