J&J abandons RSV vaccine in major strategy shift

2023-03-29

临床3期疫苗并购

Dive Brief:

Johnson & Johnson will stop developing its experimental vaccine for respiratory syncytial virus in an unexpected retreat from a high-profile research effort that had put the pharmaceutical giant among the leading companies seeking to win the first approval of a preventive shot.

The company said Wednesday it will discontinue a 23,000-person Phase 3 trial, called Evergreen, of its RSV vaccine in adults following a review of its drug pipeline. The company does not plan to develop the shot for pregnant women or infants, a spokesperson confirmed.

J&J’s pullback comes amid a restructuring of its infectious disease division, which was reported by Fierce Pharma in February. Its decision also thins the RSV vaccine competition, leaving GSK and Pfizer in the lead with shots that are currently under review by the Food and Drug Administration. Moderna is also developing an RSV vaccine and could file for approval this year.

Dive Insight:

J&J’s decision to halt work on its RSV vaccine extends a series of setbacks for the company in infectious disease.

In January, the company halted a large trial of an HIV vaccine after disappointing results, and last month, a partner company said J&J was dialing back its hepatitis B research amid the unit’s restructuring. The company successfully developed an effective vaccine for COVID-19, but concerns over rare side effects limited its use in the U.S., where it became a distant third choice after vaccines from Pfizer and Moderna.

“The decision to discontinue the Company's RSV adult vaccine program is part of a broader effort to make strategic choices for its pipeline and research and development investments to focus on medicines with the greatest potential benefit to patients,” J&J said in its statement Wednesday.

J&J began the Evergreen trial in 2021 after data from a mid-stage study showed vaccination could prevent complications from RSV infection in older adults. The Phase 3 trial, which spanned more than 300 sites across 15 countries, made J&J one of the frontrunners in development of an RSV vaccine.

No results have been made public from the study, but J&J would have had a high bar to clear the marks set by RSV vaccines from GSK and Pfizer. GSK’s shot, called Arexvy, proved 83% effective in preventing cases of lower respiratory infection caused by RSV infection when compared to a placebo in a Phase 3 study of older adults. Pfizer’s was 67% effective against moderate disease in that company’s late-stage trial.

Both vaccines recently won the backing of an FDA panel, making approvals by the FDA later this spring more likely. (FDA advisers did express some concern around safety, particularly for Pfizer’s.)

J&J will share data from the Evergreen study with the scientific community in the future, the spokesperson said.

RSV infections are usually mild in healthy adults. But the disease can be more deadly in infants and older adults. Between 6,000 to 10,000 deaths occur from RSV in older adults each year in the U.S., according to data cited by the Centers for Disease Control and Prevention.

Like other pharmas, J&J has shifted its focus more heavily to cancer and immune disease drugs, which it expects will help it reach a target of $60 billion in pharmaceutical sales by 2025.

While J&J’s infectious disease unit sells several HIV treatments, it earns relatively little from vaccines. The company’s COVID vaccine generated sales of $120 million in the U.S. and $2 billion internationally last year. But in the fourth quarter, J&J reported no U.S. sales and incurred $821 million in costs related to scaling back its manufacturing of the shot.

Wednesday’s announcement comes four years after another RSV setback for J&J. The pharma took a $900 million write-off for an RSV drug it had obtained as part of a $1.75 billion purchase of Alios BioPharma in 2014. The accounting charge followed the company’s decision to halt mid-stage clinical work on the drug.

Ned Pagliarulo contributed reporting.

Editor’s note: This story has been updated with additional detail throughout.

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