Johnson & Johnson (NYSE:JNJ) announced Monday that it expects to begin clinical testing in humans evaluating its lead coronavirus vaccine candidate by September 2020 at the latest. It stated earlier this month that it would be November before clinical studies began. The healthcare giant thinks that the first batches of this vaccine could be available for emergency use authorization (EUA) early next year. EUA can be granted by the U.S. Food and Drug Administration (FDA) to make drugs and medical devices available during public health emergencies on a much faster basis than they would be ordinarily.
J&J's efforts to develop a vaccine protecting against the novel coronavirus disease COVID-19 began in January 2020, after the genetic sequence of the virus was released. The company worked with Harvard Medical School's Beth Israel Deaconess Medical Center to create and test multiple vaccine candidates.
One key to accelerating this process was the use of J&J's AdVac technology for rapid vaccine development. This technology, along with the company's PER.C6 system for fast, large-scale production of vaccines, was previously used to develop and make its Ebola vaccine and to develop experimental Zika, respiratory syncytial virus (RSV), and HIV vaccine candidates that are currently in clinical testing.
A typical vaccine takes five to seven years of testing before it can be reviewed for regulatory approval. J&J's ability to advance an experimental vaccine from initial discovery into clinical testing to potentially being available for emergency use in early 2021 underscores how quickly the company is moving with its response to the coronavirus.
Others in development
J&J isn't the only drugmaker working on COVID-19 vaccines. Other companies should also move soon into clinical testing, including Inovio and Novavax.