Johnson & Johnson CFO Joseph Wolk said the pause in its COVID-19 vaccine trial due to an unexplained illness in a study participant should not be seen as something unusual given the large size of the study group and sought to reassure the public that “every scientific, medical, and ethical standard is being applied here” as safety protocols are followed.
In an appearance on CNBC’s Squawk Box, Wolk responded to a question about Johnson & Johnson’s announcement on Monday that the company temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials. The company said the participant’s illness was being reviewed by an independent data safety monitoring board and the company’s internal clinical and safety physicians.
“We’re waiting for the independent drug safety monitoring board to do their analysis,” Wolk said, adding that there remain a number of unknowns to be worked out.
“We still don’t know whether it’s the placebo arm or the vaccination arm. We’re letting safety protocols follow proper procedure here and we’ll just have to wait for more information to unfold,” he said, adding, “pauses are something that are not uncommon.”
Given the large size of the study, which involves some 60,000 test subjects, he said “it probably should be somewhat expected that you would see a pause for an unexpected adverse event and we’re just letting the science dictate here.”
“What it should do, also, is reassure the public that every scientific, medical, and ethical standard is being applied here—not only at Johnson & Johnson but across the industry as we all search for a vaccine to combat COVID-19,” Wolk said.
Scott Gottlieb, former head of the Food and Drug Administration, took to Twitter on Tuesday to accentuate the role of oversight boards in COVID-19 vaccine trials, writing: “The scope of clinical trials underway for a Covid vaccine is unprecedented. Never before have so many massive trials been undertaken simultaneously in pursuit of a single goal. The oversight of safety boards is evidence of the integrity, rigor, and careful nature of this process.”
Stat News reported on Monday that a document sent to outside researchers running the Johnson & Johnson clinical trial had stated that a “pausing rule” has been met, the online system used to enroll patients in the study has been closed, and the data and safety monitoring board would be convened. The company said its pre-specified guidelines for clinical studies ensure that if an unexpected serious adverse event occurs, “there can be a careful review of all of the medical information before deciding whether to restart the study.”
The J&J COVID-19 vaccine is being developed by the company’s Janssen Pharmaceutical Companies. The company announced the start of its phase three trial in late September, becoming the fourth manufacturer to reach this phase in clinical trials amid the CCP (Chinese Communist Party) virus pandemic.
The phase three trial marks the final step before drug manufacturers can seek emergency use authorization to widely distribute their vaccines. There is no authorized vaccine for COVID-19 yet.
Johnson & Johnson is pursuing a single-shot vaccine, which is different from its three rival manufacturers that are testing vaccines that would require two shots separated by several weeks.
On Tuesday, Johnson & Johnson announced its quarterly earnings results, with the company raising its annual profit forecast for the second time this year.
Mimi Nguyen-Ly contributed to this report.