This story was updated Oct. 14, at 10:18 a.m., with reports the FDA has flagged an Eli Lilly plant for quality control issues.
Oct. 13, 2020 -- Johnson & Johnson paused dosing and enrollment in all of its COVID-19 vaccine clinical trials due to an unexplained illness in a study participant, the company announced Monday.
Later in the day, Eli Lilly had to acknowledge a pause of a clinical trial of antibody treatment because of a “potential safety concern,” The New York Times reported, citing emails U.S. government officials sent to researchers.
Eli Lilly had been testing the treatment on hospitalized COVID patients, all of whom also received remdesivir.
In a statement to the Times, Eli Lily spokesperson Molly McCully confirmed the pause in the trial and said, “Safety is of the upmost importance to Lilly. Lilly is supportive of the decision by the independent (safety monitoring board) to cautiously ensure the safety of the patients participating in this study.”
But that wasn’t the only challenge facing Eli Lilly. Reuters reported late Monday that FDA inspectors found serious quality control problems at the Lilly plant where the antibody drugs are manufactured.
Inspectors in November found data on the company’s manufacturing processes at the New Jersey plant had been deleted and not correctly audited, Reuters reported, citing government inspection documents.
The FDA sent Lilly an “Official Action Indicated” notice as classified the problems as a serious level of violation, Reuters said.
Meanwhile, in the Johnson & Johnson trial, the patient’s illness is being reviewed and evaluated by an independent monitoring board and the company’s doctors that investigate safety data.
“Adverse events -- illnesses, accidents, etc. -- even those that are serious, are an expected part of any clinical study, especially large studies,” according to the announcement.
Outside researchers running the trial received a document about the pause, which STAT news obtained and first reported on Monday. Johnson & Johnson confirmed the pause with STAT but didn’t share any additional details about the patient’s illness.
“We must respect this participant’s privacy,” the company said. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
The pause allows the company to determine whether the illness is related to the COVID-19 vaccine and whether to resume the study. In its announcement, Johnson & Johnson explained the difference between a study pause and a regulatory hold of a clinical trial. A study pause temporarily halts the dosing and recruitment of new patients so safety data can be reviewed, and a regulatory hold is an enforced stop to a trial by an outside regulatory health agency, such as the FDA. Study pauses are usually communicated with the researchers but not the public, whereas a regulatory hold is disclosed with the public. For this study pause, the independent review board met Monday to review the case, STAT reported. The late-stage clinical trial began on Sept. 23, and 60,000 participants are set to be enrolled in the U.S. and other countries. As compared with other COVID-19 vaccine candidates in late-stage trials, the Johnson & Johnson vaccine doesn’t need to be frozen and requires one dose instead of two. Last month, AstraZeneca paused its COVID-19 vaccine trial to investigate an illness in a patient in the U.K. The study resumed about a week later in the U.K. and other countries but is still on hold in the U.S. The study pause isn’t an immediate concern, Ashish Jha, MD, dean of the Brown University School of Public Health, told CNN. “This is completely expected, and it’s just a reminder how ridiculous it is to try and meet a political timeline of having a vaccine before Nov. 3,” he said. “We want the vaccine to be safe and we’ve got to let the process play out, and it’s going to take a while,” Jha said. “To me it’s reassuring that companies are acting responsibly and pausing when they need to.” The Johnson & Johnson announcement is further setback for the company's timeline. The FDA announced last week that it wants drug makers to have at least two months of safety data before requesting authorization from the FDA to distribute the vaccine. Previously, Pfizer CEO Albert Bourla has said that sufficient data could be ready by late October. The two-month requirement could make that no longer possible. Top leaders at Moderna, AstraZeneca and Johnson & Johnson have said their clinical trial timelines are longer. Full FDA approval would require more data and occur sometime in early to mid-2021.
Story Credit: Carolyn Crist and Web MD