Respiratory syncytial virus vaccines could be approved and ready for arms by next fall, but a Johnson & Johnson shot won’t be among them. The pharmaceutical company on Wednesday announced it is pulling out of RSV vaccine research and stopping a Phase 3 study that aimed to enroll more than 23,000 people.
By withdrawing from RSV research, J&J is ceding this market to GSK and Pfizer, both of which have vaccines under FDA review. In its announcement, J&J said its decision followed a portfolio review to “prioritize the most transformational assets.”
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Like other RSV vaccines in various stages of development, the RSV research of J&J’s Janssen division focused on the F protein that this virus uses to enter cells. The J&J shot was designed to show the immune system a prefusion form of the protein (preF) in order to elicit an immune response. In late 2021, the pharmaceutical company reported its Phase 2b clinical trial met its goals, showing vaccine efficacy that ranged from 70% to 80% in adults 65 and older. Based on those results, the company proceeded with its Phase 3 clinical trial.
Despite the strong mid-stage results, J&J may have concluded its RSV vaccine would not be competitive with rival products. Cross trial comparisons come with many limitations, but the vaccine efficacy results posted by J&J are short of the marks achieved by RSV vaccines from GSK and Pfizer, both of which topped 80%. J&J’s results are also short of the vaccine efficacy reported by Moderna, which has said it expects to file an application with the FDA in the first half of 2023.
Last month, a Fierce Biotech article that cited internal company documents reported that J&J was conducting a comprehensive review of its portfolio. The moves included housing vaccines and infectious diseases within a single unit and implementing layoffs throughout the company. The RSV program is now one of the casualties of that plan.
“By periodically refocusing our portfolio, Janssen ensures that we are deeply invested in products that have the power to transform patients’ lives,” Bill Hait, executive vice president, chief external innovation and medical officer and interim head, Janssen R&D, said in the announcement. “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.”
Public domain image by the CDC
