Interim Results of a Phase 1–IIa trial of JNJ-78436735 Covid-19 Vaccine published in NEJM.- Johnson & Johnson

Interim Phase 1/IIa data were published in the New England Journal of Medicine demonstrating that the Company’s single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) – being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. A preview of part of these interim data was posted on medRxiv in September 2020. The Phase 1/IIa interim analysis showed that the Company’s COVID-19 vaccine candidate induced an immune response and was generally well-tolerated across all study participants. Data demonstrated that, after a single vaccination, neutralizing antibodies against COVID-19 were detected in over 90 percent of study participants at Day 29 and 100 percent of participants aged 18-55 years at Day 57. These neutralizing antibodies remained stable through Day 71, currently the latest timepoint available in this ongoing study, in all participants aged 18-55 years. Data on durability of immune responses in trial participants aged over 65 years will be available in late January and longer-term follow-up to one year is planned. The Company anticipates announcing topline Phase III data for its single-dose Janssen COVID-19 vaccine candidate in late January 2021; however, as this trial is dependent on disease events, the timing is approximate. If the single-dose vaccine is shown to be safe and effective, the Company expects to submit an application for Emergency Use Authorization with the U.S. Food and Drug Administration shortly afterwards, with other regulatory applications around the world to be made subsequently.vaccine. "Interim Results of a Phase 1–IIa Trial of Ad26.COV2.S Covid-19 Vaccine"_ Gerald Sadoff, M.D., Mathieu Le Gars, Ph.D., Georgi Shukarev, M.D., Dirk Heerwegh, Ph.D., et al.-January 13, 2021 DOI: 10.1056/NEJMoa2034201.