Johnson & Johnson Pauses Coronavirus Vaccine Trial After Illness
NEW BRUNSWICK, NJ — Johnson & Johnson announced Monday night they "temporarily paused" their COVID-19 vaccine trial, due to one of the 60,000 trial participants developing an unexplained illness.
Johnson & Johnson — which is in the final phase of its landmark trial and were expecting to know by December if their vaccine worked — said it could not say whether their vaccine made the person sick, nor did they disclose the person's symptoms. There is also a chance the illness is completely unrelated, as many participants have been given a placebo.
"We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant," said Johnson & Johnson in this statement. "Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as our internal clinical and safety physicians ... It might be related to a vaccine or study drug, so there can be a careful review of all of the medical information before deciding whether to restart the study."
As Patch previously reported, Johnson & Johnson is in the third and final stage of its trial to develop a coronavirus vaccine. Johnson & Johnson said it will know by the end of 2020 whether its vaccine works. Other pharma companies, such as Pfizer and Moderna, may have a vaccine ready even before that.
Johnson & Johnson, headquartered in New Brunswick, would not say what this new illness is or even disclose symptoms, citing the test participant's privacy.
But the illness is serious enough to qualify as what the scientists call "an unexpected serious adverse event (SAE)."
"SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants," said Johnson & Johnson in Monday night's statement. "Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received (the vaccine) or a placebo."
Johnson & Johnson also stressed that this is a voluntary "study pause" they initiated and not a "regulatory hold" imposed by the U.S. Food & Drug Administration.
Johnson & Johnson's coronavirus vaccine trial is the largest in the world: The company enrolled up to 60,000 volunteers across three continents to take their coronavirus vaccine. The study participants are 18 years old and older, "including significant representation from those that are over age 60," said Johnson & Johnson.
The trial includes those both with and without comorbidities (pre-existing conditions that can make coronavirus more deadly) and included participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.
In the U.S., their trial includes significant representation of Black, Hispanic/Latino, American Indian and Alaskan Native participants.
These voluntary participants are given a single vaccine dose of the vaccine compared to a placebo, and scientists study how well it does preventing COVID-19. Unlike other pharmaceutical companies working on a cure, the Johnson & Johnson vaccine would require just one shot instead of two.
If all goes well with this final trial, Johnson & Johnson anticipates the first batches of its COVID-19 vaccine will be available for emergency use in the United States in early 2021.
Johnson & Johnson has long maintained they are developing the vaccine on a non-profit basis, even for the U.S. market, and announced last week they are partnering with the Bill & Melinda Gates Foundation to give up to 500 million doses of that vaccine to poorer countries around the world. Johnson & Johnson did not specify which countries would get it for free.
Patch's reporting on Johnson & Johnson's coronavirus vaccine: Johnson & Johnson Begins Final Trials Of Coronavirus Vaccine (Sept. 23)
Johnson & Johnson To Give Poor Countries 500M Free COVID Vaccines (Oct. 8)
This article originally appeared on the New Brunswick Patch
