One Vaccine, One Antibody Clinical Trial Pause Because Of Health Concerns

( One coronavirus antibody treatment trial and one coronavirus vaccine trial have paused this week during health concerns.

Health regulators in the U.S. paused the late-stage trial of Eli Lilly’s leading monoclonal antibody treatment over possible safety concerns. Molly McCully, a spokeswoman for the company, said:

“Safety is of the utmost importance to Lilly. We are aware that, out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment. Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

Eli Lilly’s antibody treatment is being used in conjunction with remdesivir, developed by Gilead Sciences, which has already received emergency use authorization. The development has backing from Operation Warp Speed, which is putting lots of funding into developing COVID-19 treatments and vaccines.

The antibody treatment is designed to act as immune cells. Scientists are hoping these cells will prove effective to treat people who have become infected with coronavirus.

Earlier in the week, Johnson & Johnson announced it was pausing late-stage trials for its coronavirus vaccine after one participant reported to them an “adverse event” only the day prior.

The company had “very little information” on the specific reason for the pause. Dr. Mathai Mammen, the global head of Janssen — the research and development arm of Johnson & Johnson — said the company didn’t yet know whether the patient even received the placebo or the vaccine itself.

The company sent preliminary information for review to the data safety monitoring board.

Johnson & Johnson’s CFO, Joseph Wolk, commented on the situation, saying:

“We’re letting safety protocol follow proper procedure here. What it should also do is reassure the public that every scientific, medical and ethical standard is being applied here.”

What’s known as a “pausing rule” was met in the clinical trial’s study of 60,000 patients. Wolk wouldn’t provide further details, though, saying:

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”

Johnson & Johnson entered the phase three testing stage in September.

Pauses in late-stage trials for vaccines and treatments aren’t uncommon, medical experts have said. They stressed that the adverse reaction participants have can even be to some other unrelated illness, rather than the drug that’s being tested.

To be sure, though, extreme caution and patience is preached. That’s why the data and safety monitoring board will take the time to review the information and make a final determination about how to proceed.

Jeremy Faust, who is an emergency medicine doctor at Brigham and Women’s Health in Boston and a health policy expert, said:

“When scientists test promising treatments, sometimes unexpected side effects occur. When only a small number of patients have received a compound, it’s hard to tell what’s a real problem and what is noise. That’s why patience and prudence are always warranted before doling out experimental treatments.”