By Daniel R. Lucey M.D., MPH, FIDSA
In the past 24 hours both the Johnson & Johnson Phase 3 single-dose vaccine study, and the Eli Lilly monoclonal antibody study (studies?) have been paused, and their Data-Safety Monitoring Board (DSMB) convened to evaluate safety concern(s).
Johnson and Johnson (J&J) issued a statement saying:
“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.”The statement goes on to emphasize that this is a ”study pause” based on action taken by the study sponsor (J&J). In contrast, this action is not a “regulatory hold” that results from action by the FDA or another regulator health authority.
This study pause went into effect late yesterday. No further specific details regarding the unexplained illness have been presented yet.
Today The New York Times initially reported that Eli Lilly had placed a pause on one or more of its studies involving monoclonal antibodies. The company has several studies in different populations e.g., hospitalized or non-hospitalized patients with COVID-19, as well as in uninfected persons who are high-risk for exposure to SARS-CoV-2. Eli LIlly also has a single monoclonal antibody and a double monoclonal antibody against the virus. As of 5:30 p.m. ET, no press release was found on the Eli Lilly website that provides more specific information.
In my opinion, the pending Data Safety Monitoring Board evaluation results of these two studies will likely be forthcoming soon. It is to be hoped both studies will be able to proceed safely.
The Phase 3 AstraZeneca vaccine trial in the United States remains on hold since September 6. No participant has received a second dose.
Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee.He has served as a volunteer medical responder to outbreaks that included the West Africa Ebola crisis. He has collected information on outbreaks starting in 2001 with cases of anthrax in 2001, and including smallpox vaccination 2002, SARS 2003, H5N1 Flu 2004, MERS in 2013, and Ebola in April, 2014, He has gathered, and updated information on the spread of the coronavirus here since Jan. 6.