With GlaxoSmithKline, Pfizer and others in the running, Johnson & Johnson may need excellent data to capture the RSV vaccine market. The Big Pharma gave a further show of its credentials on Tuesday by sharing additional data from a study of thousands of seniors.
J&J shared top-line findings from the phase 2b clinical trial two months ago, revealing it hit its primary endpoint by linking the vaccine to 80% efficacy against confirmed RSV-associated lower respiratory tract disease. At that time, J&J also said the vaccine demonstrated 70% efficacy against any symptomatic RSV-associated acute respiratory infection.
This week’s Eighth European Scientific Working Group on Influenza meeting gave J&J an opportunity to share more data from the study. In a statement to discuss the update, J&J split out the efficacy of the vaccine against three case definitions.
The three definitions are: three or more symptoms of lower respiratory tract infection (LRTI); two or more symptoms of LRTI; and two or more symptoms of LRTI or one or more symptom or LRTI and one or more systemic symptom. The vaccine provided protection regardless of the criteria, with efficacy of 80%, 75% and 70% against, respectively, the first, second and third definitions.
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“We have now shown strong efficacy against a range of lower respiratory tract disease severities, and believe our vaccine has the potential to prevent the significant morbidity and mortality caused by RSV,” Penny Heaton, M.D., global therapeutic area head for vaccines at Janssen, said in a statement.
J&J also spoke about the symptoms in vaccinated patients who contracted RSV. After analyzing the RSV-specific patient-reported outcomes data, J&J found symptoms in the vaccinated subjects were less severe than in their peers who received placebo. The milder symptoms were accompanied by a faster return to usual health.
A phase 3 study is up and running. J&J disclosed the start of the study days before posting the phase 2b results, putting it on track to reach the primary completion of the 23,000-subject trial in June 2023, according to ClinicalTrials.gov.