Johnson & Johnson Halts Phase 3 RSV Vaccine Trial

This week, the Janssen Pharmaceutical Companies of Johnson & Johnson announced it had stopped its EVERGREEN phase 3 trial for its RSV investigational vaccine that was developed for adults 60 years and older.

The company said it decided to do so after reviewing the current adult RSV market.

“By periodically refocusing our portfolio, Janssen ensures that we are deeply invested in products that have the power to transform patients’ lives,” Bill Hait, MD, PhD, executive vice president, chief external innovation and Medical officer and interim head, Janssen R&D, said in a statement. “We remain focused on advancing our differentiated pipeline, improving the lives of millions of patients and developing new modalities in areas with the greatest unmet medical need.”

The decision to discontinue the 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, according to the company’s announcement.

In the last few weeks, there has been a lot of movement in this market, especially from GSK and Pfizer. They each had a meeting with the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review their data. After doing so, the committee voted to recommend each of the RSV vaccine candidates, which were developed for the senior population.

Decisions on potential FDA approvals for both vaccines could happen this spring.