An investigational COVID-19 vaccine developed by Janssen Pharmaceuticals, part of Johnson & Johnson, appears to be safe and effective at preventing moderate and severe COVID-19 in adults, according to an interim analysis of Phase 3 clinical data conducted Jan. 21, according to a press release from the National Institutes of Health (NIH).
The vaccine, called Ad.26.COV2.S or JNJ-78436725, requires only a single injection and can be stored in a refrigerator for months.
The interim analysis assessed 468 cases of symptomatic COVID-19 among 44,325 adult volunteers in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. The investigational vaccine was reportedly 66 percent effective at preventing the study's combined endpoints of moderate and severe COVID-19 at 28 days post-vaccination among all volunteers, including those infected with an emerging viral variant.
Moderate COVID-19 was defined as laboratory-confirmed SARS-CoV-2 plus either one of the following: evidence of pneumonia; deep vein thrombosis; difficulty breathing; abnormal oxygen saturation or a respiratory rate equal to or greater than 20; or two or more signs or symptoms suggestive of COVID-19, such as cough, sore throat, fever or chills. Severe COVID-19 was defined as laboratory-confirmed SARS-CoV-2 plus evidence of clinical signs at rest indicative of severe systemic illness, respiratory failure, shock, significant organ dysfunction, hospital intensive care unit admission or death.
Geographically, the level of protection for the combined endpoints of moderate and severe disease varied: 72 percent in the United States; 66 percent in Latin American countries; and 57 percent in South Africa, 28 days post-vaccination. The investigational vaccine was reportedly 85 percent effective in preventing severe/critical COVID-19 across all geographical regions. No deaths related to COVID-19 were reported in the vaccine group, while 5 deaths in the placebo group were related to COVID-19. Overall, there were 16 deaths in the placebo group, and 3 deaths in the vaccine group.
The Janssen vaccine is a recombinant vector vaccine that uses a human adenovirus to express the SARS-CoV-2 spike protein. Adenoviruses are a group of viruses that cause infections in the respiratory and gastrointestinal tracts; the adenovirus vector used in the experimental vaccine has been modified, so that it can no longer replicate in humans and cause illness. In developing the vaccine, Janssen employed the same vector used in the first dose of its prime-boost vaccine regimen against Ebola virus disease (Ad26 ZEBOV and MVN-BN-Filo), developed under a long-standing partnership with BARDA and granted marketing authorization by the European Commission in July 2020.
The Janssen Pharmaceutical served as the regulatory sponsor of the Phase 3 clinical study known as ENSEMBLE. Janssen; the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH; and the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, funded approximately 55 percent of the trial through a cost-sharing agreement.