J&J Drops Out of RSV Race, Cuts Late-Stage Vaccine Candidate

Pictured: Janssen building with logo/courtesy of Niels Wenstedt/BSR Agency/Getty Images

The RSV race has lost one high-profile contender as Johnson & Johnson's Janssen Pharmaceutical announced Wednesday it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.

This decision follows a review of the evolving RSV vaccine landscape, a J&J spokesperson told BioSpace in an email.

Terminating the RSV program is also part of a wider review of Janssen’s pipeline and R&D activities, with the goal of refocusing its resources on initiatives and products that could yield the largest benefit to patients, according to the press release.

Initiated in September 2021, EVERGREEN is a randomized, double-blinded and placebo-controlled study that enrolled 27,200 participants aged 60 years and above. The trial was designed to confirm the safety and efficacy of Janssen’s vaccine candidate in preventing lower respiratory tract disease secondary to RSV infection.

The company has yet to post data from EVERGREEN, but in the Phase IIb CYPRESS trial, Janssen’s candidate had a vaccine efficacy of 80% in participants aged 65 and older. CYPRESS also showed that the candidate could elicit robust humoral and cellular immune responses after inoculation and allowed recipients to return to usual health quicker than placebo comparators, Janssen reported in December 2021.

The FDA gave Janssen’s investigational RSV shot Breakthrough Therapy Designation in September 2019.

The last few months have been difficult for Janssen’s vaccine business. In January, the company discontinued its Phase III Mosaico trial in HIV following an independent data review that found its investigational vaccine regimen could not significantly prevent the disease.

Mosaico is J&J’s second HIV failure. In August 2021, the Phase IIb Imbokodo trial missed its primary endpoint when the company’s vaccine regimen could not significantly distinguish itself from placebo as a treatment for young women in sub-Saharan Africa at high risk of acquiring HIV. J&J also discontinued Imbokodo.

In May 2022, Janssen walked back on its HPB and HBV vaccine collaboration with Bavarian Nordic. The same month, the FDA restricted the use of the company’s COVID-19 vaccine due to clotting concerns.

The RSV Frontrunners

With J&J now out of the running, the RSV race boils down to its two frontrunners: Pfizer and GSK.

GSK is slightly ahead. The FDA gave the company's vaccine candidate priority review in November 2022, while Pfizer won this designation in December 2022. Both companies are advancing investigational shots to prevent RSV-caused lower respiratory tract disease in older adults aged 60 and above.

Both candidates also show comparably high levels of efficacy. Against severe disease, GSK’s candidate was 94.1% in the Phase III AReSVi-006 trial, while Pfizer’s Phase III RENOIR trial found an 85.7% vaccine efficacy. 

In February, the FDA’s Vaccines and Related Biological Products Advisory Committee backed GSK’s and Pfizer’s candidates and recommended their approval. The FDA’s final verdicts for both vaccines are expected in May 2023.

Correction (April 6): An earlier version of this story compared GSK's overall efficacy with Pfizer's severe disease efficacy. It has been corrected to compare severe disease numbers.