Janssen Halts Phase III RSV Vaccine Development Amid Intensifying Competition from GSK, Pfizer, and Moderna

On March 29, Janssen Pharmaceuticals, a Johnson & Johnson company, announced that after reviewing its portfolio to determine product development priorities and assessing the prospects of the respiratory syncytial virus (RSV) vaccine, it has decided to withdraw from the RSV adult vaccine program and terminate the ongoing Phase III EVERGREEN study.

EVERGREEN Study is a randomized, double-blind, placebo-controlled large-scale Phase III clinical trial that has enrolled 23,000 participants to evaluate the efficacy and safety of VAC18193 (JNJ-64400141) in preventing RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years and older.

Janssen Pharmaceuticals stated that the decision is part of a broader effort to make strategic choices regarding pipeline and research and development (R&D) investments, with the aim of focusing on developing drugs that offer the greatest potential benefit to patients.

"Bill Hait, M.D., Ph.D., Executive Vice President, Chief External Innovation and Medical Officer, and Interim Head of Janssen Research & Development, said: 'Janssen Pharmaceuticals consistently recalibrates its portfolio to ensure deep investment in products that can transform patients' lives. We remain focused on advancing our differentiated pipeline, improving the lives of millions of patients, and developing new drug modalities in areas of unmet medical need.'"

It's hard to say that Janssen Pharmaceuticals' decision has nothing to do with the strong breakthrough of GSK and Pfizer's RSV vaccines.

RSV is the most common cause of lower respiratory tract infections, with both the elderly and infants being susceptible populations. According to statistics, approximately 102,000 children and 29,000 adults worldwide die annually from RSV infections. HoweverThere is still no preventive regimen available for all infants and the elderly., existing therapeutic drugs are also limited to alleviating symptoms.

GSK and Pfizer are the two fastest-moving companies in the RSV prevention field, each with an RSV vaccine for the elderly expected to be approved by the FDA in May this year. Additionally, Pfizer's RSV vaccine is also suitable for infants (maternal active immunization).

The protective efficacy of GSK3844766A and PF-06928316 in the elderly population (referring to the reduction in the occurrence of RSV-related lower respiratory tract diseases) is respectively82.6%And66.7%, The protective efficacy of PF-06928316 against serious lower respiratory tract diseases requiring medical care in infants within 90 days of birth is81.8%Just a month ago, the FDA advisory committee voted to support the safety and efficacy of these two products, and the FDA is expected to readily approve their marketing applications. At that time, the dilemma of being unable to prevent RSV infections will be broken.

In addition to GSK and Pfizer, Moderna is also a strong competitor of Janssen Pharmaceuticals. In January 2023, Moderna announced that the Phase III ConquerRSV study of mRNA-1345 had met its primary endpoint, with the product demonstrating protective efficacy against RSV infection in the elderly population.83.7%And, Moderna has also decided to submit the marketing application for mRNA-1345 to regulatory authorities in the first half of this year.

Actually, the protective efficacy of Janssen Pharmaceuticals' VAC18193 is not bad, achieving an 80% protection rate in Phase IIb studies. However, its development progress lags far behind GSK, Pfizer, and Moderna (Phase III studies have yet to be completed), losing the first-mover advantage. Under these circumstances, Janssen Pharmaceuticals’ decision to cut its losses seems inevitable. Nevertheless, Johnson & Johnson announced last month that it would continue to focus on RSV vaccine development while merging its vaccine and infectious disease business units. The current decision to withdraw from the RSV project raises suspicions about whether the Phase III data fell short of expectations.

The RSV market in China remains a blue ocean, with only Advaccine (ADV110, Phase II) and Nuance Pharma (MVA-BN RSV, approved for clinical trials) developing vaccine products (excluding companies whose products are still in the preclinical stage), while Ark Biopharma, Ascletis Pharma, and LianBio focus on developing RSV therapeutic drugs. Recently, GSK has submitted a clinical trial application for GSK3844766A in China. The future of RSV vaccine products in China remains uncertain.

Copyright © 2023 PHARMCUBE. All Rights Reserved.

Welcome to forward, share, and reasonably cite. When citing, please clearly indicate the source of the article; for republication, please leave a message on the WeChat Official Account or send a message, specifying the name and ID of the official account.

Disclaimer: The information in this WeChat article is for general reference only and should not be used directly as decision-making content. PharmaCube assumes no responsibility for any loss incurred by any party due to the use of the content herein.

Wonderful Live Broadcast

CUBE LIVE